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510(k) Data Aggregation
(120 days)
The InMode System with Tone Applicator is used in EMS mode for:
Prevention or retardation of disuse atrophy
Maintaining or increasing range of motion
Muscle re-education
Relaxation of muscle spasms
Increasing local blood circulation
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
And in TENS mode for: Symptomatic relief and management of chronic, intractable pain Post-surgical acute pain Post-traumatic acute pain
The InMode System in combination with Tone Applicator (manufactured by InMode Ltd.), is a versatile device intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications. The InMode System with Tone Applicator consists of an AC/DC power supply unit, controller and user interface including an LCD touch screen. The delivery of the electrical energy is controlled by a Start/Stop button positioned on the front panel.
This document describes the InMode System with Tone Applicator, a powered muscle stimulator. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device (Vectra Neo Clinical Therapy System, K132284), rather than presenting a standalone study with acceptance criteria for device performance in the clinical sense (e.g., sensitivity, specificity for a diagnostic device).
Therefore, this response will reframe the "acceptance criteria" as the performance standards and safety criteria the device was tested against for regulatory clearance. The "study that proves the device meets the acceptance criteria" refers to the non-clinical (bench) performance data and compliance with recognized standards.
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a powered muscle stimulator, the "acceptance criteria" revolve around demonstrating safety, electrical performance, and biocompatibility, as well as functional equivalence to the predicate device. The "reported device performance" are the results of the non-clinical tests and conformance to standards.
| Acceptance Criteria (Performance/Safety Standard) | Reported Device Performance |
|---|---|
| Electrical Safety & Essential Performance | |
| IEC 60601-1 (General Requirements for Basic Safety and Essential Performance) | Device complies with the standard. Specific safety parameters: Patient Leakage Current - Normal Condition (<100uA), Single Fault Condition (<300uA). Method of Line Current Isolation: Independent transformer isolated. Electrical Type: Type BF. Automatic Overload Trip, No-Load Trip, Shut Off, and Patient Override Control: Yes. |
| IEC 60601-1-2 (Electromagnetic Compatibility - Requirements and Tests) | Device complies with the standard. |
| IEC 60601-2-10 (Particular Requirements for Nerve and Muscle Stimulators) | Device complies with the standard. |
| Usability | |
| IEC 60601-1-6 (Usability) | Device complies with the standard. |
| Biocompatibility of User-Contacting Materials | |
| ISO 10993-1 (Biological evaluation of medical devices) | Cytotoxicity Study: Test article extract showed no evidence of causing cell lysis or toxicity (Conclusion: Non-toxic).ISO Acute Systemic Toxicity Study: Test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig (Conclusion: Non-toxic).ISO Guinea Pig Maximization Sensitization Test: No mortality or evidence of systemic toxicity (Conclusion: No irritation/sensitization). |
| Output Waveform Validation | Bench testing demonstrated validation of output waveform. |
| Basic Unit Characteristics Validation | Bench testing demonstrated validation of basic unit characteristics. |
| Output Specifications Validation | Bench testing demonstrated validation of output specifications. See detailed specifications in the document for EMS and TENS modes (e.g., Waveform: Symmetrical Biphasic, Pulse Shape: Rectangular, Max Output Voltage/Current, Pulse Width, Frequency, Net Charge, Max Phase Charge, Max Current/Power Density, Burst Mode parameters, On/Off time, Treatment Time). All conform to design requirements. |
| Mechanical Safety Testing | Testing performed according to IEC 60601-1 standard. |
| Software Validation Testing | Testing performed. |
| Equivalence to Predicate Device (K132284) | The subject device and predicate device utilize the same technology, for the same indication for use, and with similar design specifications. Performance specifications are in range or equal to those of the predicate device. Minor technical differences do not alter safety/effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size:
- For biocompatibility testing, the sample sizes are not explicitly stated in the provided text but are typically small animal groups (e.g., mice, guinea pigs) as per ISO guidelines.
- For bench testing, the "sample size" refers to the device itself being tested, which is typically one or a few units to ensure manufacturing consistency.
- Data Provenance: The data is from non-clinical (bench) performance testing and biocompatibility assessments conducted by the manufacturer, InMode Ltd., based in Israel. There is no indication of country of origin for the data other than the manufacturer's location. The studies are prospective in the sense that they are specifically performed for this regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the provided document describes a submission for a powered muscle stimulator based on non-clinical (bench) testing and substantial equivalence. There is no clinical study involving human or image data requiring expert interpretation or ground truth establishment for the device's performance characteristics. The "ground truth" for the technical and safety performance tests are the established standards (e.g., IEC, ISO) and the device's design specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. The document does not describe a clinical study or a test set requiring adjudication by experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The device is a powered muscle stimulator, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a physical medical device (muscle stimulator), not an algorithm or AI system. Its performance evaluation is based on its physical and electrical output characteristics and safety, not on algorithmic standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by:
- Compliance with recognized consensus standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10, and ISO 10993-1. These standards define acceptable performance and safety limits.
- Device design requirements: The device's output specifications (e.g., voltage, current, frequency, pulse width). Bench tests verify that the device's actual output matches these specified requirements.
8. The sample size for the training set
This section is not applicable. As a physical medical device, the InMode System with Tone Applicator does not utilize machine learning or AI, and therefore, no "training set" of data is used in its development or validation.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as #8.
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