(597 days)
Legend Pro DMA is intended for muscle conditioning to stimulate healthy muscles.
Legend Pro DMA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
Legend Pro DMA is intended to be operated by a trained professional who is present to monitor treatment.
The Legend Pro DMA generates a sequence of electrical pulses which are delivered to the skin overlaying the muscles intended to be stimulated. The Legend Pro DMA consists of a floormounted, rolling System Console that generates voltage output delivered though metal electrodes in the three different DMA Applicators. The System Console generates electrical pulses, and delivers modulated low frequency rectangular biphasic waveforms via electrodes incorporated in different Applicators connected to the System Console:
- . LP DMA Applicator No. 1 for large Areas (includes 6 stainless-steel equidistant electrodes)
- . LP DMA Applicator No. 2 for Medium areas (includes 3 stainless-steel equidistant electrodes)
- LP DMA Applicator No. 3 for Small Areas (includes 3 stainless-steel equidistant ● electrodes)
The Legend Pro DMA is controlled by a proprietary embedded SW. The system SW provides the treatment parameters. The hardware (HW) then implements the actual pulse generation according to the parameters provided by the software. Via the GUI in the System Console, the physician selects the Applicator according to the size of the area being treated and the treatment parameters (Frequency, % Height/Amplitude, pulse width and Treatment Duration). During the treatment session, the operator moves the Applicator across the skin that is lubricated with glycerine.
The provided text does not contain detailed acceptance criteria for the Legend Pro DMA device, nor does it describe a study that explicitly proves the device meets specific acceptance criteria in the format requested.
Instead, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific, pre-defined acceptance criteria with a detailed study report. The "Performance Data" section lists various tests performed to establish safety and performance, which indirectly support the device's suitability for its intended use, but not against quantitative performance metrics.
Here's a breakdown of the requested information based on the provided text, highlighting where information is absent:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in the typical sense of numerical thresholds or performance targets. Instead, it compares the Legend Pro DMA's technical specifications to those of its predicate devices to demonstrate similarity and equivalence.
| Parameter | Acceptance Criteria (Not explicitly stated in document, inferred from predicate comparison) | Reported Device Performance (Legend Pro DMA) |
|---|---|---|
| Intended Use | To be substantially equivalent to predicate (muscle conditioning to stimulate healthy muscles) | Intended for muscle conditioning to stimulate healthy muscles. |
| Waveform | Biphasic, similar to predicate's rectangular biphasic waveform. | Biphasic, Rectangular |
| Max Output Voltage | Similar to predicate (e.g., 58V@500Ω) but not higher than 10VRMS at 500Ω. | 60V@500Ω (3.95VRMS), 200V@2000Ω (12.3VRMS), 360V@10000Ω (17.6VRMS) |
| Max Output Current | Similar to predicate (e.g., 108mA@500 Ω) | 120mA@500Ω, 100mA@2000Ω, 36mA@10000Ω |
| Pulse Width | Within ranges that do not raise issues of safety or effectiveness compared to predicate. | 20 to 400 µsec (Different from predicate's 500 to 2500 µsec, but deemed not to raise issues of safety or effectiveness) |
| Frequency | Within ranges that do not raise issues of safety or effectiveness compared to predicate. | 0.78, 1.56, 3.13, 6.25, 12.5 Hz (Different from predicate's 200 to 1200 Hz, but similar to reference's 75 Hz; deemed not to raise issues of safety or effectiveness) |
| Net Charge per pulse | Zero net charge, similar to predicate. | 0 @ 500Ω, achieved by symmetrical biphasic waveforms. |
| Max Charge per Phase | Similar to predicate (e.g., 45 µC @ 500 Ω @ 200 Hz). | 24µC @ 500Ω @ 12.5Hz |
| Max Current Density | Similar to predicate (e.g., 5 mA / cm²). | 1.1mA/cm² @ 500Ω |
| Max Power Density | Similar to predicate (e.g., 0.012 W/cm²). | 0.0044 W/cm² @ 500Ω |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-10. | Complies with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-10. |
| Software Safety | Compliance with IEC 62304 and FDA Guidance "Principles of Software Validation". | Complies with IEC 62304 and FDA Guidance "Principles of Software Validation". |
| Biocompatibility | Compliance with ISO 10993-1. | Complies with ISO 10993-1. |
Study Information
The document describes non-clinical performance data to support substantial equivalence, focusing on design verification and validation processes rather than a comparative effectiveness study.
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 Test Set: Not applicable in the context of device testing for substantial equivalence, as no patient-level test set data is described. The "Performance Data" section details engineering and laboratory testing on the device itself.
- Data Provenance: Not applicable. The tests are on the device's components and systems, not clinical data from patients.
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 is not applicable as there is no mention of a "test set" requiring expert ground truth in the clinical sense (e.g., image interpretation). The "ground truth" for the engineering and safety tests would be the established international standards and regulatory requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as there is no clinical test set requiring adjudication.
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
- No MRMC comparative effectiveness study was done or reported. The device is a powered muscle stimulator, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance data (algorithm only): The document mentions "Software verification and validation according to IEC 62304 and FDA Guidance 'Principles of Software Validation Guidance for Industry and FDA Staff, January 2002'." This confirms that the device's embedded software was validated as a standalone component, but it doesn't quantify its "performance" in the way one might for a diagnostic algorithm (e.g., sensitivity, specificity). Instead, it validates that the software functions as intended and meets safety requirements. There is no "human-in-the-loop" aspect to the software's direct operation regarding its core function of generating electrical pulses.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests is regulatory and international standards, such as:
- Risk analysis: ISO 14971
- Electrical, electromagnetic compatibility safety: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10
- Software verification and validation: IEC 62304 and FDA Guidance "Principles of Software Validation"
- Biocompatibility: ISO 10993-1
8. The sample size for the training set
- Not applicable. The device is a hardware and embedded software system, not a machine learning model that requires a "training set" in the conventional AI sense.
9. How the ground truth for the training set was established
- Not applicable for the reasons stated above.
§ 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).