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Indications For Use (Available for GM3X0T/GM3AX0T, GM3X0PP/GM3AX0PP, and TENS function of GM3X0TE/GM3AX0TE): This device is a prescription device and only for symptomatic relief of chronic intractable pain.

Indications For Use (Available for GM3X0E/GM3AX0E, & 'EMS function' of GM3X0TE/GM3AX0TE):

• Relaxation of muscle spasms.
• Prevention or retardation of disuse atrophy.
• Increasing local blood circulation.
• Muscle re-education.
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
• Maintaining or increasing range of motion.

Indications For Use (Available for GM3X0PE/GM3AX0PE):

• Relaxation of muscle spasms.

The GEM-STIM TENS series, including GM3X0T/GM3AX0T, GM3X0E/GM3AX0E, GM3X0PP/GM3AX0PP, GM3X0PE/GM3AX0PE, and GM3X0TE/GM3AX0TE are transcutaneous electrical nerve stimulator used for pain relief and/or powered muscle stimulator by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.

GEM-STIM TENS series, models GM3X0T/GM3AX0T, GM3X0E/GM3AX0E, GM3X0PP/GM3AX0PP, GM3X0PE/GM3AX0PE, and GM3X0TE/GM3AX0TE, consist mainly of two parts: the stimulus generator, electrode. The stimulus generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief.

The stimulation mode for GEM-STIM TENS includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.

This 510(k) premarket notification is for the GEM-STIM TENS series of devices (Models GM3XY and GM3AXY), which are transcutaneous electrical nerve stimulators (TENS) and powered muscle stimulators (EMS). The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

The acceptance criteria for this device and the study that proves it meets these criteria are primarily based on demonstrating substantial equivalence to predicate devices through compliance with recognized standards and non-clinical testing. The document explicitly states that formal clinical studies with specific performance metrics are not required in this context.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

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 specify a "test set" in the context of clinical performance or a patient-based study. The "test set" here refers to the parameters and functions of the device itself being tested for compliance with standards.

• Sample Size: Not applicable in the context of a biological or patient sample size. The tests performed are on the device itself.
• Data Provenance: The tests are non-clinical, likely conducted by the manufacturer (GEMORE TECHNOLOGY CO., LTD., Taiwan) or accredited testing laboratories. The document doesn't explicitly state the country of origin of the testing data beyond the submitter's location in Taiwan. The study is not a retrospective or prospective clinical study but rather engineering and software verification and validation.

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)

This section is not applicable as the submission relies on demonstrating compliance with recognized engineering and safety standards, and software verification guidance, rather than expert-derived ground truth from clinical images or patient outcomes. The "ground truth" is defined by the technical specifications and performance requirements outlined in the standards, and the predicate devices' established safety and effectiveness.

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

None. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth or interpret results. This submission focuses on non-clinical testing and compliance with predefined standards.

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

No. An MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging devices often involving AI, which is not the nature of the GEM-STIM TENS device.

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

Yes, in spirit. The "standalone" performance here refers to the device's technical specifications and electrical output conforming to the relevant standards (ANSI/AAMI, EN 60601-1, EN 60601-1-1, EN 60601-1-2) and the software performing as intended according to FDA software guidance. There is no "human-in-the-loop" performance test described in the context of the substantial equivalence demonstration, as the device's fundamental function is electrical stimulation, not interpretation or decision-making. The safety and effectiveness are established by its design and adherence to these standards.

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

The "ground truth" in this context is based on:

• Compliance with recognized voluntary standards: ANSI/AAMI, NS4-1985, EN 60601-1, EN 60601-1-1, and EN 60601-1-2. These standards define the acceptable performance and safety criteria for such devices.
• FDA software guidance: Ensuring the software functions as designed and risks are mitigated.
• Predicate devices' established safety and effectiveness: The fact that the predicate devices (Well-Life WL-2203, WL-2204, WL-2205) were already cleared by the FDA implies their safety and effectiveness form the benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI models that require a "training set" in the conventional sense. The "training" for the device's development involves engineering design, component selection, and adherence to established medical device manufacturing practices and standards.

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

Not applicable for the same reason as point 8.

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