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FUNDUS MODULE 300 is an ophthalmic camera that is used as an accessory with dedicated slit lamps to capture digital images and video of the fundus of the human eye.

FUNDUS MODULE 300 device set for retinal imaging consists of FUNDUS MODULE 300 Camera with base plate, lens cover, battery and camera USB cable (0.6 m), and FUNDUS MODULE 300 Cradle with power supply and cradle USB cable (1.5 m). FUNDUS MODULE 300 is used with dedicated HAAG-STREIT slit lamps. FUNDUS MODULE 300 is designed to be used in medical environment and it is intended for nonmydriatic imaging of the fundus of the human eve for documentation and consultation. In nonmydriatic imaging no mydriatic is needed because infrared light is used for the targeting image to the fundus and visible light is flashed when an image is taken. The pupil does not respond to the infrared light so examination is convenient for the patient. Constant white light illumination for targeting can be selected from device menu if mydriatic drops are used. Images can also be taken using infrared lightning for both aiming and capturing. The FUNDUS MODULE 300 has 9 internal fixation targets for the patient to fixate at during imaging. The middle fixation target provides a macula centred image. FUNDUS MODULE 300 can be used together with HAAG-STREIT Release Module RM02 and HAAG-STREIT EyeSuite software. Controlling the FUNDUS MODULE 300 can be performed by Camera keys or by Release Module RM02. Captured images and recorded videos are automatically transferred to the PC (EyeSuite software) after imaging. Images and videos are stored on the micro SDHC memory card and can be also transferred to the PC by using Cradle USB connection. FUNDUS MODULE 300 Camera has rechargeable Li-lon battery and the device is charged by using the Cradle. Materials of outer shells of the FUNDUS MODULE 300 are plastic, aluminum and silicon. There is no applied parts (no parts which are designed to come into physical contact with the patient) in FUNDUS MODULE 300.

The provided document does not describe acceptance criteria for a device's clinical performance, nor does it detail a study proving such performance related to accuracy or effectiveness in a clinical context.

This document is a 510(k) summary for a medical device (HAAG-STREIT FUNDUS MODULE 300), which focuses on demonstrating substantial equivalence to a predicate device. The "Performance data" section refers to engineering and regulatory compliance testing rather than clinical performance testing with human subjects or expert assessment of diagnostic capability.

Therefore, most of the requested information regarding acceptance criteria, clinical study specifics, expert involvement, and ground truth establishment cannot be extracted from this document.

However, I can provide the available information from the document based on the categories you provided:

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Engineering):

Here's the breakdown of why the other requested information is not available and what little can be inferred:

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

   • Not Available. This document describes engineering and regulatory compliance testing (e.g., electrical safety, EMC, software V&V), not clinical efficacy or diagnostic accuracy studies. Therefore, there's no mention of a "test set" in the sense of patient data.

2. 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. As there's no clinical test set with diagnostic outcomes, there's no mention of experts establishing ground truth in this context.

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

   • Not Applicable. No clinical test set data or adjudication process is described.

4. 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:

   • Not Applicable. This device is an ophthalmic camera, not an AI-powered diagnostic system. It captures images and video. No MRMC study is mentioned, nor any AI assistance.

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

   • Not Applicable. This is a hardware device for image capture; there's no "algorithm only" performance reported in a diagnostic context.

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

   • Not Applicable. For the engineering tests, the "ground truth" would be the standard's compliance requirements, not clinical diagnostic ground truth.

7. The sample size for the training set:

   • Not Applicable. This document does not describe an AI/machine learning device that would require a "training set."

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

   • Not Applicable. As above, no training set is described.

In summary, the provided document is a 510(k) summary for an ophthalmic camera, focusing on its technical specifications, changes from a predicate device, and compliance with various engineering and safety standards. It does not contain information about clinical performance studies, diagnostic accuracy, or AI evaluation.

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