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

Transcutaneous Electrical Nerve Stimulator is a product that adopts modern electronic science and technology to deliver electric pulses generated to the user's skin through the electrodes.

There are three models of Transcutaneous Electrical Nerve Stimulator which are KTR-206, KTR-208 and KTR-209. Their technical parameters are slightly different, but they share the basically same characteristics: 1) They are small, exquisite and portable; 2) various modes to satisfy different demands, applicable to a wider range of people; 3) wonderful electric pulse combination. 0~16 levels can be adjusted and chosen according to personal preference; 4) LCD display make the operation simple and easy; 5) integrated design of the body is easy for function operation and simple in practical use; 6) battery power display; 7) dual channel output. user can cover more treatment areas. For KTR-208 and KTR-209, the two channels are independently controlled for intensity adjustment which is more convenient to use.

The Transcutaneous Electrical Nerve Stimulator is mainly composed of the host and electrode patches. And it uses AAA batteries for power supply. To start therapy, first insert batteries, then paste the electrode patches onto painful areas and press on/off button to power on. The modes and intensity can be selected according to needs. And the current status is displayed on LCD.

The provided text is a 510(k) Summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This document is a premarket submission to the FDA demonstrating that the new device is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the provided text, addressing your specific questions, keeping in mind that a 510(k) typically focuses on substantial equivalence rather than a full clinical trial to establish new clinical efficacy. Therefore, some information, like detailed acceptance criteria from a clinical study or human reader performance, may not be explicitly present as they aren't usually required for a 510(k) for this type of device.

1. Table of Acceptance Criteria and the Reported Device Performance

For a TENS device, acceptance criteria in a 510(k) submission primarily revolve around safety, electrical performance, and substantial equivalence to a predicate device, rather than clinical efficacy metrics (like pain reduction improvement percentage). The document establishes "substantial equivalence" as the primary acceptance criterion.

The table below summarizes the comparison to the predicate device, which serves as the de-facto performance standard for substantial equivalence. The "Acceptance Criteria" are implied by the predicate values and compliance with recognized standards.

Notes on Differences and Compliance:

• Number of output modes: Targeted device has 5, predicate has 8, reference devices have more. The submission argues this difference doesn't affect safety and effectiveness as the output parameters of each mode were tested and passed relevant IEC standards (Note 1).
• Appearance, weight, dimensions: Differ from predicate but are deemed insignificant and do not affect safety and effectiveness (Note 2).
• Maximum Average Current: Different from predicate but all targeted device values (8.04mA, 6.89mA, 12.39mA) are < 50mA, complying with IEC 60601-2-10 requirements (Note 3), therefore not affecting safety and effectiveness.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is primarily a non-clinical study involving various tests to demonstrate compliance with recognized electrical safety and performance standards, and comparison of technical characteristics to a legally marketed predicate device. The goal is to establish "Substantial Equivalence (SE)" to the predicate, K140168.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) summary regarding a TENS device. This document describes non-clinical testing of the device itself (electrical parameters, safety, software verification) rather than testing on human subjects for clinical efficacy. There is no "test set" of patient data mentioned for evaluation of diagnostic or therapeutic performance in humans.
• Data Provenance: The data provenance is from non-clinical bench testing of the new Transcutaneous Electrical Nerve Stimulator device and comparison of its specifications to the predicate and reference devices. This is not patient data from a specific country or retrospective/prospective study.

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

• Not applicable. There is no "ground truth" related to patient outcomes or diagnoses in this 510(k) summary. The "ground truth" for the non-clinical tests would be the specifications and requirements outlined in the referenced standards (e.g., IEC 60601-1, IEC 60601-1-2) which are established by expert consensus in regulatory and technical committees.

4. Adjudication method for the test set

• Not applicable. As there is no clinical test set with patient data requiring interpretation or consensus, no adjudication method like 2+1 or 3+1 was used.

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 is a TENS device, which directly delivers electrical stimulation for pain relief. It is not an AI-powered diagnostic or assistive technology that human "readers" would use. Therefore, an MRMC comparative effectiveness study involving AI assistance is entirely outside the scope of this device and submission.

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

• Not applicable in the sense of an algorithm performance study. The device is a physical TENS unit. Its "standalone" performance is measured by its electrical output characteristics and compliance with safety standards, as detailed in the technical comparison and non-clinical tests.

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

• The "ground truth" in this context is established by international consensus standards for medical electrical equipment, particularly those related to TENS devices (e.g., IEC 60601 series). These standards define safety and performance requirements that the device must meet. Additionally, the technical specifications of the predicate device serve as a benchmark for demonstrating substantial equivalence.

8. The sample size for the training set

• Not applicable. This device is not an algorithm that requires a "training set" of data.

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

• Not applicable. As there is no training set for an algorithm, there is no ground truth established for one.

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