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The intended uses are interconnection of devices for transmission of light, hold suction tubes and instruments.

The devices are made of injected molded parts. Does not require assembly (simple product). Has vents to allow heat to escape. No contact with body surfaces. Has interlocking cone for device attachment. The device is for single use only.

The provided text describes a medical device called "Glo-Spec I, II and III," which are connectors for medical devices, primarily used for transmitting light and holding suction tubes and instruments. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo clinical study with specific acceptance criteria and detailed performance metrics.

Therefore, many of the requested elements for a rigorous device performance study are not explicitly stated or applicable in this 510(k) summary. The document does not describe a performance study with numerical acceptance criteria and results in the way a clinical trial might. Instead, it relies on a comparison to a predicate device.

Here's an analysis based on the provided text, addressing the points where information is available or inferable, and explicitly stating when information is not provided.

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

The document does not provide a table of numerical acceptance criteria. Instead, the acceptance criteria are implicitly based on demonstrating substantial equivalence to a predicate device, the Welch Allyn Kleenspec, and other devices. The "performance" is summarized as being "constructurally equivalent" and complying with "all acceptance criteria listed above" (referring to the characteristics listed under "Physical/Technical Comparison").

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

This information is not provided. The submission relies on a comparison to "millions of applications" of predicate devices, implying a general understanding of the predicate's performance rather than a specific test set for the Glo-Spec.

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 provided. As no specific test set or clinical study is detailed, the concept of expert-established ground truth for a test set is not applicable here.

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

This information is not provided. There is no described test set or adjudication process.

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

An MRMC study was not done. This device is a passive connector, not an AI-assisted diagnostic tool or an imaging device for which MRMC studies would be relevant.

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

A standalone performance study was not done or described. This device is a physical connector, not an algorithm.

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

The concept of "ground truth" as typically used in diagnostic device studies is not applicable here. The performance is assessed based on functional equivalence to predicate devices, which are assumed to be safe and effective based on their established market history ("millions of applications").

8. The sample size for the training set

This information is not provided. There is no training set mentioned as this is a physical device, not a machine learning model.

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

This information is not provided. As there is no training set, this is not applicable.

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