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Diathermy is used therapeutically to increase the temperature of tissues. It is generally accepted that heat produces the following desirable therapeutic effects:

• · Relieves pain
• · Increases the extensibility of collagen tissues
• · Decreases joint stiffness
• · Relieves muscle spasm
• Increases local blood flow

Megapulse Shortwave Diathermy system is indicated for use in the following conditions or applications:

• · Disorders of the musculoskeletal system
  • o Muscle spasm
  • o Joint stiffness
  • o Joint contractures
• · Chronic inflammatory or infective conditions
  • o Tenosynovitis
  • o Bursitis
  • o Synovitis
  • o Chronic inflammatory pelvic diseases

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I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer, along with the device's indications for use. It primarily focuses on the regulatory approval of the "Megapulse III Shortwave Diathermy" device based on substantial equivalence to existing devices.

This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods. It does not present data from a study proving the device meets specific performance criteria.

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

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Diathermy is used therapeutically to increase the temperature of tissues. It is generally accepted that heat produces the following desirable therapeutic effects:

• Increases the extensibility of collagen tissues 1.
• 2. Decreases joint stiffness
• 3. Relieves pain
• 4. Relieves muscle spasm
• న. Increases blood flow

The Megapulse Shortwave Diathermy system is indicated for use in the following con-Ditions or applications:

• Disorders of the musculoskeletal system: 1. muscle spasm joint stiffness, contractures ----------
• 2. Chronic inflammatory or infective conditions: tenosynovitis, bursitis, synovitis chronic inflammatory pelvic diseases

MEGAPULSE II is a Shortwave Diathermy system.

This document is a 510(k) clearance letter from the FDA for a device called "Megapulse II, Model 3029." It does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The letter is primarily a notification that the device has been found substantially equivalent to predicate devices already on the market, permitting it to be marketed. It lists the "Indications for Use" for the device, which are the therapeutic effects and conditions it is intended to treat.

Since the document does not contain the requested information, I cannot fill out the table or answer the specific questions about acceptance criteria and study details.

Ask a specific question about this device