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The Avanos* CORTRAK* 2 Enteral Access System (EAS) utilizes tube tracking technology to assist, in conjunction with institution protocols, qualified clinicians in guiding the placement of Avanos Medical CORTRAK* 2 feeding tubes of 8FR or greater into the stomach or small bowel of patients requiring enteral feeding.

The Avanos* CORTRAK* 2 Enteral Access System (EAS) utilizes tube tracking technology to assist, in conjunction with institution protocols, qualified clinicians in guiding the placement of Avanos Medical CORTRAK* 2 feeding tubes of 8FR or greater into the stomach or small bowel of patients requiring enteral feeding.

The provided text is a letter from the FDA regarding the 510(k) premarket notification for the CORTRAK* 2 Enteral Access System. This letter determines substantial equivalence but does not contain the detailed acceptance criteria and study information requested. It primarily focuses on regulatory compliance, general controls, and classification of the device.

Therefore, I cannot extract the specific information about:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth for the test set and their qualifications
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This type of information would typically be found in the 510(k) summary document or the full submission, which is not provided here.

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The Avanos* CORTRAK2 Enteral Access System (EAS) utilizes tube tracking technology to assist, in conjunction with institution protocols, qualified clinicians in guiding placement of Avanos Medical CORTRAK2 feeding tubes of 8FR or greater into the stomach or small bowel of patients requiring enteral feeding.

Avanos* CORTRAK* 2 Enteral Access System (EAS) device is designed to track the path of an 8 Fr or greater Avanos Medical feeding tube tip during the patient placement procedure. A coil winding at the distal end of the transmitting stylet acts as a transmitter, and its signal is detected by the externally positioned receiver unit. The received signals are input to the attached Monitor unit. The resulting raw data is processed, recorded, and presented to the operator in a meaningful and intuitive screen tracing. The Avanos* CORTRAK*2 EAS device is an electrical device that does not contact the patient, is not sterilized, and is reusable. Like the predicate device, it is intended to be used in a clinical environment by qualified trained clinicians.

This document, K220588, is a 510(k) summary for the Avanos* CORTRAK* 2 Enteral Access System (EAS). It asserts substantial equivalence to a predicate device (CORTRAK* 2 Equilateral EAS, K191340) and focuses on labeling updates, particularly a clarification in the indications for use.

Based on the provided text, the device itself has not undergone a study to prove it meets acceptance criteria for altered performance characteristics, because there were no changes to its design, materials, or performance. The 510(k) submission states: "There were no other changes in the design, materials, performance, and technological characteristics from the predicate device." and "The labeling changes have no effect on the technologic characteristics. The labeling difference has no impact on the intended use, technological principles, safety, or effectiveness of the subject device when compared to the predicate device."

Therefore, much of the requested information about acceptance criteria and study details for device performance cannot be extracted from this document, as a performance study demonstrating new acceptance criteria for the device itself was not conducted. Instead, the submission focuses on verifying that labeling changes do not negatively impact safety or effectiveness.

Here’s an breakdown of the requested information based on what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As no performance changes were made to the device in this 510(k) submission, and the submission is focused on labeling updates, there isn't a table of new acceptance criteria for device performance or new reported device performance data presented. The device's performance is assumed to be consistent with the predicate device (K191340).

The key "criteria" addressed are that the labeling changes should not raise new or different questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No new clinical or performance test set data was generated or analyzed for the device itself as part of this 510(k) given that the changes were limited to labeling. The evaluation focused on risk analysis related to labeling.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No new test set requiring expert-established ground truth was part of this submission. The evaluation was primarily regulatory and risk management based on labeling changes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new test set requiring adjudication was part of this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an "Enteral Access System" that uses "tube tracking technology" to guide feeding tube placement. It is not an AI-assisted diagnostic imaging device for which MRMC studies are typically conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is an Enteral Access System that assists clinicians, implying human-in-the-loop operation. No standalone algorithm performance was evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No new ground truth was established for the device's performance given the nature of the submission (labeling changes only). The "ground truth" for the predicate device would have been established during its original clearance process, likely through clinical studies verifying accurate tube placement. For this submission, the "truth" being assessed was whether the labeling changes impacted the established safety and effectiveness.

8. The sample size for the training set

Not applicable. This document describes a 510(k) for an Enteral Access System with labeling changes, not an AI/ML device that requires training sets.

9. How the ground truth for the training set was established

Not applicable. This document describes a 510(k) for an Enteral Access System with labeling changes, not an AI/ML device that requires training sets.

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CORTRAK* 2 Equilateral Enteral Access System is an electrical device designed to aid qualified operators in the placement of Avanos NG feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. CORTRAK* 2 Equilateral Enteral Access System can be used to confirm placement of feeding tubes prior to commencing the delivery of enteral nutrition.

CORTRAK* 2 Equilateral Enteral Access System (EAS) device is designed to track the path of an 8 Fr or greater Avanos feeding tube tip during the patient placement procedure. A coil winding at the distal end of the transmitting stylet acts as a transmitter, and its signal is detected by the externally-positioned receiver unit. The received signals are input to the attached All-In-One Monitor unit. The resulting raw data is processed, recorded, and presented to the operator in a meaningful and intuitive screen tracing. The CORTRAK*2 Equilateral EAS device is an electrical device that does not contact the patient, is not sterilized, and is reusable. Like the predicate device, it is intended to be use in clinical environment.

The provided document describes a device modification for the CORTRAK® 2 Equilateral Enteral Access System. However, it does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of diagnostic performance or clinical effectiveness.

The document focuses on demonstrating substantial equivalence to a predicate device (K113351) by showing that the changes made (updated PC Single Board Computer, Display Processor Module, Operating System, GUI, removal of USB boot, removal of battery conditioning requirement) do not alter the intended use, safety, or effectiveness.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment as it is not present in the provided text.

Here is what I can extract based on the information provided, explaining why certain sections cannot be filled:

1. A table of acceptance criteria and the reported device performance

   • Not Available. The document outlines "nonclinical testing" which focuses on compliance with standards (IEC 60601-1, IEC 60601-1-2, IEC 62366-1, IEC 62304) to demonstrate that the modified device continues to meet performance specifications and that the changes do not raise new safety or effectiveness issues. It does not present specific diagnostic performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics against such criteria. The "Results" column in the table only states "Pass" for compliance with these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not Available. The nonclinical testing mentioned does not involve a "test set" in the context of clinical performance or diagnostic accuracy. It refers to engineering and software verification tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not Available. Ground truth establishment by experts is not relevant to the type of nonclinical testing described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not Available. Adjudication methods are not relevant to the nonclinical testing described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not Applicable. The device described (CORTRAK® 2 Equilateral Enteral Access System) is an electrical device designed to aid operators in placing feeding tubes and confirming placement. It is not an AI-assisted diagnostic tool that would typically involve human readers or MRMC studies for improved diagnostic effectiveness. The changes are technical updates to electronics and software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not Applicable. As mentioned above, this device "aids qualified operators." It is not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not Applicable. Ground truth in the context of diagnostic/clinical performance is not discussed. The nonclinical testing refers to compliance with engineering and quality standards.

8. The sample size for the training set

   • Not Available. The document does not describe the development of an AI algorithm or a "training set."

9. How the ground truth for the training set was established

   • Not Available. As there is no described AI algorithm or training set, this information is not present.

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The CORTRAK 2 System is an electrical device designed to aid qualified operators in the placement of the CORPAK MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. CORTRAK 2 can be used to confirm placement of feeding tubes prior to commencing the delivery of enteral nutrition.

The CORTRAK 2 System is an electrical device.

This document is a 510(k) clearance letter from the FDA for the CORTRAK 2 Enteral Access Device. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is "substantially equivalent" to legally marketed predicate devices and outlines general regulatory obligations.

Therefore, I cannot provide the requested information based on the provided text.

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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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The CORTRAK™ System is an electrical device designed to aid qualified operators in the placement of feeding tubes of 8 FF or larger in the stomach or small bowel of patients requiring enteral feeding. Confirmation of correct tube placement by X-ray or acceptable hospital protocol is required.

Not Found

This document is extremely limited in the information it provides regarding the acceptance criteria and study details. It is a 510(k) clearance letter for the CORTRAKT™ device and does not include the detailed study results or acceptance criteria.

Therefore, I cannot provide the requested information from the provided document. The letter only states that the device is "substantially equivalent" to a legally marketed predicate device, meaning it has similar indications for use and technological characteristics.

To answer your questions, one would need to review the actual 510(k) submission (K041987) which would contain the performance data and the specifics of the studies conducted. This document only serves as the FDA's clearance notice.

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