(87 days)
The Sohniks Endoscopy Arthroscopes are intended for use by qualified surgeons during procedures of small and large joints. The intended use for Sohniks Endoscopy, Inc.'s arthroscopes are for examining, diagnosing, visualizing and to aid in treating the interior problems of orthopedic joints, otolaryngology, thinology, endoscopic plastic and reconstructive surgery. Our arthroscopes are intended for use in the shoulder, wrist, knee, ankle, elbow, and jaw and visualization of the hip joint to diagnose disease and removal of loose bodies.
The Söhniks Arthroscopes are reusable manually operated surgical devices that are provided in 0. 30. 45. and 70 degree direction of view. The Arthroscopes are provide non-sterile and must be cleaned and sterilized by the user prior to each use. The components that contact the body are composed of surgical grade stainless steel, which is commonly used in medical devices and has a long history of biocompatibility for human use.
This document is a 510(k) summary for the Sohniks Endoscopy Arthroscope from 2003. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance data on a novel AI-powered device. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and AI-specific metrics (like MRMC studies) cannot be extracted from this document.
Here's what can be gathered based on the provided text, and where gaps exist:
1. A table of acceptance criteria and the reported device performance:
This document does not specify quantitative acceptance criteria or report specific performance metrics for the Sohniks Arthroscope in the way one would for a new diagnostic or AI-powered device. The submission focuses on demonstrating substantial equivalence.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
| (The document states: "The Söhniks Arthroscope is substantially equivalent to its predicate devices. The basic design, materials and intended uses are the same and there are no new issues of safety and effectiveness.") |
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable/not specified. This document is a 510(k) summary for a manual surgical device (arthroscope), not a data-driven AI device. There is no mention of a "test set" of data in the context of evaluating performance.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a "test set" or establishing ground truth by experts for the evaluation of this device.
4. Adjudication method for the test set:
- Not applicable. No test set mentioned.
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:
- Not applicable. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a manual surgical device.
7. The type of ground truth used:
- Not applicable. No ground truth is mentioned for the evaluation of this arthroscope. The evaluation relies on demonstrating equivalence to existing, legally marketed arthroscopes.
8. The sample size for the training set:
- Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of Device and Regulatory Context (Based on Document):
- Device: Arthroscope
- Intended Use: Examining, diagnosing, visualizing, and aiding in treating interior problems of orthopedic joints (shoulder, wrist, knee, ankle, elbow, jaw, hip joint visualization for diagnosis and loose body removal), otolaryngology, rhinology, endoscopic plastic and reconstructive surgery. For use by qualified surgeons during procedures of small and large joints.
- Device Description: Reusable, manually operated surgical device available in 0, 30, 45, and 70-degree directions of view. Provided non-sterile, requiring user cleaning and sterilization. Components are surgical grade stainless steel.
- Regulatory Basis: The FDA determined the device is substantially equivalent to predicate devices marketed prior to May 28, 1976. This means the FDA believes the device is as safe and effective as legally marketed devices, and does not require a rigorous performance study with specific acceptance criteria as would be needed for a novel device or an AI/software as a medical device. The focus is on similar design, materials, and intended uses to existing devices, with "no new issues of safety and effectiveness."
In conclusion, this document describes a 510(k) submission for a traditional, manually operated medical device where substantial equivalence to existing devices is the primary criterion for market clearance, rather than a study demonstrating performance against specific acceptance criteria for a novel technology like AI.
§ 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.