(128 days)
The PainShield"M MD diathermy device is intended to apply ultrasounic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.
The PainShield™ MD is an ultrasonic diathermy device used to apply deep heat to tissues in the body with a transducer/applicator that is incorporated into a patch that adheres to the skin, as does a bandage.The PainShield™ MD is used to generate continuous wave ultrasound at 90 kHz, through a reusable applicator/transducer that covers an area of about 6 cm². The small applicator allows treatment of less accessible body parts such as, for example, the heel, the achilles tendon and the wrist. The device includes the above-mentioned transducer, a small, rechargeable, battery-powered driver unit and a cable that connects the driver to the transducer.
The provided text is a summary of safety and effectiveness for a medical device called PainShield™ MD, a 510(k) clearance letter from the FDA, and the indications for use. It primarily focuses on demonstrating substantial equivalence to a predicate device and regulatory compliance.
Crucially, the document DOES NOT contain information regarding acceptance criteria, performance studies with specific statistical outcomes, sample sizes for test or training sets, ground truth establishment, expert qualifications, or details about any comparative effectiveness studies (MRMC) or standalone performance studies.
The "Summary of Safety and Effectiveness" section describes the device, its intended use, and lists several advantages it has over existing devices. It concludes by stating, "The Painshield™ MD complies with the FDA standard for ultrasonic therapy products." This is a general statement of compliance, not a detailed report of performance against specific acceptance criteria.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or information about the studies mentioned in your prompt because this information is not present in the provided text.
The text is a regulatory submission about the device, not a scientific study of the device's performance against specific metrics. It focuses on regulatory equivalence and safety assurances.
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.