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Integrated Endoscopy's Nuvis® Battery Arthroscope is an endoscopic device introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy . Integrated Endoscopy's Nuvis® Battery Arthroscopes are indicated for use in arthroscopic procedures performed in the knee, shoulder, hip, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release).

Integrated Endoscopy's Battery Arthroscope is an optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, and hip joint. Integrated Endoscopy's Battery Arthroscope has a 141mm working length, an outside diameter of 4mm, a field of view of 105 °, and a direction of 30 °. The Arthroscope is Battery Powered and three selectable light settings. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 141mm. The Arthroscope is supplied sterile and is for SINGLE USE ONLY. DO NOT REUSE OR RE-STERILIZE.

The provided document describes the FDA 510(k) premarket notification for the "Nuvis Battery Arthroscope" by Integrated Endoscopy, Inc. This submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets novel acceptance criteria through a full-scale clinical study with extensive data analysis as typically seen for AI/ML-based medical devices.

The information primarily concerns the performance data summary for a medical device, specifically an arthroscope, and its comparison to a predicate device for FDA 510(k) clearance. It is not a study that proves an AI/ML device meets specific acceptance criteria in the sense of a multi-reader, multi-case study with AI assistance. Therefore, many of the requested points related to AI/ML device validation (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this document.

The document discusses "acceptance criteria" in terms of meeting design and performance requirements through bench testing, rather than clinical performance metrics in AI/ML validation.

Here's the information extracted from the provided text as it pertains to the device's validation:

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

The document does not present a formal table of acceptance criteria with specific quantitative thresholds met, but rather summarizes that the device "met all specified design and performance requirements" and "passed electromagnetic compatibility (EMC), electrical safety and biocompatibility testing requirements." Performance was demonstrated through direct comparison to the predicate device and established standards.

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

The document describes bench testing, simulations, and engineering analyses, not human study data from real-world patients. Therefore, specific "sample sizes" in the context of a clinical test set or "data provenance" (country of origin, retrospective/prospective) are not applicable. The device was tested post-sterilization to ensure functionality.

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

Not Applicable. Ground truth, in the AI/ML sense, was not established by human experts for a test set. This was a physical device performance evaluation using laboratory tests and established engineering standards.

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

Not Applicable. No human adjudication of images or clinical data was involved in this type of device performance evaluation.

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 was not an AI/ML device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not Applicable. This is not an algorithm-based device. "Standalone performance" here refers to the physical device's characteristics against engineering standards.

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

The "ground truth" for this device's performance was established by adherence to voluntary safety and international agency standards (e.g., ISO, IEC, AAMI/ANSI standards) and bench testing results against specified physical and electrical design requirements. This is a technical and engineering-based evaluation, not a medical "ground truth" derived from patient data or expert consensus on clinical findings.

8. The sample size for the training set

Not Applicable. This device is not an AI/ML product, so there is no training set in the machine learning context.

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

Not Applicable. As there is no AI/ML training set, this question does not apply.

Summary of the study that proves the device meets the acceptance criteria:

The study that proves the Nuvis Battery Arthroscope meets its acceptance criteria is a series of bench tests and engineering analyses. These tests were conducted on post-sterile devices to assess functionality and suitability for intended use. The performance evaluation primarily involved:

• Comparison to a predicate device: The Nuvis Battery Arthroscope's images and characteristics were compared to those of the legally marketed predicate device, the Integrated Endoscopy NuVis® Arthroscope (K140903).
• Adherence to recognized international and voluntary standards: The device was tested to ensure compliance with a comprehensive list of ISO, IEC, and AAMI/ANSI standards related to biological evaluation, electrical safety, electromagnetic compatibility, optical performance, and sterilization.
• Specific performance tests: The regimen included: visual inspection, leak and condensation, visual image check, pointer/direction, distal tip smoothness, scope diameter/cannula interface, angle of view (AOV) measurement, field of view (FOV) measurement, resolution, LED light intensity verification, PX3 Liquid Penetration and Ingress, biocompatibility, packaging, and shelf life stability.

The conclusion drawn from these studies was that the Nuvis Battery Arthroscope "met all specified design and performance requirements" and "can perform as intended," demonstrating substantial equivalence to the predicate device. No animal or clinical studies were performed or required for this 510(k) submission.

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