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The MS-39 is designed to capture scans of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye. To evaluate: - anterior and posterior corneal shape (elevation maps, curvature maps, power maps); - anterior chamber features (Anterior Chamber Depth ACD, Aqueous Depth AD); - corneal thickness (Central Corneal Thickness CCT, corneal thickness map); - corneal epithelia map; - corneal stroma map; - lens thickness.

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The provided document is an FDA 510(k) clearance letter for a device named MS-39, an ophthalmoscope. It describes the device's indications for use (capturing scans of the anterior segment of the eye and evaluating various features).

However, the document does NOT contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, or any details typically found in a clinical study report or device validation summary.

Therefore, I cannot provide a response that directly addresses your request based solely on the provided text. The document is an administrative clearance letter, not a technical report detailing the device's performance validation.

To answer your questions, you would need access to the actual 510(k) submission, which would include the performance data and the study details.

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The CSO Cobra Fundus Camera is intended for taking digital images of a human retina with or without the use of mydriatic agent. The retinal image can be stored to an image filing device.

Cobra is intended for taking digital images of a human retina with or without the use of a mydriatic agent. A function for retinal plane capturing is provided. The instrument is furnished with an integrated 5MP CCD camera, and uses one (1) white LED for flashing, one (1) IR led for alignment and Infrared acquisitioning.

Cobra can be used with pupil diameters starting from 2.5 mm, and therefore can be used without the need for a mydriatic agent. Acquisition transfer is performed from the instrument to the accompanying PC via a Firewire cable.

This document is a 510(k) premarket notification for the Cobra Fundus Camera, seeking clearance from the FDA. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent clinical study with specific acceptance criteria in the typical sense for an AI/CADe device.

Therefore, many of the requested sections (e.g., effect size of human readers with AI assistance, detailed sample sizes for test and training sets with ground truth establishment for AI, number of experts for ground truth, adjudication method) are not applicable or not explicitly stated in this type of submission, as the device itself is a fundus camera, not an AI diagnostic system. The "performance test" section refers to engineering and regulatory compliance tests, not a clinical study to evaluate diagnostic accuracy against a ground truth.

Here's the closest interpretation of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the context of this 510(k) submission. The "performance tests" mentioned are engineering and regulatory compliance studies, not clinical trials with patient data.
• Data Provenance: Not applicable.

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

• Not applicable. This submission doesn't describe a clinical study requiring ground truth established by experts.

4. Adjudication method for the test set

• Not applicable.

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. This device is a fundus camera, not an AI/CADe system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

• No. This is a hardware device (fundus camera), not an algorithm.

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

• Not applicable in the context of a clinical performance evaluation. The "ground truth" for the performance tests would be the fulfillment of established engineering standards (e.g., electrical safety, EMC requirements).

8. The sample size for the training set

• Not applicable. This device is a fundus camera, not an AI system that requires a "training set."

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

• Not applicable.

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A manual device intended to measure intraocular pressure by applanation (applying a small flat disk to the cornea)

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The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for the CSO Models A900 and F900 Applanation Tonometers. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain the detailed study information typically requested regarding acceptance criteria, device performance, and ground truth establishment.

Therefore, many of the requested details cannot be extracted from this specific document.

Here's what can be inferred or stated based on the provided text:

• Acceptance Criteria and Reported Device Performance: This information is not present in the document. The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical performance studies with defined acceptance criteria for novel device performance claims.
• Sample size for the test set and data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
• Standalone (algorithm only without human-in-the-loop performance) study: Not mentioned. Since this is a manual tonometer, the concept of an "algorithm only" performance study is not applicable.
• Type of ground truth used: Not mentioned.
• Sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

Summary based on the document:

This document is a regulatory clearance for a manual applanation tonometer. Its clearance is based on substantial equivalence to predicate devices marketed prior to May 28, 1976. This regulatory pathway means that no specific new clinical performance study, acceptance criteria, or ground truth establishment details are typically required to be submitted or are present in this type of 510(k) summary letter. The device's performance is implicitly considered acceptable because it is substantially equivalent to a device already deemed safe and effective.

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