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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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Integrated Endoscopy`s nuvis™ 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™ 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 nuvis™ Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, and hip joint. Integrated Endoscopy's nuvis™ Arthroscope has a 140mm working length, an outside diameter of 4mm, a field of view of 105°, and a direction of view of 30°. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 140mm. The Arthroscope is supplied sterile and is for Single Use Only. It is not intended to be re-used or re-sterilized.

The nuvis™ Arthroscope is a long tube containing a series of lenses. At the distal end, a lens captures the image of the object and transfers it via a series of lenses along the long tube to the eye piece or Camera Monitor System at the proximal end of the arthroscope. The nuvis™ Arthroscope is made of materials that are commonly used in medical devices such as stainless steel, copper, glass, sapphire and plastics. The operating site is magnified by approx. two to five times its actual size depending on the distance between the tip of the endoscope and the object being visualized.

This document describes the nuvis™ Arthroscope, a rigid endoscopic optical instrument for visualizing internal joint anatomy. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study with human readers and ground truth.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Reported Device Performance

Study Details:

The provided text does not describe a clinical study with human readers, specific patient data, or ground truth as typically understood for AI/CADe device evaluations. Instead, it describes engineering and non-clinical performance testing.

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

   • Test set sample size: Not applicable for a clinical study. The "performance testing also included comparison of images taken by the nuvis™ Arthroscope and its predicate, the Stryker Arthroscope." However, the number of images, cases, or specific test scenarios for this comparison is not provided.
   • Data provenance: Not applicable. The "comparison of images" would have been generated in a controlled, non-clinical environment rather than from patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human expert "ground truth" was established for a clinical evaluation in this submission. The "ground truth" for the performance tests was defined by engineering specifications and predicate device performance.

3. Adjudication method for the test set: Not applicable. There was no clinical test set requiring adjudication.

4. 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 MRMC study was done, as this is not an AI/CADe device. It is a manually operated arthroscope.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.

6. The type of ground truth used: For the image comparison, the implicitly defined "ground truth" was the expected image quality and performance of the predicate device (Stryker Arthroscope) and the design specifications for the nuvis™ Arthroscope. For other tests (EMC, electrical safety, biocompatibility), the ground truth was conformance to specific regulatory and industry standards.

7. The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The design and manufacturing process would involve internal testing and validation, but this is not typically referred to as a "training set" in this context.

8. How the ground truth for the training set was established: Not applicable.

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