(105 days)
The P200DTx scanning laser ophthalmoscope is indicated for use as a widefield and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina.It is also indicated for use as a widefield scanning laser ophthalmoscope for viewing choroidal circulation patterns that are illuminated using Indocyanine Green dye and for aiding in both the assessment of choroidal circulation and in the diagnosis of choroiditis or choroidal diseases.
The Optos P200DTx is a scanning laser ophthalmoscope that uses lasers as a light source to illuminate the eye. The device consists of the following components and accessories:
- . A scanhead which houses the lasers, the scanning elements of the light input path and the light return path including the detectors which convert light into electronic signal. The scanhead with its integral head and chin rest forms the key patient interface in conjunction with a facepad and associated aperture where the eye is placed. The image capture is controlled by a computer and associated embedded software including a safety module within the scanhead. This software runs on a Linux operating system.
- . A touchscreen is attached by a cable to the scanhead to assist the operator in optimal patient positioning and to initiate an image capture. An image is displayed on the screen to allow the operator to confirm a suitable image has been taken. Patient positioning and image capture can also be conducted via a hand control.
- o A personal computer with a monitor to allow image review and storage in a Windows environment.
The provided text is a 510(k) summary for the P200DTx scanning laser ophthalmoscope. It describes the device, its intended use, and the testing conducted to demonstrate substantial equivalence to predicate devices. However, this document does not contain acceptance criteria and a study proving a device meets these criteria in the context of clinical performance or diagnostic accuracy.
Instead, the document focuses on compliance with engineering specifications, safety standards, and biocompatibility. There is no information about diagnostic performance metrics (like sensitivity, specificity, accuracy) or clinical studies involving human patients to assess the device's ability to aid in diagnosis or monitoring of diseases.
Therefore, many of the requested items cannot be extracted from this document, as they pertain to clinical performance studies, which are not detailed here.
Here's an analysis based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided are primarily engineering and safety specifications, not clinical performance metrics related to diagnostic accuracy.
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Optomap plus resolution | 14um | Conformance proven during verification testing |
| Angular Field of View - external to eye | 148 degrees x 115 degrees | Conformance proven during verification testing |
| Pixel Density | 25 pixels/degree | Conformance proven during verification testing |
| Minimum pupil size | 2mm | Conformance proven during verification testing |
| Patient Prescription Variation | +/- 12D | Conformance proven during verification testing |
| Electrical Safety | AAMI ANSI 60601-1:2005 & A1:2012 | Meets requirements, no deviations |
| EMC Compliance | IEC 60601-1-2 and 47 CFR Part 15 subpart B | Compliant, no abnormalities |
| Light Hazard Classification | IEC 60825 (Class I) | Device is Class I |
| Biocompatibility (Cytotoxicity) | Test article not considered to have cytotoxic potential | Not considered to have cytotoxic potential |
| Biocompatibility (Irritation/Sensitization) | Test article sites not significantly greater biological rate than control | Did not show significantly greater biological rate |
| Biocompatibility (Kligman sensitization) | Grade 1 sensitization rate not significant | Grade 1 sensitization rate not considered significant |
| Medical Instrument Classification | ISO 15004-2 (Group 1 Ophthalmic Instrument) | Device is a Group 1 ophthalmic instrument |
| Software Development Lifecycle Verification & Validation | No unresolved major or critical bugs | No unresolved major or critical bugs |
2. Sample size used for the test set and the data provenance
- Test set: The document refers to "in-house developed test targets" for device specifications and "off the shelf commercial ray tracing software" for patient eye variation. These are technical tests, not clinical evaluations on a human patient test set. Therefore, there is no sample size of human patients or data provenance (country, retrospective/prospective) for a clinical test set mentioned.
- Data provenance for safety/engineering: The testing was done internally by Optos Plc. ("in-house developed test targets," "internal design validation"). The data provenance is from the manufacturer's testing, not from a clinical patient population.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests described are engineering and safety tests, not diagnostic performance evaluations requiring expert clinical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no clinical test set or diagnostic accuracy evaluation mentioned.
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
Not applicable. This document is for a medical imaging device (ophthalmoscope), not an AI-powered diagnostic system. There is no mention of AI or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The P200DTx is a medical imaging device that requires a human operator and interpretation. It is not an algorithm performing a standalone diagnostic task.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the engineering and safety tests, the "ground truth" was established by the specifications and standards themselves (e.g., a specific optical resolution, a safety threshold, a biocompatibility limit). No clinical ground truth (like pathology or expert consensus on disease presence) is mentioned.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.