Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
Critical Care Suite with Enteric Tube Positioning AI Algorithm
Ge Medical Systems, LLC
Authorized purpose: Analyze frontal chest and abdominal X-ray images to detect and localize a nasally or orally inserted enteric tube, its tip and side port if present, and the diaphragm and airways for radiologist review.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Analyze frontal chest and abdominal X-ray images to detect and localize a nasally or orally inserted enteric tube, its tip and side port if present, and the diaphragm and airways for radiologist review.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Analyze frontal chest and abdominal X-ray images to detect and localize a nasally or orally inserted enteric tube, its tip and side port if present, and the diaphragm and airways for radiologist review.
- Which images or clinical context are in scope? Modality: X-ray/Radiography Anatomy or clinical context: Chest/lung and abdomen/stomach; enteric tube, tube tip and side port, diaphragm, and airways including carina and left/right bronchi Input: Frontal chest and abdominal X-ray images from digital X-ray systems, including studies of patients with a nasally or orally inserted enteric tube; the evaluation included adult and pediatric images, including babygrams.
- Who uses it? Intended users: Licensed qualified healthcare professionals trained to independently place or assess enteric tubes inserted nasally or orally, and radiologists
- What does the software produce? Output: On-screen overlays for the enteric tube, tube tip, side port if present, diaphragm, and airways; a secondary DICOM annotated image and DICOM tag identifying whether an enteric tube was detected. The comparison table reports no quantification output.
- What is its most important limitation? Key limitation: Not for use in lieu of full patient evaluation or as the sole basis to make or confirm a diagnosis, and not a replacement for qualified-HCP review of the X-ray image. Side-port output is conditional on a side port being present.
Clinical takeaway
Clinical role: Analyze frontal chest and abdominal X-ray images to detect and localize a nasally or orally inserted enteric tube, its tip and side port if present, and the diaphragm and airways for radiologist review.
Evidence takeaway
Evidence from the reviewed source record: The FDA clinical ground-truth study used 954 independent images from five sites across North America and the United Kingdom, spanning neonates to patients over 65 years, both chest and abdominal images, multiple tube types, varied image quality, and at least eight vendors. Five expert annotators performed two reads with arbitration. The packet reports enteric-tube detection sensitivity 0.992 (0.982, 0.997) and specificity 0.975 (0.947, 0.991); tube-tip sensitivity 0.957 (0.935, 0.973) and specificity 0.941 (0.901, 0.968); side-port sensitivity 0.931 (0.904, 0.952) and specificity 0.859 (0.801, 0.905); tube Dice 0.911 (0.912, 0.921), airway Dice 0.741 (0.730, 0.753), diaphragm Dice 0.821 (0.808, 0.834), and mean localization errors of 1.789 mm for the tube tip and 2.575 mm for the side port.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- Analyze frontal chest and abdominal X-ray images to detect and localize a nasally or orally inserted enteric tube, its tip and side port if present, and the diaphragm and airways for radiologist review.
- Intended users
- Licensed qualified healthcare professionals trained to independently place or assess enteric tubes inserted nasally or orally, and radiologists
- Care setting and population
- Critical-care/acute-care imaging workflow, including mobile X-ray use for patients with limited mobility; indicated for adult and pediatric patients
- Workflow role
- Detection/localization and immediate visualization/notification support; no quantification is provided
- Required input
- Frontal chest and abdominal X-ray images from digital X-ray systems, including studies of patients with a nasally or orally inserted enteric tube; the evaluation included adult and pediatric images, including babygrams.
- Output and human action
- On-screen overlays for the enteric tube, tube tip, side port if present, diaphragm, and airways; a secondary DICOM annotated image and DICOM tag identifying whether an enteric tube was detected. The comparison table reports no quantification output.
- Limitations
- Not for use in lieu of full patient evaluation or as the sole basis to make or confirm a diagnosis, and not a replacement for qualified-HCP review of the X-ray image. Side-port output is conditional on a side port being present.
Regulatory identity
FDA record and catalog context
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
- FDA submission
- K253502
- Modality
- X-ray/Radiography
- Anatomy
- Chest/lung and abdomen/stomach; enteric tube, tube tip and side port, diaphragm, and airways including carina and left/right bronchi
- Clearance type
- 510(k)
- Decision date
- 2026-04-14
- FDA status
- FDA-cleared
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The software module can be deployed on PACS, on-premise, on-cloud, or digital projection radiographic systems; AMX Navigate mobile X-ray was the initial deployment platform. Results are sent as a secondary DICOM image and DICOM tag to a PACS, image-storage system, X-ray system, or other DICOM destination.
- Deployment and data flow
- Vendor documentation pending
The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- Security and privacy
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Critical Care Suite with Enteric Tube Positioning AI Algorithm; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
- Evidence summary
- The FDA clinical ground-truth study used 954 independent images from five sites across North America and the United Kingdom, spanning neonates to patients over 65 years, both chest and abdominal images, multiple tube types, varied image quality, and at least eight vendors. Five expert annotators performed two reads with arbitration. The packet reports enteric-tube detection sensitivity 0.992 (0.982, 0.997) and specificity 0.975 (0.947, 0.991); tube-tip sensitivity 0.957 (0.935, 0.973) and specificity 0.941 (0.901, 0.968); side-port sensitivity 0.931 (0.904, 0.952) and specificity 0.859 (0.801, 0.905); tube Dice 0.911 (0.912, 0.921), airway Dice 0.741 (0.730, 0.753), diaphragm Dice 0.821 (0.808, 0.834), and mean localization errors of 1.789 mm for the tube tip and 2.575 mm for the side port.
- Reported sensitivity
- enteric tube detection: 99.2% (95% CI: 98.2%, 99.7%) ; tube tip detection: 95.7% (95% CI: 93.5%, 97.3%); side port detection: 93.1% (95% CI: 90.4%, 95.2%)
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- enteric tube detection: 97.5% (95% CI: 94.7%, 99.1%) ; tube tip detection: 94.1% (95% CI: 90.1%, 96.8%); side port detection: 85.9% (95% CI: 80.1%, 90.5%)
Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Critical Care Suite with Enteric Tube Positioning AI Algorithm regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult and Pediatric
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K253502
- Samplen=954
- Sites5
- IndependenceIndependence not established
K253502
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
Costs and setup
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Vendor documentation pending
No public price or quote for the exact K253502 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
- Postmarket safety review
- The exact-identifier FDA recall query returned no native recall record for K253502. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
Buyer worksheet
Open questions to take to the vendor
- Verify deployment and data flow: The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K253502 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-20Last searched
25Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, acr ai central product, fda decision summary, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history
Source ledger
-
FDA K253502: Critical Care Suite with Enteric Tube Positioning AI Algorithm
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
Critical Care Suite with Enteric Tube Positioning AI Algorithm model card (K253502)
Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K253502
Scope: postmarketSafety
Research history
-
K253502 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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