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The Zeta Diagnostic Retinal Imaging System is intended to be used to capture, archive, and display digital images of the eye, particularly the retina obtained through the use of an ophthalmic camera (fundus camera). The Zeta System is an automated imaging device used in conjunction with a fundus camera that requires minimal intervention during the capture of an image. The system is simple to use and requires minimal training for a user to become proficient with the system. Like the listed predicate devices, the Zeta System is comprised of a digital imaging camera or cameras, computer hardware, and a software platform intended to be used to store images captured by the fundus camera. Thus the Zeta Diagnostic Retinal Imaging System has the same intended use and indications as the listed predicate devices.

The Zeta Diagnostic Retinal Imaging System is intended to be used to capture, archive, recall and display black and white, and color images of the retina captured using an ophthalmic camera during angiography non-invasively.

The Zeta Diagnostic Retinal Imaging System is comprised of the following components: A digital sensor head (digital camera) a computer interface circuit board (digital image capture card), and connecting cables. These components are then combined and sold together with our "eyepix" proprietary imaging software and a computer (CPU) monitor, keyboard and mouse. This total system with imaging software provides acquisition and hardware control capabilities used in conjunction with a fundus camera to take digital pictures of the retina which are then transferred via the digital camera and connecting cable to the computer system where they can be viewed, modified, stored or printed. The Zeta system is intended to capture and store images of the fundus, and it is also indicated for use as an ophthalmic camera for individuals where examination of the fundus have been requested for pathologies.

The provided text describes a 510(k) premarket notification for the Zeta Diagnostic Retinal Imaging System, which primarily focuses on demonstrating substantial equivalence to predicate devices for capturing, archiving, and displaying digital images of the eye. However, this document does not contain specific acceptance criteria, performance metrics, or study details typically found in a clinical study report or product validation documentation. The information provided is more aligned with regulatory submission requirements for demonstrating substantial equivalence based on intended use, technological characteristics, and principles of operation, rather than a detailed performance study with quantitative results against predefined acceptance criteria.

Therefore, it is not possible to complete the requested table and answer many of the questions as the information is not present in the provided document.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

Explanation: The document does not define specific performance metrics or quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, image resolution, processing speed, etc.) that the device was tested against. It largely relies on qualitative statements of equivalence and successful software validation tests without providing the results of those tests in detail.

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

• Sample size for test set: Not stated. The document mentions "several software validation tests" but does not provide details on the data used.
• Data provenance: Not stated.

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 applicable/Not stated. The document describes a system for capturing, archiving, and displaying images, not for making an automated diagnosis or generating a ground truth dataset in the context of a clinical performance study. The ground truth would typically refer to the confirmed diagnosis or finding against which an AI's performance is measured, which is not the function of this device.

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

• Not applicable/Not stated. As no specific clinical performance study with expert-adjudicated ground truth is described, there's no adjudication method 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. The document describes a system for image acquisition and management, not an AI-assisted diagnostic tool or a comparative effectiveness study involving human readers.

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

• Not applicable. The Zeta Diagnostic Retinal Imaging System described captures and stores images for human interpretation, it is not an algorithm performing a standalone diagnostic function. The "algorithm" here is the system's software for image acquisition, storage, and retrieval, which is not evaluated in a standalone clinical performance context.

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

• Not applicable/Not stated. A "ground truth" in the clinical context of a diagnostic AI is not relevant for this device, which focuses on image capture and management. The "validation tests" mentioned likely refer to technical performance (e.g., image quality, data integrity, software functionality) rather than diagnostic accuracy.

8. The sample size for the training set:

• Not applicable/Not stated. This device does not use machine learning in a way that would require a "training set" in the context of developing a diagnostic AI. The software validation tests don't imply a training phase like that of an AI model.

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

• Not applicable/Not stated. As there is no training set mentioned in the context of AI development, how its ground truth was established is not relevant.

Summary of what the document does state regarding validation/performance:

• "Zeta Development Laboratories has performed several software validation tests the results of which clearly indicate that the Zeta device meets comparable system and software standards exhibited by the predicate devices listed." (Page 3)
• The system allows users to "monitor, capture, and process, verifying the device is operating correctly." (Page 4)

These statements indicate that some form of validation was performed, but they lack the specific quantitative details and methodological rigor required to answer the questions about acceptance criteria and study design as typically applied to advanced diagnostic algorithms. The document's purpose is to establish "substantial equivalence" to existing devices, which primarily involves comparing intended use, technological characteristics, and principles of operation, rather than presenting a novel performance study against quantitative clinical endpoints.

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