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The CORTRAK™ System is an electrical device designed to aid qualified operators in the placement of VIASYS MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. Prior to commencing the delivery of food, confirmation of correct tube placement by acceptable hospital protocol is required.

The CORTRAK™ System is an electrical device.

The provided document is a 510(k) clearance letter from the FDA for the CORTRAK™ System. It states that the device is substantially equivalent to a legally marketed predicate device. While it includes the intended use and regulatory information, it does not contain any details about acceptance criteria, specific device performance, or a study that proves the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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The CORTRAK™ System is an electrical device designed to aid qualified operators in the placement of VIASYS MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding, Prior to commencing the delivery of food, confirmation of correct tube placement by X-ray or acceptable hospital protocol is required.

The CORTRAK™ System is an electrical device designed to aid qualified operators in the placement of VIASYS MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding.

I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study proving such criteria are met. The document is an FDA 510(k) clearance letter for the CORTRAK™ Enteral Access Device, indicating that the device has been found substantially equivalent to a predicate device.

The letter discusses:

• The device name and regulation details.
• The FDA's determination of substantial equivalence.
• General controls and regulations applicable to the device.
• Contact information for further inquiries.
• The "Indications for Use" for the CORTRAK™ System.

It does not include details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, or study types (retrospective/prospective).
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Training set sample size.
9. How ground truth for the training set was established.

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