(17 days)
The MR Compatible Model 90 Electrosurgical Probe is designed to supply energy (generated by the RITA Medical Systems' electrosurgical generator) for use in electrosurgery and is designed for the following:
- Incorporation of multiple needles on each probe minimizing the number of . invasive accesses necessary to achieve desired lesions.
- Provide a minimally invasive laparoscopic, percutaneous, or intraoperative . access to the targeted tissue.
- Deliver radiofrequency energy in a controlled fashion to create coagulative . necrotic lesions.
- Incorporate thermocouples for temperature feedback. .
- Provide for local delivery of fluid. .
This RITA® MR Compatible Model 90 device is available in 15 cm and 25 cm lengths for a variety of medical applications. The secondary electrodes deploy out from the trocar tip. The RITA MR Compatible Model 90 device consists of the following components:
primary electrode: hypodermic tubing with a portion exposed as an electrode
secondary electrodes: extendible flexible hypodermic tubing at the distal end of probe
trocar insulation: shrink tubing
handle: polymer materials with markings to indicate the amount of electrode array deployment from the trocar
RF pathway: connection through a Lemo connector built into the handle
fluid infusion: delivery through Luer port at side of the handle
temperature sensors: five temperature sensors at the periphery of the array
depth indicators: Incremental 1-cm marks denote needle penetration depth.
The provided text is a 510(k) summary for a medical device (MR Compatible Model 90 Electrosurgical Probe) and does not contain information about acceptance criteria or a study that evaluates the device's performance against specific clinical or AI-related metrics.
The "Performance Data" section states: "The MR Compatible Model 90 devices were subjected to a battery of electrical, mechanical, biocompatibility, and magnetic resonance testing to verify that the devices met the specifications. The devices met the specifications and the materials did not elicit toxicological responses." This indicates that engineering and safety tests were performed, but it does not detail:
- Specific quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity).
- Reported device performance values against such criteria.
- Any study involving sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details, as these are typically associated with AI/software performance evaluation.
Therefore, I cannot fulfill your request for the detailed table and information as the provided text pertains to a traditional electrosurgical probe and not an AI/software device whose performance is measured in the ways you've outlined.
In summary, the document does not contain the information required to answer your questions regarding acceptance criteria and performance studies in the context of an AI-enabled device.
§ 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.