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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 for the treatment of many conditions such as:

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

The AutoTherm 390 is a shortwave diathermy device that operates at 27.12 MHz. It provides shortwave diathermy therapy using condenser and electromagnetic inductive coil fields in both continuous and pulsed modes of operation. It is suited for all diathermy treatments in both the clinic and medical practice. The ME 390 is portable and easily transportable between treatment rooms. A four-wheel cart is provided when the optional induction electrode and arm are used. Two of these wheels have brakes that can be locked to prevent movement during use. The membrane control panel is mounted on the top of the unit. It is easily cleaned and contains all the controls and displays for operating the AutoTherm 390. 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 cables for the condenser and inductive coil 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 documentation for the AUTO*THERM 390, MODEL ME 390 (K042554) does not include a study describing the acceptance criteria or a study proving the device meets said criteria.

The information primarily consists of:

• 510(k) Summary Statement: Details the device name, predicate device, a description of the proposed device, and its intended use.
• FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence to a predicate device.
• Indications for Use Statement: Reiterates the intended uses of the device.

There is no mention of:

• Specific acceptance criteria (performance metrics, thresholds).
• A study design or execution.
• Sample sizes (test, training, or validation sets).
• Data provenance.
• Expert involvement or adjudication for ground truth.
• Comparative effectiveness studies (MRMC).
• Standalone performance studies.
• Ground truth methodologies.

The clearance of this device (K042554) was based on substantial equivalence to a predicate device (Auto*Therm 395, Model 395) as stated in the FDA clearance letter ("determined the device is substantially equivalent... to legally marketed predicate devices"). In substantial equivalence pathways, it is common for manufacturers to demonstrate that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate, rather than conducting new clinical performance studies with pre-defined acceptance criteria, especially for well-established technologies like shortwave diathermy.

Therefore, I cannot provide the requested information as it is not present in the provided text.

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