(21 days)
The ArthroCare Electrosurgery System is indicated for soft tissue resection and ablation and coagulation of blood vessels during general surgical procedures.
The ArthroCare Electrosurgery System is a bipolar, high frequency electrosurgical System designed for use in general surgical procedures where ablation and resection of soft tissue and coagulation of blood vessels is desired. The System consists of three components: an electrosugical generator called the Controller, the reusable Cable, and the disposable Wand. The Controller utilizes radio frequency (RF) energy as a power source. RF energy is delivered to the patient via the Cable and the Wand. The Cable is designed to connect the Controller to the Wand for patient treatment. The single use, sterile Wand is the patient contacting component of the System, and is available with suction and/or irrigation. The Wand can be configured with single or multiple electrodes. The ArthroCare Electrosurgery System uses bipolar technology in the design of the Wand, eliminating the need for a patient contacting dispersive pad used in monopolar devices.
This document is a 510(k) summary for a medical device modification, not a study report. It states that the device's substantial equivalence is based on the fact that modifications to the ArthroCare Electrosurgery System's Wands "are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the device." Therefore, it does not contain specific acceptance criteria, device performance metrics, or details of a study that proves the device meets such criteria in the way a clinical or performance study would.
Instead, the submission for K992972 is a Special 510(k) for modifications to an already cleared device (K971532). It claims substantial equivalence to the predicate device because the technology, principle of operation, and intended use remain the same.
Therefore, most of the requested information regarding acceptance criteria and a study to prove they are met cannot be extracted directly from this document.
Here's what can be gathered, addressing your points where possible:
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A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The submission asserts that the modifications do not significantly affect safety or efficacy, implying that the modified device's performance is still within the acceptable range of the original cleared device. No new performance metrics or acceptance criteria are defined or reported. -
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 document does not describe a performance or clinical study with a test set. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable/Not provided. This document does not describe a performance or clinical study requiring ground truth establishment by experts. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Not provided. This document does not describe a performance or clinical study with a test set. -
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 an electrosurgery system, not an AI-assisted diagnostic tool leveraging human readers. Therefore, an MRMC study is not relevant. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an electrosurgery system and does not involve an algorithm for standalone performance evaluation in the described context. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable/Not provided. As there is no described performance study, there is no ground truth data. The submission relies on demonstrating that modifications do not change the fundamental safety and efficacy established for the predicate device. -
The sample size for the training set:
Not applicable/Not provided. This document does not describe a performance study involving a training set. -
How the ground truth for the training set was established:
Not applicable/Not provided. As there is no training set described, there is no ground truth established for it.
§ 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.