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510(k) Data Aggregation
(76 days)
The MC1 Plus is indicated for:
a) Therapeutic Massager:
- Provides temporary relief of minor muscle aches and pains;
- Relieves muscle spasms;
- Temporarily improves local blood circulation;
- Temporarily reduces the appearance of cellulite.
b) Ultrasonic Diathermy: - Relief of pain;
- Muscle spasms;
- Joint contractures;
- NOT for the treatment of malignancies.
MC1 Plus is a computerized body massager and ultrasound diathermy system. The MC1 Plus is supplied with two handpieces: one ultrasonic handpiece with two 1 MHz transducers mounted on it and one handpiece for computerized body massager.
The provided text is a 510(k) Summary for the General Project MC1 Plus device, a computerized body massager and ultrasound diathermy system. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (MC1, K091615), rather than describing a study with acceptance criteria for a novel device's performance.
Therefore, the requested information categories (1-7, 9) cannot be fully populated as they pertain to clinical studies designed to establish specific performance metrics against pre-defined acceptance criteria for a new device. This document primarily relies on engineering and electrical safety testing, and performance testing for equivalence to a predicate, not clinical trials to prove device efficacy against acceptance criteria.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the context of a clinical study for intended use. Instead, it demonstrates compliance with recognized electrical safety and performance standards, and comparison to a predicate device.
| Acceptance Criteria Category | Specific Criteria (from standards or predicate comparison) | Reported Device Performance (MC1 Plus) |
|---|---|---|
| Electrical Safety | Conformance to AAMI/ANSI ES60601-1 | Conforms |
| Electromagnetic Compatibility (EMC) | Conformance to IEC 60601-1-2 | Conforms |
| Ultrasonic Physiotherapy Equipment Electrical Safety | Conformance to IEC 60601-2-5 (3rd ed.) | Conforms |
| Tissue Heating Performance | Equivalence to MC1 (K091615) in terms of increasing tissue temperature to at least 40°C | "Testing showed that the MC1 Plus increases tissue temperature as required for ultrasonic diathermy.""The two 1 MHz ultrasound transducers can be considered equivalent to the MC1 in terms of heating tissue temperature to at least 40° C." |
| Leakage Current (Ground NC) | <0.500 mA (from IEC 60601-1) | 0.085 mA |
| Leakage Current (Ground SFC) | <1.0 mA (from IEC 60601-1) | 0.107 mA |
| Leakage Current (Patient NC DC) | <0.01 mA (from IEC 60601-1) | <0.001 mA |
| Leakage Current (Patient NC AC) | <0.10 mA (from IEC 60601-1) | <0.01 mA |
| Leakage Current (Patient SFC DC) | <0.05 mA (from IEC 60601-1) | <0.001 mA |
| Leakage Current (Patient SFC AC) | <0.50 mA (from IEC 60601-1) | <0.01 mA |
| Maximum Ultrasonic Power Output | Complies with IEC 60601-2-5 3rd ed. (reduced from prior device) | 15 W (reduced from 21 W) |
| Maximum Ultrasonic Intensity | Complies with IEC 60601-2-5 3rd ed. (reduced from prior device) | 3 W/cm² (reduced from 7 W/cm²) |
| ERA (Effective Radiating Area) | Complies with IEC 60601-2-5 (modified from prior device) | 4.9 cm² (modified from 3 cm²) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the context of human subjects or patient data. The "performance data" refers to engineering and electrical safety testing of the device itself. There is no information about data provenance (country of origin, retrospective/prospective) because it's not a clinical data study.
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)
Not applicable. Ground truth establishment by clinical experts is not mentioned as this is not a study involving diagnostic interpretation or clinical outcomes adjudicated by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" requiring adjudication in the context of clinical or diagnostic performance.
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
Not applicable. This device is a therapeutic massager and ultrasonic diathermy system; it does not involve "human readers" or "AI assistance" for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical therapeutic device, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is not applicable. The device's performance stands alone in its function without a human interpretation loop.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance claims appears to be:
- Engineering measurements and standards: Conformance to internationally recognized electrical safety and EMC standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-5) through direct testing of the device's electrical parameters and output.
- Comparison to predicate device: Demonstration that the MC1 Plus performs "similarly" to the predicate MC1 in terms of its ability to increase tissue temperature to at least 40°C. This implies that the predicate's established performance serves as the benchmark for this equivalence.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI model, there is no ground truth establishment for a training set.
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