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The PowerDot PD-01 device, used with PowerDot Mobile Application, is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The PowerDot PD-01 device and PowerDot Mobile Application are not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind.

PowerDot PD-01 Muscle Stimulator is a battery-powered neuromuscular stimulator intended to stimulate healthy muscles in order to improve or facilitate muscle performance and, with that regard, may be considered a technique or method for muscle training. PowerDot PD-01 device is designed to be used together with PowerDot Mobile Application. PowerDot PD-01 device uses Bluetooth™ Low Energy (Bluetooth 4.0, Class II) wireless radio frequency protocol for communication with supported range of mobile devices (such as smartphones and/or tablets) via PowerDot Mobile Application. Accessories include lead cables of 2 different lengths, USB charging cable, 2 types of hydrogel-based self-adhesive electrode pads and carrying case.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way you are asking. The document is a 510(k) premarket notification decision letter from the FDA, and it focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance study results.

Here's a breakdown of why I cannot fulfill your request with the given information:

• Acceptance Criteria and Reported Device Performance: The document provides a comparison table between the PowerDot PD-01 and a predicate device (Compex Sport Plus) for various technical parameters. However, these are comparative features, not specific acceptance criteria with quantitative performance metrics. For example, for "Patient Leakage Current," it states "< 25 µA" for the PowerDot, but this is presented as a characteristic meeting IEC 60601-1 safety criteria, not as an explicit acceptance criterion for a performance study.
• Sample Size and Data Provenance: No information on sample sizes for test or training sets, or data provenance (country of origin, retrospective/prospective) is provided.
• Number of Experts and Qualifications: There is no mention of experts used to establish ground truth or their qualifications.
• Adjudication Method: No adjudication method is described.
• MRMC Comparative Effectiveness Study: The document does not describe an MRMC study or any effect size for human readers. This device is a muscle stimulator, not an AI for image interpretation that would typically involve human readers.
• Standalone Performance: The document doesn't explicitly refer to "standalone performance" in the context of an algorithm's output without human intervention. Instead, it describes "Software Verification and Validation" showing that "all software requirement specifications were met."
• Type of Ground Truth: The concept of "ground truth" (expert consensus, pathology, outcomes data) is not applicable or discussed, as this is a physical medical device (muscle stimulator) rather than a diagnostic or AI-powered imaging device.
• Training Set Sample Size and Ground Truth Establishment (for Training Set): There is no mention of a training set or how ground truth for it was established.

What the document does provide regarding testing and compliance is summarized below:

The document focuses on non-clinical tests to establish safety and substantial equivalence:

1. Biocompatibility Testing:
   • Skin-contacting hydrogel (electrode pads) tested to ISO 10993-1:2009.
   • TPU, ABS, and PVC Compound materials (housing and lead cables) evaluated for biocompatibility based on Material Safety Data Sheets from vendors.
2. Software Verification and Validation:
   • PowerDot Firmware and PowerDot Mobile Application software documentation provided (consistent with a moderate level of concern).
   • System Validation Testing proved that all software requirement specifications were met and all software hazards were mitigated to an accepted risk level.
3. Electrical Safety and Electromagnetic Compatibility Testing:
   • Designed to comply and tested for compatibility with applicable clauses of:
     • IEC/EN 60601-1:2005 (General Safety)
     • IEC 60601-2-10:2012 (Nerve and Muscle Stimulators)
     • IEC/EN 60601-1-2:2014 (EMC)
     • IEC/EN 60601-1-11:2010 (Home Healthcare Environment)
4. Battery Testing:
   • Lithium-Polymer battery tested to FDA-recognized UL 1642 Standard.
5. Engineering Bench Testing:
   • Included testing in accordance with FDA's "Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning" (Attachment 11, Section 1 - Output Waveforms).
   • Oscilloscope tracings obtained for device output waveforms under maximum supported voltage and pulse widths under loads of 500 Ω, 2 kΩ, and 10 kΩ.
   • System validation testing scenarios covering mitigation of wireless risks (referencing FDA's "Radio Frequency Wireless Technology in Medical Devices - Guidance").
6. Clinical Performance Data: "No applicable." The device "does not diagnose, cure, mitigate, treat or prevent disease or affect the function of the human body." Clinical effectiveness was based on a literature review.

The conclusion states that "Test results demonstrate the PowerDot PD-01 device with PowerDot Mobile Application is safe and effective for its intended use and the results support determination of substantial equivalent." However, this is a general statement about the outcome of the non-clinical tests and literature review, not a specific breakdown of acceptance criteria and performance against those criteria.

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