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The RS-1000 Zoom Slitlamp with option is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

The RS-1000 Zoom slitlamp microscope consists of a microscope with a halogen lamp which illuminates the inner eye for examination with an optional attachment for photographic or video capabilities and an illumination power supply.

The provided documents describe a 510(k) premarket notification for the RS-1000 Zoom Slitlamp with option. This device is an AC-powered slitlamp biomicroscope intended for eye examination. The acceptance criteria and the study proving it meets these criteria are outlined in the "Performance testing" section.

Here's an analysis of the requested information:

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

2. Sample size used for the test set and the data provenance:

The document describes performance testing in accordance with IEC standards, which typically involves testing of the device itself rather than a test set of patient data. Therefore, there is no sample size of patient data mentioned for a test set, nor any information about data provenance (country of origin, retrospective/prospective). The testing focused on the device's electrical, mechanical, and electromagnetic properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the study did not involve establishing ground truth from patient data with expert readers. The testing was focused on engineering and performance standards for the medical device itself.

4. Adjudication method for the test set:

This information is not applicable as there was no test set involving human interpretation of medical images or data requiring adjudication.

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:

No MRMC study was done, and therefore, no effect size of human reader improvement with AI assistance is mentioned. This device is a diagnostic illumination microscope and does not incorporate AI.

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

This information is not applicable. The device is an optical instrument, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's performance assessment appears to be the established technical and safety standards (IEC 60601-1 and IEC 60601-1-2) themselves. Compliance with these standards indicates the device performs as expected for its intended use. Equivalency to the predicate device also serves as a comparative "ground truth" for its clinical utility.

8. The sample size for the training set:

The document does not describe a "training set" in the context of machine learning or AI. The performance testing was on the manufactured device itself.

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

This information is not applicable as there was no training set in the context of machine learning or AI.

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The AURIGA Holmium Laser system is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (f. e. strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (f. e. DCR), Lithotripsy, Orthopedics, Discectomy and General Surgery.

The AURIGA is a pulsed solid-state Holmium YAG-Laser System with a wavelength of approx. 2080 nm. The system is suitable for interdisciplinary use in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (f. e. strictures) , ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (f. e. DCR), Lithotripsy, Orthopedics, Discectomy and General Surgery.

The provided document is a 510(k) summary for the AURIGA Holmium Laser System. It focuses on establishing substantial equivalence to predicate devices and detailing the device's intended use. Crucially, the document explicitly states "Performance Data not presented" and does not include any studies proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document only provides the following:

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

• No acceptance criteria or reported device performance are presented in the document. The document states "Performance Data not presented."

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

• Not provided. No test set data or provenance is mentioned.

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 provided. No information on ground truth establishment for a test set is present.

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

• Not provided. No adjudication method for a test set is mentioned.

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:

• No MRMC study was done or reported. This device is a surgical laser, not an AI-assisted diagnostic tool, so such a study would not be applicable in this context.

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

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

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

• Not provided. No ground truth information is available as no performance data or studies are presented.

8. The sample size for the training set:

• Not provided. No training set is mentioned as no algorithm or AI is discussed.

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

• Not provided. No training set or ground truth establishment for it is mentioned.

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