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The Leonardo Mini Blue 445nm Laser is intended for incision, vaporization, ablation, hemostasis and coagulation of soft tissue.

The laser family LEONARDO® Mini Blue is a laser system with functions and ergonomics specially developed for medical applications. A control panel is used to set treatment parameters, such as laser power. User-friendly menu navigation ensures a reliable operation while allowing physicians to concentrate on the essential aspects of treatment. The fiber-coupled semiconductor laser diodes convert electrical energy to coherent laser radiation with the wavelength of 445 nm (aiming beam 635 nm). A beam transporting system delivers this energy to affected surfaces and organs. Depending on the model, the LEONARDO® Mini Blue laser has the following maximum laser output power: LEONARDO® Mini Blue: 10W@445nm. LEONARDO® Mini Blue is available as a single-wavelength device with 445 nm. All LEONARDO® Mini Blue laser can be operated in continuous mode. Additional special treatment modes for specific treatment procedures or in combination with corresponding application fibers are available, depending on the configuration of the unit. For safety reasons, the LEONARDO® Mini Blue laser is equipped with a system for automatic recognition of the optical fibers used. Application fibers from CeramOptec have coding for communicating with the laser device.

This document is a 510(k) Premarket Notification for the Leonardo Mini Blue 445nm Laser. It focuses on demonstrating substantial equivalence to a predicate device (A.R.C. Laser GmbH Device Wolf 445nm K192272) rather than presenting a study of diagnostic accuracy or a specific set of acceptance criteria for an AI/CADe device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/CADe device (specifically, clinical study design elements like sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details) is not applicable to this submission.

This submission is for a surgical laser, and its demonstration of substantial equivalence relies on:

• Comparison of Technical Characteristics: Showing that the Leonardo Mini Blue 445nm Laser has similar design, power, wavelength, and operational modes to the predicate device, with minor differences not affecting safety or effectiveness.
• Compliance with Recognized Standards: Demonstrating the device meets relevant electrical safety, EMC, usability, and laser safety standards (e.g., IEC 60601 series, IEC 60825-1, ISO 14971).
• Bench Testing: Stating that bench testing was performed and indicated the new device is as safe and effective as the predicate.
• Software Validation: The firmware was validated according to the FDA Guidance for software in medical devices.

Summary of what is present in the document related to "acceptance criteria" (non-AI/CADe context):

1. A table of acceptance criteria and the reported device performance:
   The document includes a "Substantial Equivalence Chart" (pages 4-5) which compares the characteristics of the Leonardo Mini Blue 445nm Laser (proposed device) to the A.R.C. Laser GmbH Device Wolf 445nm (predicate device). This serves as the "acceptance criteria" in the context of substantial equivalence for a medical device without an AI component.

   Characteristic	Acceptance Criteria (Predicate Device)	Reported Device Performance (Proposed Device)	Compliance / Justification
   Indications for Use	Incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue.	Incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue.	SAME
   Display	Touch Screen	Touch Screen	SAME
   Mode	Diode Laser	Diode Laser	SAME
   Laser Power	0.5 W up to 10 W	Up to 10 W	SAME
   Laser Type	Diode Laser	Diode Laser	SAME
   Wavelength	445 nm	445 nm	SAME
   Aiming Beam	532 nm	635 nm	Both predicate and proposed device aiming beams are within the readily visible spectrum. No adverse safety or effectiveness impact.
   Aiming Beam Power	≤ 5 mW	Max. 4 Mw	Comparable. No adverse safety or effectiveness impact.
   Laser Class	4	4	SAME
   Operation Mode	Pulsed, Continuous Wave (CW)	Pulsed, Continuous Wave (CW)	SAME
   Pulse Length/Duration	≤ 4 Watt: 1 ms to 45 sec and CW

4 Watt: 1 ms to 60 ms | 10 Watt: 10 ms to 1 sec and CW. | Useful range for the indications. No adverse safety or effectiveness impact. |
| Pulse Frequency | ≤ 4 Watt: 0.01 Hz to 500 Hz and SP
4 Watt: 0.02 Hz to 6.6 Hz and SP | 10 Watt: 0.5Hz - 50Hz | Useful range for the indications. No adverse safety or effectiveness impact. |
| Cooling | Air | Internal Fan. | No adverse safety or effectiveness impact. |
| Main Power Supply | 100-240 V~, 47-63 Hz, 1.06-0.45 A | Mains operated OR Li-ion rechargeable battery. | No adverse safety or effectiveness impact. |
| Dimensions of System | H 10.06 cm, W 20.3 cm, 23.9 cm | H 6 cm, W 9 cm, L 21.5 cm. | SMALLER. No adverse safety or effectiveness impact. |
| Weight | 2.8 kg (6.17 pounds) | 0.960kg (without batteries) + 2x 0.045kg (battery weight) | LIGHTER WEIGHT. No adverse safety or effectiveness impact. |

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study for diagnostic accuracy on a test set. This is a comparison of technical specifications and compliance with standards.

3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for diagnostic performance is not established as no such study was conducted.

4. Adjudication method: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done as this is not an AI/CADe device requiring such a study to demonstrate improved reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used: Not applicable.

8. The sample size for the training set: Not applicable. This is not an AI/ML device trained on a dataset.

9. How the ground truth for the training set was established: Not applicable.

Instead, the document states:

• "The results of bench testing indicate that the new device is as safe and effective as the predicate device." (Page 5, Section 6)
• "Firmware was validated according to the FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. Software validation documents were provided for a moderate level of concern." (Page 5, Section 7)
• Compliance with various recognized consensus standards (e.g., IEC 60601-1, IEC 60601-2-22, ISO 14971, IEC 62304) tested by an accredited laboratory (EZU) is cited as evidence of safety and effectiveness. (Pages 5-6, Section 7)
• "Clinical testing was not required to establish substantial equivalence." (Page 6, Section 8)

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