(29 days)
The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist) |
|---|---|
| Ablation and Debridement | |
| • ACL/PCL | Knee |
| • Acromioplasty | Shoulder |
| • Articular Cartilage | All Joints |
| • Bursectomy | All Joints |
| • Chondroplasty | All Joints |
| • Facia | All Joints |
| • Ligament | All Joints |
| • Notchplasty | Knee |
| • Scar Tissue | All Joints |
| • Soft Tissue | All Joints |
| • Subacromial Decompression | Shoulder |
| • Synovectomy | All Joints |
| • Tendon | All Joints |
| Excision and Resection | |
| • Acetabular Labrum | Hip |
| • Articular Labrum | All Joints |
| • Capsule | All Joints |
| • Capsular Release | Knee |
| • Cartilage Flaps | Knee |
| • Cysts | All Joints |
| • Discoid Meniscus | Knee |
| • Frozen Shoulder Release | Shoulder |
| • Glenoidale Labrum | Shoulder |
| • Lateral Release | Knee |
| • Ligament | All Joints |
| • Loose Bodies | All Joints |
| • Meniscal Cystectomy | Knee |
| • Meniscectomy | Knee |
| • Plica Removal | All Joints |
| • Scar Tissue | All Joints |
| • Soft Tissue | All Joints |
| • Synovial Membrane | All Joints |
| • Tendon | All Joints |
| • Triangular Fibrocartilage (TFCC) | Wrist |
| • Villusectomy | Knee |
| Coagulation | |
| • ACL/PCL | Knee |
| • Articular Cartilage | All Joints |
| • Carpal Ligaments | Wrist |
| • Glenohumeral Capsule | Shoulder |
| • Ligament | All Joints |
| • Medial Retinaculum | Knee |
| • Rotator Cuff | Shoulder |
| • Tendon | All Joints |
| • Wrist Tendons | Wrist |
The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.
The ArthroCare ArthroWands are electrosurgical devices indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Here's an analysis of the acceptance criteria and supporting study information:
1. Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and performance data for a new, independent study.
- Acceptance Criteria: No specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) were explicitly stated for the ArthroCare ArthroWands in this document. The primary "acceptance criterion" for this 510(k) submission was to demonstrate substantial equivalence to the previously cleared ArthroWands (K013463).
- Reported Device Performance: The document states, "The modified ArthroWands, as described in this submission, are substantially equivalent to the predicate ArthroWands. The proposed modification in performance specifications, materials, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." This implies that the performance characteristics of the modified device are considered to be within acceptable limits as defined by the predicate device, although specific performance metrics (e.g., operating temperature range, tissue ablation rate, coagulation effectiveness) are not detailed.
Since the submission is for modifications to an already cleared device and focuses on substantial equivalence, the "study" proving acceptance criteria is a comparison to the predicate device and an assessment that the modifications do not negatively impact safety or efficacy. No new clinical or performance study data is presented.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document is a 510(k) summary for modifications to a previously cleared device, focusing on substantial equivalence. It does not present data from a new test set or clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. There is no mention of a new test set requiring expert ground truth establishment in this 510(k) summary.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a new test set requiring adjudication in this 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This document does not describe an MRMC study. The device is a surgical tool, not an AI-assisted diagnostic tool, so such a study would not typically be relevant for its approval.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is an electrosurgical device, not an algorithm, so standalone performance in the context of AI is not relevant. Its performance is intrinsically linked to its intended use in arthroscopic and orthopedic procedures with human operators.
7. Type of Ground Truth Used
Not applicable. As this 510(k) submission focuses on substantial equivalence for product modifications, it relies on the established safety and efficacy data of the predicate device (K013463). There is no new ground truth established for a new clinical study in this document.
8. Sample Size for the Training Set
Not applicable. As this is not an AI/ML device, the concept of a training set is not relevant.
9. How the Ground Truth for the Training Set was Established
Not applicable. As this is not an AI/ML device, the concept of a training set is not relevant.
In summary, the provided document is a 510(k) summary for a modified electrosurgical device. The primary "acceptance criterion" demonstrated is substantial equivalence to a predicate device, arguing that the modifications do not significantly alter its safety or efficacy. It does not contain information about new clinical studies, test sets, or ground truth establishment typically associated with performance evaluations of AI/ML or novel diagnostic devices.
§ 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.