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The Righton Zoom Slit Lamp NS-2D with photo 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 NS-2D zoom slit lamps are designed for ophthalmic observation and microphotography. These slit lamps feature zoom stereoscopic converging microscopes that can be used for ophthalmic observation. Each instrument consists primarily of the main unit and the illumination power supply unit.

The provided 510(k) summary for the Righton Zoom Slit Lamp NS-2D with option does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

This submission focuses on establishing substantial equivalence to predicate devices. Substantial equivalence is determined by comparing the new device's intended use, technological characteristics, and safety and effectiveness to legally marketed predicate devices, rather than establishing new performance criteria through a specific study with defined acceptance criteria.

Therefore, many of your requested points cannot be answered from the provided text.

Here's a breakdown of what can and cannot be answered:

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

• Cannot be answered. The submission does not define specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) for the device itself or its imaging software. Instead, it compares the device's technical specifications to those of its predicate devices.

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

• Cannot be answered. No test set or associated data is mentioned. The submission is based on non-clinical testing and comparison to predicate devices, not a clinical study with a test set.

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):

• Cannot be answered. No ground truth establishment is described as there is no clinical test set.

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

• Cannot be answered. No adjudication method is mentioned as there is no clinical test set.

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:

• Cannot be answered. This is not an AI-assisted device, and no MRMC study is mentioned. The device is a slit lamp for ophthalmic observation and microphotogrpahy.

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

• Cannot be answered. Not applicable, as this is not an algorithm-only device. The device is a diagnostic instrument.

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

• Cannot be answered. No ground truth is described.

8. The sample size for the training set:

• Cannot be answered. No training set for an algorithm is mentioned.

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

• Cannot be answered. No training set or ground truth establishment is mentioned.

Summary of available information:

The submission focuses entirely on demonstrating substantial equivalence to existing legally marketed predicate devices by comparing their intended use and technological characteristics.

Table of Comparison (substituting "Acceptance Criteria" with "Predicate Device Specifications" as no specific acceptance criteria were provided):

Study to Prove Acceptance Criteria:
The "study" cited is a non-clinical testing results and a comparison to predicate devices, which concluded that the Righton Zoom Slit Lamp NS-2D with option and its data collection/image manipulation software are substantially equivalent to the predicate devices. This means that the device is considered safe and effective because it is similar enough to devices already legally on the market. It does not involve a specific study to meet pre-defined performance acceptance criteria as would be the case for a novel device or an AI algorithm requiring validation of diagnostic performance.

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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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