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K Number
K971532
Device Name
ARTHROCARE ELECTROSURGERY SYSTEM
Manufacturer
ARTHROCARE CORP.
Date Cleared
1997-07-23

(86 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
K943450,K955531,K961069,K962445,K963123,K964849,K800617,K850668
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ArthroCare Electrosurgery System is intended for use in general surgical procedures to remove soft tissue and to control bleeding.
The ArthroCare Electrosurgery System is indicated for soft tissue resection and ablation and coagulation of blood vessels during general surgical procedures.

Device Description

The ArthroCare Electrosurgery System is comprised of three components: the Probe, the Probe Cable, and an electrosurgical generator called the Controller. The Probe Cable connects the Controller to the Probe. The Probe is provided in a variety of models with the distal tip of the probe as straight or bent at angles up to 90 degrees. The distal tip may be configured with multi-electrodes or as a loop electrode. The Probe is supplied sterile and intended for single patient use. The Probe Cable is designed for repeat sterilization by either ethylene oxide gas or steam autoclaving methods, as selected by the user. The Controller is a high frequency electronic instrument. There is no software utilized in the operation of the Controller.
The ArthroCare 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.

AI/ML Overview

This document is a 510(k) Premarket Notification for the ArthroCare Electrosurgery System. It does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria through performance metrics.

Instead, a 510(k) submission generally aims to demonstrate substantial equivalence to a predicate device already legally marketed in the US, rather than proving performance against specific quantitative acceptance criteria through a standalone study with performance metrics like sensitivity, specificity, etc.

Here's why the requested information cannot be fully provided from this document:

  • Nature of the submission: This is a 510(k) for an electrosurgical system. These submissions primarily focus on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, and does not raise different questions of safety and effectiveness.
  • Medical Device vs. AI/Software: The questions provided are highly tailored for AI/Software-as-a-Medical-Device (SaMD) or diagnostic devices where performance metrics (e.g., sensitivity, specificity, AUC) are key. This document describes a physical electrosurgical system, which is broadly different. The document explicitly states "There is no software utilized in the operation of the Controller."
  • Focus on Equivalence: The document repeatedly emphasizes "substantial equivalence" and states "The technological characteristics of the ArthroCare Electrosurgery System are identical to those of the predicate ArthroCare devices, as well as the devices distributed by other manufacturers. These devices are equivalent in terms of design, materials, principle of operation, product specifications and sterilization."

Therefore, I cannot populate the table or answer most of the questions as they are not applicable to the type of information presented in this 510(k) for an electrosurgical system.

However, I can extract the following relevant details from the provided text:

  • Device Name: ArthroCare Electrosurgery System
  • Intended Use: "The ArthroCare Electrosurgery System is intended for use in general surgical procedures to remove soft tissue and to control bleeding." (Section D) and "The ArthroCare Electrosurgery System is indicated for soft tissue resection and ablation and coagulation of blood vessels during general surgical procedures." (Indications Statement)
  • Predicate Devices: K943450, K955531, K961069, K962445, K963123, K964849 (all ArthroCare systems) and K800617, K850668 (Conmed Hyfrecator).
  • Key Technological Feature: Bipolar operation with an integral return electrode on the shaft, eliminating the need for a separate return pad and preventing energy penetration through the patient's body (unlike monopolar devices).
  • Lack of Software: "There is no software utilized in the operation of the Controller."

Regarding your specific questions:

  1. A table of acceptance criteria and the reported device performance: This document does not provide such a table. Performance against specific quantitative acceptance criteria is not typically required for a 510(k) submission where substantial equivalence to a predicate device is established based on technological characteristics and intended use.
  2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable/not provided. This type of data is associated with clinical studies or performance studies, which are not detailed here as the submission relies on substantial equivalence.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. Ground truth establishment is relevant for diagnostic performance studies, not for a 510(k) of an electrosurgical device based on technological equivalence.
  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/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. The device is an electrosurgical system, not an AI-assisted diagnostic tool. There's no AI involved ("no software utilized").
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The submission is based on substantial equivalence, not performance against an established ground truth.
  8. The sample size for the training set: Not applicable. No machine learning training set is involved.
  9. How the ground truth for the training set was established: Not applicable. No machine learning training set is involved.

§ 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.