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The MPP is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise and normal household and work activities.

The MPP is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance.

The MPP consists of a portable battery operated electrical stimulation device with two channels, two sets of lead wires, six packages of self-adhesive electrodes, and a battery charger. Each channel has a pair of buttons to select the desired frequency and a dial to control the intensity of the signal. The stimulator also is supplied with an output jack for each channel, a charging jack, timer buttons, and an LCD display. The device creates stimulation at frequencies of 1-70 Hz depending on the desired effects.

The provided text describes a 510(k) summary for the MPP device, a transcutaneous electrical nerve stimulator. However, it does not contain any information about acceptance criteria or a study that proves the device meets those criteria, nor does it provide performance data in the format requested.

The document states that the MPP device conforms to several recognized consensus standards (IEC 60601-2-10, IEC 60601-1, and IEC 60601-1-2) and that its software was validated for a moderate level of concern. It also establishes substantial equivalence to predicate devices (K081998, K121757, K112485) based on identical or substantially similar intended uses and output parameters. This is the basis for regulatory clearance.

Therefore, I cannot fulfill your request for specific acceptance criteria and performance study details from this document.

Summary of missing information:

• Acceptance Criteria Table: Not present. The submission relies on conformance to standards and substantial equivalence to predicate devices.
• Reported Device Performance: No specific performance metrics (ee.g., accuracy, sensitivity, specificity) are reported.
• Sample Size for Test Set: No clinical study data is provided.
• Data Provenance: Not applicable, as no clinical study data is presented.
• Number of Experts & Qualifications: Not applicable, as no clinical study data is presented.
• Adjudication Method: Not applicable, as no clinical study data is presented.
• MRMC Comparative Effectiveness Study: Not mentioned or conducted.
• Standalone Performance Study: Not mentioned or conducted.
• Type of Ground Truth: Not applicable, as no clinical study data is presented.
• Sample Size for Training Set: Not applicable, as no machine learning training data is discussed.
• Ground Truth for Training Set: Not applicable.

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