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The DOLORCLAST Focused Shock Waves System is intended to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The DOLORCLAST Focused Shock Waves system is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.

The DOLORCLAST Focused Shock Waves system is composed of the DolorClast console, a handpiece, interchangeable gel pads (3 different sizes) and optional cart. EMS DolorClast Gel, previously approved under P050004 and K220538, is also provided for transmitting shock waves between the piezoceramic elements to the gel pad and coupling the treatment gel pad to the patient's skin.

The DOLORCLAST Focused Shock Waves system generates acoustic pressure waves generated using piezoelectric technology. A high-voltage impulse, controlled by the console, is used to stimulate the piezoceramic elements arranged across a concave surface in the emission source (the handpiece), causing the elements to expand simultaneously and briefly by a few micrometers, thus generating a focused shock wave. The shock waves are delivered to the patient's body via the handpiece, through a gel pad in a focused manner, and the treatment depth varies in line with the gel pad used.

The provided 510(k) clearance letter and summary for the DOLORCLAST Focused Shock Waves device do not describe a study involving acceptance criteria for an AI/ML-based medical device performance benchmark (e.g., accuracy, sensitivity, specificity). Instead, the document focuses on demonstrating substantial equivalence to a predicate device through physical and electrical performance testing, and biocompatibility, as well as characterization of its acoustic properties and software validation.

The acceptance criteria mentioned in the document are related to:

• Acoustic Pulse Characterization: Comparing the pressure field output to publicly available information on the predicate device.
• System Functional Performance Testing: Confirming correct operation of the console and handpiece at all treatment settings.
• Lifetime Testing: Confirming the console and handpiece function and meet performance specifications for their claimed useful lifetimes.
• Software Validation: Compliance with IEC 62304.
• Electrical Safety and EMC: Compliance with IEC 60601-1 and IEC 60601-1-2.
• Biocompatibility Testing: Compliance with various ISO 10993 standards.

Since the request asks for information relevant to AI/ML device performance (like acceptance criteria related to accuracy, sample size for test sets, expert ground truth, MRMC studies, etc.), and the provided text does not contain this information for the DOLORCLAST Focused Shock Waves device, I cannot fulfill the request as written.

The DOLORCLAST Focused Shock Waves device is a physical therapeutic device, not an AI/ML diagnostic or assistive device. Therefore, the types of studies and acceptance criteria typically associated with AI/ML devices (like sensitivity, specificity, MRMC studies, and expert adjudication of ground truth) are not applicable or described in this 510(k) submission.

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