(30 days)
The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures: Ablation and Debridement (ACL/PCL, Acromioplasty, Articular Cartilage, Bursectomy, Chondroplasty, Facia, Ligament, Notchplasty, Scar Tissue, Soft Tissue, Subacromial Decompression, Synovectomy, Tendon), Excision and Resection (Acetabular Labrum, Articular Labrum, Capsule, Capsular Release, Cartilage Flaps, Cysts, Discoid Meniscus, Frozen Shoulder Release, Glenoidale Labrum, Lateral Release, Ligament, Loose Bodies, Meniscal Cystectomy, Meniscectomy, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane, Tendon, Triangular Fibrocartilage (TFCC), Villusectomy), Coagulation (ACL/PCL, Articular Cartilage, Carpal Ligaments, Glenohumeral Capsule, Ligament, Medial Retinaculum, Rotator Cuff, Tendon, Wrist Tendons).
The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.
The provided 510(k) summary for the ArthroCare ArthroWands is a submission that proposes modifications in the materials specification of a previously cleared device (K082323). This is a "Special 510(k)" submission.
For Special 510(k)s, substantial equivalence is claimed when design or manufacturing changes are made to a manufacturer's own legally marketed device, and the changes do not significantly affect the safety or effectiveness of the device. Therefore, the "study" demonstrating that the device meets acceptance criteria is typically a demonstration that the new materials do not negatively impact the performance of the device or pose new safety risks, rather than a clinical performance study against specific acceptance criteria. The existing performance of the predicate device is assumed to be acceptable.
Based on the provided text, the specific details regarding acceptance criteria and a study proving performance as one might expect for a de novo device or a traditional 510(k) for a novel device are not explicitly stated in this summary. Instead, the document focuses on demonstrating that the modifications do not change the safety and effectiveness relative to the predicate.
Here's how to interpret the request in the context of this Special 510(k):
1. A table of acceptance criteria and the reported device performance
Since this is a Special 510(k) for material changes, there are no new performance acceptance criteria outlined. The acceptance criterion is effectively that the device's performance, safety, and effectiveness remain unchanged from the predicate device despite the material specification modifications.
| Acceptance Criteria (Inferred from Special 510(k)) | Reported Device Performance (Inferred) |
|---|---|
| Indications for Use remain unchanged. | Remains identical to predicate K082323. |
| Technology remains unchanged. | Remains identical to predicate K082323. |
| Principle of operation remains unchanged. | Remains identical to predicate K082323. |
| Sterilization parameters remain unchanged. | Remains identical to predicate K082323. |
| Safety is not significantly affected. | Modifications are not substantial; safety not significantly affected. |
| Efficacy is not significantly affected. | Modifications are not substantial; efficacy not significantly affected. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical "test set" or clinical data provenance. The assessment for a Special 510(k) regarding material changes typically involves bench testing, biocompatibility testing, and potentially some limited non-clinical performance testing to ensure the new materials meet specifications and do not negatively impact the device. The specific sample sizes for such engineering or materials tests are not provided in this summary.
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 applicable. The submission is about material changes and relies on bench and non-clinical testing, not expert-adjudicated clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring expert adjudication is described.
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 applicable. This device is an electrosurgical tool, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electrosurgical tool, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a Special 510(k) involving material changes, the "ground truth" would be established specifications and standards for the materials themselves (e.g., biocompatibility standards, mechanical property specifications, electrical performance safety standards). The summary does not detail the specific standards or how compliance was achieved.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
Summary of the Study Proving Device Meets Acceptance Criteria (as per the Special 510(k) context):
The "study" in this context is the design control process and testing performed by ArthroCare Corporation to ensure that the proposed material changes do not affect the safety or efficacy of the ArthroWands. The document states:
"The proposed modifications in the materials is not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices."
This statement serves as the conclusion of their internal assessment and testing (e.g., bench testing, biocompatibility, electrical safety, performance testing specific to the material change) that would have been conducted to demonstrate continued substantial equivalence to the predicate device K082323. The 510(k) summary itself does not provide the detailed results or methodology of these tests, but rather asserts their outcome. The FDA's clearance (K082980) indicates that they reviewed this assessment and agreed with the manufacturer's conclusion.
§ 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.