(132 days)
The ArthroCare Dermal Electrosurgery System and ConMed Hyfrecator are intended for use in dermatologic surgical procedures to remove soft tissue and to control bleeding.
The ArthroCare Dermal Electrosurgery System is comprised of three components: the Dermal Handpiece with Cable unit, the disposable Dermal Handpiece Tip, and an electrosurgical generator called the Controller. The Dermal Handpiece Tip attaches to the distal end of the Dermal Handpiece and Cable. The proximal end of the Dermal Handpiece and Cable unit connects to the Controller. The Dermal Handpiece Tip is provided in a variety of models, ranging in diameters from 0.5 mm to 2.5 mm with the distal tip of the dermal Handpiece as straight or bent at angles up to 90 degrees. The distal tip is configured with multi-electrodes. The Dermal Handpiece Tip is supplied sterile and intended for single patient use. The Dermal Handpiece and Cable unit are designed for repeat sterilization by either ethylene oxide gas or steam autoclaving methods. The Controller is a high frequency electronic instrument. There is no software utilized in the operation of the Controller. The ArthroCare Dermal Electrosurgery System is bipolar, incorporating a return electrode on the shaft of the device. This means that a return pad is not required for operation. The return energy in a bipolar device with an integral return electrode does not penetrate the tissue as in a monopolar device. In a monopolar device, the energy passes through the patient's body to reach the return pad.
This document is a Premarket Notification (510(k) Summary) for a medical device (ArthroCare Dermal Electrosurgery System), not a study evaluating its performance against acceptance criteria. Therefore, most of the information requested in your prompt (such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance) is not present in the provided text.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, not on proving device performance against specific acceptance criteria through a study.
Here's what can be extracted from the provided text in relation to your questions:
- Acceptance Criteria and Reported Device Performance: This information is not provided in the 510(k) summary. The document asserts "substantial equivalence" based on design, principle of operation, materials, and intended use, rather than reporting performance metrics against specific criteria.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no performance study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI/software-based interpretive system.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an electrosurgical unit, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Essentially, the provided text describes a medical device and claims its substantial equivalence to existing devices, but it does not detail any studies with acceptance criteria or performance metrics.
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ArthroCare Corporation Sunnyvale, California Premarket Notification November 29, 1996
APR 1 4 1997
X. 510(k) Summary
964849
Name of Device A.
| Trade name: | ArthroCare Dermal Electrosurgery System |
|---|---|
| Common name: | Electrosurgical Unit and Accessories |
| Classificationname: | Electrosurgical Cutting and Coagulation Device andAccessories (21 CFR 878.4400) |
Predicate devices B.
| Device | PremarketNotification |
|---|---|
| ArthroCare Arthroscopic Electrosurgery System | K943450 |
| ArthroCare Dental Electrosurgery System | K962445 |
| ArthroCare Bipolar Loop Electrosurgery System | K955531 |
| ArthroCare Urologic Multi-electrode ElectrosurgerySystem | K961069 |
| ConMed Hyfrecator Plus | K800617 |
C. Device description
The ArthroCare Dermal Electrosurgery System is comprised of three components: the Dermal Handpiece with Cable unit, the disposable Dermal Handpiece Tip, and an electrosurgical generator called the Controller. The Dermal Handpiece Tip attaches to the distal end of the Dermal Handpiece and Cable. The proximal end of the Dermal Handpiece and Cable unit connects to the Controller. The Dermal Handpiece Tip is provided in a variety of models, ranging in diameters from 0.5 mm to 2.5 mm with the distal tip of the dermal Handpiece as straight or bent at angles up to 90 degrees. The distal tip is configured with multi-electrodes. The Dermal Handpiece Tip is supplied sterile and intended for single patient use. The Dermal Handpiece and Cable unit are designed for repeat sterilization by either ethylene oxide gas or steam autoclaving methods. The Controller is a high frequency electronic instrument. There is no software utilized in the operation of the Controller.
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ArthroCare Corporation Sunnyvale, California Premarket Notification November 29, 1996
The ArthroCare Dermal Electrosurgery System is bipolar, incorporating a return electrode on the shaft of the device. This means that a return pad is not required for operation. The return energy in a bipolar device with an integral return electrode does not penetrate the tissue as in a monopolar device. In a monopolar device, the energy passes through the patient's body to reach the return pad.
D. Intended use
The ArthroCare Dermal Electrosurgery System and ConMed Hyfrecator are intended for use in dermatologic surgical procedures to remove soft tissue and to control bleeding.
Technological characteristics E.
The technological characteristics of the ArthroCare Dermal Electrosurgery System are the same as those of the ConMed Hyfrecator Plus as well as the ArthroCare Arthroscopic System, Bipolar Loop, Dental, and Urologic Multielectrode Systems. These devices are equivalent in terms of materials, principle of operation and sterilization.
F. Summary
By virtue of design, principle of operation, materials and intended use, we believe the ArthroCare Dermal Electrosurgery System is substantially equivalent to devices currently marketed in the United States. We believe that the ArthroCare Dermatologic Electrosurgery System, which is intended for removal of dermatologic lesions and hemostasis in dermatologic surgical procedures, does not raise any new issues of safety and/or effectiveness.
20
§ 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.