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Interferential Current Mode: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post surgical and post traumatic pain.

Neuromuscular Stimulator Mode: Relaxation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding disuse atrophy, muscle re-education, and immediate post surgical stimulation of calf muscles to prevent venous thrombosis.

The PMD-2000 Interferential Stimulator is a battery or AC wall adapter powered device intended for clinic, and outpatient use. Once prescribed by a physician it gives the clinician a variety of electrotherapy modes to treat a range of indications. The PMD-2000 is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The PMD-2000 incorporates the following features:

• Two independent stimulation channels, which provide true interferential current and neuromuscular stimulation.
• Continuous or pulsed stimulation. Various sweep and ramp times.
• Adjustable amplitude and frequency.
• Fifteen preset therapy protocols.
• Pause button to allow temporary suspension of treatment and a resume button to allow the resumption of treatment. When a treatment session is paused, the timer does not countdown. Upon resumption of treatment, the timer resumes its countdown and the amplitude (intensity) is reset to zero.
• Easy to connect, easy to handle, patient lead wire/cable assembly with a "one way" connector and color coded lead wires contribute to improved patient experience and improved therapy outcomes.
• Timed therapy sessions.
• Double A (AA) battery system accommodates standard alkaline, NiCad and Nickel Metal Hydride batteries.
• The PMD-2000 user interface incorporates a 16 character (8x2) Liquid Crystal Display (LCD) and tactile switches for menu navigation.

Here's a breakdown of the acceptance criteria and study information for the PMD-2000 Interferential Stimulator, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a quantitative manner for specific performance metrics (e.g., "output frequency must be within +/- X%"). Instead, the acceptance criteria are implicitly defined by the demonstration of "substantial equivalence" to a legally marketed predicate device (CS3101 Interferential Stimulator) through qualitative and comparative bench testing.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not specify a numerical sample size for the test set used in a clinical study. Instead, it mentions "Bench testing was performed on the marketed device and the PMD-2000." This indicates that the comparison was likely done on a limited number of physical units of both the PMD-2000 and the predicate device (CS3101).
• Data Provenance: The data provenance is from bench testing. No information is provided regarding country of origin or whether it was retrospective or prospective, as it was a technical comparison of device outputs, not patient data.

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

This information is not provided in the document. The "ground truth" for this device's performance seems to be established by physical measurements and comparisons against the known operational characteristics of the predicate device, rather than expert interpretation of complex data (like medical images).

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Given that the evaluation was based on bench testing of device outputs, there would be no need for an adjudication method involving human interpretation.

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, an MRMC comparative effectiveness study was not done.
• This device is an electrical stimulator, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this product.

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

• Yes, a standalone performance assessment was done in the form of bench testing. The document states: "Bench testing was performed on the marketed device and the PMD-2000 and the therapy output and performance characteristics for both units was substantially equivalent." This constitutes a standalone evaluation of the device's functional output without human interaction in the loop determining its primary effectiveness.

7. The Type of Ground Truth Used

The ground truth used for assessing the PMD-2000's performance was the measured therapy output and performance characteristics of the legally marketed predicate device (CS3101 Interferential Stimulator). Essentially, the predicate device defined the acceptable "truth" for output waveform, frequency, amplitude, etc., which the PMD-2000 had to match or be substantially equivalent to.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The PMD-2000 is an electrical stimulator and is not described as involving machine learning or AI algorithms that would require a "training set" in the conventional sense. Its design and functions are based on established biophysical principles of electrical stimulation.

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

This information is not applicable and therefore not provided, as there is no mention of a "training set" for an AI model.

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