(292 days)
Eyer® Retinal Camera model NM-STD is a medical non-mydriatic digital camera with a Samsung Galaxy S10 smartphone to capture digital images and videos of the funan eye, surface of the human eye and surrounding areas
The Eyer Retinal Camera NM-STD retinography is accompanied by accessories: dock station (1pc), lens protector (1 pc), allen wrench (1pc), eyecap (2 pcs) cleaning cloth (1 pc) and slit lamp adapter (1pc). Eyer Retinal Camera NM-STD is designed for use in a medical environment. Captured images and video are used for documentation. The images and videos are stored in an internal database of the smartphone application, in a security way. For the retinal function, Eyer Retinal Camera NM-STD is designed for non-mydriatic fundus imaging. In non-mydriatic imaging no mydriasis is needed because infrared light is used for targeting the fundus and white light is flashed when an image is taken. The pupil does not respond to the infrared light, so examination is convenient for the patient. With small pupils, it is recommended to use mydriatic drops. Eyer Retinal Camera NM-STD has eleven fixation targets for the patient to fixate on during imaging. The middle fixation target provides a macula-center image. It is possible to fix the center by selecting the appropriate point. For the anterior function, Eyer Retinal Camera NM-STD has a white light source for imaging eye surface and surrounding areas, in this configuration the device does not make contact with the patient. The transfer of images to a PC is carried out via FTP, DICOM or CFIS communication, with the client responsible for the connection and subsequent storage. The Eyer Retinal Camera NM-STD, energy comes from the smartphone that has a rechargeable Li-lon battery and is charged when the device is docked on charge station, which is connected to the mains by power supply cable.
The provided text is a 510(k) Premarket Notification summary for the Eyer Retinal Camera NM-STD. It primarily focuses on demonstrating substantial equivalence to a predicate device (Optomed Aurora Camera) for regulatory approval. As such, it does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning AI/algorithm performance.
The document discusses various performance data, but these relate to the device's hardware and general functionality (electrical safety, optical safety, optical performance, software verification/validation, environmental testing, biocompatibility, and usability), not directly to an AI's diagnostic performance. There is no mention of an AI component or diagnostic algorithm in the provided text.
Therefore, I cannot provide information on the following points:
- A table of acceptance criteria and reported device performance related to AI/algorithm. The document only lists general compliance with technical standards for the camera.
- Sample size used for the test set and data provenance for an AI study.
- Number of experts and their qualifications for establishing ground truth for an AI study.
- Adjudication method for an AI study.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used for an AI study.
- Sample size for the training set for an AI study.
- How ground truth for the training set was established for an AI study.
The document states: "Eyer® Retinal Camera model NM-STD is a medical non-mydriatic digital camera with a Samsung Galaxy S10 smartphone to capture digital images and videos of the funan eye, surface of the human eye and surrounding areas." This indicates the device is primarily an imaging tool, not a device that incorporates an AI for automated diagnosis or analysis.
Conclusion:
Based on the provided document, the Eyer Retinal Camera NM-STD is a hardware device for image acquisition, and the performance data presented concerns its technical and safety compliance. There is no indication or discussion of an AI or diagnostic algorithm being part of this device or its validation process as described in this 510(k) summary. Therefore, a study proving an AI component meets acceptance criteria cannot be extracted from this text.
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.