(24 days)
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.
| Acceptance Criteria Category (General) | Reported Device Performance |
|---|---|
| Design and Performance Requirements | Met all specified design and performance requirements. |
| Electromagnetic Compatibility (EMC) | Passed EMC testing requirements. |
| Electrical Safety | Passed electrical safety testing requirements. |
| Biocompatibility | Passed biocompatibility testing requirements (Meets ISO 10993-1 requirements). |
| Visual Inspection | Performed and passed. |
| Leak and Condensation Test | Performed and passed. |
| Visual Image Check | Performed and passed. |
| Pointer/Direction Test | Performed and passed. |
| Distal Tip Smoothness | Performed and passed. |
| Scope Diameter/Cannula Interface Test | Performed and passed. |
| Angle of View (AOV) Measurement | Performed and passed (AOV: 30°). |
| Field of View (FOV) Measurement | Performed and passed (FOV: 105°). |
| Resolution Test | Performed and passed (Resolution: 1 to 5 times actual size, dependent on distance). |
| LED Light Intensity Verification | Performed and passed. |
| PX3 Liquid Penetration and Ingress Tests | Performed and passed (IPX3 for subject vs. IPX1 for predicate device enclosure). |
| Packaging Testing (Pouch seal, Transportation valuation) | Performed and passed. |
| Shelf Life Stability Testing | Performed and passed. |
| Electrical (Power Supply Output) | Consistent with predicate: variable output power of |
§ 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.