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Shortwave diathermy delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as:

1. Relieving pain;
2. Reducing muscle spasm;
3. Increasing range of motion of contracted joints using heat and stretch techniques; and
4. Increasing blood flow to tissues in the treatment area.

The Auto*Therm 395 is a shortwave diathermy device that operates at 27.12 MHz. It provides traditional shortwave diathermy therapy using condenser and electromagnetic coil fields in both continuous and pulsed modes of operation. It is suited for all diathermy treatments in both the clinic and the medical practice.

The ME 395 has four wheels for easy transportation between treatment rooms. Two of these wheels have brakes that can be locked to prevent movement during use. The membrane control panel is mounted on top of the unit. It is easily cleaned and contains all the controls and displays for operating the Auto*Therm 395.

The intensity control knob adjusts the output power via an encoder. The power switch is on the upper left side of the unit. Screw holes for attaching the arms are located on the rear of the unit. The sockets for connecting the cables for the condenser and coll applicators and the detachable mains power supply cable including fuses are also located on the back of the unit. The ripcord for the patient emergency-OFF switch passes through a bushing mounted on the back of the unit so that it can be pulled from all directions.

The provided text is a 510(k) Summary for the AUTO*THERM ® 395, Model ME 395. This document focuses on demonstrating substantial equivalence to a predicate device, as required for FDA clearance, rather than presenting a detailed clinical study with specific acceptance criteria and performance data in the format of a typical clinical trial.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a clinical study proving device performance against acceptance criteria cannot be extracted directly from this document.

This 510(k) summary primarily provides:

• Device Description: What the AUTO*THERM ® 395 is and how it functions.
• Intended Use Statement/Indications for Use: The medical conditions the device is intended to treat.
• Comparison to a Predicate Device: A table comparing the technological characteristics of the new device with a legally marketed predicate device (Curapuls 419). This comparison is the primary "study" that proves the device meets the regulatory acceptance criteria for substantial equivalence, not a clinical performance study.
• FDA Clearance Letter: Confirming the device's substantial equivalence to the predicate.

Based on the provided text, here is why a direct answer to your request is not possible in the format you've outlined:

• Acceptance Criteria & Reported Device Performance: These are not presented in terms of specific clinical metrics (e.g., pain reduction percentage, range of motion improvement with statistical significance). Instead, the "acceptance criteria" for this submission would be demonstrating that its technological characteristics and intended use are substantially equivalent to the predicate device. The "reported device performance" is implicitly that it operates similarly to the predicate and can achieve the stated indications for use.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth: These are all elements of a clinical study designed to test the performance or effectiveness of a device. A 510(k) submission, especially for a device like a shortwave diathermy which operates on well-understood physical principles and has a predicate, often relies on demonstrating engineering and functional equivalence rather than new clinical efficacy trials. The document does not describe such a clinical study.
• Training Set Information: No machine learning or AI components are mentioned, so there is no training set.

In summary, the provided document is a regulatory submission focused on substantial equivalence rather than a clinical study report. It does not contain the detailed clinical performance data, acceptance criteria, or study methodologies you've requested.

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