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The Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

The Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) is a dual channel transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the user's skin. The output and waveform characteristic are fixed for every operation mode, only the intensity is adjustable within specified limit. The Balego™ TENS Digital Edition consists mainly of two parts: the stimulus generator, electrode. The stimulus generator 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 user's skin so as to transmit this stimulus current for pain relief.

The stimulation modes for Balego™ TENS Digital Edition are pre-program modes with fixed pulse width, pulse rate, frequency. The amplitude for each program are adjustable. The subject and predicate devices both use Everyway Electrode, Wire Series/ model no. KF5050, size 50x50mm, wire type as a standard accessory. The Electrode was cleared under K083302.

With the combination of the main device parts, the device can be placed on the treatment locations as recommended in the user manual for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

This regulatory submission for the Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) (K181207) does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics. Instead, the submission relies on demonstrating substantial equivalence to a previously cleared predicate device (EV-804 OTC Pain Relief TENS, K172919). This means that the acceptance criteria are implicitly met by virtue of being essentially the same as the predicate device, which presumably met its own acceptance criteria during its clearance.

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

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

The document does not explicitly define acceptance criteria as performance thresholds for this specific device in comparison to a clinical outcome. Instead, the acceptance criteria are met by demonstrating the device's technical specifications and intended use are identical or very similar to the predicate device.

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 in this context. The submission relies on technical comparison to a predicate device rather than a new clinical test set.
• Data Provenance: Not applicable for a traditional test set. The data presented focuses on the technical specifications and comparison to a predicate device. The manufacturing establishment is in Taiwan.

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 as no clinical test set requiring expert ground truth establishment was conducted.

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

• Not applicable as no clinical test set requiring adjudication was conducted.

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 MRMC comparative effectiveness study was done. This device is a TENS unit for pain relief, not an AI-powered diagnostic tool engaging human readers.

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

• No standalone algorithm performance study was done. This device is a physical TENS unit.

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

• Not applicable for a "ground truth" in the typical sense of a diagnostic or prognostic device. The "ground truth" for this submission is the established performance and safety profile of the predicate device based on its own prior clearance.

8. The sample size for the training set

• Not applicable. There is no training set for an AI algorithm mentioned.

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

• Not applicable. There is no training set for an AI algorithm mentioned.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that "proves" the device meets acceptance criteria is a technical and regulatory comparison study against a legally marketed predicate device (EV-804 OTC Pain Relief TENS, K172919). The core argument is that, because the Balego™ TENS Digital Edition is identical in all material respects (intended use, technological characteristics, manufacturing, and general labeling) to its predicate device, it is therefore substantially equivalent and inherently meets the same safety and effectiveness standards that the predicate device met for its clearance.

The report states: "Non-clinical performance data is not required to determine the safety and performance of the device. The subject device is identical to the predicate device with regards to intended use, technological characteristics, manufacturing, and labeling (apart from the different tradename). Therefore, descriptive information alone is sufficient to address the substantial equivalence determination." This explicitly indicates that a new dedicated study to establish functional performance or clinical efficacy was not undertaken for K181207.

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