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The Vesco Medical Nasoenteric Feeding Tubes), with and without flow-through stylet, are for the administration of nutrition, fluids, and medications to the stomach or small bowel by the nasoenteric route in pediatric, adult or elderly patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition. The Vesco Medical Nasoenteric Feeding Tubes have not been tested for use longer than short-term use (

The Vesco Medical Nasoenteric Feeding Tubes (NE Tubes) are non-sterile, single use devices consisting of flexible, radiopaque, polyurethane tubing adhered to a plastic male ENFit single-port connector with a tethered, twist-on cap. The plastic ENFit port allows for connection to enteral feeding sets and enteral-specific syringes while reducing the likelihood of misconnections to non-enteral devices. The cap allows for port coverage when enteral devices are not in use. The distal tip of the tubing is open and has four (4) evenly spaced, alternating eyelet openings to allow for first three inches of the distal tip are coated with a hydrophilic lubricant to aid in friction reduction during tube insertion. The tubing is printed with graduated markings in centimeters, the length from the distal tip in order to provide users with approximate insertion depth information. Certain models of the Vesco Medical Nasoenteric Feeding tube are provided with a stylet wire attached to a flow-through, ENFit hub. The stylet wire is intended to stiffen the tube during insertion and be removed after insertion is complete. The proposed device will be offered in sizes ranging between 8 French and 14 French.

This document is a 510(k) Premarket Notification from the FDA regarding the Vesco Medical Nasoenteric Feeding Tubes. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe a study involving an AI/ML device or its performance criteria in the way requested.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/ML device from this document. The document pertains to a traditional medical device (nasoenteric feeding tubes) and its regulatory clearance based on substantial equivalence and non-clinical performance testing.

However, I can extract information about the non-clinical performance testing that was done for this specific device, which serves as its "acceptance criteria" and "study" for regulatory clearance.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

This document describes non-clinical laboratory testing of physical samples of the device. It does not refer to a "test set" in the context of an AI/ML algorithm or patient data. The provenance of the testing data is not explicitly stated in terms of country of origin, but it is implied to be laboratory testing conducted for regulatory submission in the U.S. There is no concept of "retrospective or prospective" testing for these types of physical bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable to the non-clinical physical device testing described. Ground truth for the performance of a physical device against a standard is established by the specifications of the standard itself and measurable physical properties, not expert consensus.

4. Adjudication method for the test set

Not applicable to non-clinical physical device testing. The "adjudication method" for these tests is whether the device passed or failed the specified criteria of the international standards and Vesco Medical's design requirements.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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

The "ground truth" for the non-clinical tests described is defined by:

• International Standards: ISO 80369-3, EN1615:2000, EN1618:1997, EN 13868:2002, ISO 10993-1, ISO 10993-5, ISO 14971:2012.
• Vesco Medical Design Requirements: For visual inspections, patency, and stylet removal force.
• Predicate Device Performance: Used as a benchmark for patency/flow rate and resistance to kinking, demonstrating "as well as or better than" performance.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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The Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube is intended to provide short-term enteral access for delivery of nutrition and/or medications to the small bowel in patients older than 12 years old.

The Tiger 2" Self-Advancing Nasal Jejunal Feeding Tube consists of a 14 Fr polyether-urethane tube manufactured with a length of 153 cm. It has 5 sideports on the distal end for the purpose of delivering nutrition and/or medication. The shaft of the Tiger 2" Self-Advancing Nasal Jejunal Feeding Tube includes 26-28 flaps cut into the tubing over the distal 40 cm segment of the device. These flaps provide a means for the catheter to be advanced by the natural peristaltic action of the gastrointestinal tract. The most distal flap is placed at approximately 2 cm from the distal tip of the catheter. Markings are placed along the shaft of the Tiger 2" Self-Advancing Nasal Jejunal Feeding Tube in 5 cm increments (labeled at 10 cm increments). The proximal end of the shaft is attached to a red feeding adapter marked with the text "ENTERAL FEED/MED." The Tiger 2 " Self-Advancing Nasal Jejunal Feeding Tube will be supplied sterile and is intended for one-time use.

The provided text describes a 510(k) summary for the "Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube". This document focuses on demonstrating substantial equivalence to a predicate device through various tests.

Based on the information provided, here's a breakdown of the acceptance criteria and the study details:

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

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

The document does not provide specific sample sizes for any of these tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these engineering and biocompatibility tests. These types of tests are typically conducted in a laboratory setting, not with patient data.

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)

This document describes performance testing of a physical medical device (feeding tube), not a diagnostic algorithm that requires expert ground truth. Therefore, this question is not applicable. The "ground truth" for these tests are the physical and chemical properties measured against predefined standards.

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

This question is not applicable as the document describes performance testing of a physical medical device, not a diagnostic algorithm.

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

This question is not applicable as the document describes performance testing of a physical medical device, not an AI algorithm.

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

This question is not applicable as the document describes performance testing of a physical medical device, not an AI algorithm.

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

For Tensile Strength, Liquid Leakage, and Misconnection tests, the "ground truth" is defined by the predetermined acceptance criteria and relevant industry standards (e.g., ISO 80369-1:2010 for misconnection). These are objective, measurable physical parameters.

For Biocompatibility Testing, the "ground truth" is established by adherence to ISO 10993-1 and FDA guidance, which includes standardized toxicology and biological evaluation methods. The results are compared against these established safety thresholds.

8. The sample size for the training set

This question is not applicable as the document describes performance testing of a physical medical device, not a machine learning model.

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

This question is not applicable as the document describes performance testing of a physical medical device, not a machine learning model.

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The Nutrisafe 2 – ENFit adaptor is indicated for enteral use only. It enables the connection between an administration set equipped with a female ENFit connector at its distal end and a Nutrisafe 2 feeding tube equipped with a male Nutrisafe 2 connector at its proximal end.

The Nutrisafe 2 – ENFit adaptor is indicated for enteral use only. It enables the connection between an administration set equipped with a female ENFit connector at its distal end and a Nutrisafe 2 feeding tube equipped with a male Nutrisafe 2 connector at its proximal end. Vygon has not previously submitted any 510(k)s for the subject device.

The provided text is a 510(k) summary for the "Nutrisafe 2 - ENFit Adaptor" device. It describes the device's indications for use, technological characteristics, and non-clinical testing. However, it does not contain information about acceptance criteria or a study proving the device meets such criteria in the context of an AI/ML device.

The document refers to a "non-clinical verification" through "bench testing" that confirmed physical attributes and device performance meet "the requirements of standards performance." It lists several tests that were performed (dimensional analysis, fluid leakage, stress cracking, resistance to separation, resistance to overriding, disconnection by unscrewing, flow testing, and misconnection risk analysis). However, it does not specify the numerical acceptance criteria for each of these tests, nor does it provide the detailed results of these tests.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving an AI device's performance. The document describes a traditional medical device (an adaptor) and its regulatory submission, not an AI/ML powered device.

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