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APPLICABLE FOR MH8000 (TENS/EMS COMBINATION UNIT) AND MH6000 (TENS/EMS COMBINATION UNIT) AND MH8200 (TENS) AND MH6200 (TENS): This device is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for (1) Symptomatic relief and management of chronic (long term) intractable pain and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems.

APPLICABLE FOR MH8000 (TENS/EMS COMBINATION UNIT) AND MH6000 (TENS/EMS COMBINATION UNIT) AND MH8100 (EMS) AND MH6100 (EMS): This device is an electrically powered muscle stimulator indicated for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy.

Device Description

The MH8000 Series, which includes models MH8000, MH8100, MH8200, MH6000, MH6100, MH6200, are Transcutaneous Electrical Nerve Stimulator for pain relief and/or Electrical Muscle 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 three models MH8000, MH8100 and MH8200 have the same housing. The three models MH6000, MH6100 and MH6200 have the same housing.

The process to set the parameter and attach lead wires to the six models are also the same. Yet, they have different liquid crystal display and parameters for patients to create their own settings.

The MH8200 and MH6200 are the TENS device with 5 modes and adjustable pulse rate, pulse width and timer. The MH8100 and MH6100 are the EMS device with 3 modes and adjustable pulse rate, pulse width, on time, off time, ramp time and timer, The MH8000 and MH6000 are the combination unit with both TENS and EMS functions, The function can be selected by press buttons. The range of settings are identical to those of MH8200, MH8100, MH6100 and MH6200. The difference on the six units can be identified by the liquid crystal display.

AI/ML Overview

The provided text is a 510(k) summary for TENS/EMS devices. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new, unique device. Therefore, many of the requested categories related to medical imaging AI study design are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the way one would for a performance study of a diagnostic device. Instead, it demonstrates substantial equivalence by comparing the technological characteristics and output specifications of the new devices (MH8000 Series) to those of predicate devices (Comfy STIM, Comfy EMS, Comfy TENS). The "acceptance criteria" can be inferred as being substantially equivalent to the predicate device across various parameters, within acceptable deviations that do not raise new questions of safety or effectiveness.

Key Performance Metrics (Technological Characteristics & Output Specifications Comparison):

Feature/Parameter	Acceptance Criteria (Predicate Device K071951)	Reported Device Performance (New Devices MH8000 Series)	Meets Criteria? (Inferred)	Notes/Differences
Primary Safety Standards	EN60601-1, EN60601-1-2	Voluntary EN60601-1, EN60601-1-2	Yes	New device explicitly states "Voluntary" compliance but confirms meeting the same standards. Test report numbers provided (UT96026, UT96027, EM/2007/20045, EM/2007/20046).
Power Source	9 volt battery type 6F22	9 volt battery type 6F22	Yes	Identical.
Number of Output Modes	TENS/EMS Combo: 7; EMS: 3; TENS: 5	TENS/EMS Combo: 7; EMS: 3; TENS: 5	Yes	Identical.
Number of Output Channels	2	2	Yes	Identical.
Channel Isolation	By TRANSFORMER	By TRANSFORMER	Yes	Identical.
Waveform	Asymmetrical biphasic pulse	Asymmetrical biphasic pulse	Yes	Identical.
Shape	Rectangular	Rectangular	Yes	Identical.
Pulse Width Control Range	50µS and 300µS	50µS and 300µS	Yes	Identical.
Pulse Rate Control Range	2 Hz and 150 Hz	2 Hz and 150 Hz	Yes	Identical.
ON Time (EMS)	Adjustable, 2~90 seconds, 1 Sec./step	Adjustable, 2~90 seconds, 1 Sec./step	Yes	Identical.
OFF Time (EMS)	Adjustable, 2~90 seconds, 1 Sec./step	Adjustable, 2~90 seconds, 1 Sec./step	Yes	Identical.
Burst Mode (TENS)	Pulses per buster: 10; Burst per second: adjustable, 0.5~~5; Burst duration: 100 mSec.; Duty Cycle: adjustable 50~~500 mSec.	Pulses per buster: 9; Burst per second: 2; Burst duration: 100 mSec.; Duty Cycle: 200 mSec.	Yes	Difference noted, but determined not to pose new questions of safety/effectiveness. New device's burst rate is fixed at 2Hz (for TENS mode B) or fixed burst rate = 21Hz (for TENS mode B on page 8 table), while predicate is adjustable (0.5~~5 Hz). New device's duty cycle is fixed at 200msec, predicate is adjustable (50~~500 msec). Pulses per buster are 9 vs 10.
Max Output Voltage (+/- 20%)	TENS/EMS: 50V @ 500 Ohm; EMS: 50V @ 500 Ohm; TENS: 50V @ 500 Ohm	TENS/EMS: 40.8V @ 500 Ohm; EMS: 40.8V @ 500 Ohm; TENS: 40.8V @ 500 Ohm	Yes	Difference noted, new device is smaller than predicate (and also for 2000 & 10000 Ohm). Determined not to pose new questions of safety/effectiveness.
Max Output Current (+/- 20%)	TENS/EMS: 100mA @ 500 Ohm; EMS: 100mA @ 500 Ohm; TENS: 100mA @ 500 Ohm	TENS/EMS: 81.6mA @ 500 Ohm; EMS: 81.6mA @ 500 Ohm; TENS: 81.6mA @ 500 Ohm	Yes	Difference noted, new device is smaller than predicate (and also for 2000 & 10000 Ohm). Determined not to pose new questions of safety/effectiveness.
Max Phase Charge	30 micro-coulombs @ 500 Ohm	24 micro-coulombs @ 500 Ohm	Yes	Difference noted, new device is smaller than predicate. The document argues this is within the safe range (3 micro-coulombs minimum for effectiveness) and therefore acceptable.
Max Current Density	1.33mA/$cm^2$ @ 500 Ohm	1.06mA/$cm^2$ @ 500 Ohm	Yes	Difference noted, new device is smaller than predicate. Determined not to pose new questions of safety/effectiveness.
Max Power Density	3.7mW/$cm^2$ @ 500 Ohm	2.4mW/$cm^2$ @ 500 Ohm	Yes	Difference noted, new device is smaller than predicate. Determined not to pose new questions of safety/effectiveness. (This metric is not explicitly mentioned for the TENS-only device EV-804 but for EMS EV-805).
Patient Leakage Current	Not explicitly quantified in table for predicate, but predicate implied to meet standards.	Normal condition: 1.5uA; Single fault condition: 1.7uA	Yes	Explicit values for new device provided; implied compliance with safety standards for both. These values would need to be within accepted limits for medical devices.
Weight	150 grams (battery included)	162 grams (battery included)	Yes?	Difference noted, new device is slightly heavier. Determined not to pose new questions of safety/effectiveness.
Dimensions	10.1(L)x6.1(W)x2.45(H)(cm)	13.6(L)x7(W)x2.7(H)(cm)	Yes?	Difference noted, new device is larger. Determined not to pose new questions of safety/effectiveness.
Housing Materials	ABS, 94V-1, 80°C, UL Approved; PC board: FR4, 94V-1, 105°C, UL Approved	ABS, 94V-1, 80°C, UL Approved; PC board: FR4, 94V-1, 105°C, UL Approved	Yes	Identical.

The document concludes that "Above differences of Technological Characteristics do not pose any new questions of safety and effectiveness." and "According to above conclusions, the new devices are substantially equivalent to the predicate devices and any differences between the devices do not pose any new questions of safety and effectiveness."

Study Information (Not an AI-based Diagnostic Device Study)

The provided text is a 510(k) Pre-market Notification for a TENS/EMS device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo clinical trial or AI performance study with the specific elements requested (sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance for AI, etc.).

Therefore, for the following points, the answer derived from the provided text is that the information is not applicable in the context of an AI-based diagnostic device study, or the study type is a non-clinical bench test comparison rather than a clinical performance study.

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. This is a non-clinical, bench testing comparison against specifications derived from a predicate device, not a human reader or AI performance study with a "test set" of cases/data points.
Data Provenance: Not applicable. The "data" consists of electrical output measurements and physical characteristics of the devices themselves, measured during manufacturing/testing processes, not patient data from a specific country or collected retrospectively/prospectively.

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" for this type of device comparison is established by reference to engineering specifications, national/international standards (e.g., EN60601-1, EN60601-1-2), and the technical characteristics of the predicate device. No human experts are used to establish ground truth on patient outcomes or interpretations in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no "adjudication" in the sense of resolving discrepancies in expert interpretations found in AI studies. The determination of whether the new device meets specifications is based on direct measurement and comparison to predefined engineering and safety limits.

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 imaging device or an AI assistant for human readers. No MRMC study was conducted or is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device (TENS/EMS unit) which functions directly on a patient; it does not involve a "standalone algorithm" in the context of AI performance. Its function is its standalone performance in delivering electrical stimulation according to its parameters.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: The "ground truth" here is based on engineering specifications, compliance with recognized international safety and EMC standards (EN60601-1, EN60601-1-2), and the established output characteristics of the legally marketed predicate device (K071951). The intent is to show that the new device's physiological effects (pain relief, muscle stimulation) will be similar because its electrical output characteristics are substantially equivalent within safe parameters. References to textbooks for efficacy of TENS/EMS treatments are cited (Meryl Roth Gersh, Val Robertson, etc.), indicating that the principles of electrotherapy for the stated indications are well-established.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

In summary, the provided document describes a bench testing and specifications comparison study to demonstrate substantial equivalence for a TENS/EMS device, not an AI performance study as typically seen for diagnostic algorithms. The "acceptance criteria" were met by showing that the new device's technical characteristics and output parameters are either identical to or within acceptable safety and effectiveness limits compared to the predicate device, especially considering that any differences (like slightly lower maximum output) were determined not to raise new questions of safety or effectiveness.

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