(87 days)
sEMG:
Biofeedback, Relaxation & Muscle Re-Education purposes;
NMES (muscle stimulation) and sEMG triggered stimulation (Including ETS, PAS and MIRROR Mode):
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Relaxation of muscle spasms;
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Prevention or retardation of disuse atrophy;
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Increasing local blood circulation;
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Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis;
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Maintaining or increasing range of motion;
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Stroke Rehab by Muscle re-education.
The Nerve and Muscle Stimulator (model: XFT-2003K) is an electrical muscle stimulator for contraction of muscles as indicated above. The Nerve and Muscle Stimulator (model: XFT-2003K) is also an electromyography device. It is intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves and to monitor and display the electrical activity produced by nerves. The indications for use are muscle reeducation, relaxation and biofeedback.
Nerve and Muscle Stimulator (model: XFT-2003K) is powered by MAINS SUPPLY AC 100-240V, 50-60Hz, and used together with Electrode cup (including Sponge).
The device is used for prescription. It is neither for life-supporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterilized.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Nerve and Muscle Stimulator:
The provided document is a 510(k) Summary for a medical device (Nerve and Muscle Stimulator, model XFT-2003k) seeking substantial equivalence to a predicate device (MYOTRAC INFINITI, K053266). This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than proving its absolute safety and effectiveness through extensive new clinical trials.
Therefore, direct acceptance criteria and a "study that proves the device meets the acceptance criteria" in the traditional sense of a de novo device approval are not present in this document. Instead, the document provides a comparison to a predicate device and relies on adherence to recognized standards and the established safety and effectiveness of the predicate.
Here's a breakdown of the requested information based on the provided text, with explanations where direct answers are not available:
1. Table of acceptance criteria and the reported device performance
As mentioned, there are no explicit "acceptance criteria" presented as specific performance metrics and thresholds for the subject device to meet independently. The core of this 510(k) submission is to demonstrate substantial equivalence to the predicate device. The "performance" reported is primarily in terms of compliance with recognized electrical safety, EMC, and biocompatibility standards, and a detailed parameter-by-parameter comparison with the predicate device.
Here's a table summarizing the reported device performance in relation to the predicate, as presented in the "SE Comprehensive Comparison Table" and "SE General Specification Comparison Table":
| Acceptance Criteria (Implied by Predicate Comparison & Standards) | Reported Subject Device Performance |
|---|---|
| Intended Use/Indications for Use: Equivalent to predicate. | sEMG: Biofeedback, Relaxation & Muscle Re-Education purposes. |
| NMES (muscle stimulation) and sEMG triggered stimulation (Including ETS, PAS and MIRROR Mode): 1) Relaxation of muscle spasms; 2) Prevention or retardation of disuse atrophy; 3) Increasing local blood circulation; 4) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; 5) Maintaining or increasing range of motion; 6) Stroke Rehab by Muscle re-education. (Stated as "SE" (substantially equivalent) to predicate, which has largely similar indications with 7 points.) | |
| Biocompatibility: Compliance with ISO 10993-1/-5/-10. | Compliance with ISO 10993-1/-5/-10: All patient contacting materials are in compliance. ("Same" as predicate.) |
| Electrical Safety: Compliance with IEC 60601-1. | Compliance with IEC 60601-1: Demonstrated. ("Same" as predicate.) |
| EMC: Compliance with IEC 60601-1-2. | Compliance with IEC 60601-1-2: Demonstrated. ("Same" as predicate.) |
| Performance (general): Compliance with IEC 60601-2-10. | Compliance with IEC 60601-2-10: Demonstrated. ("Same" as predicate.) |
| Line Current Isolation: 2MOPP. | 2MOPP. ("Same" as predicate.) |
| Patient Leakage Current (Normal Condition): ≤ 1 μA. | ≤ 1 μA. ("Same" as predicate.) |
| Patient Leakage Current (Single Fault Condition): ≤ 1 μA. | ≤ 1 μA. ("Same" as predicate.) |
| Waveform: Functionally equivalent to predicate. | Pulsed, Symmetrical balanced biphasic wave (rectangular). ("SE" (substantially equivalent) to predicate's asymmetrical balanced pulsed current, indicating functional equivalence for its purpose.) |
| Maximum Output Voltage: Within acceptable therapeutic range. | Ranges vary by mode (e.g., NMES P1-P6: 50V@500Ω, 125V@2kΩ, 125V@10kΩ). Compared to predicate (50V@500Ω, 100V@2kΩ, 100V@10kΩ). ("SE" with remark that NMES modes are compared to STIM mode of predicate, and ETS/PAS/Mirror modes compared to Threshold/Triggered modes of predicate. Values are often the same or slightly different but within therapeutic range.) |
| Maximum Output Current: Within acceptable therapeutic range. | Ranges vary by mode (e.g., NMES P1-P6: 100mA@500Ω, 62.5mA@2kΩ, 12.5mA@10kΩ). Compared to predicate (100.0mA@500Ω, 50mA@2kΩ, 10mA@10kΩ). ("SE" with similar remarks as Max Output Voltage. Values are often the same or slightly different but within therapeutic range.) |
| Pulse Duration/width: Within acceptable therapeutic range. | Ranges vary by mode (e.g., NMES P1: 250µs; P3: 50µs; P29-P34: 400µs). Compared to predicate (50-400µs). ("SE" to predicate's range.) |
| Frequency: Within acceptable therapeutic range. | Ranges vary by mode (e.g., NMES P1: 5Hz; P4: 100Hz; P43: 2-250Hz). Compared to predicate (2-100Hz). ("SE" to predicate's range, with some subject device modes exceeding the predicate's upper range or having different specific frequencies.) |
| Net Charge per pulse: 0 (balanced). | 0@500Ω. ("Same" as predicate.) |
| Maximum Phase Charge: Within acceptable therapeutic range. | Ranges vary by mode (e.g., NMES P1, P6: 25@500Ω; P29, P33, P37: 40@500Ω). Compared to predicate (60@500Ω). ("SE", generally lower than predicate, considered safe.) |
| Maximum Current Density: Equivalent or lower than predicate. | NMES: P43: 0.38977@500Ω (EC001); 0.14696@500Ω (EC002). Compared to predicate's 0.24mA/cm2 (895220) and 0.08mA/cm2 (895340). (Note 05 states treatment effect is mainly determined by Max Power Density.) The values are within the range or comparable to predicate. |
| Maximum Power Density: Equivalent or lower than predicate. | NMES: P30, P34, P43: 11.69@500Ω (EC001); 4.41@500Ω (EC002). Compared to predicate's 16mW/cm2 (895220) and 5.3mW/cm2 (895340). (Note 06 argues these values are "effective" by referencing other cleared devices with lower power densities, demonstrating it is within an acceptable therapeutic range.) |
| Burst Mode: Functionally equivalent or therapeutically acceptable. | (a) Pulses per burst: 2~6000 (Predicate: 4-2000). (Note 07 states difference does not affect safety/effectiveness because duty cycle is same.) |
| (b) Bursts per second: 0.05~1 (Predicate: 0.05-0.5). | |
| (c) Burst duration (seconds): 1~20 (Predicate: 2-20). | |
| (d) Duty Cycle: 1 (Predicate: 1). ("Same" as predicate.) |
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 (N/A). The submission explicitly states "Brief discussion of clinical tests: N/A." The evaluation is based on non-clinical testing (bench testing, standards compliance) and a comparison to a predicate device, not on a clinical test set from a study.
- Data provenance: N/A for clinical data. Non-clinical testing data would be generated in Shenzhen, China (manufacturer's location).
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)
- Number of experts and qualifications: N/A. No clinical test set with human-established ground truth was used. The ground truth for substantial equivalence is derived from the predicate device and established medical device standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: N/A. No clinical test set was used 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
- MRMC study: N/A. This is an electrical stimulator, not an imaging device with human readers or AI assistance in the way typically discussed for MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone performance: The assessment for this device is essentially "standalone" in that it's the device's technical specifications and electrical outputs being compared to standards and the predicate. There isn't an "algorithm-only" component as might be found in AI/ML submissions. Its performance is evaluated on its inherent properties and safety characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: The "ground truth" in this 510(k) context is the established safety and effectiveness of the legally marketed predicate device (Thought Technology Ltd. MYOTRAC INFINITI, K053266) and adherence to recognized performance and safety standards for powered muscle stimulators (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993). The "truth" is that the predicate is safe and effective for its intended use, and the new device is substantially equivalent if it meets similar technical specifications and standards.
8. The sample size for the training set
- Sample size for training set: N/A. There is no mention of a training set for an algorithm, as this device is a hardware-based electrical stimulator, not an AI/ML device.
9. How the ground truth for the training set was established
- How ground truth for training set was established: N/A. No training set was used.
In summary: The provided document is a 510(k) summary, which aims to demonstrate "substantial equivalence" to a predicate device, not to prove de novo safety and effectiveness through clinical trials. Therefore, many of the questions related to clinical studies, test sets, ground truth establishment by experts, and AI performance are not applicable to this type of regulatory submission as presented. The "study" that proves the device meets the (implied) acceptance criteria is the non-clinical testing demonstrating compliance with relevant international safety and performance standards (e.g., IEC 60601 series, ISO 10993) and the detailed comparison of its technical specifications to those of a legally marketed predicate device.
§ 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).