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The ArthroCare Timer is an accessory, supplied separately, that can be used with the Electrosurgery System in the following indications:

• 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 Timer is an accessory that can be used with ArthroCare's Electrosurgery System. It is designed to control the duration of therapy treatment during soft tissue ablation procedures.

The provided document is a 510(k) Summary for the ArthroCare® Timer, an accessory to an electrosurgery system. This submission modifies the performance specifications and labeling for an already cleared electrosurgery system.

Crucially, the document explicitly states: "The proposed addition of the ArthroCare Timer performance specifications and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System."

Therefore, this submission does not contain a new study proving the device meets acceptance criteria. Instead, it leverages the fact that the changes are deemed non-substantial and rely on the prior clearance of the predicate device (K020557 ArthroCare® ArthroWands). The acceptance criteria for the Timer accessory itself would likely be related to its function of timing, which would be tested internally against its design specifications rather than requiring a clinical study with patients or experts.

Given this, I cannot provide the information requested in your numbered points because a new study to prove the device meets acceptance criteria as typically understood for new medical devices (i.e., clinical trials, AI performance studies) was not conducted or reported in this 510(k) summary.

The document is primarily a regulatory filing asserting substantial equivalence based on the minor nature of the modification.

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