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HFC-1 fundus camera is intended to capture digital images for the anterior and retina segment of the eye without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health.

HFC-1 Fundus Camera captures, store and display color fundus images with built-in 20 Mega pixel colored channel up to 45-degree field of view. HFC-1 Fundus Camera is designed as a non-contact, non-invasive and high resolution digital imaging device. HFC-1 Fundus Camera has a retinal imaging system that provides digital images of the eyes to assist physicians in diagnostic examinations. The anterior of an eye is illuminated by IR light, the retina of an eye is illuminated by a white LED, emitted by the fundus illumination optical system. The fundus observation/photography optical system obtains an image with image sensors and images are observed and manipulated on the display panel.

The Huvitz Co., Ltd. HFC-1 Fundus Camera is intended to capture digital images for the anterior and retina segment of the eye without the use of a mydriatic agent, aiding clinicians in evaluating and diagnosing ocular health.

The device's performance was evaluated through a series of bench tests, including electrical and mechanical safety testing, electromagnetic compatibility, light hazard testing, and disinfection tests, all adhering to relevant international standards. The primary effectiveness study involved comparing the HFC-1's image quality and technical features against a predicate device, the Nidek AFC-330 Non-Mydriatic Auto Fundus Camera (K113451), and assessing its conformity to ISO 10940:2009 (Ophthalmic Instruments-Fundus Cameras).

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

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: The document does not specify a distinct "test set" in terms of patient images or clinical cases for the performance evaluation. Instead, the performance tests relied on model eyes, standardized targets (e.g., USAF chart, scales), and physical measurements of the device.
• Data Provenance: The testing appears to be prospective bench testing conducted by the manufacturer, Huvitz Co., Ltd., which is based in Gyeonggi-do, Republic of Korea. No patient data or clinical data from specific countries are mentioned for these performance tests.

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)

• For the objective quantitative tests (e.g., resolution, image capture angle, pupil diameter, pixel pitch, working distance, moving range, auto tracking, sleep mode, LCD tilting angle, cornea flare, lens flare), the acceptance criteria were established based on ISO 10940 Standard or opinions of Huvitz senior engineers and researchers. There is no mention of external experts or their specific qualifications for establishing ground truth for these objective measurements.
• For the Image Quality Comparison Test, images from the HFC-1 and the predicate device were "shown to the physician for comparison in image quality." The document does not specify the number of physicians, their qualifications, or how their comparisons were aggregated to form a "ground truth" or judgment.

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

• For the objective bench tests, the adjudication method was none in the sense of expert consensus. The results were compared directly against pre-defined numerical or descriptive criteria derived from ISO standards or internal expert opinion.
• For the Image Quality Comparison Test, the document states images were "shown to the physician for comparison," but it does not describe an adjudication method (e.g., majority vote, consensus meeting) for interpreting the physician's comparison.

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 comparative effectiveness study was done. The device is a fundus camera, which is an imaging device, not an AI-powered diagnostic algorithm designed to assist human readers. The effectiveness study focused on the image capture capabilities and image quality of the camera itself.

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

• This question is not applicable as the HFC-1 Fundus Camera is an imaging device, not an AI algorithm. Its performance is about its ability to capture images, not interpret them.

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

• For the objective performance tests, the "ground truth" was based on internationally recognized standards (ISO 10940) and internal engineering specifications/expert opinions.
• For the Image Quality Comparison Test, the "ground truth" was based on the direct visual comparison of images by an unnamed physician. This is closer to a subjective expert assessment rather than objective and independently verified ground truth like pathology.

8. The sample size for the training set

• No training set is mentioned or applicable, as the HFC-1 Fundus Camera is an imaging device, not a machine learning algorithm that requires training data.

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

• Not applicable as there is no training set for this device.

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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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