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The Daytona ICG scanning laser ophthalmoscope is indicated for use as a wide field scanning laser ophthalmoscope for viewing choroidal circulation patterns that are illuminated using indocyanine green dye and for aiding both in the assessment of choroidal circulation and in the diagnosis of choroiditis or choroidal diseases.

The Optos P200TICG is a scanning laser ophthalmoscope that uses a laser as a light source to illuminate the eye. The device consists of the following components and accessories:

• A scanhead which houses the lasers, the scanning elements of the light input path and the . light return path including the detectors which convert light into electronic signal. With the exception of the chin support, the scanhead forms the key patient interface with a facepad and associated aperture where the eye is placed and a griphandle at each side of the scanhead. The image capture is controlled by a computer and associated embedded software including a safety module within the scanhead. This software runs on a Linux operating system.
• A chin support is juxta-positioned to the scanhead to support the patient head and reduce . patient movement when the eye is placed at the aperture of the scanhead.
• · A touchscreen is attached by a cable to the scanhead to assist the operator in ootimal patient positioning and to initiate an image capture. An image is displayed on the screen to allow the operator to confirm a suitable image has been taken.
• A personal computer with a monitor to allow image review and storage in a Windows . environment.

The provided text describes the Optos Daytona ICG (P200TICG) Ophthalmoscope and its substantial equivalence to a predicate device. However, it does not contain information about a study with acceptance criteria and specific reported device performance in the way typically found for a diagnostic algorithm or a clinical trial.

Instead, the performance data presented focuses on engineering and safety compliance rather than a clinical effectiveness study against specific diagnostic metrics.

Here's a breakdown of the requested information based on the provided text, highlighting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy for a particular condition) are explicitly stated for the Daytona ICG (P200TICG) device in the provided text. The performance data focuses on compliance with various safety and operational standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: No specific "test set" in a clinical sense (i.e., human subjects or patient data for diagnostic accuracy) is mentioned. The performance data relies on laboratory ex vivo testing and compliance with engineering standards.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective):
  • Ex Vivo Testing: Equine blood and a phantom eye were used. This is a laboratory setting, not clinical patient data.
  • Electrical, Light Hazard, Biocompatibility, Software Testing: Conducted to international standards (e.g., IEC, ISO). The location of these tests is not specified in the summary, but the submitter is based in the UK. This is engineering verification, not clinical data provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided as there was no clinical "test set" for diagnostic performance in the traditional sense, and thus no expert ground truth establishment for a clinical diagnosis. The "ground truth" for the ex-vivo testing was based on known concentrations of ICG in equine blood.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• This information is not applicable as there was no clinical "test set" requiring expert adjudication for diagnostic ground truth.

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 or comparative effectiveness study involving human readers or AI assistance is mentioned. This device is a standalone imaging device, not an AI diagnostic algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This device is an imaging instrument (ophthalmoscope), not an algorithm. Its performance is evaluated based on its ability to capture images and meet safety/engineering standards, not as a diagnostic algorithm. Therefore, "standalone" algorithm performance in the context of an AI device is not applicable. The device itself operates "stand-alone" in terms of capturing images for physicians to interpret.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the ex-vivo testing, the "ground truth" was the known, controlled concentrations of indocyanine green (ICG) in equine blood passing through a phantom eye.
• For safety and electrical testing, the ground truth was compliance with international standards and regulations (e.g., IEC, ISO).

8. The Sample Size for the Training Set

• This information is not applicable. The document describes an imaging device, not an AI model that would require a training set.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable as there was no training set for an AI model.

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