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The Cynosure Acclaim Dermatology Laser is indicated for the treatment of benign cutaneous vascular lesions and hair removal.

The Acclaim is a pulsed solid state laser, emitting at the near intra-red wavelength of 1064nm. Laser activation is both by finger switch and footswitch. Overall weight of the laser is 285lbs, and the size is 44"x19"x24" (HxWxD). Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, single phase.

This document is a 510(k) summary for the Cynosure Acclaim Dermatology Laser, submitted in 2001. It is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a modern medical AI device submission would. This is because the device is a laser system, not an AI or software as a medical device (SaMD), and the regulatory requirements and types of performance studies were fundamentally different in 2001.

Therefore, I cannot extract the requested information from the provided text. The document focuses on demonstrating substantial equivalence to predicate laser devices based on intended use, principle of operation, wavelength, and pulse energy range, rather than on detailed performance metrics from a clinical study with acceptance criteria.

Here's why the requested information is not present:

• Acceptance Criteria and Reported Device Performance (Table): This type of detailed performance data with specific numerical acceptance criteria is typical for clinical studies of new drug efficacy, diagnostic accuracy for IVD/imaging devices, or AI/SaMD performance. For a laser system in 2001, "performance" was largely assessed by comparing technical specifications and intended use to existing, legally marketed devices.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Studies, Training Set Details: These items are all highly relevant to the evaluation of AI/ML-based medical devices or complex diagnostic systems. A laser device like the Acclaim Dermatology Laser does not involve these types of evaluations. Its effectiveness is based on the known biophysical interaction of laser light with tissue, which was established through a long history of use for similar devices. The regulatory pathway in 2001 for this type of device primarily required demonstrating technical similarity and safe operation compared to predicates.

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