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The Fundus Camera RetiCam 3100 is intended to capture digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.

The RetiCam 3100 fundus camera is capable to capture, display, story, manage, process digital images of the posterior and external structures of the eye continuously, in real time.

The RetiCam 3100 fundus camera displays color fundus images continuously, in real time. The fundus digital image acquisition and image processing system is capable to perform measurement of the length (digital caliper), and perform area measurements, image comparison and image montage.

The RetiCam 3100 fundus camera function module includes: optical module, mobile platform module, power supply module, control module, chin rest module.

Optical Module
The optical module is responsible for providing background light illumination, flash shooting, fixing lamp control, lens focal length adjustment and pupil monitoring of patients when the fundus camera works. The optical module mainly consists of two parts: the light source module and the lens light path module.

• 1. The light source component is the source of the light source when the product works, including background light, fixation light and flash when shooting.
• 2. The lens light path is responsible for reflecting the patient's fundus image to the digital camera. The functions of lens focusing, pupil size switching and double camera pupil monitoring are used to ensure that the patient's fundus image can be presented clearly and reliably.

Mobile Platform Module
This module is mainly responsible for control of the position of optical module (i.e. up, down, left, right, back and forth movement of the optical module). This includes X, Y, Z axes, which are designed with servo motor and bearing, which are controlled by PCB board in the control module.

Power Supply Module
Power supply to each module through medical switching power supply.

Control Module
To enable operators to control the product, understand the working status of the product, observe the patient's condition, and carry out the corresponding inspection work normally.

There is a computer system integrated in the product, the input and output function are realized by touch screen display.

Chin Rest Module
To place the patient's head and keep the patient's eyes stable and easy to observe.

The provided document is a 510(k) summary for the Fundus Camera RetiCam 3100. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for an AI/algorithm-based diagnostic device.

Here's a breakdown of why many of your requested items cannot be found in this document:

• This document describes a medical device (a fundus camera) for image capture, not an AI/algorithm for diagnosis. Therefore, the concepts of "acceptance criteria for an AI algorithm," "AI vs. without AI assistance," "standalone algorithm performance," and "ground truth for test/training sets" are not applicable to the content presented.

However, I can extract information related to the performance specifications and the study (non-clinical testing) conducted for the device itself.

Acceptance Criteria and Reported Device Performance (Non-Clinical Testing)

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a non-clinical test conducted by Chongqing Bio NewVision Medical Equipment Ltd. This testing aimed to verify that the proposed device met all design specifications and was substantially equivalent to the predicate device.

Here's what can be inferred/extracted about the "study":

1. Sample size used for the test set and the data provenance: Not applicable/Not provided. This was not a study involving human data or labeled datasets for an algorithm. It was a performance validation of a hardware device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. This was a technical performance test of a camera, not a diagnostic assessment requiring expert ground truth.
3. Adjudication method for the test set: Not applicable/Not provided.
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: No. This document explicitly states, "No clinical study is included in this submission." Furthermore, the device is a fundus camera, not an AI algorithm, so the concept of human readers improving with AI assistance is not relevant to this submission.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This device is a fundus camera, not a standalone algorithm.
6. The type of ground truth used: For the performance parameters (resolving power, field of view, pixel pitch, range of focus), the "ground truth" was established by technical specifications and measurement standards, specifically ISO 10940, rather than clinical outcomes or expert consensus.
7. The sample size for the training set: Not applicable/Not provided. This is a hardware device; there is no training set for an AI algorithm.
8. How the ground truth for the training set was established: Not applicable/Not provided.

Summary of Non-Clinical Testing:

The non-clinical tests involved verifying compliance with several international and national standards, including:

• AAMI/ANSI/ES 60601-1:2005+A1:2012 (Medical Electrical Equipment - Basic Safety and Essential Performance)
• IEC 60601-1-2:2014 (EMC for Medical Electrical Equipment)
• ISO 15004-1:2006 (Ophthalmic instruments - General requirements)
• ISO 15004-2:2007 (Ophthalmic instruments - Light hazard protection)
• ISO 10940:2009 (Ophthalmic instruments - Fundus cameras)
• ISO 10993-5:2009 & ISO 10993-10:2010 (Biological Evaluation of Medical Device - Cytotoxicity, Irritation, and Hypersensitivity)
• ANSI Z80.36-2016 (American National Standard for Ophthalmics - Light Hazard Protection)

The results demonstrated that the proposed device complies with these standards, specifically meeting or exceeding the resolving power, field of view, pixel pitch, and focus range specifications outlined in ISO 10940.

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