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The EndoVive™ 3S Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression.

The EndoVive™ 3S Extension Set is intended to connect to a low profile balloon for enteral feeding, medication administration and gastric decompression.

The EndoVive™ 3S Low Profile Balloon is indicated for use in adult and pediatric patients who require long term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

The EndoVive™ 3S Extension Set is indicated for the delivery of nutrition, hydration and/or medication into the stomach through a low profile balloon and also provides a mechanism for gastric decompression.

The EndoVive™ 3S Low Profile Balloon Kit contains an EndoVive™ 3S Low Profile Balloon which is a sterile, low profile balloon gastrostomy tube. The kit also contains the following accessories which are intended to facilitate placement and use of the EndoVive™ 3S Low Profile Balloon: Continuous and Bolus feeding extension sets, a stiffener, transition adapters, syringes, lubricating jelly, gauze pads and a patient care bag.

The EndoVive™ 3S Extension Sets will be sold separately in a non-sterile 5-pack configuration.

The low profile gastrostomy tube is normally placed in a clinical setting and can be replaced and used in both a clinical and home care setting. The extension sets and syringes included with the kit may also be used in both a clinical and home care setting.

Before using the EndoVive™ 3S Low Profile Balloon, the stoma tract must be measured and the tube size appropriate for the patient must be identified by the healthcare provider. The distal end of the tube is inserted through a gastrointestinal stoma tract and into the stomach. Then the balloon is inflated with sterile or distilled water. The fitment of the tube is verified by ensuring that the external bolster is flush against the abdomen.

Extension sets are connected to the feeding port of the low profile gastrostomy tube to begin enteral administration and gastric decompression. The male ENFit connectors attached to the proposed devices are then connected to enteral sets and syringes incorporating female ENFit connectors. If enteral accessories incorporating female ENFit connectors are not available, the feeding port and medication port transition adapters may be connected to commonly available enteral administration sets and syringes. The male ENFit connectors attached to the EndoVive "" 3S Extension Sets were designed to reduce the likelihood of unwanted connections between enteral connectors. Until the ENFit connectors become widely available, the ENFit transition adapters will be provided with the EndoVive™ 3S Low Profile Balloon Kit to mitigate the risk of inaccessibility to care within the use environment.

The general types of materials used for the proposed devices consist of silicones, thermoplastics and non-DEHP PVC materials.

This document describes the FDA's 510(k) premarket notification for the ExoVive™ 3S Low Profile Balloon Kit and Extension Sets. As such, it is not a study proving the device meets acceptance criteria, but rather a submission for substantial equivalence to existing predicate devices. Therefore, a table of acceptance criteria and device performance as well as other numerical data points typically found in a clinical study report (such as sample sizes, number of experts, adjudication methods, details of MRMC studies, specific ground truth methods, and training set information) are not present in this regulatory document.

However, the document does outline the types of performance data that were generated to support the substantial equivalence claim.

Here's an analysis of the provided information based on the request:

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

The document does not provide a direct table of acceptance criteria with specific numerical targets and corresponding reported device performance. It states that "Key performance specifications and device characteristics were derived from device-specific functionality and performance standards such as ASTM F2528-06 - Standard Test Methods for Enteral Feeding Devices with a Retention Balloon, AAMI/ANSI/ISO 80369-1 and EN 1615 - Enteral feeding catheters and enteral giving sets for single use and their connectors: Design and testing."

It generally concludes: "In conclusion, the proposed device performed equivalent to or better than the primary predicate device."

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

The document describes nonclinical (bench) testing. There is no mention of human subject test sets or patient data. Therefore, data provenance such as country of origin, retrospective or prospective, is not applicable. The sample sizes for the bench tests are not explicitly stated.

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 is not applicable as the document describes nonclinical bench testing, not a study involving human expert interpretation or ground truth establishment in a clinical context.

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

This is not applicable as the document describes nonclinical bench testing, not a study involving human interpretation or adjudication.

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 is not applicable. The device is a medical device (gastrostomy tube and extension sets), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

This is not applicable as the device is a medical device, not an algorithm. Bench tests were performed on the device itself.

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

For the nonclinical bench testing, the "ground truth" would be the established performance standards (e.g., ASTM F2528-06, AAMI/ANSI/ISO 80369-1, EN 1615) and expected physical properties of the materials and device components. Compliance with these standards and functional specifications served as the basis for evaluation.

8. The sample size for the training set

This is not applicable for a nonclinical bench test of a physical medical device. There is no "training set" in the context of machine learning or AI development.

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

This is not applicable as there is no training set mentioned in the context of this device submission.

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