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For Transcutaneous electrical nerve stimulator.

This device is a prescription device and only for symptomatic relief of chronic intractable pain.

For Power Muscle Stimulator.

• 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.

For Interferential Stimulator.

The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

The GEM-STIM Combo Stimulator; Model: GM304/GM384/GM394 is the combination of transcutaneous electrical nerve stimulator(TENS) and Interferential stimulation (IF) used for pain relief and/or powered muscle stimulator(EMS) 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.

The GEM-STIM Combo Stimulator: Model: GM304/GM384/GM394 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 or muscle stimulation of intended use purpose.

The GEM-STIM Combo Stimulator; Model: GM304/GM504 is basically the dual output channels unit which 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. And the model GM384/GM394 is the 4 channels model with the housing to install two independent units of GM504 and to provide the similar operation buttons which allow each unit of device being operated independently as that of the model GM504.

Basically the new models GM304/GM504/GM384/GM394 was developed from the predicate model GM38Y/Z (K042559). For the new models GM304/GM504/GM384/GM394, the stimulation waveform, significant specification, and the indication for use(IFU) were remained the same as that of Gemore 510(K) cleared predicate model GM38Y/Z (K042559).

Here's an analysis of the provided text, focusing on the acceptance criteria and the study performed:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define quantitative acceptance criteria or report specific device performance metrics in a comparative table. Instead, it relies on demonstrating "substantial equivalence" to a predicate device.

The core of the "acceptance criteria" can be inferred as:

• Maintain the same intended use as the predicate device.
• Maintain the same technological characteristics (e.g., stimulation waveform, significant specifications) as the predicate device.
• Comply with applicable voluntary standards.
• Demonstrate that engineering differences do not affect intended use or alter fundamental scientific technology.

2. Sample Size Used for the Test Set and Data Provenance:

The document describes non-clinical tests (compliance to standards, software verification) rather than a clinical study with a "test set" of patient data. Therefore, concepts like sample size and data provenance (country of origin, retrospective/prospective) are not applicable in the context of this 510(k) submission. The evaluation is based on device specifications and engineering comparisons.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Since no clinical "test set" with patient data was used, the concept of establishing ground truth by experts is not applicable. The "ground truth" for this submission refers to adherence to engineering standards and the equivalence of device specifications to the predicate.

4. Adjudication Method for the Test Set:

As there is no clinical "test set" involving patient data and human readers, an adjudication method is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No MRMC comparative effectiveness study was done. This 510(k) submission is for a device that relies on physical stimulation (TENS, EMS, IF), not image-based diagnosis requiring human interpretation. The study is focused on engineering specifications and safety/effectiveness equivalence.

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

This device is a physical stimulator. The concept of "standalone performance" typically applies to AI algorithms that process data or images. In this context, the device's "standalone performance" would be its ability to generate the specified electrical outputs. The non-clinical tests (compliance to standards, software verification) assess the device's inherent functionality and safety without a human-in-the-loop performance measurement.

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

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

• Engineering Specifications and Performance: Comparison to the established specifications of the predicate device.
• Voluntary Standards: Adherence to recognized national and international standards (e.g., ANSI/AAMI, IEC 60601-1, IEC 60601-1-2).
• Software Verification Guidelines: Compliance with FDA's software guidance.

8. The sample size for the training set:

As this is not an AI/machine learning device being trained on data, the concept of a "training set" and its sample size is not applicable.

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

Since there is no training set, this question is not applicable. The "ground truth" for the overall submission is established via engineering design conformity and compliance with regulatory standards.

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