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The Y-Glide™ Hemostatic Wye Adapter is to be used for maintaining a hemostatic seal around inserted devices with an outside diameter up to 0.120" (3.04 mm) during the use of diagnostic/interventional devices for transluminal procedures.

The Thomas Medical Products Inc. Y-Glide™ Hemostatic Valve Wye Adapter contains a hemostasis valve with a secondary locking seal, a rotating luer lock, and a sideport. The primary hemostasis seal is opened by depressing the cap thereby enabling valve flushing, and a conduit for introduction and withdrawal of diagnostic/interventional devices. When the cap is not depressed, the seal returns to the closed position to allow device positioning with minimal fluid loss. The secondary locking seal can be adjusted when the internal threads are engaged, by rotating the cap clockwise while slightly depressing it until the threads catch. Clockwise turns of the cap thereafter will close the locking seal. Rotating counterclockwise will open the locking seal. Closing the locking seal will secure the position of the inserted diagnostic/interventional device and/or permit pressure injections up to 450 psi (30.6 Atm.).

The provided text does not describe a study that uses acceptance criteria and reports device performance in the way typically expected for an AI/ML device.

This document is a 510(k) summary for a physical medical device, specifically a hemostatic valve wye adapter. The regulatory pathway for this type of device (Class II, 510(k)) focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against predefined quantitative acceptance criteria through a clinical or algorithmic study as would be the case for an AI/ML diagnostic tool.

Therefore, many of the requested fields are not applicable or cannot be extracted from this document because the described evaluation process is different.

Here's an attempt to answer the questions based on the provided text, indicating where information is not available or not relevant:

1. Table of acceptance criteria and the reported device performance

This document does not describe quantitative acceptance criteria and reported performance in the typical sense of a study for an AI/ML diagnostic. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The "performance" assessment is based on a comparison of characteristics.

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

• Not applicable. This document describes a 510(k) submission for a physical medical device, not an AI/ML diagnostic. There is no "test set" in the sense of a dataset for an algorithm. The evaluation is based on a comparison to a predicate device and engineering analyses rather than a clinical study with a patient sample.

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)

• Not applicable. No ground truth determination by experts is described for a test set in this 510(k) summary. The assessment is primarily engineering-focused and regulatory-focused, comparing the new device to a predicate.

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

• Not applicable. There is no "test set" or adjudication method described in this document.

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 document is for a physical medical device (hemostatic valve), not an AI/ML product. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

• Not applicable. This device is a passive physical component; there is no algorithm or standalone performance in the context of AI/ML.

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

• Not applicable. For this type of device, "ground truth" as understood in AI/ML is not relevant. The "truth" for substantial equivalence lies in demonstrating that the device's characteristics, safety, and effectiveness are comparable to a legally marketed predicate device. This is typically supported by bench testing, material comparisons, and adherence to relevant standards, rather than clinical outcomes or diagnostic accuracy against a "ground truth" diagnosis.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set" or ground truth establishment for it.

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