(490 days)
TG-BODY, MI&Body, S-Trainer are intended to stimulate healthy muscles in order to improve or facilitate muscle performance and not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
The MIGA Co.,Ltd OTC EMS System . model TG-Body. S-Trainer and Mi&Body are intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance; it is not intended as a therapy for any medical condition. Basically the model TG-body, powered by 4.8V, S-Trainer, powered by 3.6V and Mi&Body, powered by 3.7V are muscle stimulation devices and identical to the predicate device -K011880 (Compex Sport) with the following features: It is a portable, battery operated neuromuscular electronic stimulation system. It contains 6 programs as similar to the predicate device; the output waveform is selectable pre-programming change among P1-P6 (in case of TG-body 10) The output strength is adjustable at 0-100mA via regulated voltage, with variable set time 5-60 minutes counting from starting session. The LCD display is provided for the indication of operation status including operation mode, output program mode, output intensity, time to cut-off, and battery low indication.
This is an interesting case where the provided document is a 510(k) summary for a powered muscle stimulator, not an AI/ML device. Therefore, many of the requested categories (like sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable.
However, I can extract the acceptance criteria and the methods used to demonstrate the device meets those criteria, primarily through comparison to a predicate device and adherence to industry standards for medical electrical equipment.
Here's an analysis based on the provided text, indicating where information is not applicable for a non-AI/ML medical device submission:
Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for "TG-BODY, MI&Body, S-Trainer" are implicitly defined by its substantial equivalence to the predicate device (K011880 Compex Sport Stimulator) and compliance with relevant safety and performance standards. The "performance" is demonstrated by showing that the new devices have comparable characteristics and meet the same standards.
| Feature/Criterion (Implicit Acceptance Criteria: Equivalent to Predicate or Standard) | TG-BODY Performance | Mi&Body Performance | S-Trainer Performance | Predicate Device (K011880 Compex Sport) |
|---|---|---|---|---|
| Intended Use (Improve/facilitate muscle performance, not for medical conditions) | Same as Predicate | Same as Predicate | Same as Predicate | Stimulate healthy muscles |
| Technological Characteristics | Equivalent | Equivalent | Equivalent | - |
| Performance Properties | Equivalent | Equivalent | Equivalent | - |
| Power Source(s) | 4.8V | 3.7V | 3.6V | 7.2V |
| Method of Line Current Isolation | Transformers isolation | Transformers isolation | Transformers isolation | Transformers isolation |
| Patient Leakage Current - Normal Condition | 2uA | 2uA | 2uA | 2uA |
| Patient Leakage Current - Single Fault Condition | 13uA | 13uA | 13uA | 15uA |
| Number of Output Mode | 1 | 1 | 1 | 1 |
| Number of Output Channels | 4 | 2 | 1 | 4 |
| Synchronous or Alternating | Synchronous | Synchronous | Synchronous | Synchronous |
| Method of Channel Isolation | Galvanic | Galvanic | Galvanic | Galvanic |
| Regulated Current or Regulated Voltage? | 500ohm RMS 26mA/13.0V, 2Kohm RMS 8.4mA/16.8V | 500ohm RMS 15mA/7.5V, 2Kohm RMS 4.0mA/8.1V | 500ohm RMS 15mA/7.5V, 2Kohm RMS 4.0mA/8.1V | 500ohm RMS 21mA/11.8V, 2Kohm RMS 7mA/16V |
| Software/Firmware/Microprocessor Control | Yes | Yes | Yes | Yes |
| Automatic Overload Trip | Yes | Yes | Yes | Yes |
| Automatic No-Load Trip | Yes | Yes | Yes | Yes |
| Automatic Shut Off | Yes | Yes | Yes | Yes |
| Patient Override Control | Yes | Yes | Yes | Yes |
| Indicator Display - On/Off Status | Yes | Yes | Yes | Yes |
| Indicator Display - Low Battery signal | Yes | Yes | Yes | Yes |
| Indicator Display - Voltage/Current Level | No | No | No | No |
| Timer Range (Minutes) | 1 ~ 60 | 20 ~ 33 | 20 ~ 33 | 1 ~ 60 |
| Compliance with Voluntary Standards | EN 60601-1, -1-1, -1-2, -2-10 | EN 60601-1, -1-1, -1-2, -2-10 | EN 60601-1, -1-1, -1-2, -2-10 | EN 60601-1, -1-1, -1-2, -2-10 |
| Compliance with 21 CFR 898? | Yes | Yes | Yes | Yes |
| Weight | 360g | 120g | 70g | 350g |
| Dimensions(WHD) | 10616238.5(mm) | 64.8103.626(mm) | 515114(mm) | 1429936(mm) |
| Housing Materials and Construction | ABS | ABS | ABS | Plastic case |
| Name of the output Mode | Square wave | Square wave | Square wave | Square wave |
| Clearly labeled amplitude and times axes | 0~300 | 0~300 | 0~300 | 0~300 |
| Identification of the amplitude baseline | - | - | - | - |
| List of all output parameter setting the load resistance | - | - | - | - |
| Waveform | Symmetrical biphasic square | Symmetrical biphasic square | Symmetrical biphasic square | Symmetrical biphasic square |
| Shape | Rectangular | Rectangular | Rectangular | Rectangular |
| Maximum output Voltage | 100V peak | 40V peak | 40V peak | 100V peak |
| Maximum output Current | 26mA | 14.4mA | 13.3mA | 21mA |
| Pulse Width | 50 ~300 | 150-300 | 150~300 | 200 ~ 400 |
| Frequency(Hz) | 4 ~100 | 4~100 | 4~100 | 1 ~ 120 |
| Beat Frequency(Hz) | - | - | - | - |
| For multiphasic waveforms only | - | - | - | - |
| Symmetrical phases | Yes | Yes | Yes | Yes |
| Phase duration(include units) | 1 - 0.005 | 0.25 ~ 0.01 | 0.25 ~ 0.01 | 0.1 - 0.001 |
| Net charge(mC per pulse) | 0 | 0 | 0 | 0 |
| Maximum Phase charge Density(uC) | 36 | 24 | 24 | 18 |
| Maximum Current Density(mA/cm2) | 1.0432 | 0.20571 | 0.26473 | 9.6 |
| Maximum Power Density(W/cm2) | 0.06259 | 0.01059 | 0.00823 | 0.046 |
| Burst mode | - | - | - | - |
| ON time(seconds) | 10 | 10 | 10 | - |
| OFF time(seconds) | 10 | 10 | 10 | - |
2. Sample size used for the test set and the data provenance
This is not an AI/ML device and therefore does not have a "test set" in the context of machine learning. The "testing" involved bench testing to verify performance specifications and compliance with standards. The document does not specify the number of units tested.
- Data Provenance: Not applicable for this type of device submission. The device is manufactured by Miga Medical Co., Ltd in Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device does not rely on interpretation of medical data or images requiring expert ground truth.
4. Adjudication method for the test set
Not applicable. There is no "test set" or human interpretation 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
Not applicable. This is not an AI/ML device, nor does it involve human readers or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used
Not applicable. The "ground truth" for this device's performance is objective measurement against engineering specifications and compliance with recognized safety and performance standards (e.g., EN 60601 series).
8. The sample size for the training set
Not applicable. This is not an AI/ML device and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets its acceptance criteria is based on:
- Substantial Equivalence Comparison: A detailed comparison table ([1], [2]) demonstrates that the new devices (TG-BODY, MI&Body, S-Trainer) have equivalent intended use, technological characteristics, and performance properties to the predicate device (K011880 Compex Sport stimulator). While some specific values (like maximum current, voltage, and pulse width) differ, these differences are presented within the context of demonstrating overall equivalence for safety and effectiveness for the stated intended use.
- Compliance with Consensus Standards: The devices meet consensus standards EN 60601-1 (general requirements for basic safety and essential performance), EN 60601-2-10 (particular requirements for nerve and muscle stimulators), EN 60601-1-2 (electromagnetic compatibility), and 21 CFR 898 (reports of adverse events). This is a critical component for demonstrating safety and performance.
- Bench Testing: The summary explicitly states, "Bench testing was also conducted to demonstrate performance specifications." This indicates physical testing was performed on the devices to verify that their measured characteristics (e.g., output parameters, timing, safety features) matched their design specifications and were consistent with the comparison to the predicate device.
Conclusion:
The manufacturer concluded that the TG-BODY, MI&Body, and S-Trainer devices are safe and effective and substantially equivalent to the predicate device based on the information provided in the premarket notification, including the comparison table, adherence to recognized standards, and bench testing results. The FDA's letter (K122393) confirms this determination of substantial equivalence.
§ 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).