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The indication for use of this device includes the prescription TENS, NMS, Interferential stimulation as follows:

Transcutaneous Electrical Nerve Stimulator (TENS/IF TENS) & Program can be used for the following applications :

· For symptomatic relief of chronic intractable pain.

Neuromuscular electrical stimulation (NMS) & Program stimulation can be used for the following applications :

• · Relax muscle spasms
• · Prevent or retard disuse atrophy
• Increase local blood circulation
• · Re-educate muscles
• Maintain or increase the range of motion

The Well-Life 4 Channels Multiple Modes Electrical Stimulator/ Model: WL-2504A is the The Well-che of Channels Matiple Motion Leorve stimulator(TEMS) and Interferential Combination (IF) used for pain relief and/or powered muscle stimulator(EMS) by applying Stimulation (if ) ascu for pain rollor which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.

The Well-Life 4 Channels Multiple Modes Electrical Stimulator/ Model: WL-250A consisted The Well-Life + Chamble Modisle Model Eloctive. The stimulus generator generator generator summer mainly of two parts. the stimulas gonorator, close. The output port transmits the output current oulput current Specificular 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 Well-Life 4 Channels Multiple Modes Electrical Stimulator/ Model: WL-2504 includes The Well-Life + Channels Modes as mentioned on the comparison table. These its moin several unlerent operation modes as montonou on the microprocessor as its main control unit.

Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary:

This device (Well-Life 4 Channels Multiple Modes Electrical Stimulator/ Model: NuvoStim IV, WL-2504A) is an electrical stimulator. The 510(k) summary focuses primarily on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with voluntary standards, rather than a clinical study evaluating diagnostic accuracy or reader performance typically associated with AI/imaging devices.

Therefore, many of the requested points related to AI studies, ground truth, and expert adjudication are not applicable to this type of device submission.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in the provided text. Instead, the "performance" shown is in the form of electrical output ranges for various functions of the device, which are implicitly compared to the performance of predicate devices. The claim of the study is that these output characteristics are "identical" or "substantial equivalent" to the predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable. This submission relies on engineering and electrical output testing, not a clinical test set with patient data. The "test set" would be the device itself undergoing various electrical measurements.
   • Data Provenance: Not applicable. The data is generated from laboratory testing of the device's electrical outputs.

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

   • Number of Experts: Not applicable. Ground truth, in the sense of clinical interpretations or diagnoses, is not established for this type of submission. The "ground truth" here is the accurate measurement of electrical output according to standardized procedures.
   • Qualifications of Experts: This would involve electrical engineers or technicians trained in performing these measurements and verifying compliance with standards. Their specific qualifications are not detailed in the summary.

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

   • Adjudication Method: Not applicable. This is not a study involving human interpretation or subjective assessments.

4. 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:

   • MRMC Study: No. This is not an AI or imaging device, so an MRMC study is irrelevant.

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

   • Standalone Performance: Not applicable. This is an electrical stimulating device, not an algorithm.

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

   • Type of Ground Truth: For this device, the "ground truth" for non-clinical testing refers to the established scientific principles and industry standards for electrical measurements, electrical safety, and electromagnetic compatibility. This would be verified by calibrated equipment and standard test protocols.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This is not an AI device, so there is no "training set."

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

   • Ground Truth Establishment for Training Set: Not applicable.

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