(126 days)
The ArthroCare System 15000 is 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 |
| • Fascia | 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 |
| Continued | |
| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist) |
| • 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 |
The ArthroCare System 15000 consists of a bipolar, high frequency, electrosurgical generator called the Controller, a family of disposable, bipolar, single use Wands and Foot Control.
This document describes the ArthroCare® System 15000, an electrosurgical device for arthroscopic and orthopedic procedures. However, the provided text does not contain any information regarding acceptance criteria or the results of a study designed to prove the device meets specific acceptance criteria.
The document is a 510(k) summary for premarket notification to the FDA, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical or performance study with detailed metrics.
Therefore, I cannot provide the requested information in the format requested. The document primarily discusses the device description, intended uses, and asserts substantial equivalence to predicate devices based on a comparison of specifications and "performance testing" without detailing the nature, methods, or results of this testing.
There is no information in the provided text to fulfill the following requirements of your request:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or performance metrics are detailed.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method: Not mentioned.
- 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 mentioned; this device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned; this is an electrosurgical device, not an algorithm.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
The document states: "Additionally, performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare System 15000 to the predicate device. The performance testing and device comparison demonstrated that the subject devices are substantially equivalent to the predicate devices, and is safe and effective for its intended use." This is a general statement and does not provide the detailed information requested about acceptance criteria or study specifics.
§ 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.