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The Diode Laser System model Dawn-S is indicated for incision, ablation, vaporization, and coagulation of body soft tissues in surgical application.

The 980mm diode laser is generally indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue, including: general surgery, ENT (ear, nose, and throat) and oral surgery (otolaryngoloty), dental procedures, dermatology, plastic surgery, podiatry, urology, gastroenterology, and gynecology. The laser is further indicated for laser assisted lipolysis.

The 1470mm diode laser is indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular, coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The laser is further indicated for laser assisted lipolysis.

The Diode Laser System model Dawn-S is intended for delivery of dual wavelength laser beam to soft tissue. The Diode Laser System model Dawn-S generates a 1470nm wavelength laser and 980nm wavelength laser.

The laser is controlled via a high-resolution color touch screen display includes a user interface allowing selection of CW and Pulse mode as well as duty cycle and frequency of operation, laser power level and Stand-by/Ready selection.

The laser system consists of an optical block with contains the laser diode, mirrors, lens, and aiming beam diode, an air cooling system, and the laser power system, as well as an external footswitch for laser activation.

This FDA 510(k) summary provides information on the Diode Laser System model Dawn-S. The information focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study establishing new acceptance criteria or specific performance metrics with detailed statistical analysis.

Based on the provided document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific performance endpoints (e.g., accuracy, sensitivity, specificity) with numerical targets. Instead, it relies on comparison to predicate devices and compliance with recognized standards.

2. Sample Size Used for the Test Set and the Data Provenance

The document explicitly states: "No human clinical data is need for Diode Laser System model Dawn-S". Therefore, there was no "test set" of patient data for a clinical study as would be understood for an AI/diagnostic device.

The "test set" for this device appears to be the physical device itself undergoing non-clinical (bench) testing to demonstrate compliance with various IEC standards. No information is provided regarding the specific number of units tested, the origin of these units, or if any particular "data provenance" (e.g., country of origin) applies to non-clinical bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. As no human clinical data was used and the device's performance was evaluated through non-clinical testing against recognized standards, there was no "ground truth" to be established by experts in the context of evaluating diagnostic accuracy or clinical outcomes. The "ground truth" here is the adherence to engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring expert adjudication of results. The non-clinical testing involved engineers and technicians performing standardized tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a laser surgical instrument, not a diagnostic AI device requiring human reader interpretation, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a hardware medical device (laser system), not an AI algorithm. Its performance is inherent in its operation, not derived from an algorithm producing an output for a human to interpret.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" for demonstrating its safety and effectiveness is primarily established by:

• Compliance with Recognized Standards: The primary "ground truth" is that the device meets the specifications and safety requirements outlined in the cited IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22).
• Substantial Equivalence to Predicate Devices: The comparison to legally marketed predicate devices (K212734, K240747, K240644) serves as a form of "ground truth" by demonstrating that the new device shares fundamental technological characteristics and indications for use with devices already deemed safe and effective.

No pathology, expert consensus on images, or patient outcome data from a clinical trial were used to establish ground truth for this 510(k) submission.

8. The Sample Size for the Training Set

Not applicable. This is a hardware medical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

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