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The Kangaroo™ Gastrostomy Feeding Tube with ENFit Y-Port is indicated for use in an established gastrostomy tract as a replacement tube for the administration of nutrition, fluids, and medications to the stomach of a patient, 2 years and older, that are physically unable to manage nutritional intake through normal mastication and deglutition.

The Kangaroo™ Gastrostomy Feeding Tube is a silicone qastrostomy tube with a balloon retention device located at the tip of the tube. An external skin disc is provided on the outer lumen of the device and is used in conjunction with the balloon to provide a secure retention system for the Kanqaroo™ Gastrostomy Feeding Tube. The ENFit Y-Port Enteral Adapter is secured within the funnel end of the Gastrostomy Tube Lumen. The Kangaroo™ Gastrostomy Feeding Tube with ENFit Y-Port is packaged with a packet of water-soluble jelly used to ease the insertion of the device.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria, formatted as requested:

This document is a 510(k) summary for a medical device (Kangaroo™ Gastrostomy Feeding Tube with ENFit Y-Port) which focuses on demonstrating substantial equivalence to a predicate device, rather than defining novel acceptance criteria for a new AI/software device. Therefore, many of the requested categories related to AI performance, expert review, and clinical studies are not applicable or cannot be extracted from this document.

The "acceptance criteria" for this device are essentially compliance with recognized standards and demonstration of comparable performance to the predicate device through non-clinical (laboratory) testing.

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

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

• Sample Size: Not explicitly stated as a number of devices or units tested for each specific test. The document refers to "the proposed device" and specific French sizes (12Fr, 16Fr, 18Fr, 24Fr, 28Fr) being tested, implying multiple samples of varying sizes were subjected to the tests.
• Data Provenance: The tests were "Laboratory testing" conducted to support substantial equivalence. No information on country of origin or whether it was retrospective/prospective is provided, as it's non-clinical bench testing.

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 information is not applicable and not provided. The study is non-clinical bench testing of a physical medical device, not an AI or diagnostic imaging device requiring expert ground truth establishment.

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

• This information is not applicable and not provided, as this is non-clinical bench testing of a physical medical device.

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

• No. This is not an AI-assisted device, and no MRMC study was conducted.

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

• Not applicable. This is a physical medical device.

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

• Not applicable in the typical sense of AI/diagnostic devices. The "ground truth" for this device's performance is defined by the technical specifications outlined in recognized standards (EN 1615:2000, ASTM F 2528-06, ISO 80369-3) and the performance of the legally marketed predicate device (AQUARIUS™ Gastrostomy Replacement Tube, K143378).

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/machine learning device requiring a training set.

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

• Not applicable. This is a physical medical device.

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The Balloon Gastrostomy Tube Kit is indicated for use in percutaneous placement of a gastrostomy tube for feeding and/or medication in conjunction with an established gastrostomy tract, or using a Stamm Procedure. The gastrostomy tube may also be used for gastric decompression

The Balloon Gastrostomy Tube Kit includes a gastrostomy tube, pre-filled syringe, guidewire, gauze, drainage sponge, swabsticks, lubricating jelly, and antibiotic ointment. The gastrostomy tube is made of silicone and is available in lengths from 7-18" and diameters from 10-28 Fr.

The provided document does not contain information about acceptance criteria or a study demonstrating that the device meets specific performance criteria. Instead, it is a 510(k) summary for a medical device, the Microvasive Balloon Gastrostomy Tube Kit, and primarily focuses on establishing "substantial equivalence" to predicate devices.

The document discusses:

• Indications for Use, Contraindications, and Potential Complications: These describe the intended use and potential risks of the device, but not measurable performance criteria.
• Descriptive and Technological Characteristics: A comparison is made between the proposed device and two predicate devices (MRI All Silicone Gastrostomy Tube and Corpak Medsystems CorfloTM-Dual GT Gastrostomy Tubes) in Figure 9-1. This comparison highlights similarities and differences in materials, dimensions, and kit components.
• Performance Characteristics (stated absence of change): The document explicitly states: "The components of the Balloon Gastrostomy Tube Kit have the same characteristics as those devices that are currently marketed. There is no change in the performance characteristics or intended use." This indicates that no new performance study was undertaken to establish specific acceptance criteria for this device, as its performance is asserted to be equivalent to existing, already marketed devices.
• Packaging, Sterilization, and Pyrogenicity: These are standard manufacturing and quality control aspects, with pyrogenicity testing performed periodically, but not as part of a performance study with defined acceptance criteria for the device's functional use.

Therefore, I cannot provide the requested table or details about a study proving the device meets acceptance criteria because such information is not present in the provided text. The submission relies on establishing substantial equivalence rather than presenting new performance data against specific acceptance metrics.

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