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The Dornier Medilas™H Laser is intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand piece).

The Dornier Medilas™ H Laser is indicated for use in medicine and surgery, in the following specialties: Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, and General Surgery.

The Dornier Medilas™ H Laser Fiber Cables used in this premarket notification are the same accessory devices as in the previously cleared Dornier Medilas™ H Laser System under 510(k) #K984591 and maintain the same previously cleared indications for use as stated below.

This document is a 510(k) summary for a medical device (Dornier Medilas™ H Laser Fiber Cables). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way one would for a novel AI/software medical device.

Therefore, the prompt's requested information, which is tailored for performance studies proving a device meets acceptance criteria (especially relevant for AI/ML devices), is not applicable in this context.

Here's why and how I'll address your request based on the provided text:

• No Acceptance Criteria or Performance Study: The document explicitly states: "The safety and effectiveness of the Dornier Medilas™ H Laser Fiber Cables are based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device..." It further emphasizes: "Based on the technological characteristics and overall performance of the devices, Dornier MedTech America, Inc. believes that no significant differences exist between the Dornier Medilas™ H Laser Fiber Cables and the predicate device."
• Substantial Equivalence: The entire submission is built on the concept of substantial equivalence to a legally marketed predicate device (SlimLine Fibers in 365, 550 and 1,000 micron sizes, 510(k) #K980685). This means the manufacturer is asserting their device is as safe and effective as the predicate, not that it meets specific, novel performance metrics via a new study.
• No AI/Software Component: The device is a laser fiber cable, a hardware component. There is no mention or indication of any AI or software component, which would typically necessitate the kind of performance study and ground truth establishment described in your prompt.

Given this, I cannot provide the requested table or answer most of the questions because the information is not present in the provided 510(k) summary. The document does not describe a study to prove acceptance criteria in the manner of an AI/ML device.

Response based on available information:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated as performance metrics but implicitly the device must be "substantially equivalent" to the predicate device in terms of safety and effectiveness.
   • Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity) or clinical study results are reported to demonstrate meeting novel acceptance criteria. The performance is asserted to be equivalent to the predicate.

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

   • Not applicable. No new performance study or test set described.

3. 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):

   • Not applicable. No ground truth establishment for a performance study described.

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

   • Not applicable. No test set or adjudication described.

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 device is a laser fiber cable, not an AI-assisted diagnostic or therapeutic device that would involve human readers.

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

   • Not applicable. This is a hardware device, not an algorithm.

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

   • Not applicable. No ground truth for a performance study described.

8. The sample size for the training set:

   • Not applicable. This device is a laser fiber cable. There is no AI/ML model requiring a training set.

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

   • Not applicable. No AI/ML model or training set described.

In summary, this 510(k) submission relies on demonstrating substantial equivalence to a previously cleared device, not on presenting novel performance data from a clinical or analytical study with defined acceptance criteria.

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