(11 days)
The ArthroCare Topaz ArthroWands are indicated for debridement, resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
| Procedures | Body Structure as described below |
|---|---|
| • Fasciotomy | Foot |
| • Synovectomy | Foot |
| • Tendonotomy | Knee, Wrist, Elbow, |
| Ankle, Shoulder, Foot | |
| • Rotator Cuff Tendonotomy | Shoulder |
| • Capsulotomy | Foot |
The ArthroCare Topaz ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.
This is a 510(k) premarket notification for a modification to an existing device, the ArthroCare® Topaz® ArthroWands®. As such, the submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo study with detailed acceptance criteria and performance data for a novel device. Therefore, much of the requested information regarding a study proving acceptance criteria and specific performance metrics for this modified device is not explicitly present in the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Strict acceptance criteria and reported device performance (in terms of specific metrics like sensitivity, specificity, accuracy, or effect size) for the modified device are not provided in this 510(k) summary. This document primarily asserts that the modified device remains substantially equivalent to its predicate.
However, the "Summary of Safety and Effectiveness" section implicitly refers to acceptance criteria by stating: "The modified ArthroCare Topaz ArthroWands, as described in this Special 510(k), are substantially equivalent to the predicate device. The proposed modification in the material is a not substantial change or modification, and does not significantly affect the safety or efficacy of the devices."
This implies that the "acceptance criteria" are met if the modifications:
- Do not substantially change the device.
- Do not significantly affect the safety.
- Do not significantly affect the efficacy.
The "reported device performance" is not quantified in this document, but rather relies on the performance of the predicate devices. The modifications are a change in performance specifications, materials, and labeling, but the "indications for use, technology, principle of operation, and sterilization parameters of the ArthroCare Topaz ArthroWands remain the same as in the predicate cleared 510(k)s."
2. Sample size used for the test set and the data provenance
No specific test set or data provenance (e.g., country of origin, retrospective/prospective study) is described as this is a Special 510(k) for device modification, not a clinical trial evaluating a new device. The substantial equivalence argument relies on the predicate's established safety and efficacy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new ground truth establishment is described for a test set in this 510(k) summary.
4. Adjudication method
Not applicable. No adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study is not mentioned as part of this 510(k) submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electrosurgical device, not an AI or algorithm-based system.
7. The type of ground truth used
Not applicable in the context of this 510(k) for device modification. The "ground truth" for the original predicate device's safety and efficacy would have been established through pre-market testing and clinical experience, but not detailed here.
8. The sample size for the training set
Not applicable. This is not an AI/ML device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.