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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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