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The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

Urology

• Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
• Laser Resection of the Prostrate (LRP)
• Laser Enucleation of the Prostate (LEP)
• Laser Ablation of the Prostate (LAP)
• Transurethral Incision of the Prostate (TUIP)
• Condylomas
• Urethral/ureteral structures
• Lesions of external genitalia
• Bladder neck incisions (BNI)
• Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
• Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
• Treatment of distal impacted fragments remaining in the ureters following lithotripsy

Lithotripsy and Percutaneous Urinary Lithotripsy Indications

• Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
• Endoscopic fragmentation of renal calculi
• Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

• Appendectomy
• Polyps
• Biopsy
• Gall Bladder calculi
• Biliary/Bile duct calculi
• Ulcers
• Gastric ulcers
• Duodenal ulcers
• Non Bleeding Ulcers
• Pancreatitis
• Haemorrhoids
• Cholecystectomy
• Benign and Malignant Neoplasm Gynecology
• Angiodysplasia
• Colorectal cancer
• Telangiectasias
• Telangiectasias of the Osler-Weber-Renu disease
• Vascular Malformation
• Gastritis
• Esophagitis
• Esophageal ulcers
• Varices
• Colitis
• Mallory-Weiss tear
• Gastric Erosions

Gynecology
Open, endoscopic (including hysteroscopic) and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.

All variants of the laser family LEONARDO® Duster are laser systems with functions and ergonomics specially developed for medical applications. A touchscreen is used to set treatment parameters, such as Power in Continuous mode, Pulse energy (J) and Frequency (Hz) with Pulse width options in Pulse mode. User-friendly menu navigation and microprocessor-supported control ensure reliable operation while allowing physicians to concentrate on the essential aspects of treatment. The Thulium doped fiber laser module produce a coherent laser radiation with the wavelength of 1940nm±3nm (aiming beam 525nm +/-10nm). An optical fiber delivers this energy to affected surfaces and organs. All fields of application are listed in the indications for use statement.

The subject model LEONARDO® Duster laser has a maximum laser output power of 60W. @ 1940nm The LEONARDO® Duster is available only as a single-wavelength device with 1940nm. All LEONARDO® Duster lasers can be operated in two basic modes, CONTINUOUS or PULSE MODE. Two application modes are available which defines the intended use of the device: Lithotripsy and Other. For safety reasons, the LEONARDO® Duster laser is equipped with a system for automatic recognition of the used optical fibers. Application fibers from CeramOptec are RFID encoded for communicating with the laser device. Reusable fiber probes are available in 6 different sizes. They are initially EO sterilized. Subsequent sterilization is via autoclave. Single patient use fiber probes come in 7 different sizes. They are initially EO sterilized.

This document is a 510(k) clearance letter for the Leonardo Duster laser system. It asserts substantial equivalence to a predicate device based on non-clinical testing. This type of clearance typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often without requiring new clinical trials for effectiveness if the indications for use and technological characteristics are sufficiently similar.

Therefore, the provided text does not describe a study involving acceptance criteria related to device performance in a clinical or AI-centric context, nor does it present acceptance criteria for an AI-powered device. It primarily focuses on the safety and effectiveness of a physical medical device (a laser surgical instrument) compared to a predicate device, which is a common pathway for 510(k) clearance.

The "acceptance criteria" presented here are inferred from the regulatory requirements for 510(k) clearance, namely, demonstrating substantial equivalence to a predicate device based on:

1. Identical Indications for Use.
2. Similar technological characteristics without raising new questions of safety or effectiveness.
3. Compliance with relevant performance standards and non-clinical testing (e.g., software validation, reprocessing validation, biocompatibility, sterilization, electrical safety, EMC, usability, laser safety).

Since this is not an AI/ML device or a comparative effectiveness study, many of the requested fields (e.g., sample size for test set, data provenance, ground truth experts, adjudication, MRMC study, standalone performance, training set size) are not applicable.

Here's the breakdown based on the provided text's focus on a physical laser device clearance:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Determination)

Study Details Pertaining to the Leonardo Duster 510(k) Clearance

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • N/A. This 510(k) clearance is based on non-clinical (bench) testing and comparison to a predicate device, not a performance study on a test set of data (like for an AI/ML device). The "test set" in this context refers to physical devices and components being tested in a lab setting. These tests were conducted by "accredited testing laboratories," but the location is not specified beyond "Bonn, Nordrhein-Westfalen, Germany" for the manufacturer. No patient data is involved in this type of submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • N/A. No ground truth established by medical experts for a "test set" of patient data was carried out. The "ground truth" for a physical device like this is its adherence to engineering specifications and regulatory performance standards.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. No adjudication of expert opinions on medical cases was performed as this is not a clinical or AI performance study.

4. 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:

   • No. An MRMC study was not done. This is a physical laser surgical instrument, and the clearance is for the device itself, not an AI/ML component assisting human readers.

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

   • No. This is not an algorithm, but a physical medical device. Software validation was performed for the device's firmware, but this does not represent a "standalone algorithm" performance in the context of AI/ML.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • N/A. As this is a physical device, the "ground truth" for its clearance is based on its adherence to engineering specifications, national and international consensus standards for medical devices (e.g., electrical safety, laser safety, biocompatibility, sterilization, usability), and its functional output parameters (e.g., laser power, wavelength, pulse characteristics). There's no clinical "ground truth" like pathology or outcomes data presented for this 510(k) summary, as "Clinical testing was not required to establish substantial equivalence."

7. The sample size for the training set:

   • N/A. No training set was used as this device is a physical laser surgical instrument, not an AI/ML algorithm.

8. How the ground truth for the training set was established:

   • N/A. No training set was used.

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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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