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Precision Optics Corporation's ENT Endoscopes - Sinuscopes are indicated for use to mination and visualization of these regions.

ENT Endoscope - Sinuscope

This 510(k) summary does not contain the detailed information necessary to complete all parts of the requested table and study description. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary does not outline specific performance criteria or report results from a study designed to meet them. It primarily states that the device is substantially equivalent to predicate devices because its basic features, design, and primary functions are the same, and any minor differences raise no new issues of safety and effectiveness.

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

This information is not provided. As no specific performance study is detailed, there's no mention of a test set or its sample size or data provenance.

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

This information is not provided. There is no mention of an expert panel or ground truth establishment for a test set.

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

This information is not provided. No adjudication method is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. The device is an ENT Endoscope (Sinuscope), which is a hardware device for direct visualization, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

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

This information is not provided. As an endoscope, there is no "algorithm only" performance separate from human-in-the-loop use.

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

This information is not provided. There is no mention of a ground truth being established for any performance evaluation in this 510(k) summary.

8. The sample size for the training set

This information is not applicable/not provided. As this is a hardware device (endoscope), there wouldn't typically be a "training set" in the context of machine learning or algorithms. The manufacturing and design process relies on established engineering principles and materials science.

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

This information is not applicable/not provided for the same reasons as point 8.

Summary of the Study (as described in the 510(k) statement):

The "study" or justification for clearance in this 510(k) document is a substantial equivalence comparison to predicate devices, not a performance study with specific acceptance criteria.

• Rationale for Substantial Equivalence: Precision Optics Corporation's ENT Endoscope - Sinuscope is considered substantially equivalent to previously cleared endoscopes (Laparoscope and Arthroscope by Precision Optics Corporation) because:
  • Basic features, design, and primary functions are the same.
  • Any minor differences in design and dimensions (e.g., tube diameter and insertion length) are not deemed to raise new issues of safety and effectiveness.
  • External materials, construction, and fundamental operational principles are identical to the cleared predicate devices (K914084 and K945684), with only variations in physical dimensions.

This type of submission relies on the established safety and effectiveness of the predicate devices. The "proof" is the detailed comparison of design, materials, and intended use to those already cleared devices, demonstrating that the new device does not introduce new risks or questions of effectiveness.

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