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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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