(14 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 provided document, K030551, is a 510(k) Pre-market Notification for the ArthroCare ArthroWands. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive clinical studies with reported performance metrics.
Therefore, much of the requested information regarding acceptance criteria, study details, and performance metrics for the device itself (as if it were a novel device undergoing clinical efficacy trials) is not present in this document. The document primarily attests that the modifications to the ArthroWands do not significantly affect safety or efficacy compared to the previously cleared predicate device (K020557).
Here's an breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
This document does not contain a table of acceptance criteria or reported device performance in the way one would expect for a de novo submission or a clinical trial report. The "acceptance criteria" here is implicitly "substantial equivalence" to the predicate device. The performance is assessed through the unchanged indications for use and principle of operation.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintain safety and effectiveness as predicate device (K020557) | "The proposed modification in dimensional specifications, materials, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." (page 2) |
| Indications for Use remain identical to predicate device | The stated "Indications for Use" for the modified ArthroWands are identical to those of the predicate device (pages 1-2 and 5-6). |
| Technology and Principle of Operation remain identical to predicate device | "The indications for use, technology, principle of operation, performance specifications, materials, and sterilization parameters of the ArthroWands remain the same as in the predicate cleared 510(k)." (page 2) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. As a 510(k) for modifications to a predicate device, it likely relies on non-clinical testing (e.g., bench testing for dimensional changes, material compatibility) and a comparison to the established safety and efficacy of the predicate device, rather than a clinical "test set" in the traditional sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. The document does not describe a clinical study requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. There is no description of a clinical test set requiring adjudication.
5. 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
This information is not applicable/not provided. This device is an electrosurgical tool, not an AI-powered diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This is an electrosurgical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable/not provided. The assessment relies on substantial equivalence to the predicate device, which would have had its own methods of demonstrating safety and effectiveness originally (likely through a combination of non-clinical and potentially some clinical data, but not detailed here).
8. The sample size for the training set
This information is not applicable/not provided. This document does not describe a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided. No training set is mentioned as this device is not an AI/ML product.
§ 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.