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TENS (TENS 1 and TENS 2)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
PMS (STIM1 STIM2 STIM3 and STIM4)
To stimulate healthy muscles in order to improve and facilitate muscle performance.

The Electrical Stimulator System delivers electric pulses to the user's body areas in shoulder, waist, back, arm, and leg. The portable and compact device has multiple modes frequencies, including transcutaneous electrical nerve stimulation (TENS) and power muscle stimulation (PMS) that is also called Electical Muscle Stimulation (EMS). It includes the operating elements of an M button, intensity increase button, intensity decrease button, and can be attached and detached to electrodes.

The provided document is an FDA 510(k) Premarket Notification review, not a study report. It states that no clinical test data was used to support the decision of substantial equivalence (Section 12). Therefore, the document does not contain the information requested about acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies for a device performance study.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics, performance specifications, and compliance with recognized standards through non-clinical bench tests.

Based on the information provided in the document, here's what can be extracted, and what cannot be answered as it pertains to a clinical performance study:

Information NOT available from this document regarding a device performance study:

• A table of acceptance criteria and the reported device performance for a clinical study. (No clinical study performed)
• Sample sizes used for the test set and the data provenance. (No clinical study performed)
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts. (No clinical study performed)
• Adjudication method for the test set. (No clinical study performed)
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done. (No clinical study performed)
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done. (Not applicable, this is a hardware stimulator, not an AI/algorithm-based device)
• The type of ground truth used. (No clinical study performed)
• The sample size for the training set. (Not applicable, not an AI/ML device that requires a training set)
• How the ground truth for the training set was established. (Not applicable)

Information available from this document regarding the basis for market clearance:

The acceptance criteria and "study" proving the device meets these criteria are primarily based on non-clinical testing and comparison to predicate devices, rather than a clinical performance study involving human patients.

1. Acceptance Criteria and Reported Device Performance (Non-Clinical / Bench Testing)

The document primarily relies on compliance with a set of international and FDA-recognized standards as its acceptance criteria for device safety and performance. The "reported device performance" refers to the successful testing to these standards and the comparison of technical specifications to predicate devices.

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

• Sample Size: Not applicable. The "test set" here refers to the physical device prototypes undergoing non-clinical bench testing, not a dataset of patient cases. The number of physical units tested is not specified but is assumed to be standard for device verification.
• Data Provenance: The tests were conducted by the manufacturer (Gymmax Technology Shenzhen Co., Ltd.) or contracted labs in China, as indicated by the company's address and the application correspondent's company (IMD Medical & Drug Technology Services Institutions) also based in China. The data provenance is from non-clinical bench testing, not from human subjects, and therefore is not retrospective or prospective in the clinical sense.

3. Number of Experts and Qualifications:

• Experts: Not applicable for establishing ground truth as no clinical ground truth was established by human experts for device performance. Ground truth would be defined by the measurement standards of the bench tests themselves.
• Qualifications: Not applicable.

4. Adjudication Method:

• Method: Not applicable. No human interpretation or adjudication of test results, beyond standard engineering and quality control procedures, is mentioned for the bench tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was it done? No. The document explicitly states "No clinical test data was used to support the decision of substantial equivalence" (Section 12). This type of study is relevant for AI/ML diagnostic interpretation devices, not for a physical stimulator.
• Effect Size: Not applicable.

6. Standalone Performance (Algorithm Only):

• Was it done? Not applicable. This device is an Electrical Stimulator System, a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used:

• For Non-Clinical Tests: The ground truth is established by engineering specifications, international consensus standards (e.g., IEC, ISO), and the performance characteristics of legally marketed predicate devices. The device needs to demonstrate that its electrical outputs, safety features, and material properties are compliant with these standards and comparable to accepted devices.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

• Method: Not applicable.

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TENS (Modes 1 and 6)

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS (Modes 2, 3, 4 and 5)

To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

The Electrical Stimulator System delivers electric pulses to the user's body areas such as the back, neck, and foot through the electrodes. The portable and compact device has multiple modes of different pulse frequencies, including transcutaneous electrical nerve stimulation (TENS) and power muscle stimulation (PMS) that is also called Electrical Muscle Stimulation (EMS). It includes the operating elements of an ON/OFF button, intensity increase button, intensity decrease button, mode selection button, and can be attached and detached to electrodes.

The electrodes cleared include the electrode pads and electrode garments, which may be packaged separately and/or together with the subject device.

The associated accessories include: Arm Pad ( 34x56mm±2mmx2 ) * 1 Abdominal Pad(34x56mm±2mmx6) * 1 Gel Pad ( 34x56mm±2mm,produced by GMDASZ with K092546) * 8 USB Cable * 1 Operating Instruction * 1

The provided document is a 510(k) summary for an Electrical Stimulator System (K192201). It outlines the comparison of the proposed device to a predicate device and details the non-clinical tests performed to demonstrate substantial equivalence.

Based on the document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate device (Electronic Pulse Stimulator, K153520) through compliance with recognized standards and comparable technical characteristics. The reported device performance is presented as its adherence to these standards and measurements of its electrical characteristics.

Here's a table summarizing the implicit acceptance criteria based on substantial equivalence and the reported performance:

2. Sample sizes used for the test set and the data provenance

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." This means there was no "test set" in the sense of a clinical patient cohort. The tests performed were bench tests and non-clinical tests to verify that the proposed device met design specifications and was substantially equivalent to the predicate.

• Sample size: Not applicable in the context of human subjects or a clinical test set. For bench testing, sample size would refer to the number of units tested, which is not specified but would typically be a small number of devices to demonstrate consistent performance.
• Data Provenance: The tests were "bench tests" performed by the manufacturer (Gymmax Technology Shenzhen Co., Ltd. in PEOPLE'S REPUBLIC OF CHINA). The data is therefore from laboratory/engineering testing, not clinical data, and is retrospective for the purpose of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As noted above, there was no clinical test set using human subjects to determine "ground truth" for clinical performance. The "ground truth" for substantial equivalence was established by demonstrating compliance with recognized standards and comparing technical specifications to the predicate device. This typically involves engineers and quality assurance professionals with expertise in medical device testing and regulatory compliance.

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

Not applicable, as there was no clinical test set requiring human expert adjudication of results.

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 analysis AI device. No MRMC study was conducted.

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

Not applicable. This device is not an algorithm for diagnostic interpretation. Its "performance" is its electrical output and safety, which was assessed in bench tests, effectively in a "standalone" manner (device operating alone without a human interpreting its output for diagnostic purposes).

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

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

• Compliance with recognized industry standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993 series.
• Comparison to the predicate device's established safe and effective performance: The predicate device (K153520) serves as the benchmark for "substantial equivalence."
• Safety calculations and engineering analysis: Justification provided for differences in pulse width, maximum phase charge, and frequency range relies on calculations demonstrating continued safety within acceptable limits.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its design and performance are based on electro-mechanical principles and engineering, not machine learning.

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

Not applicable, for the same reason as point 8.

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