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Transcutaneous Electronic Nerve Stimulator is indicated 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 or normal household work activities. It is intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with osteoarthritis.

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I am sorry, but the provided text does not contain any information about acceptance criteria for a device, nor does it describe a study that proves a device meets such criteria.

The document is an FDA 510(k) clearance letter for Transcutaneous Electronic Nerve Stimulators. It discusses:

• The FDA's review and determination of substantial equivalence for the listed devices.
• Regulatory aspects such as general controls, special controls, quality system regulations, UDI rules, and adverse event reporting.
• Contact information for FDA resources.
• Crucially, it includes the "Indications for Use" for the devices.

There is no mention of:

• Specific performance metrics or acceptance criteria for the TENS device's functionality (e.g., electrical output, consistency, safety).
• Any studies involving test sets, training sets, ground truth establishment, expert readers, or multi-reader multi-case (MRMC) studies. These types of studies are typically associated with AI/ML-enabled devices, diagnostic imaging devices, or devices requiring clinical performance evaluation beyond basic safety and electrical parameters.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number and qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC studies or effect sizes for human reader improvement with AI.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

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Transcutaneous Electronic Nerve Stimulator is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

Transcutaneous Electronic Nerve Stimulator (Models: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494) is a portable and battery powered multifunctional device, offering Transcutaneous Electronic Nerve Stimulator. They can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation.

For models: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2342 have 3 operation modes:

For models: KTR-2491, KTR-2493, KTR-2493, KTR-2494 have 15 operation modes, 9 manual mode, and 6 automatic mode. They can be remotely controlled with an accessory remote control. And there is a LCD displays on remote control, which display mode and treatment time.

The electronic stimulator module has unified the operating elements of ON/OFF button. Intensity adjust button and Mode selection button.

The device is equipped with accessories of electrode pads, batteries and remote control (For KTR-249X series).

The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

The provided text describes a 510(k) premarket notification for a Transcutaneous Electronic Nerve Stimulator (TENS) and does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically understood in the context of diagnostic or prognostic AI/ML medical devices.

Instead, this document is a regulatory submission demonstrating substantial equivalence to previously cleared predicate devices. The "Test Summary" and "Comparison to predicate device" sections outline engineering tests and comparisons of technical specifications, rather than clinical performance studies against specific acceptance criteria for diagnostic accuracy.

Therefore, an output table as requested cannot be fully populated. However, I can extract the relevant information regarding the tests performed to support the "substantial equivalence" claim.

Here's a breakdown of what is available:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a TENS device, the "acceptance criteria" are related to industrial standards and engineering specifications rather than diagnostic performance metrics (e.g., sensitivity, specificity, AUC) typically seen with AI/ML devices. The reported "performance" is compliance with these standards and comparison of technical specifications to predicate devices.

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