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The Schwartz Electro-Optics, Inc. CrystaLase 755 is indicated for removal of tattoos of various types and colors and benign epidermal pigmented lesions.

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This 510(k) submission (K973867 for the Schwartz Electro-Optics, Inc. CrystaLase 755) does not contain the information needed to answer your request about acceptance criteria and a study proving the device meets those criteria.

The provided documents are a 510(k) summary and the FDA's clearance letter. These documents are primarily focused on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance study data against specific acceptance criteria.

Here's why the information is missing:

• 510(k) Summary: This document states that "from a technology perspective, theory of operation of all the aforementioned devices are all the same" and "Schwartz Electro-Optics, Inc. believes that the technological characteristics of the CrystaLase 755 are similar to the predicate lasers." It also states "Schwartz Electro-Optics, Inc. believes that the slight differences in the performance characteristics of these devices raises no concerns." This language indicates a reliance on the predicate device's established safety and effectiveness rather than new, extensive performance studies for the CrystaLase 755 itself.
• FDA Clearance Letter: This letter confirms the device is "substantially equivalent" to predicate devices. Substantial equivalence means that the new device is as safe and effective as a legally marketed predicate device, and it does not necessarily require new clinical or performance data if technological characteristics are similar and do not raise new questions of safety or effectiveness.

Therefore, I cannot fill out the requested table or answer the specific questions about the study details for this particular submission.

This type of information (acceptance criteria, detailed study design, sample sizes, ground truth establishment, etc.) would typically be found in direct performance studies, clinical trial reports, or more detailed sections of a 510(k) submission if the device presented novel technology or significant differences from its predicate. As this submission relies on substantial equivalence and similarity to predicate devices, such detailed a study is not provided here.

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