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The G-Tube is indicated for placement in adult populations that require enteral feeding, medication or gastric decompression through an established gastrointestinal stoma tract.

The Gastrostomy Feeding Tube (G-Tube) consists of two product versions (models): a Bi-Funnel G-Tube and a Tri-Funnel G-Tube. Each G-Tube version is offered in varying shaft French (FR) sizes and balloon sizes. Both versions are offered in the same functional length. The overall difference between the Bi-Funnel and Tri-Funnel G-Tube is that the Tri-Funnel G-Tube allows for simultaneous delivery of feeding solutions and medications while the Bi-Funnel G-Tube allows for delivery of either feeding solutions or medications at a time. Both Bi-Funnel and Tri-Funnel G-Tubes consist of a silicone funnel, shaft, adjustable external balloon. The funnel for the Bi-Funnel G-Tube has two ports: one port houses the balloon inflation valve which allows for balloon inflation and deflation, and the other port houses the male ENFit* connector (also known as PG Lock* connector) which allows for delivery of feeding solutions and medication. The Tri-Funnel G-Tube has three ports: one port houses the balloon inflation valve, the center port houses the male ENFit connector which allows for delivery of feeding solutions, and the last (side) port houses another male ENFit connector which allows for delivery of medications. Attached to the ENFit connectors are a tether and a cap. The cap is intended to cover the ENFit connector when the device is not in use and the tether is intended to secure the connector when the device is in use. The same ENFit connector, tether and cap components are used for both Bi-Funnel and Tri-Funnel G-Tubes. The remaining components (shaft, adjustable bolster and balloon) are commonly shared for the Bi-Funnel and Tri-Funnel G-tubes and identical in both versions.

The document describes a 510(k) submission for the Bi-Funnel Gastrostomy Feeding Tube and Tri-Funnel Gastrostomy Feeding Tube, hereafter referred to as "the device". The submission aims to demonstrate substantial equivalence to a predicate device, the Flow-Thru (Compat®) Balloon Replacement Gastrostomy Tubes (K885339).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria with pass/fail thresholds for each test. Instead, it describes the types of performance characteristics tested and generally concludes that the proposed device performed "equivalent to or better than" the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "nonclinical (bench) test results" but does not specify the sample sizes used for any of the individual tests. Similarly, it does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature). The tests appear to be laboratory-based bench tests, implying they are prospective in nature, but this is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish a "ground truth" for the test set in the context of diagnostic accuracy or clinical interpretation. The testing described is primarily engineering and performance-based (e.g., physical properties, and functional capabilities). Human factors testing is mentioned, which would involve human users, but the role of "experts" in establishing a ground truth for interpretation is not relevant or described.

4. Adjudication Method for the Test Set

As the testing is primarily bench-based and performance-oriented rather than involving subjective interpretation, an adjudication method for a "test set" in the traditional sense (e.g., 2+1, 3+1 for clinical image review) is not applicable and therefore not described in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The performance testing revolved around the physical and functional characteristics of the device itself and its connectors, rather than diagnostic interpretation by human readers. The mention of "Human Factors Validation Study" implies testing with human users to ensure safe and effective use, but this is distinct from an MRMC study comparing human interpretive performance with and without AI assistance.

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

This question is not applicable to the device described. The device is a medical tube, not an AI algorithm or software. Therefore, there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests would have been established by engineering specifications, validated test methods (like ASTM F2528), and industry standards. For example, a balloon's burst volume would be compared against a predefined specification derived from the predicate device's performance or relevant safety standards.

• For ASTM F2528 and other physical tests: The ground truth would be the defined physical properties (e.g., flow rate, burst volume, tensile strength) as measured by calibrated equipment and compared against established engineering specifications or the predicate device's performance.
• For Biocompatibility: The ground truth is established through validated biological testing methods and compliance with ISO 10993 series standards.
• For Sterilization and Packaging: The ground truth is validated through established sterilization cycles and packaging integrity tests, ensuring sterility assurance levels (SALs) and barrier integrity.
• For Misconnection Assessment: The ground truth in this context would be the successful prevention of misconnections when using the ENFit connectors as designed, as demonstrated through testing scenarios.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical tube, not an AI system that requires a training set.

9. How the Ground Truth for the Training Set was Established

This question is not applicable as there is no training set for this device.

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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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