(67 days)
The Arthrex Arthroscopes are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the shoulder, knee, elbow, ankle, wrist, and jaw, and also to provide illumination and visualization during arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the hip joint as size/length appropriate.
Hip diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondromatosis Unresolved hip pain Labral tears
Arthrex Arthroscopes are rigid, fixed arthroscopes with a wide-angle view. Arthrex Arthroscopes have surgical stainless steel shafts and lens housings for durability and are available with a 30 or 70 degree angle view. The optical components are sealed to provide a durable focusing mechanism. The arthroscopes may be attached to a video camera and are available in various sizes, diameters and lengths, to provide for differences in arthroscopic surqical site and surgeon preference.
This document is a 510(k) premarket notification for a medical device, an arthroscope. The information provided heavily emphasizes substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria.
Therefore, many of the requested details about specific acceptance criteria and a study proving the device meets them are not explicitly present in the provided text. The document acts as a regulatory submission demonstrating similarity, not an independent efficacy study.
Here's a breakdown of what can be inferred or is missing, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The "acceptance criteria" for K030096 are based on substantial equivalence to predicate devices, meaning the Arthrex Arthroscopes are considered safe and effective if they are similar in design, materials, and intended use to already legally marketed devices.
- Reported Device Performance: No specific quantitative performance data (e.g., optical resolution, illumination strength, durability test results) is provided in this summary. The performance is implicitly "similar to predicate devices."
| Feature/Criterion | Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Inferred/Stated) |
|---|---|---|
| Design | Similar to predicate devices | Rigid, fixed arthroscopes; Wide-angle view |
| Materials | Similar to predicate devices | Surgical stainless steel shafts and lens housings |
| Intended Use | Similar to predicate devices | Illumination and visualization of shoulder, knee, elbow, ankle, wrist, jaw, and hip. |
| Durability | Similar to predicate devices | Optical components sealed to provide durability |
| Safety | No new issues of safety raised compared to predicate | Considered safe by Arthrex, Inc. |
| Effectiveness | No new issues of effectiveness raised compared to predicate | Considered effective by Arthrex, Inc. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable/Not mentioned. No independent test set of patients or cases was used for a performance study. The evaluation is based on comparison to existing devices.
- Data Provenance: Not applicable. There is no specific data from clinical or performance testing detailed in this document. The "provenance" of the equivalence argument is the legal framework of 510(k) substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable/Not mentioned. Since no independent performance study requiring a "test set" and "ground truth" was conducted and described in this summary, there is no mention of experts establishing ground truth. The safety and effectiveness are established by the FDA's acceptance of the substantial equivalence claim.
4. Adjudication Method for the Test Set
- Not applicable/Not mentioned. No test set was used in the context of an efficacy study as described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a MRMC comparative effectiveness study was not done (or at least not described in this 510(k) summary). The document focuses on demonstrating substantial equivalence to predicate devices, not on a comparative effectiveness study involving human readers and AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is an arthroscope, a physical medical instrument for visualization, not an algorithm or AI system. Therefore, standalone algorithm performance is irrelevant.
7. The Type of Ground Truth Used
- Not applicable/Not mentioned in the context of a performance study. The "ground truth" for the 510(k) process is the established safety and effectiveness of the predicate devices to which the new device is being compared.
8. The Sample Size for the Training Set
- Not applicable/Not mentioned. This is not an AI/algorithm-based device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI/algorithm-based device requiring a training set or ground truth for training.
§ 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.