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The Dornier Medilas H Laser is intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue in coniunction 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 Pulsed Holmium YAG Laser is a compact pulsed HO: YAG laser emitting laser radiation in the invisible range of 2080 nm. The Medilas H provides a temperature-controlled method for contact cutting and non-contact coagulation and vaporization with a bare fiber. The modified Medilas H has the same principles of operation and similar technological characteristics as the previously unmodified Medilas H (K981718). The modified Medilas H and the unmodified Medilas H laser systems have photoelectric power meters and are automatically calibrated. They also have a 2-stage waterproof and explosion proof footswitch and both lasers incorporate a watchdog-monitored microprocessor. Both Lasers depict a graphic display panel which show the laser operating parameters, application modes, time functions, system status and messages for the user. The Medilas H lasers provide a temperature controlled method for contact cutting and non-contact coagulation and vaporization with fibers made of quartz glass with a bare fiber tip. These fibers are available in diameters of 400 and 600 µm. The Medilas H lasers feature one mode of operation: Standard. The microprocessor controlled Dornier Medilas H lasers have been developed in accordance with the latest technical standards. The lasers have a cooling system that includes an air-cooled, temperature controlled, internal closed circuit water system. As a safety feature, both Medilas H lasers have a single rotating magnetic shutter which moves the filter out of the laser beam. One microprocessor controls the shutter. The Medilas H lasers contain a single shutter with two parallel running microprocessors. Whenever one microprocessor runs differently from the other, the Medilas H laser hardware initiates a "system fault" routine. During any "system fault" laser production and release immediately halt.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Dornier Medilas H Pulsed Laser:

Acceptance Criteria and Study Analysis for the Dornier Medilas H Pulsed Laser

Based on the provided 510(k) summary, the device is a modified version of an already cleared predicate device (K981718). The submission focuses on demonstrating substantial equivalence rather than presenting an entirely new device with novel performance curves. Therefore, the "acceptance criteria" here are framed around compliance with existing standards and the assertion that modifications do not impact safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion	Reported Device Performance
   Compliance with Class IV performance standards for light emitting products per Radiation Control Health and Safety Act of 1968 (21 C.F.R. § 1040.10 and §1040.11).	The Dornier Medilas H laser is in compliance with these class IV performance standards.
   Compliance with applicable requirements of voluntary standards IEC-601, IEC 825/VDE 0837/2.86.	The laser also complies with these applicable requirements.
   Modified aiming beam wavelength (635 nm) and power (1mW) compared to predicate (630 nm, 1mW) does not present new safety/effectiveness issues.	Stated that "These modifications do not present any new issues of safety or effectiveness of the device."
   New housing dimensions do not present new safety/effectiveness issues.	Stated that "These modifications do not present any new issues of safety or effectiveness of the device."
   Principle of operation and key technological characteristics (e.g., photoelectric power meters, automatic calibration, footswitch, watchdog-monitored microprocessor, graphic display, cooling system, single rotating magnetic shutter with two parallel running microprocessors) are the same or similar to the predicate device.	The modified Medilas H has the same principles of operation and similar technological characteristics as the previously unmodified Medilas H (K981718). Specific features are listed as being identical or having minor, non-impactful differences.

2. Sample size used for the test set and the data provenance:
   The document does not specify a numerical sample size for a test set. This submission relies on demonstrating compliance with existing regulatory and voluntary standards, and the assertion that minor modifications (aiming beam wavelength, housing) do not affect safety or effectiveness. There is no mention of a clinical or performance study with a distinct "test set" in the traditional sense of evaluating a diagnostic or interventional outcome on a set of patients or samples. The "data provenance" primarily consists of engineering specifications and compliance assessments against published standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided in the document. As there is no explicitly defined "test set" and ground truth establishment in a clinical or diagnostic context, expert involvement in such a capacity is not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   An adjudication method is not applicable and not mentioned. There is no clinical or performance study involving multiple reviewers of data for consensus.

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:
   An MRMC comparative effectiveness study was not done. This device is a laser system, not an AI-assisted diagnostic tool, and the submission is not focused on evaluating human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   A standalone performance study in the context of an algorithm or AI is not applicable and was not done. The device is a medical laser. The "performance data" refers to compliance with safety standards for laser products.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the modifications, the "ground truth" used is essentially engineering verification and validation against known laser safety standards and the established performance of the predicate device. The assertion is that changes are minor and do not alter the already-cleared performance characteristics. There is no biological or clinical "ground truth" established for this specific submission beyond demonstrating compliance with existing laser safety regulations.

8. The sample size for the training set:
   A "training set" is not applicable and not mentioned. This device is a laser system, not a machine learning model, so there is no concept of a training set as would be used for AI development.

9. How the ground truth for the training set was established:
   This information is not applicable as there is no training set for this device.

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