(15 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 text is a 510(k) summary for the ArthroCare ArthroWands, an electrosurgical device. It primarily focuses on demonstrating substantial equivalence to a predicate device (K032504) rather than presenting a study proving that the device meets specific acceptance criteria through performance validation.
Therefore, many of the requested details about acceptance criteria, the study design, sample sizes, expert involvement, and ground truth are not present in this document.
Here's the breakdown of what can and cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
- Not present. The document explicitly states: "The proposed modifications in materials are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." This implies that no new performance testing was conducted against new acceptance criteria. Instead, the device's performance is assumed to be equivalent to the predicate device due to the nature of the modifications.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not present. No specific test set or associated data is described as part of this 510(k) submission, as it relies on substantial equivalence to the predicate device.
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)
- Not present. Ground truth establishment is not relevant in this context because no performance study on a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not present. No test set or related adjudication process is mentioned.
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
- Not present. This document discusses an electrosurgical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not present. This is not an algorithm, but a medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not present. No ground truth is established for a new performance study.
8. The sample size for the training set
- Not present. This is not a machine learning or AI device that would involve a training set.
9. How the ground truth for the training set was established
- Not present. Not applicable.
Summary of the document's content relevant to performance and equivalence:
- Basis for Equivalence: The submission is a "Special 510(k)" proposing "modifications in materials for the ArthroCare ArthroWands."
- Key Statement on Equivalence: "The proposed modifications in materials are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." This means that the manufacturer is asserting that the changes are minor enough that new specific performance testing isn't required to assure safety and effectiveness, as the device is considered substantially equivalent to its predicate.
- Predicate Device: ArthroCare® System (K032504), cleared on August 21, 2003.
- Attributes Remaining the Same: "The indications for use, technology, principle of operation, packaging, sterilization parameters, and labeling of the ArthroCare ArthroWands remain the same as in the predicate cleared 510(k)."
In essence, this 510(k) relies on the premise that because the changes are only material modifications and do not alter the fundamental operation or intended use, the device inherently meets its (unchanged) performance expectations, which were previously established for the predicate device. No new "acceptance criteria" or a new "study proving device meets acceptance criteria" are detailed in this specific document.
§ 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.