(99 days)
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
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Technical Performance | Electromagnetic Compatibility (EMC) requirements | Met all specified design and performance requirements. Passed EMC testing. |
| Electrical Safety requirements | Met all specified design and performance requirements. Passed electrical safety testing. | |
| Biocompatibility requirements | Met all specified design and performance requirements. Passed biocompatibility testing. | |
| Image Quality | Image quality comparable to predicate device (Stryker Arthroscope) | Comparison of images taken by the nuvis™ Arthroscope and its predicate, the Stryker Arthroscope, was performed. The device "met all specified design and performance requirements" which implies comparable image quality. No specific quantitative metrics like resolution, contrast, or distortion are provided, nor a threshold for "comparable." |
| Design Requirements | All specified design requirements | Met all specified design and performance requirements. |
| Performance Requirements | All specified performance requirements | Met all specified design and performance requirements. |
| Safety and Suitability | Compliance with Voluntary Safety and International Agency Standards (e.g., ISO, AAMI/ANSI, IEC standards related to biological evaluation, electrical safety, endoscopes, optical resolution, sterilization) | The device "followed in the development of the nuvis™ Arthroscope to ensure its safety and suitability for its intended use." This indicates adherence to the standards, implying the device meets safety and suitability criteria specified within those standards. |
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.
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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.
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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.
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Adjudication method for the test set: Not applicable. There was no clinical test set requiring adjudication.
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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.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
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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.
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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.
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How the ground truth for the training set was established: Not applicable.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.