(211 days)
The InMode PLUS System with the PLUS/PLUS90 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℃. The hand pieces are operated while continuously moving them over the treatment area. This ensures uniform and safe heating of the entire trea.
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.
Two InMode PLUS hand pieces are available:
- InMode PLUS hand piece (held perpendicular to the treatment area)
- InMode PLUS90 hand piece (held parallel to the treatment area)
Following are the InMode PLUS System specifications: Maximal RF Output Power: 50 Watt RF Output Frequency: 1.0[MHz] ± 2% Maximum Temperature (skin surface): 42°C ± 2°C
The provided document is a 510(k) Premarket Notification from the FDA for the InMode PLUS System. It details the device's indications for use, technical specifications, and the basis for its substantial equivalence to a predicate device.
However, it does not contain information about a clinical study involving human patients, human readers, or AI assistance for diagnostic purposes. The document explicitly states "Clinical Performance Data: Not Applicable."
The performance data presented is based on bench testing and ex-vivo tissue studies, not in-vivo human studies. Therefore, I cannot provide information on acceptance criteria related to human performance, multi-reader multi-case studies, or AI-assisted diagnoses.
The document discusses the following performance tests relevant to the device's substantial equivalence for its stated indications (temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation):
1. Acceptance Criteria and Device Performance (Bench and Ex-vivo Studies Only):
| Acceptance Criteria Category | Specific Criteria (Implicit from study design) | Reported Device Performance |
|---|---|---|
| RF Output Power Settings | Emitting RF energy within specified range. | "The InMode Plus System operates in compliance with the system requirements, emitting RF energy of up to 50W." (Maximum RF Output Power: 50 Watt) |
| Temperature Elevation Profile | Elevating tissue temperature to specified maximum safely. | "while elevating the tissue temperature up to 42ºC." (Maximum Temperature (skin surface): 42°C ± 2°C) |
| Ex-vivo Tissue Study | Evaluation of safety and temperature tissue penetration/depth profile. | Results demonstrated safety and appropriate penetration. (Specific numerical depth not provided, but deemed acceptable for comparison to predicate.) |
| Side-by-Side Bench Tests | Comparison of device RF performance settings to the predicate device for substantial equivalence. | "the InMode Plus System is as safe and effective as the predicate device for the same intended use." and "the InMode Plus System is substantially equivalent to the predicate Viora V10 System with the ST hand piece." |
| Cleaning Validation | Device can be effectively cleaned for re-use. | "The device had successfully passed the cleaning validation test." |
| Biocompatibility | Materials in contact with patients are biocompatible. | "All of the handpiece materials are biocompatible based on the established biocompatibility of the materials and per ISO 10993-1." |
| Electrical & Mechanical Safety | Compliance with relevant safety standards (IEC 60601-1, IEC 60601-2-2). | "The performance tests demonstrated that the minor differences in the device specifications meet the system requirements and do not raise new safety or effectiveness concerns." and "safety features and compliance with safety standards in the InMode Plus System are similar to the safety features and compliance with safety standards found in the predicate device." |
| Electromagnetic Compatibility (EMC) | Compliance with relevant EMC standards (IEC 60601-1-2). | "...electromagnetic compatibility testing according to IEC 60601-1-2." (Implied successful compliance). |
| Software Verification & Validation | Software meets requirements and performs as intended. | "The InMode Plus System underwent additional performance tests, including software verification and validation testing..." (Implied successful completion). |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of a clinical test set with human subjects/data. The testing involved benchtop components and ex-vivo tissue. Specific quantities of tissue or bench components are not detailed, but the studies were sufficient to demonstrate substantial equivalence for the stated indications.
- Data Provenance: The studies were non-clinical (bench) and ex-vivo tissue studies. The country of origin of the data is not specified beyond the manufacturer being in Israel and the regulatory submission to the USA. They were not retrospective or prospective human clinical studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. Ground truth, in this context, refers to the physical and electrical parameters measured during the bench and ex-vivo tests, as well as the established safety and performance characteristics of the predicate device. These are objective measurements rather than subjective interpretations by human experts for diagnostic purposes.
- Qualifications of Experts: N/A. The evaluation was based on engineering and scientific measurements and comparisons to established standards and the predicate device.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. There was no need for adjudication as the testing involved objective physical measurements and comparisons, not subjective interpretations requiring consensus among multiple readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Done?: No. This was a non-clinical submission, and no human studies (including MRMC studies) were conducted or reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):
- Done?: Not applicable. This device is an electrosurgical cutting and coagulation device, not an AI algorithm. Its performance is inherent to its physical operation and energy delivery, not an independent algorithmic output.
7. Type of Ground Truth Used:
- The "ground truth" used was based on:
- Objective Physical and Electrical Measurements: RF output power, temperature elevation, energy delivery profiles, etc.
- Established Material Properties and Safety Standards: Biocompatibility testing (ISO 10993-1), electrical and mechanical safety (IEC 60601-1, IEC 60601-2-2), and EMC (IEC 60601-1-2).
- Comparison to Legally Marketed Predicate Device: The performance and safety profile of the Viora V-ST Handpiece (K150035) served as the benchmark for substantial equivalence.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms. Its design and operational parameters are set by engineering principles.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable as there is no training set for this type of 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.