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The Dornier Medilas D 1064 Laser model (trade name Medilas D30) is indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, ENT, Radiology. The Dornier Medilas D 1064 Laser model (trade name Medilas D30) is intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), and in the treatment and/or removal of vascular lesions (tumors).

The Dornier Medilas D 1064 Laser is a continuous-wave diode laser emitting laser radiation in the invisible range of 1064 nm. Each is calibrated during the manufacturing process and during service calls. The end-user does not calibrate fibers for this system. The Medilas D 1064 Laser incorporate a graphic display panel, which shows laser operating parameters, application modes, time functions, system status and messages for the user. The Medilas D 1064 Laser features several operating modes, including Standard, Fibertom, LITT and LPS. The laser can be used in contact or non-contact open surgery with or without handpieces.

The provided document is a 510(k) summary for the Dornier Medilas D 1064 Laser. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device meets specific de novo acceptance criteria through rigorous clinical studies for performance metrics like sensitivity, specificity, etc.

Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/diagnostic device.

Here's why and what information is available:

• Type of Device: The Medilas D 1064 Laser is a surgical laser, not an AI or diagnostic device that would typically have performance metrics like those for image analysis, disease detection, or treatment efficacy quantified by sensitivity, specificity, F1-score, etc.
• Regulatory Pathway: The 510(k) pathway focuses on demonstrating "substantial equivalence" to a predicate device. This means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to a device already on the market.
• Performance Data (as presented): The "Performance Data" section explicitly states: "While no performance standards have been established for Diode lasers under Section 514 of the Federal Food, Drug, and Cosmetic Act, the Dornier Medilas D 1064 Laser is in compliance with class IV performance standards for light emitting products promulgated under the Radiation Control for Health and Safety Act of 1968... The laser also complies with the applicable requirements of the following voluntary standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE)."
  • This indicates compliance with safety and electrical standards for laser devices, not clinical performance metrics on patient outcomes or AI accuracy.

In summary, the requested information (performance acceptance criteria, study details, sample sizes, ground truth methodology, expert qualifications, MRMC studies, standalone performance) is not applicable to this type of device and regulatory submission.

The document confirms that:

• The Medilas D 1064 Laser emits laser radiation at 1064 nm.
• It operates in continuous-wave mode.
• It is calibrated during manufacturing and service.
• It has a graphic display and several operating modes (Standard, Fibertom, LITT, LPS).
• It can be used in contact or non-contact open surgery, with or without handpieces.
• Its intended use is for cutting, vaporization, ablation, and coagulation of soft tissue in various medical specialties, including with endoscopic equipment, and for treating/removing vascular lesions.

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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, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery. The Dornier Medilas H Laser is indicated for use in medicine and surgery, in the following specialities: 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.

This document describes a 510(k) submission for the Dornier Medilas H Pulsed Laser. The provided text is a summary seeking clearance for the device, and as such, it does not detail a study proving the device meets specific performance acceptance criteria in the manner one might find for a diagnostic or AI-based device. Instead, it focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant safety standards.

Therefore, many of the requested elements regarding acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable or not present in this type of submission.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a laser device demonstrating substantial equivalence, explicit "acceptance criteria" for a specific disease or diagnostic task are not provided in the same way they would be for a clinical diagnostic device.

The "performance" is primarily focused on demonstrating that the device operates safely and effectively within established laser standards and is technologically similar to predicate devices.

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

This is not applicable. The submission does not describe a clinical study in the traditional sense involving a "test set" of patient data. It relies on technological comparison and compliance with standards rather than clinical performance data against a specific disease outcome.

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

This is not applicable. No ground truth for a test set was established as no such study is described.

4. Adjudication Method for the Test Set

This is not applicable. No test set requiring expert adjudication is 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

This is not applicable. This is not an AI-assisted diagnostic device, but a surgical laser. No MRMC study was performed.

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

This is not applicable. This is a surgical laser, not an algorithm.

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

This is not applicable. The submission is based on demonstrating substantial equivalence to predicate devices and compliance with safety and performance standards for laser devices, not on a ground truth related to a specific disease diagnosis or outcome in a study. The closest concept to "ground truth" here would be the established safety and efficacy profiles of the predicate devices and the regulatory standards themselves.

8. The Sample Size for the Training Set

This is not applicable. This is not a machine learning device that requires a training set.

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

This is not applicable. As above, this is not a device requiring a training set with established ground truth.

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