(384 days)
The Olsen Medical Electrosurgical Cables/Adapters is intended for connecting monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument.
The Olsen Medical Electrosurgical Cables/Adapters has been designed as an accessory to various electrosurgical instruments where monopolar/bipolar electrosurgical cutting and coagulation is desired during surgery. Examples of such instruments are; scissors, forceps, dissectors, lap electrodes and handles. The device connects to the high frequency generator on one end and the active instrument on the other end for cutting and coagulation. It is comprised of an insulated cord and a fixed instrument and generator connector on either end as the means of conveying high frequency electrosurgical energy from the generator to the standard electrosurqical instrument during surgery.
The adapter interfaces between the instrument cable and various model of electrosurgical generators to match a proper fit for ESU model output connection.
This document describes a 510(k) premarket notification for electrosurgical cables/adapters, which are accessories to existing medical devices. It is not a study assessing the performance of an AI-powered device, but rather a submission for regulatory clearance of a standard medical accessory. As such, the information requested in your prompt regarding acceptance criteria for AI devices and studies proving their performance is not applicable to this document.
The document focuses on demonstrating substantial equivalence to previously marketed predicate devices, a requirement for 510(k) clearance, rather than proving the performance of a new, innovative device feature through specific performance metrics like those for AI.
Here's a breakdown of why this document doesn't fit the requested format, based on the information provided:
- No AI-powered device: The device described is "Olsen Medical Electrosurgical Cables/Adapters," which are accessories for electrosurgical instruments. There is no mention of any AI component or functionality.
- No acceptance criteria for AI performance: The "Device Testing" section states, "The new device is technologically the same as the predicate device. Device qualification criteria meet or exceeds the minimum qualification criteria for the predicate device and conforms to applicable ASTM and ISO Standards for biocompatibility of materials. All tests will meet the applicable requirements of AAMI/ANSI/IEC 60601-2-2:2009 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories." This refers to standard electrical and safety compliance for medical devices, not performance metrics like sensitivity, specificity, or AUC for an AI algorithm.
- No study proving AI device meets acceptance criteria: The document focuses on demonstrating that the device is "substantially equivalent" to predicate devices based on "intended use, materials, design, and technological characteristics," and that it meets established safety and performance standards for electrosurgical accessories. There is no mention of any study that would involve a "test set," "ground truth," "experts," "adjudication," or "training set" as these terms relate to AI performance evaluation.
- No MRMC comparative effectiveness study or standalone algorithm study: These types of studies are relevant for evaluating AI's impact on human performance or AI's intrinsic performance, neither of which is discussed here.
In summary, the provided text is a 510(k) submission for a non-AI medical accessory, and therefore, cannot be used to answer questions about acceptance criteria and studies for AI-powered devices.
§ 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.