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The PMT Soft-Touch™ external TENS Electrodes are indicated for use with transcutaneous electrical stimulation devices as a non-sterile, disposable device for single patient use only. The PMT electrodes provide the conductive interface between the TENS generator and the patient's skin.

The PMT TENS electrode Soft-Touch™ are designed for, and to be used with marketed and FDA approved TENS stimulators.

The PMT Soft-Touch™ electrodes are high quality carbon electrodes.

The provided text is a 510(k) Summary for a medical device (TENS electrodes) and a letter of clearance from the FDA. This type of document, particularly for Class II devices, typically focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device) rather than presenting a full study with acceptance criteria and performance data in the format you've requested for AI/software-as-a-medical-device (SaMD).

Here's why a direct answer to your request isn't possible based on the provided text:

• Device Type: The "Soft-Touch TM TENS electrode" is a passive medical device, a physical product, not a software algorithm or AI. Your request for "acceptance criteria," "test set," "ground truth," "MRMC," and "standalone performance" are concepts primarily applicable to evaluating the performance of AI/Machine Learning systems or diagnostic tools, not a conductive electrode.
• 510(k) Process: For this type of device, a 510(k) submission generally relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness profiles as a predicate device. This often involves bench testing (physical and chemical properties), biocompatibility testing, and electrical performance testing to show it performs equivalently to the predicate, rather than meeting specific quantitative diagnostic performance metrics.
• Missing Information: The document explicitly states "Refer to NAMSA Reports (Attachments 3, 4, 5)" for summaries of pre-clinical and clinical studies, and conclusions. These attachments, which would contain the detailed study data if any existed beyond predicate comparison, are not included in the provided text.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies because the provided document does not contain this information for a device of this nature.

Instead, the document highlights:

• Predicate Devices: K915333 and K912643 electrodes are the predicate devices.
• Substantial Equivalence: The primary conclusion is that the PMT Soft-Touch™ electrodes are "substantially equivalent" in design and performance characteristics to the predicate devices.
• Safety and Performance: This was established through "similarities in design and performance characteristics as well as performance testing" and comparison of "Materials, performance specifications and essential design characteristics." The details of this "performance testing" are not in the provided text.

If this were an AI or SaMD device, the "NAMSA Reports" would be crucial for your request. Without them, we only have the conclusion of equivalence, not the detailed data or methodology usually associated with performance studies for AI/diagnostic devices.

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