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substantially equivalent to other pulsed Nd: Y AG laser systems currently in interstate commerce for use in procedures for incision, excision, coagulation or vaporization of soft tissues, such as: subcutaneous tissues, striated and smooth muscle, mucous membranes, along with organs and glands, in both open, endoscopic and microscopic procedures.

The DCL8 Enhanced Pulsed Nd:YAG laser system has the same operating characteristics as the pulsed Nd: Y AG laser systems offered by Sunrise Technologies and American Dental Technologies with respect to average power to tissue, pulse rates, operating controls and indicators. The DCL8 Enhanced Pulsed Nd: YAG laser system incorporates a red diode aiming beam, touch pad controls for setting of operating parameters, and uses the same input power (110 VAC) as the pulsed Nd: YAG laser systems offered by Sunrise Technologies and American Dental Technologies. The DCL8 Enhanced Pulsed Nd: YAG laser system uses the industry standard SMA 905 fiberoptic connector system for its fiberoptic delivery systems.

This document, "Summary of Safety and Effectiveness F.", does not describe a study involving an AI/Machine Learning device or a device with performance metrics that would typically be associated with acceptance criteria in the manner requested.

Instead, this document is a 510(k) Pre-market Notification for the DCL8 Enhanced Pulsed Nd: YAG laser system. The purpose of this document is to demonstrate "substantial equivalence" to other legally marketed devices, rather than to establish specific performance acceptance criteria based on a clinical study with a test set, ground truth, and expert evaluation.

Therefore, I cannot provide the information requested in the format specified because:

1. Acceptance criteria and reported device performance: This document does not outline specific performance metrics (e.g., sensitivity, specificity, AUC) for the DCL8 laser system that would be compared against acceptance criteria. Its acceptance is based on substantial equivalence to predicate devices, focusing on similar intended use and technological characteristics.
2. Sample size used for the test set and data provenance: No test set or associated data is mentioned, as this is not a performance study.
3. Number of experts used to establish ground truth and qualifications: Ground truth establishment is not relevant in this context.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted, as this is not an AI-assisted diagnostic device.
6. Standalone performance study: Not applicable in the context of substantial equivalence for a medical laser system.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: There is no training set for an AI model.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a regulatory submission (510(k)) for a laser system seeking market clearance based on substantial equivalence, not a performance study for an AI/ML device.

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