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The Vacutore Air/Water Bottle Tubing is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device.

The Vacutore CO2 Source Tubing with Luer Connector is intended to be used with a carbon dioxide (CO2) source with the purpose of supplying CO2 to the endoscope during endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device.

The Vacutore® Air/Water Bottle Tubing and CO2 Source Tubing with Luer Connector (Hereafter called CQ2 Source Tubing) are intended for 24-hour multi-patient use. Air/water bottle tubing is supplied in sterile and CO2 Source Tubing is supplied in non-sterile.

The Vacutore® Air/Water Bottle Tubing is manufactured for use in conjunction with sterile water bottle, and together with Fujifilm 500/600 and 700 series endoscopes. The air/water bottle tubing is individually packed in sealed package, sold as a sterile device. The air/water bottle tubing is designed to be attached to the air/water port of the endoscopes to provide irrigation through the air/water channel to the distal end of endoscope.

The Vacutore® CO2 Source Tubing with Luer Connector is manufactured for use in conjunction with air/water bottle tubing and CO2 insufflator. The CO2 Source tubing is individually packed in sealed package, sold as a non-sterile device. The CO2 Source Tubing is designed to be attached to the air/water bottle tubing and the outlet of the CO2 insufflator to provide irrigation and CO2 insufflation through the air/water channel to the distal end of endoscope.

This document is a 510(k) Pre-Market Notification from GA Health Company Limited to the FDA for their Vacutore® Air/Water Bottle Tubing and Vacutore® CO2 Source Tubing with Luer Connector. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove the device's meeting of specific acceptance criteria in the context of an AI/ML study.

Therefore, the requested information for acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness studies is not applicable to this type of regulatory submission. This document pertains to traditional medical devices, not AI/ML-driven software.

The document primarily focuses on demonstrating that the new devices are as safe and effective as existing (predicate) devices through:

• Comparison of Technological Characteristics: Tables 2, 3, and 4 extensively compare the design, features, principles of operation, materials, and other specifications of the Vacutore® devices to their predicate devices.
• Non-Clinical Performance Data (Bench Testing): Section 9 describes various bench tests performed to ensure the devices meet their intended functional requirements.

Here's a breakdown of the relevant information provided, aligning with the spirit of your request as much as possible for a non-AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for AI/ML performance metrics. Instead, it describes various performance tests conducted to show functional equivalence to predicate devices and ensure safety and efficacy. The reported "performance" is that the devices passed these tests.

2. Sample size used for the test set and the data provenance:

The document states that the bench testing was performed on "GA Health samples from initial production lots." It does not specify the exact number of units tested for each "test set" (i.e., for each individual test like air flow or leak test).

• Sample Size: Not explicitly stated as a number of devices per test.
• Data Provenance: The tests were performed in-house by GA Health Company Limited (the manufacturer). This is direct prospective testing of their own new device.

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

Not applicable. This is a physical device, and the "ground truth" for performance is determined by established engineering and medical device standards and functional testing, not by expert interpretation in a clinical or image-based context.

4. Adjudication method for the test set:

Not applicable for a physical device's bench testing. Performance is measured against physical specifications and validated test methods.

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 not an AI/ML product for medical image interpretation or diagnosis.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for these physical devices is based on:

• Engineering Specifications: Design tolerances, material properties, and functional requirements.
• Established Standards: e.g., ANSI/AAMI/ISO 10993-7:2008 for biocompatibility.
• Functional Performance: Direct measurement and observation of device operation (e.g., flow rates, leak prevention, integrity).
• Predicate Device Performance: The predicate devices themselves set a de-facto standard for expected performance and safety, against which the new device is compared to show substantial equivalence.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML product that requires 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 Vacutore® Air/Water Bottle Tubing (Model GAR025, GAR076) is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. It is a 24-hour multi-patient use device.

The Vacutore® Air/Water Bottle Tubing is intended for 24-hour multi-patient use. Air/water bottle tubing is supplied in sterile. The Vacutore® Air/Water Bottle Tubing is manufactured for use in conjunction with sterile water bottle, and together with Olympus 160 and Pentax 90 series endoscopes. The air/water bottle tubing is individually packed in sealed package, sold as a sterile device. The air/water bottle tubing is designed to be attached to the air/water port of the endoscopes to provide irrigation through the air/water channel to the distal end of endoscope.

The provided document is a 510(k) Premarket Notification for a medical device called "Vacutore® Air/Water Bottle Tubing." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through a comprehensive study with specific acceptance criteria related to a diagnostic output or algorithm performance.

Therefore, the typical metrics for acceptance criteria and study descriptions (like sensitivity, specificity, types of ground truth, number of experts, MRMC studies, effect sizes, and separate test/training sets with explicit ground truth establishment) are generally not applicable in the context of this device and submission type.

Instead, the acceptance criteria here relate to the performance, safety, and functional equivalence of the tubing device compared to an existing predicate.

Here's an analysis based on the information provided, addressing the questions as much as possible for this type of device:

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

The document does not explicitly state numerical "acceptance criteria" and "reported device performance" in the way one would for an AI diagnostic device (e.g., "sensitivity > 90%"). Instead, it lists tests performed and states that these tests support substantial equivalence. The "performance" is implicitly "met all tests successfully" to be considered substantially equivalent.

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 does not specify a "sample size" in terms of number of patients or images, as this is a tubing device. The testing was performed on "Smartdata samples from initial production lots." The provenance of these samples would be the manufacturer, Smartdata Suzhou Co., Ltd., in China. These would be considered prospective in the sense they are new production samples being tested.

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

This is not applicable. The device is a piece of medical tubing, not a diagnostic or AI-driven decision support system that requires expert interpretation for ground truth. The "ground truth" here is physical performance (e.g., does it leak? does it flow water correctly? is it sterile?).

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

This is not applicable. Adjudication methods are used to establish ground truth in studies involving human interpretation or clinical outcomes. For bench testing of a physical device, the results are typically objectively measured and do not require expert adjudication in this manner.

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. An MRMC study is relevant for diagnostic or AI-assisted interpretation, where human readers evaluate cases with and without AI assistance. This device is a piece of tubing used in endoscopic procedures, not an AI diagnostic tool.

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

No. This refers to the performance of an algorithm without human input, which is not relevant for this device. The testing described is "standalone" in the sense that the tubing itself was tested for its physical and functional properties.

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

The "ground truth" for this device's performance is based on objective measurement of physical properties and adherence to established standards. Examples include:

• Physical integrity (no leaks, secure connections)
• Flow rates (water flow test)
• Sterility (Sterility Assurance Level, EO residuals)
• Material compatibility (biocompatibility tests)
• Durability (shelf life accelerated aging)
• Functional performance (back-flow prevention, compatibility with endoscopes/bottles).

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI models.

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

Not applicable, as there is no training set.

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