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• The ENTec ReFlex Wand is indicated for ablation and coagulation of soft tissue in . otolaryngological (ENT) procedures, including the treatment of snoring, nasal airway obstruction by reduction of hypertrophic nasal turbinates, and submucosal tissue shrinkage.
• The ArthroCare System 2000 is indicated for resection, ablation, and coagulation of . soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.
• The ENTec Surgery System is intended for ablation and coagulation of soft tissue in . otorhinolaryngology (ENT) surgery including head, neck, oral, and sinus surgery.
• The ArthroCare Orthopedic Electrosurgery System is indicated for resection, . ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, and spinal procedures.
• The ArthroCare Electrosurgery System is indicated for resection, ablation, and . coagulation of soft tissue and hemostasis of blood vessels in general, plastic, and reconstructive surgery. It is intended to be used in procedures using conductive solutions, such as normal saline.
• The Visage Cosmetic Surgery System is a bipolar electrosurgical device intended for . general dermatologic surgery that may include skin resurfacing for the treatment of wrinkles, rhytids, and furrows, as well as soft tissue resection/removal and hemostasis/coagulation. It is intended to be used in procedures using conductive solutions such as normal saline.
• The ArthroCare Bipolar Loop is indicated for resection, ablation, and excision, as . well as hemostasis of blood vessels in patients requiring endoscopic surgery for general urological procedures including transurethral prostatectomy (TURP), transurethral incisions in the prostate (TUIP), and non-malignant tumors of the bladder wall.

The ArthroCare Electrosurgery Systems are bipolar, high frequency electrosurgical Systems consisting of three components: an electrosurgical generator called the System 2000 Controller, a disposable bipolar single use Wand designed for specific indications, and the reusable patient Cable.

This 510(k) submission, K011634, focuses on a modification in materials for the Wand component of several ArthroCare Electrosurgery Systems. It is a "Special 510(k)," meaning it relies on the predicate devices' prior clearances to demonstrate substantial equivalence, rather than new extensive studies. Therefore, much of the information typically found in a full effectiveness study is not present in this summary.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) for a material modification, specific quantitative acceptance criteria and performance metrics for the modified device are not detailed in this summary. The core claim is substantial equivalence to the predicate devices. The document explicitly states:

"The technology, principle of operation, intended uses, performance specifications, dimensional specifications, labeling, packaging, and sterilization parameters of the Electrosurgery Systems remain the same as in the previously cleared 510(k)s."

This implies that the modified device is expected to perform identically to the predicate devices and meet their original performance specifications. Because the performance specifications are unchanged, there are no new "reported device performance" values to present for this specific submission.

2. Sample Size Used for the Test Set and Data Provenance

No specific test set or sample size for an effectiveness study are mentioned. The "study" here is the assessment of the material modification. This type of submission relies on bench testing and material characterization to demonstrate that the new material does not negatively impact the device's function or safety. Details of such testing (e.g., biocompatibility testing, mechanical testing) are typically performed, but are not summarized in this FDA 510(k) document. The data provenance would be internal laboratory testing from ArthroCare Corporation. It would be prospective with respect to the material change but would not involve patient-specific data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of submission. There is no "ground truth" that would be established by external experts in the context of clinical interpretation. The "ground truth" for the material modification is its compliance with specifications and regulatory standards, which is assessed internally by the manufacturer and reviewed by the FDA.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" requiring adjudication in the sense of expert review for diagnostic accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not mention any MRMC study. These devices are electrosurgical tools, not AI-powered diagnostic systems, so MRMC studies are not relevant.

6. Standalone (Algorithm Only) Performance Study

No. These are physical electrosurgical devices, not algorithms.

7. Type of Ground Truth Used

The "ground truth" in this context is the performance specifications and safety profile of the predicate devices. The material modification is assessed against these established parameters. This would involve:

• Engineering specifications and testing (e.g., electrical safety, mechanical strength, material compatibility).
• Biocompatibility data for the new material.
• Risk assessment to ensure the change does not introduce new hazards.

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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