(110 days)
To be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Muscle Trainer is a product that adopts modern electronic science and technology to delivers electric pulses generated to the user's skin through the electrodes.
Muscle Trainer is mainly composed of the host and electrode patches, as well as it is powered by CR2023 battery. Of which, the electrode patch is cleared in K171381.
Muscle Trainer includes KTR-230 series (KTR-230B, KTR-230W, KTR-230P), KTR-231, KTR-232, KTR-233 and KTR-234 model. All models have three operation modes and one channel, which can give certain electrical pulse through electrode patches on the skin. Their technical parameters are slightly different, but they share the basically same characteristics:
- Electric pulse combination, 0~12 levels can be adjusted and chosen according to personal preference.
- CR2032 Button batteries (DC3V) power supply, easy to use and safe.
The main differences among them are the followings but not affect its intended use:
- Appearance
- The number of control button: KTR-230 series, KTR-231 and KTR-232 have two buttons to control: KTR-233 and KTR-234 have three buttons to control.
- The number of electrode patch used: KTR-230 series, KTR-233 and KTR-234 are equipped with one electrode patch; KTR-231 is equipped with six electrode patches as well as KTR-232 is equipped with two electrode patches.
- Applied parts: KTR-230 series, KTR-233 and KTR-234 apply to abdomen, shoulder, arm, thigh and calf; KTR-231 applies to abdomen in the place where between ribs and hip bones; KTR-232 applies to waist, shoulder, arm, thigh and calf.
The provided text does not contain a typical "acceptance criteria" table with reported device performance metrics in the way one might expect for an AI/ML medical device, as this is a 510(k) for a physical medical device (a powered muscle stimulator). The "acceptance criteria" are implied by the compliance with various international standards and the demonstration of substantial equivalence to predicate devices.
Here's an interpretation of the "acceptance criteria" and "device performance" based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Description & Standard/Reference | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Direct contact components (electrode patches, support belt) must be biocompatible. (Electrode patches cleared under K171381). | Electrode patches are from a qualified supplier with FDA clearance (K171381). |
| Electrical Safety | Compliance with IEC 60601-1 (General requirements for basic safety and essential performance). | Passed IEC 60601-1. |
| EMC Safety | Compliance with IEC 60601-1-2 (Electromagnetic compatibility - Requirements and tests). | Passed IEC 60601-1-2. |
| Specific Safety (Stimulators) | Compliance with IEC 60601-2-10 (Particular requirements for the basic safety and essential performance of nerve and muscle stimulators). | Passed IEC 60601-2-10. |
| Software Verification | Compliance with FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices. | Software verification carried out according to FDA Guidance. |
| Home Healthcare Environment | Compliance with IEC 60601-1-11 (Requirements for medical electrical equipment and systems used in the home healthcare environment). | Passed IEC 60601-1-11. (Implies suitability for OTC use). |
| Waveform Output | Output specifications verified according to FDA Guidance for Powered Muscle Stimulator 510(k)s (Load conditions of 0.5kΩ, 2kΩ, 10kΩ). | Graphic waveform, output level, and max charge/current/power calculations recorded and passed. All models exhibit biphasic pulsed symmetric waveforms and consistent output design. |
| Electrode Patch Performance (Dispersion & Shelf Life) | Verification of current dispersion and shelf life per FDA Guidance Shelf Life of Medical Device and ASTM F 1980-07. Impedance uniformity across active areas. | Current Dispersion: No significant difference in impedance across multiple electrode patches, indicating uniform current distribution. All test results passed. |
| Shelf Life: Test results confirmed. | ||
| Output Electrical Parameters | Maximum output voltage, current, average current, phase charge, current density, power density, pulse frequency, and pulse duration within range of predicates and compliant with standards. | All reported values (Mode 1, 2, 3) are within the range of the predicate devices and compliant with IEC 60601-1, IEC 60601-2-10, and FDA Guidance for Powered Muscle Stimulator. |
| Substantial Equivalence | The device must not raise different questions of safety and effectiveness compared to predicate devices based on intended use, design, specifications, and performance. | Conclusion: The subject device Muscle Trainer is substantially equivalent to the predicate devices. |
Regarding the AI/ML-specific questions (2-9), the provided document does NOT discuss an AI/ML component or study of that nature.
The "Muscle Trainer" is a physical medical device (powered muscle stimulator) and the performance data section focuses on electrical safety, EMC, biocompatibility, and output waveform characteristics – typical for hardware-based medical devices seeking 510(k) clearance via substantial equivalence.
Therefore, for questions 2 through 9, the answer is that the provided document does not contain this information as the device is not described as an AI/ML product.
Specifically:
- 2. Sample sized used for the test set and the data provenance: Not applicable. Performance testing is standard engineering/electrical testing, not a clinical study involving a "test set" of patient data for an algorithm.
- 3. Number of experts used to establish the ground truth... and the qualifications of those experts: Not applicable. Ground truth as typically understood in AI/ML is not relevant here.
- 4. Adjudication method: Not applicable.
- 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.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
This document clearly outlines studies related to compliance with electrical safety standards, biocompatibility of materials, and validation of the device's electrical output parameters against established guidance and predicate devices, which are typical for traditional medical device clearance. It does not mention any AI or machine learning components.
§ 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).