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3nethra neo HD FA:

3nethra neo HD FA is used as a wide-field retinal imaging digital camera for photo documentation of ocular diseases that manifest in infants. The device acquires only images and does not provide any pathological analysis or diagnosis for treatment.

3nethra neo HD:

3nethra neo HD is used as a wide-field retinal imaging digital camera for photo documentation of ocular diseases that manifest in infants. The device acquires only images and does not provide any pathological analysis or diagnosis for treatment.

The 3nethra neo-HD FA is a handheld wide-angle fundus imaging system for neonatal screening. It is designed to acquire, display, store and transmit images of the posterior and anterior surfaces of human eye. The images assist clinicians in the evaluation and documentation of visual health in retinopathy of prematurity (ROP) and other problems. It operates in contact with the cornea of the eye under test. 3nethra neo HD FA uses continuous white light for operation and hence need pupil dilation. It also equipped with blue light source and green filters for fundus fluorescein angiography (FFA).

The 3nethra neo-HD is a handheld wide-angle fundus imaging system for neonatal screening. It is designed to acquire, display, store and transmit images of the posterior and anterior surfaces of human eye. The images assist clinicians in the evaluation and documentation of visual health in retinopathy of prematurity (ROP) and other problems. It operates in contact with the cornea of the eye under test. 3nethra neo HD uses continuous white light for operation and hence need pupil dilation. The 3nethra neo HD is a lower end variant of the 3nethra neo HD FA without the Fluorescein Angiography feature.

The provided 510(k) clearance letter and summary describe the acceptance criteria and a study to prove the device's performance. Here's a breakdown of the information requested:

The device in question, 3nethra neo HD FA and 3nethra neo HD, are ophthalmic cameras intended for wide-field retinal imaging and photo documentation of ocular diseases in infants. They acquire images only and do not provide pathological analysis or diagnosis.

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this device, based on the provided document, is substantial equivalence to existing predicate devices, particularly in terms of image quality for the FA functionality. The study focuses on demonstrating that the fluorescent angiography (FA) images produced by the subject device are comparable in quality to those produced by a predicate device.

Study Details

The study described is a clinical observational study focused on image quality comparison.

1. Sample size used for the test set and the data provenance:

   • The document states "of all study images," implying that all images collected within the clinical observational study were used for the comparison. However, the exact numerical sample size (number of images or patients) for the test set is not explicitly stated in the provided text.
   • Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. It is described as a "clinical observational study," which typically implies prospective data collection, but this is not confirmed.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not explicitly state the number of experts used or their specific qualifications (e.g., number of years of experience, specific certifications). It simply refers to the primary objective being to demonstrate comparability to a cleared reference device. The process of expert evaluation for "comparable quality" is not detailed.

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

   • The document does not describe any specific adjudication method for evaluating image quality. It states that "all study images were found to be of comparable quality," but the process by which this finding was made (e.g., consensus, majority vote) is not provided.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs. without AI assistance:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in the provided text.
   • The device is described as an "Ophthalmic Camera" that "acquires only images and does not provide any pathological analysis or diagnosis for treatment." Therefore, there is no AI assistance component for human readers to be compared against. The study focused on assessing the image quality of the camera itself, not the impact of AI on human interpretation.

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

   • This question is not applicable as the device is an imaging camera that acquires images for human interpretation, not an algorithm providing a standalone diagnostic or analytical output. The study assessed the quality of the images produced by the device.

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

   • The ground truth for the "comparable image quality" assessment appears to be based on a clinical observational study comparing the subject device's images to those from a predicate device (RetCam 3). The implicit ground truth is the accepted, established quality of images from the predicate device.
   • The document does not mention pathology or outcomes data as a direct ground truth for image quality assessment in this context. The study aimed to show that the images themselves were of sufficient quality for their intended purpose (photo documentation) by comparing them to a cleared device.

7. The sample size for the training set:

   • The document does not mention a training set. This is because the device is an imaging camera, not a machine learning or AI algorithm that requires a training set.

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

   • This question is not applicable as there is no mention of a training set for this device.

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General ophthalmic imaging including retinal, corneal, and external structures of the eye.

The Phoenix Clinical ICON is a battery and AC-powered, cart-based, non-sterile, wide-field, handheld, high resolution, real-time retinal imaging device. It is intended to be used for general ophthalmic imaging including retinal, corneal, and external structures of the eye. The intended users of the Phoenix Clinical ICON are clinical imaging technicians, ophthalmic technicians, nurses, and physicians. The Phoenix Clinical ICON may be used in hospitals, medical clinics, and physician's offices. The Phoenix Clinical ICON is a system comprised of a hand-held camera with an interchangeable LED based light source incorporated into the hand piece that is attached to the cart contains the battery, the keyboard controls, monitor, attached foot pedal, and computer with software. The hand piece is designed such that the glass lens in the tip will come into contact with the cornea. LED light is emitted into the eye to illuminate the retina for image capture. The Phoenix ICON is operated by attaching the appropriate module (white or blue LED) to the handpiece and, after the software is running, placing the camera lens in direct contact with the patient's cornea. The Phoenix Clinical ICON software can capture either video or still images and store them on the cart computer for later review. The Phoenix Clinical ICON may be connected to, under IT supervision, IT networks.

The Phoenix Clinical ICON device is compared to a predicate device (RetCam 3 K102859) to establish substantial equivalence for general ophthalmic imaging. The acceptance criteria and the study that proves the device meets the acceptance criteria are detailed below:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document doesn't explicitly state the sample size for the test set in terms of cases or patients. However, it mentions that "images from the predicate device and the ICON were presented to a panel." This suggests that the test set consisted of images from both devices.

The data provenance is not explicitly mentioned as country of origin, retrospective or prospective. It appears that images were acquired from both the predicate device and the ICON for comparison.

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

• Number of Experts: Five
• Qualifications: "Five clinicians" were used for the comparison of image quality. Specific qualifications (e.g., years of experience, subspecialty) are not provided beyond "clinicians."

4. Adjudication Method for the Test Set:

The document describes that the "images from the predicate device and the ICON were presented to a panel of five clinicians for comparison in four parameters of image quality." This implies a consensus or comparative evaluation method, but no specific adjudication method like 2+1 or 3+1 is mentioned. It seems to be a qualitative comparison by a panel.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A formal MRMC comparative effectiveness study, designed to quantify the improvement of human readers with AI vs. without AI assistance, was not performed. The study involved a panel of clinicians qualitatively comparing images from the new device and the predicate device. There is no AI component mentioned in the context of assisting human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

A standalone algorithm performance study was not performed. The device, Phoenix Clinical ICON, is an ophthalmic camera for image acquisition, not an AI-powered diagnostic algorithm. The testing focused on the device's ability to capture images with comparable quality and safety to a predicate device.

7. Type of Ground Truth Used:

For establishing image quality equivalence, the ground truth was based on:

• Expert Consensus/Qualitative Comparison: A "panel of five clinicians" compared images from both devices in terms of image quality.
• Bench Performance Metrics: ISO standards (ISO 10940:2009 for image quality and ISO 15004-2:2007 for light safety) and objective metrics like "vascular edges as a resolution target" and use of the "NIH analytical tool ImageJ" were used. This suggests a blend of objective measurements and expert assessment.

8. Sample Size for the Training Set:

The document does not mention any "training set." This device is an imaging system, not an AI/ML algorithm that would typically require a training set. The evaluation is for hardware performance and image capture capabilities.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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