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The Dornier Thulio Laser is intended for minimally-invasive stone fragmentation, surgical tissue preparation such as cutting, ablation, coagulation and vaporization, in the following medical specialties: Urology a) Lithotripsy - Endoscopic fragmentation and pulverization of urethral, ureteral, bladder and renal stones - b) Benign Prostatic Hyperplasia (BPH) - c) Urethral Strictures - d) Bladder Neck Incision of the Prostate (BNI) e) Superficial and invasive bladder, urethral and ureteral tumors

The Dornier Thulio is a compact, mobile, diode pumped Thulium, pulsed, single wavelength surgical laser with a wavelength of 2013 nm. The Dornier Thulio laser is comprised two functional components: (1) a laser console and (2) a dual pedal footswitch (wired or wireless). The laser console emits laser radiation which is transmitted to the application site by a sterile fiber optic delivery system (fiber cable) with a SMA 905 connector. A graphic control panel regulates and displays the operating parameters, application modes, time functions, system status and messages to the user. The control panel consists of a display with integrated touch screen panel applications to control the functions of the laser. Laser energy is transmitted by depressing a foot pedals, both the wired and wireless models, are water-proof and explosion-proof. The Dornier Thulio laser also has the same principles of operation as other currently available medical lasers (switch on the device, set energy, set frequency, set laser mode, connect the lightguide, prepare the footswitch, activate the laser device). The laser energy is transmitted via the use of a laser fiber connected to the Thulio laser.

The Dornier Thulio Laser, a Thulium-doped YAG laser operating at 2013 nm, was evaluated against established performance criteria primarily through non-clinical bench testing and literature review to demonstrate its substantial equivalence to predicate devices, especially the Lumenis Pulse™ 100H/120H (K170121).

Here's a breakdown of the acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The direct acceptance criteria with specific numerical targets are not explicitly stated as "acceptance criteria" in the provided text. Instead, the evaluation focuses on demonstrating comparability and equivalence to known predicate and reference devices regarding clinical functions. Therefore, the "acceptance criteria" are implied to be achieving comparable performance to the predicate/reference devices in key urological applications.

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

• Sample Size for Test Set: The document does not specify exact "sample sizes" in terms of number of cases or experimental repetitions for the non-clinical bench testing mentioned. The descriptions refer to "in-vitro experiments" and "a study" for lithotripsy and cutting/coagulation.
• Data Provenance: The studies were non-clinical bench tests (in-vitro experiments). Therefore, there is no country of origin for human data, as no human or animal subjects were involved. The provenance is laboratory-based testing.

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

This information is not provided in the document. As the studies were non-clinical bench tests (in-vitro), the concept of "experts establishing ground truth for a test set" in a clinical sense does not directly apply. The 'ground truth' for these tests would be the physical measurements and observations made during the bench testing, with the comparison being against established performance characteristics of the reference Ho:YAG lasers.

4. Adjudication Method for the Test Set

Since the studies were non-clinical bench tests focusing on physical properties and performance metrics (pressure, dusting, fragmentation, retropulsion, enucleation), an adjudication method as typically applied to human-read medical imaging or clinical outcomes (e.g., 2+1, 3+1 consensus) is not applicable or described. The results would likely be based on direct measurements and quantitative analysis of the physical parameters.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The studies described are non-clinical bench tests comparing the physical effects of the Dornier Thulio Laser to other laser devices. There is no mention of human readers or AI assistance.

6. Standalone (Algorithm Only) Performance

This question is not applicable to this device. The Dornier Thulio Laser is a physical surgical laser device, not an AI algorithm or software. Its performance is inherent to its hardware and operational parameters, not a standalone algorithm.

7. Type of Ground Truth Used

The ground truth for the non-clinical performance studies was primarily based on:

• Physical measurements and quantitative analysis of laser effects in an in-vitro (bench test) environment (e.g., pressure produced, fragmentation efficiency, retropulsion force, tissue cutting/coagulation depth/area).
• Comparison against the known and established performance characteristics of the predicate and reference Ho:YAG lasers (Medilas H Solvo 35 and Medilas H140), which serve as the "ground truth" for what is considered acceptable or comparable performance in the field.

8. Sample Size for the Training Set

This information is not applicable as the Dornier Thulio Laser is a hardware device (surgical laser) and not an AI or machine learning model that requires a training set.

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

This information is not applicable as the device does not use a training set.

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The Multicavity Holmium laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynaecology, ENT and General Surgery.

The devices belonging to Multicavity Holmium laser family are laser devices based on a Holmium laser source. The main parts (subsystems) of the device are the Holmium laser source, the power electronics, the optical delivery system, the control electronics and the cooling system. A specific software controls the device functions and allows the user selections. Laser emission is triggered by a footswitch.

The provided document is a 510(k) premarket notification for a medical device called "Litho 150, Cyber Ho 150" (Multicavity Holmium laser). It describes device modifications and asserts substantial equivalence to a predicate device (Litho 100/60, K192600).

However, this document does not contain the detailed information necessary to complete the requested table and answer questions 2-9.

Here's why and what information is missing:

• Acceptance Criteria and Reported Performance: The document states that the device "underwent and successfully passed electrical safety, EMC and performance testing" according to specific standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and "Software Verification and Validation Testing". However, it does not provide specific numerical acceptance criteria (e.g., "power output must be within +/- 5%") or the actual numerical performance results of these tests (e.g., "power output was 150W +/- 2W"). It only confirms successful passing of these tests.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: These questions are typically relevant for studies evaluating the clinical effectiveness or diagnostic accuracy of a device, especially those involving AI/ML models, image analysis, or outcomes assessment. This 510(k) is for a surgical laser, and the "performance testing" mentioned refers to engineering and safety standards, not a clinical study to establish diagnostic or treatment efficacy performance metrics in terms of sensitivity, specificity, accuracy, or similar measures against a clinical ground truth.

Therefore, I cannot populate the table or answer questions 2-9 based on the provided text.

However, I can extract the available information regarding the device's technical specifications and the standards it met:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other questions (2-9):

The document provides no information on these points because the submission is a "Special 510(k)" for device modifications based on hardware changes (increased power and frequency) to an already cleared device (K192600). The basis for this type of submission relies on demonstrating that the modified device remains substantially equivalent to the predicate through engineering and safety testing, not typically through new clinical studies involving human subjects or extensive ground truth establishment in the manner described by these questions. Such detailed clinical study methodology would be expected for novel devices or significant changes impacting clinical performance but is not provided for this specific submission type.

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