(296 days)
The EVOLVE System with the Tone Applicator is an electro-muscle and transcutaneous nerve stimulation device for the treatment of different body areas.
The EVOLVE System with Tone Applicator is designed to operate in two modes - EMS and TENS.
In EMS mode it is used for:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
And in TENS mode is intended for
- Symptomatic relief and management of chronic, intractable pain
- Post-surgical acute pain
- Post-trauma acute pain
The EVOLVE System in combination with Tone Applicator (manufactured by InMode Ltd.), is a computerized device intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications.
The EVOLVE System with the Tone Applicator consists of an AC/DC power supply unit, controller and user interface including an LCD touch screen. The Tone Applicator is connected to the console via a cable, each of the subject device applicator units consist of a designated cable and of a connection port to be directly connected to one of the four connectors positioned on the rear side of the console. Up to four Tone Applicator units can be connected to the console simultaneously.
The delivery of the electrical energy is controlled by a Start/Stop button positioned on the LCD screen.
The System supports the following components:
- LCD display touch screen .
- Audio loudspeaker ●
- . 48V AC/DC power supply
- Controller
- . Fans
The System operates while connected to the Tone Applicator.
The provided document is a 510(k) summary for the InMode Ltd. EVOLVE System with the Tone Applicator. This type of submission to the FDA focuses on demonstrating substantial equivalence to a predicate device, rather than proving independent effectiveness through extensive clinical trials. Therefore, the information typically found in a study demonstrating acceptance criteria for the device's performance (especially related to clinical efficacy or AI model performance) is largely absent.
The "acceptance criteria" discussed in this document primarily refer to compliance with recognized consensus standards for safety and basic performance (bench testing) and demonstrating similar characteristics to a predicate device. There is no mention of an AI model within this submission, nor are there any clinical effectiveness studies, MRMC studies, or details on establishing ground truth for AI algorithms.
However, I can extract the information related to the device's performance based on the provided text, focusing on the available "acceptance criteria" (which are regulatory conformity and bench testing results) and the performance data for those criteria.
Based on the provided FDA 510(k) summary (K201285), here's an analysis of the "acceptance criteria" and the "study" proving the device meets them:
Crucial Caveat: This 510(k) summary does not describe an AI/ML model or its performance. The "acceptance criteria" and "study" described here pertain to the safety and basic functional performance of a medical device (an electro-muscle and transcutaneous nerve stimulator) demonstrating substantial equivalence to a legally marketed predicate device. Therefore, many of the requested points related to AI/ML model evaluation (e.g., sample sizes for training/test sets, expert adjudication of ground truth, MRMC studies) are not applicable and will not be found in this document.
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here are framed as compliance with recognized consensus standards and meeting design requirements through bench testing. The "reported device performance" is the confirmation that these tests were passed and the design requirements were met. The table below summarizes the key performance specifications and their acceptance against the predicate device.
| Acceptance Criteria (What was measured) | Reported Device Performance (Subject Device) | Comparison/Comment (Relative to Predicate K192249) | Proving Study/Method |
|---|---|---|---|
| General Safety and Essential Performance | Compliance with ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 | Complied. Similar to predicate. | Bench testing, Electrical and mechanical safety testing |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 Edition 4.0 2014-02 | Complied. Similar to predicate. | EMC testing |
| Nerve and Muscle Stimulator Specific Safety | Compliance with IEC 60601-2-10 Edition 2.1 2016-04 | Complied. Similar to predicate. | Safety and essential performance testing |
| Usability | Compliance with IEC 60601-1-6 Edition 3.1 2013-10 | Complied. Similar to predicate. | Usability assessment/compliance |
| Biocompatibility of Patient-Contacting Materials | Compliance with ISO 10993-1 standard | Complied. Similar to predicate. | Biocompatibility testing |
| Output Waveform | Symmetrical Biphasic, Rectangular shape (Both EMS & TENS modes) | Identical to predicate. | Bench testing (validation of output waveform) |
| Maximum Output Voltage (EMS) | 56V @ 500Ω, 2 kΩ, 10 kΩ (± 10%) | Identical to predicate. | Bench testing (validation of output specifications) |
| Maximum Output Current (EMS) | 92.86 mA @ 500 Ω, 26.7 mA @ 2 kΩ, 5.4 mA @ 10 kΩ (± 10%) | Subject device current slightly lower at 500Ω (92.86mA vs 98.46mA) and 2kΩ (26.7mA vs 27.3mA) than predicate, identical at 10kΩ. Considered "minor differences." | Bench testing (validation of output specifications) |
| Pulse Width (EMS & TENS) | 20 to 400 μs | Identical to predicate. | Bench testing (validation of output specifications) |
| Frequency (EMS & TENS) | 3 to 200 Hz | Identical to predicate. | Bench testing (validation of output specifications) |
| Maximum Phase Charge (EMS) | 43.2 μC @ 500Ω | Identical to predicate. | Bench testing (validation of output specifications) |
| Maximum Current Density (EMS) | 0.72 mA/cm² (Surface = 12cm²) | Identical to predicate. | Bench testing (validation of output specifications) |
| Maximum Power Density (EMS) | 55 mW/cm² @ 500Ω | Identical to predicate. | Bench testing (validation of output specifications) |
| Maximum Output Voltage (TENS) | 36V @ 500Ω, 2 kΩ, 10 kΩ (± 10%) | Identical to predicate. | Bench testing (validation of output specifications) |
| Maximum Output Current (TENS) | 67.8 mA @ 500 Ω, 17.7 mA @ 2 kΩ, 3.6 mA @ 10 kΩ (± 10%) | Subject device current slightly lower at 500Ω (67.8mA vs 72mA) and 2kΩ (17.7mA vs 18mA) than predicate, identical at 10kΩ. Considered "minor differences." | Bench testing (validation of output specifications) |
| Maximum Phase Charge (TENS) | 28.8 μC @ 500Ω | Identical to predicate. | Bench testing (validation of output specifications) |
| Maximum Current Density (TENS) | 0.48 mA/cm² (Surface = 12cm²) | Lower than predicate (0.48 mA/cm² vs 0.65 mA/cm²). Considered "minor differences." | Bench testing (validation of output specifications) |
| Maximum Power Density (TENS) | 17.3 mW/cm² @ 500Ω | Lower than predicate (17.3 mW/cm² vs 22.7 mW/cm²). Considered "minor differences." | Bench testing (validation of output specifications) |
| Software/Firmware/Microprocessor Control | Yes | Identical to predicate. | Software validation testing (mentioned under performance tests) |
| Automatic Overload/No-Load Trip, Automatic Shut Off | Yes | Identical to predicate. | Bench testing, adherence to safety standards |
| Patient Override Control | Yes | Identical to predicate. | Device functionality review |
| Timer Range | 0-60 minutes | Identical to predicate. | Device functionality review |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: This is a medical device safety and performance submission, not an AI/ML model evaluation. Therefore, there are no "test set" sample sizes in the sense of patient data for clinical performance evaluation. The "tests" performed are bench tests and compliance with recognized standards.
- Data Provenance: The "data" comes from mandated bench testing and compliance documentation. There is no mention of patient data, clinical studies, or data provenance (e.g., country of origin, retrospective/prospective) in the context of efficacy testing. The document explicitly states "Clinical Performance Data: Non-Applicable."
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This submission does not involve an AI/ML model where "ground truth" adjudicated by experts is typically needed. The "ground truth" for this device's performance is established by direct physical measurements during bench testing and adherence to engineering and safety standards.
4. Adjudication Method for the Test Set:
- Not Applicable. As there is no clinical or image-based "test set" requiring expert interpretation or labeling, no adjudication method (e.g., 2+1, 3+1) was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable. No MRMC study was done, as this is not an AI-assisted diagnostic device, nor is it reporting on human reader performance. The document states "Clinical Performance Data: Non-Applicable."
6. Standalone (Algorithm Only) Performance:
- Not Applicable. There is no AI algorithm being evaluated. The device functions as a physical muscle/nerve stimulator.
7. Type of Ground Truth Used:
- Technical Specifications and Compliance with Standards. The "ground truth" for this device's acceptance is its adherence to a specified design and its ability to pass established engineering, electrical safety, EMC, and specific performance standards for muscle/nerve stimulators (e.g., IEC 60601 series). This is verified through direct measurement and documentation from bench testing.
8. Sample Size for the Training Set:
- Not Applicable. There is no AI/ML model for which a "training set" would be used.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no AI/ML model, there is no training set or associated ground truth establishment process.
In summary: The provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device. It focuses on engineering specifications, safety compliance, and bench testing, not on the performance of a software algorithm or clinical efficacy requiring a test set, ground truth experts, or training data for AI.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).