(64 days)
The Digiscope is an automated imaging device of the fundus that is intended to capture, store, and transmit images of the fundus using lossless compression to a distant location for display. The Digiscope requires minimal operator training and intervention during the imaging process. It is indicated for individuals where examination of the fundus for pathologies is requested.
The Digiscope Ophthalmic camera consists of: (1) a video camera; (2) an imaging system: (3) a computer with image acquisition and hardware control capabilities; (4) a monitor; and (5) EyeTel's Digiscope software. The Digiscope is intended to capture, store, and transmit images of the fundus and is indicated for use as an ophthalmic camera for individuals where examination of the fundus for pathologies is requested. The images of the fundus are digitized, stored on the Digiscope's hard drive, and transmitted via lossless compression for display at distant locations.
The Digiscope's user/software interface allows the images of the eye to be acquired, monitored, stored, and retrieved. Data is input into the Digiscope software via a touchscreen. Imaging, focusing, and camera orientation in relation to the retina are controlled by the software with verification and monitoring by the user. The software allows the user to monitor the image capture process and verify that the device is operating appropriately.
The image of the fundus is acquired by the Digiscope and stored in individual image data files in an uncompressed state on the hard drive of the computer system and displayed electronically. The images may then be transmitted via lossless compression to distant locations for display using a modem and standard telecommunications connections.
The provided text describes a 510(k) premarket notification for the EyeTel Digiscope Ophthalmic Camera. A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria and a comprehensive study demonstrating direct performance against such criteria. The document explicitly states: "The minor differences between the Digiscope and the predicate devices do not raise any new questions of safety or effectiveness. Thus, the EyeTel Digiscope ophthalmic camera is substantially equivalent to legally marketed ophthalmic cameras." This strongly suggests that a standalone study with pre-defined acceptance criteria, akin to clinical trials for novel devices, was not performed or deemed necessary.
Therefore, many of the requested details, such as specific acceptance criteria, sample sizes for test and training sets, expert qualifications, and detailed ground truth establishment, are not present in this document.
However, based on the provided text, here's what can be inferred and explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device. This is assessed by comparing intended use, indications for use, principles of operation, and technological characteristics. The document argues that any differences do not raise new questions of safety or effectiveness.
- Reported Device Performance: The document describes the device's functional performance in terms of its ability to capture, store, and transmit images of the fundus.
| Feature/Criterion | Acceptance/Comparison Point | Digiscope Ophthalmic Camera Performance / Characteristics |
|---|---|---|
| Intended Use | Capture and store images of the retina taken by a fundus camera. Capture, store, and transmit images of the fundus using lossless compression to a distant location for display. Indicated for individuals where examination of the fundus for pathologies is requested. | Same as predicate devices. Intended to capture, store, and transmit images of the fundus using lossless compression to a distant location for display. Indicated for examination of the fundus for pathologies. |
| Principles of Operation | Ophthalmic camera functionality: viewing retina, light source for imaging, image capture, digitization, storage, viewing on monitor. | Similar to predicate devices. Acquires images, digitizes, stores, and can transmit. |
| Technological Characteristics | Fundus camera, computer hardware/software, image acquisition, storage, display. | Utilizes a dedicated camera, automated illumination system, computer with acquisition/control, monitor, and EyeTel's Digiscope software. Automates targeting and focusing. Lossless compression for transmission. |
| Safety/Effectiveness Implications | No new questions of safety or effectiveness should be raised by technological differences. | "The minor differences ... do not raise any new questions of safety or effectiveness." |
2. Sample Sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided: The document does not describe a clinical performance study with a 'test set' in the traditional sense, as it focuses on demonstrating substantial equivalence. Therefore, there is no mention of sample size or data provenance for such a test set.
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)
- Not Applicable/Not Provided: Since no formal performance test set or ground truth establishment is described for the device's image capture and transmission capabilities, this information is not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided: No adjudication method is mentioned, as there is no described test set requiring expert adjudication for ground truth.
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: The document does not describe any MRMC comparative effectiveness study. The device is an ophthalmic camera for image capture and transmission, not an AI-powered diagnostic tool, so such a study would be outside its scope.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable to this type of device: The Digiscope is an imaging device, an ophthalmic camera, not an algorithm meant for standalone diagnostic performance. While it has automated features (targeting, focusing, image acquisition), its output is an image for human interpretation. The "standalone" concept as typically applied to AI algorithms is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable/Not Provided: The document does not describe the establishment of a "ground truth" for the device's performance in the context of diagnostic accuracy, as its purpose is image capture and transmission, which are evaluated against the performance of predicate devices.
8. The sample size for the training set
- Not Applicable/Not Provided: The Digiscope is an imaging system, not a machine learning model requiring a training set in the AI sense.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided: As mentioned above, a "training set" and associated "ground truth" are not applicable to the description of this device.
In summary: The provided 510(k) submission leverages the concept of substantial equivalence to existing predicate devices (Tomey Corporation ImageScape Digital Retinal Imaging System and Topcon, Inc. ImageNet Digital Imaging System). The "study" proving the device meets its acceptance criteria is the comparative analysis presented in the 510(k) document itself, which argues that the Digiscope shares the same intended use, similar principles of operation, and similar technological characteristics as the predicates, and that its minor differences (automation in targeting/focusing, storage media, lossless compression for transmission) do not raise new safety or effectiveness concerns. This means that a detailed, independent clinical performance study with defined acceptance criteria, sample sizes, and ground truth as one might expect for a novel diagnostic device was not mandated or performed for this particular submission.
§ 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.