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1. To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain
2. Muscle re-education
3. Increasing blood flow
4. Maintain or increase mandibular range of motion

This device is a current stimulation device with Therapeutic Electro Muscle Stimulator function. Power is supplied by the built-in rechargeable lithium batter. The stimulation current generated by the output circuit of the main body is supplied to the user through the electrode to realize current stimulation. The device is equipped with PAIN mode and MCR mode. Each CH can output independently and be adjusted. If it outputs in CARE mode, it can be used for both outputs at the same time.

Upon reviewing the provided document, it appears to be an FDA 510(k) clearance letter for a medical device called "D function," a powered muscle stimulator. The document primarily focuses on demonstrating the substantial equivalence of the "D function" to legally marketed predicate devices, rather than presenting a detailed study proving the device meets specific performance acceptance criteria for diagnostic accuracy or clinical effectiveness in the way one might expect for an AI/ML-based diagnostic device.

The document does not contain the following information typically found in a study proving a device meets acceptance criteria:

• A table of acceptance criteria and reported device performance related to clinical outcomes or diagnostic accuracy.
• Sample sizes used for test sets or data provenance for such studies.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods for test sets.
• MRMC comparative effectiveness study results.
• Standalone performance results.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for and ground truth establishment for training sets (this device is a stimulator, not an AI/ML diagnostic).

Instead, the document focuses on:

• Regulatory information: Device classification, product codes, predicate devices.
• Device description: How the device works (current stimulation).
• Indications for Use: What the device is intended to treat (muscle spasm, TMJ dysfunction, muscle re-education, blood flow, range of motion).
• Comparison of technological characteristics: Comparing pulse width, output frequency, and output current with predicate and reference devices, highlighting differences and justifying how these differences are supported by existing devices.
• Performance Data (Non-clinical Testing): This section refers to compliance with standards (e.g., electrical safety, EMC, software life cycle processes), and verification/validation that the device meets design/software requirements. It states that "The verification results demonstrate that the proposed device complies with the standard, IEC62304:2006/ Amd.1: 2015 Medical device software - Software life cycle processes. Additionally, the proposed device meets its design requirements in accordance with the requirements of FDA's guidance for the Content of Premarket Submissions for Software." It also states "The validation results demonstrate that the software specifications conform to user needs and that the particular requiremented through the proposed device can be consistently fulfilled."

Given the nature of this document (510(k) for a powered muscle stimulator), the "acceptance criteria" and "study" are primarily focused on non-clinical performance (electrical safety, electromagnetic compatibility, software validation, and physical/electrical specifications) to ensure the new device is as safe and effective as existing legally marketed predicate devices, despite some technological differences. It is not an AI/ML device, so typical AI/ML performance metrics (accuracy, sensitivity, specificity, AUC) are not applicable or presented.

Therefore, I cannot extract the information requested in the prompt as it pertains to AI/ML diagnostic device regulatory submissions, because this document describes a traditional medical device (a stimulator).

If you can provide a document related to an AI/ML medical device, I would be happy to attempt to extract that information.

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