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The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.

The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.

This is a 510(k) premarket notification for a medical device (ArthroCare ArthroWands). It is not a study about an AI/ML device. Therefore, the provided text does not contain the information required to answer your specific questions regarding acceptance criteria, device performance, study types (MRMC, standalone), sample sizes, ground truth establishment, or expert qualifications in the context of an AI/ML study.

The document primarily states that the proposed modifications to the ArthroCare ArthroWands are "not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." It asserts substantial equivalence to a predicate device (K082980) based on unchanged indications for use, technology, principles of operation, and sterilization parameters, with only material specification changes.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from an AI/ML study, nor any of the other requested details related to such a study, because the provided text does not describe an AI/ML product or performance study.

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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 (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), 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 describes a 510(k) summary for the ArthroCare ArthroWands. However, it does not contain any information about acceptance criteria, device performance metrics, or details of a study (such as sample sizes, ground truth establishment, or expert involvement) that proves the device meets specific criteria.

The document states that the ArthroCare ArthroWands are substantially equivalent to predicate devices (K070958 and K040338). The current submission (K071963) is a Special 510(k) for modifications in performance specifications and labeling, noting that "The indications for use, technology, principle of operation, and sterilization parameters of the ArthroCare ArthroWands remain the same as in the predicate cleared 510(k)s." It explicitly states, "The proposed modification in the material is a not substantial change or modification, and does not significantly affect the safety or efficacy of the devices."

Therefore, based solely on the provided text, I cannot fill out the requested information about acceptance criteria or a study proving those criteria are met. The FDA's determination of substantial equivalence implies that the device is deemed safe and effective because it is similar to devices already legally marketed, rather than through a new, comprehensive performance study outlined in this document.

To briefly address each point based on the absence of information:

1. A table of acceptance criteria and the reported device performance: Not provided. The document relies on substantial equivalence to predicate devices.
2. Sample sized used for the test set and the data provenance: Not provided. No specific test set or study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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 is 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 applicable. This is an electrosurgical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided.
8. The sample size for the training set: Not applicable; not a machine learning device.
9. How the ground truth for the training set was established: Not applicable; not a machine learning device.

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The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.

The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.

This document is a 510(k) summary for a medical device (ArthroCare ArthroWands) and does not contain the acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical validation reports for AI/CADe devices.

Instead, this document is focused on demonstrating substantial equivalence to a previously cleared predicate device for a modification in material. The relevant sections state:

• "This Special 510(k) proposes modifications in material for the ArthroCare ArthroWands, which were previously cleared in K052686 (October 5, 2005). The indications for use, technology, principle of operation, and sterilization parameters of the ArthroCare ArthroWands remain the same as in the predicate cleared 510(k)s."
• "The modified ArthroCare ArthroWands, as described in this Special 510(k), are substantially equivalent to the predicate device. The proposed modification in the material is a not substantial change or modification, and does not significantly affect the safety or efficacy of the devices."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because it is not present in the provided text. The document's purpose is to show that a material change does not alter the device's safety or effectiveness, not to present a new performance study.

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