(130 days)
MT9000 Combo TENS/EMS/IF/MIC Stimulator:
For TENS mode: 1. Symptomatic relief of chronic intractable pain, 2. Post traumatic pain 3. Post surgical pain
For EMS mode: 1. Relaxation of muscle spasm 2. Increase of local blood flow circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion. 6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis
For IF mode: 1. Symptomatic relief of chronic intractable pain, 2. Post traumatic pain 3. Post surgical pain
For MIC mode: 1. Symptomatic relief of chronic intractable pain, 2. Post traumatic pain 3. Post surgical pain
MT9001 TENS Stimulator: 1. Symptomatic relief of chronic intractable pain, 2. Post traumatic pain 3. Post surgical pain
MT9002 EMS Stimulator: 1. Relaxation of muscle spasm 2. Increase of local blood flow circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion. 6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis
MT9003 IF Stimulator: 1. Symptomatic relief of chronic intractable pain, 2. Post traumatic pain 3. Post surgical pain
MT9004 MICROCURRENT Stimulator: 1. Symptomatic relief of chronic intractable pain. 2. Post traumatic pain 3. Post surgical pain
The MT9000 Series Stimulator, which includes models MT9000, MT9001, MT9002, MT9003, MT9004, are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients. The five models MT9000, MT9001, MT9002, MT9003 and MT9004 have the same housing in a molded portable plastic case with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The case shape is rectangular. The LCD is located on the upper half of the rectangular face of the device, above the keypad. The LCD is used to display system information to the user. The device is equipped with a keypad composed of push buttons which are located below the LCD. The function for each button is defined by a symbol on the LCD corresponding to the button immediately below it. The process to set the parameter and attach lead wires to the five models is also the same. Yet, they have different liquid crystal display and parameters for patients to create their own settings. The MT9000 Combo TEN/EMS/IF/MIC Stimulator is the combination unit with the TENS, EMS. IF and MICROCURRENT functions, the function can be selected by press buttons. The range of settings is identical to those of MT9001, MT9002, MT9003 and MT9004. The difference on the five units can be identified by the LCD display.
The provided 510(k) summary for the MT9000 Series Electro-Stimulator (K093138) does not include acceptance criteria or a study demonstrating that the device meets such criteria.
Instead, this submission is a premarket notification (510(k)) that establishes substantial equivalence to a predicate device, the Sonicator Plus 940, ME940 Stimulator (K071137). The 510(k) process typically focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a specific study.
Here's a breakdown based on the information provided, highlighting what's present and what's explicitly absent:
1. Table of acceptance criteria and reported device performance:
- Not Applicable. The document explicitly states: "The MT9000 Series Electro-Stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence." (Section 7)
- The comparison focuses on technological characteristics and intended use to demonstrate substantial equivalence, rather than quantitative performance metrics against acceptance criteria.
2. Sample size used for the test set and the data provenance:
- Not Applicable. No clinical test set or data provenance is mentioned as no clinical studies were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No clinical test set and therefore no ground truth established by experts is mentioned.
4. Adjudication method for the test set:
- Not Applicable. No clinical test set and therefore no adjudication method is mentioned.
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 an electrical stimulator, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is an electrical stimulator, not an algorithm.
7. The type of ground truth used:
- Not Applicable. No clinical studies were performed to establish ground truth. Substantial equivalence was based on non-clinical testing against voluntary design standards and comparison with a predicate device.
8. The sample size for the training set:
- Not Applicable. No machine learning or AI component, thus no training set.
9. How the ground truth for the training set was established:
- Not Applicable. No machine learning or AI component, thus no ground truth for a training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the document):
The document explicitly states: "The MT9000 Series Electro-Stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Nonclinical testing was performed in order to validate the design according with the company's specified design requirements, and to assure conformance with the following voluntary design standards:" (Section 7)
The "study" or evidence provided to support the device's safety and effectiveness (and thus, its "acceptance" for market clearance via 510(k)) is based on:
- Non-clinical testing to validate design requirements.
- Conformance with voluntary design standards:
- IEC 60601-1 "Medical electrical equipment - Part 1: General requirements for safety".
- IEC 60601-1-2 "Medical electrical equipment - Part 1-2: General requirements for safety - Collateral Standard".
- IEC 60601-2-10 "Medical electrical equipment - Part 2: Particular requirements for the safety of nerve and muscle stimulators".
- Bench testing, safety report, and Risk Analysis Report documentation (Section 8).
- Biocompatibility testing for the ABS material of the device shell and reliance on the predicate's electrodes (K070612) (Section 5).
- A "side-by-side comparison" between the MT9000 Series Electro-Stimulator and the predicate device (Sonicator Plus 940, ME940 Stimulator, K071137) to establish substantial equivalence in intended use, fundamental technology, and operational characteristics (Section 6).
In essence, the device's "acceptance" is based on demonstrating it is sufficiently similar to an already cleared device and meets relevant electrical safety and performance standards, rather than proving novel clinical efficacy against specific, pre-defined quantitative acceptance criteria through a dedicated performance study.
§ 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).