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This device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic acute pain.

The IF-4000 generates small pulses of electrical current. Delivered along lead cables to electrodes placed on your skin, these pulses pass through the skin and activate underlying nerves. The relief from chronic and acute pain that the IF-4000 can provide results from this electrical stimulation.

This submission describes a medical device, the IF-4000 Portable Interferential Stimulation Device, and compares it to a predicate device, the IF-4150. The core of this 510(k) summary is to demonstrate substantial equivalence, not to prove the device meets specific acceptance criteria through a clinical study with performance metrics in the way a novel AI algorithm might.

Therefore, the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not applicable to this type of regulatory submission for a medical device that relies on substantial equivalence to a predicate device.

Here's how we can address the specific points based on the provided text, primarily noting what is not present in this type of submission:

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

Note: The "acceptance criteria" for this type of submission are primarily that the device is "as safe and as effective" as the predicate device, demonstrated through meeting recognized safety standards and showing comparable technical specifications and intended use. There are no performance metrics like sensitivity, specificity, or accuracy stated for a diagnostic AI, as this is a therapeutic electrical stimulation device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This submission discusses non-clinical tests (electrical safety, EMC, etc.) comparing the device specifications to industry standards and a predicate device. It does not involve a "test set" of patient data for performance evaluation in the way an AI/diagnostic device would.

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. There is no "ground truth" to establish for a test set in this context. The "truth" for safety and effectiveness is established by adherence to standards and comparison to a legally marketed predicate device.

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

• Not applicable. No adjudication method for a test set is relevant here.

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 therapeutic electrical stimulation device, not a diagnostic device involving "human readers" or AI assistance.

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

• Not applicable. This is not an algorithmic or AI-based device.

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

• Not applicable. No "ground truth" in this sense is used. The basis for safety and effectiveness is adherence to recognized standards (e.g., UL-544, AAMI/ANSINS-4) and direct comparison to a predicate device's established safety and efficacy profile.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set."

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

• Not applicable. This device does not involve a "training set" or "ground truth" establishment in this context.

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

The study proving the device meets the "acceptance criteria" (i.e., is substantially equivalent to a predicate device and safe/effective for its intended use) is documented through non-clinical tests and a comparison to a predicate device (IF-4150).

• Non-Clinical Tests: The manufacturer performed the following tests and confirmed they met required standards specifications:

  • UL-544 (Safety Standard for Medical and Dental Equipment)
  • AAMI/ANSI NS-4 Specifications for TENS Devices (American Association for Medical Instrumentation/American National Standards Institute standard for Transcutaneous Electrical Nerve Stimulators)
  • EMC Testing (Electromagnetic Compatibility)
  • Allowable variations in supply voltage
  • Patient Applied Risk Current

• Comparison to Predicate Device (IF-4150): A detailed comparison chart was provided, demonstrating that the IF-4000 has similar technological characteristics and intended use to the predicate device. Key differences noted (e.g., the IF-4000 not having a timer or high voltage protection, and having a lower maximum output current/voltage) were implicitly deemed not to raise new questions of safety or effectiveness.

• Conclusion: Based on these non-clinical tests and the comparison, the manufacturer concluded that the IF-4000 is "as safe as effective as the predicate - which is the INF-4150." No clinical trials were deemed necessary ("Non applicable" for clinical tests).

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