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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.

The subject device is a hand-held and battery-powered unit of TENS. It combines the electrical characteristics of TENS with the point stimulation delivered through the electrodes of a metal contact tip and a metal grounding contact on the device has only one TENS mode of the low frequency (2 Hz), and only one button (Power Button). When the Power Button is held down, the device will turn on and deliver the fixed stimulation output to the user's body skin; when the Power Button is released, the device will turn off and the stimulation output will stop. Therefore, the device is very simple and easy to use. The device is designed to generate small pulses of electrical current and delivers the pulses to the user's skin through the metal contact tip such that the underlying nerves and/or muscles are activated for pain relief.

The provided document is a 510(k) Premarket Notification from the FDA for a device called "Medi-Direct TENS Pen." This document is primarily concerned with demonstrating "substantial equivalence" to legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study with a test set, expert ground truth, or MRMC studies that would be typical for more complex medical devices, especially those involving AI or nuanced diagnostic capabilities.

Therefore, the information requested about acceptance criteria, detailed study design (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details) is not present in this document. This typically applies to devices that rely on complex algorithms, imaging analysis, or diagnostic accuracy, which is not the case for this TENS device.

Instead, the document details a comparison of technical specifications to predicate devices and adherence to voluntary electrical safety and electromagnetic compatibility standards.

Here's what can be extracted and inferred from the document regarding "acceptance" for this specific type of device, based on the principle of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

For this type of device, "acceptance criteria" are not framed as performance metrics (e.g., sensitivity, specificity) against a clinical outcome. Instead, they are framed as meeting safety standards and having comparable technical characteristics and intended use to existing, cleared devices. The "reported device performance" is essentially the device's technical specifications and its compliance with standards.

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

• Sample Size: Not applicable. This document refers to non-clinical testing for electrical safety and electromagnetic compatibility, not a clinical "test set" in the sense of patient data for performance evaluation.
• Data Provenance: Not applicable for patient data. The non-clinical tests were performed on the device itself.

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

• Not applicable. Ground truth as typically understood (e.g., expert radiological reads, pathological confirmation) is not relevant for this device's premarket notification, which focuses on engineering specifications and safety compliance.

4. Adjudication Method for the Test Set:

• Not applicable. There was no clinical test set requiring adjudication.

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 a Transcutaneous Electrical Nerve Stimulator (TENS) Pen, a physical therapy device for pain relief. It does not involve AI, image reading, or human interpretation that would necessitate an MRMC study.

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

• Not applicable. No algorithm in the sense of a diagnostic or interpretative AI is involved. The device's "performance" is its electrical output and safety compliance.

7. The Type of Ground Truth Used:

• For this device, "ground truth" equates to engineering specifications, compliance with international voluntary standards (IEC 60601 series), and a comparison to the known, cleared characteristics of existing predicate devices. There is no clinical "ground truth" derived from patient outcomes or expert diagnoses mentioned.

8. The Sample Size for the Training Set:

• Not applicable. There is no AI model or complex algorithm that requires a training set.

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

• Not applicable for the same reason as above.

Summary of the Study Proving Acceptance for this Specific Device:

The "study" proving the device meets "acceptance criteria" (defined as substantial equivalence) is primarily non-clinical testing and a detailed comparison to established predicate devices.

• Non-Clinical Tests Performed (Section 8):

  • Validation of design and assurance of conformance with voluntary standards.
  • Standards Covered:
    • IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
    • IEC 60601-1-2: Electromagnetic Compatibility (EMC) requirements and tests.
    • IEC 60601-2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
  • The document states: "The subject device does not conduct, nor rely upon, clinical tests to determine substantial equivalence."

• Substantial Equivalence Comparison (Section 6, Table 1):

  • A direct comparison of the "Medi-Direct TENS Pen" (subject device) to three predicate devices (K162517, K141260, K133789) across numerous parameters.
  • Key Parameters Compared: Intended Use, Prescription/OTC status, Power Source, Electrical Characteristics (leakage current, output channels, regulated current/voltage, waveform, shape, maximum output voltage/current, pulse duration, frequency, maximum phase charge, current density, power density), Software/Firmware, Safety Features (Overload/No-Load Trip, Automatic Shut-Off), User Controls, Indicators, Compliance with Standards, and Housing Materials.
  • Conclusion of Comparison: The document explicitly states: "the maximum output voltage and current of the subject device are within those ranges of the predicate device; the pulse duration, period, frequency, maximum phase charge, and maximum current density of the subject device are smaller or almost the same as those of the predicate device; the maximum average power density of the subject device is within the range of the predicate device. Therefore, the differences do not affect safety or effectiveness." And ultimately, "There are no new safety or effectiveness issues concerning the subject device, which offers substantially equivalent technical specifications, features, intended use, and effective results to the predicate device."

In conclusion, for the Medi-Direct TENS Pen, "acceptance" for FDA clearance was demonstrated through engineering and electrical compliance testing against consensus standards and a feature-by-feature comparison to already cleared similar devices, rather than a clinical study evaluating diagnostic or treatment efficacy.

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