(130 days)
The InMode PLUS System with the PLUS/PLUS90/PLUS-PLUS Hand pieces is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation
The InMode PLUS System delivers RF energy to gradually heat the skin and subcutaneous tissue. The RF power levels used by the device can be adjusted from 10 to 50 Watts and the maximum skin temperature cutoff can be adjusted from 35℃ to a maximum of 42°C. The hand pieces are operated while in continuous movement over the treatment area. This ensures uniform and safe heating of the entire treatment area.
Each InMode PLUS hand piece is comprised of the hand piece handle, a cable 250 cm long, and a connector, which connects to the rear connector of the InMode PLUS System.
Three InMode PLUS hand pieces are available:
- . InMode PLUS hand piece
- InMode PLUS90 hand piece
- InMode PLUS-PLUS hand piece (
The provided text does not describe the acceptance criteria and study proving a device meets these criteria in the context of an AI/ML-based medical device. Instead, it is a 510(k) premarket notification summary for the InMode PLUS System, an electrosurgical cutting and coagulation device. This document focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) submissions.
Therefore, I cannot provide the requested information regarding acceptance criteria, performance studies (like MRMC or standalone AI performance), sample sizes for AI training/testing sets, expert ground truth establishment, or any information typical for an AI/ML device submission.
The document states:
- "Clinical Performance Data: Not Applicable" (Page 5)
- "Software & Cybersecurity: The InMode PLUS System software is based on the software modules of the predicate device... The device software was adjusted to support the integration and operation of the PLUS-PLUS hand piece. The software is designed in accordance with ISO 62304 standard - Medical device software- Software life cycle processes. The InMode PLUS System is a closed, standalone system and as such it is not effected by cybersecurity related issues." (Page 6)
This clearly indicates:
- No clinical trials were performed or were necessary for this submission.
- The software is for basic device operation and control, not for diagnostic or predictive AI functions. It's an update to existing software for a new handpiece, following standard software lifecycle processes.
To answer your request based only on the provided text, I can only state that the document does not contain the information you are asking for, as it pertains to a different type of medical device submission and a different type of technology.
§ 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.