(88 days)
The OPTO Global Digital Fundus Camera System Model ADS 1.5 is intended to be used to capture, archive, recall and display black and white, and color images of the retina, as well as surrounding areas, to aid in the diagnosis and monitoring of diseases of the eye that may be viewed and photographed non-invasively.
The OPTO Global ADS 1.5 Digital Fundus Camera System is an automated imaging device used in conjunction with a digital camera that requires ninimal intervention during the capture of an image. The system is simple to use and requires minimal training for a user to become proficient with the system. Like the listed predicate devices, the Opto Global Digital Fundus Camera System Model ADS 1.5 is comprised of a digital imaging camera, computer hardware, and a software platform intended to be used to store images captured by the fundus camera.
The Opto Global Digital Fundus Camera System Model ADS 1.5 is comprised of the following components: A digital sensor head (digital camera) a computer interface circuit board (digital image capture card), and connecting cables. These components are then combined and sold together with our "OPTO Global Capture" proprietary imaging software and a computer (CPU) monitor, keyboard and mouse. This total system with imaging software provides acquisition and hardware control capabilities used to take digital pictures of the retina which are then transferred via the digital camera and connecting cable to the computer system transment can be viewed, modified, stored or printed.
The provided text does not contain detailed information about specific acceptance criteria and a study proving device performance in the way typically seen for AI/ML-based medical devices. This 510(k) summary is for a digital fundus camera system, which primarily focuses on image capture, archiving, and display, rather than an AI algorithm for diagnostic interpretation. The submission relies on substantial equivalence to predicate devices, rather than an independent performance study against defined acceptance criteria.
However, I can extract the information that is present and highlight what is missing based on your request.
Here's a breakdown:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria as quantitative metrics (e.g., sensitivity, specificity, accuracy) nor does it report specific device performance against such metrics. The "performance characteristics" section describes the components and functions of the system.
Instead, the submission argues for substantial equivalence based on:
- Same intended use: "to capture, archive, and display digital images of the eye, particularly the retina obtained through the use of an ophthalmic camera (fundus camera)."
- Same indications for use: "to capture, archive, recall and display black and white, and color images of the retina, as well as surrounding areas, to aid in the diagnosis and monitoring of diseases of the eye that may be viewed and photographed non-invasively."
- Equivalent principles of operation and technological characteristics: Digital imaging camera, computer hardware, software platform for image storage.
- Similar basic software functions: image acquisition, storage, analysis, and retrieval.
- Similar operation manner: User (ophthalmologist or photographer) views the patient's eye through a fundus camera with a digital camera to capture, manipulate, and archive images.
The closest to "acceptance criteria" mentioned are:
- "OPTO Global Inc. has performed several software validation tests the results of which clearly indicate that the Opto Global Digital Fundus Camera System Model ADS 1.5 meets comparable system and software standards exhibited by the predicate devices listed." (No specific results or standards are provided.)
- The system allows the user to "monitor, capture, and process, images thus verifying the device is operating correctly."
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Intended Use | The Opto Global Digital Fundus Camera System Model ADS 1.5 has the same intended use as predicate devices. |
| Indications for Use | The Opto Global Digital Fundus Camera System Model ADS 1.5 has the same indications for use as predicate devices. |
| Principles of Operation | The Opto Global Digital Fundus Camera System Model ADS 1.5 has equivalent principles of operation to predicate devices. |
| Technological Characteristics (Hardware/Software) | The Opto Global Digital Fundus Camera System Model ADS 1.5 has similar technological characteristics (digital camera, computer, software) to predicate devices. Minor differences in processor type/speed and GUI "do not raise any new issues of safety or effectiveness." Software validation tests "clearly indicate that the Opto Global Digital Fundus Camera System Model ADS 1.5 meets comparable system and software standards exhibited by the predicate devices." |
| Basic Software Functions | The Opto Global Digital Fundus Camera System Model ADS 1.5 has the same basic software functions (image acquisition, storage, analysis, retrieval) as predicate devices. |
| Manner of Operation | The Opto Global Digital Fundus Camera System Model ADS 1.5 is operated in the same manner as predicate devices. |
| Safety and Effectiveness | Minor differences do not raise new or additional questions regarding safety or efficacy. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This submission relies on substantial equivalence and software validation, not a clinical performance study with a test set of images.
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. No ground truth for image interpretation or diagnosis was established, as the device is for image capture and display, not AI-driven interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided.
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. This is a digital fundus camera system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is a digital fundus camera system, not a standalone AI algorithm. The performance is related to its ability to capture, store, and display images, with the user ("Ophthalmologist, or Photographer") in control.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. The "ground truth" for this device's performance would likely be related to image quality metrics (resolution, clarity, color accuracy), storage integrity, and display accuracy, which are not detailed in this summary for substantial equivalence.
8. The sample size for the training set
- Not Applicable / Not Provided. This is not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided.
§ 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.