(46 days)
The ArthroCare System 12000 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 |
| • Wrist Tendons | Wrist |
The ArthroCare System 12000 is a bipolar, high frequency, electrosurgical generator called the Controller that is intended to be used with a family of disposable, bipolar, single use Wands.
The provided text is for a 510(k) premarket notification for a medical device called the "ArthroCare System 12000." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in a clinical study for an AI/ML-driven diagnostic device.
Therefore, the requested information about acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable to this document.
Here's why and what the document does state:
- No Acceptance Criteria or Performance Metrics: The 510(k) summary for the ArthroCare System 12000, an electrosurgical device, does not contain a table of acceptance criteria or reported device performance metrics in the way one would see for an AI/ML diagnostic. Its purpose is to demonstrate that it is as safe and effective as a previously approved device.
- Substantial Equivalence, Not De Novo Performance: The core of this 510(k) is "Substantial Equivalence" to a predicate device (ArthroCare® System K032504). This means that the device manufacturer is asserting that their new device is similar enough in intended use, technology, safety, and effectiveness to a device already on the market.
- Performance Testing Mentioned, but Details Absent: The document states, "Additionally, performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare System 12000 to the predicate device." However, it does not provide details about this performance testing, such as specific metrics, sample sizes, data provenance, ground truth, or expert involvement. It simply concludes that the testing "demonstrated that the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use."
- No AI/ML Component: The ArthroCare System 12000 is described as a "bipolar, high frequency, electrosurgical generator... intended to be used with a family of disposable, bipolar, single use Wands." This is a physical and electrical medical device, not an AI/ML-driven diagnostic or assistive system. Therefore, concepts like "AI assistance," "standalone algorithm performance," "training set," and "test set" in the context of AI are irrelevant.
In summary, the provided text does not contain the information required to populate the table or answer the specific questions about acceptance criteria and study design for an AI/ML diagnostic device. It's a regulatory document for a traditional electrosurgical device seeking market clearance through substantial equivalence.
§ 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.