(256 days)
HEINE Direct ophthalmoscopes are intended for examination of the media (cornea, aqueous humour, lens, vireous humour) and retina of the eye.
HEINE BETA® 200, HEINE BETA® 200S and HEINE K180® Ophthalmoscopes are battery powered hand-held devices to that provide illumination, viewing optics, apertures and filters in order to examine the media and the retina of a patient's eye. Each device consists of an instrument head with bulb and a battery handle that can be attached to the instrument head. The devices are differentiated by the various number and type of apertures and filters and by the different range and number of corrective lenses.
This document is a 510(k) premarket notification for HEINE BETA® 200, HEINE BETA® 200S, and HEINE K180® Direct Ophthalmoscopes. It asserts substantial equivalence to a predicate device. As such, it does not detail a clinical study with acceptance criteria and device performance in the way a de novo or PMA submission might.
Therefore, many of the requested criteria cannot be directly extracted from this document, as a substantial equivalence filing focuses on demonstrating that a new device is as safe and effective as an already legally marketed device, often through non-clinical testing and comparison of technological characteristics.
Here’s what can be inferred or directly stated from the provided text, and what cannot:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in a 510(k) summary focused on substantial equivalence. The document states that the devices were "tested according to the 'Ophthalmoscope Guidance' in respect to optical radiation hazard with ophthalmoscopes (ISO 10942)" and "additional testing in accordance with applicable requirements of ISO 15004-2 'Ophthalmic instruments - Fundamental requirements and test methods' has been performed." However, specific acceptance criteria for these tests or the quantitative performance results are not detailed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No clinical test set data or sample sizes are mentioned because this is a 510(k) submission based on substantial equivalence, relying on non-clinical performance testing and comparison to a predicate device.
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, as no clinical test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set requiring adjudication is described.
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 device is a direct ophthalmoscope, a diagnostic tool used by a human practitioner. It is not an AI-assisted diagnostic system, nor is an MRMC study described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical diagnostic device, not an algorithm, and is intended for human-in-the-loop use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical test set requiring ground truth is described. The performance testing appears to be against international standards for ophthalmoscopes, which would specify technical requirements rather than clinical performance metrics based on ground truth.
8. The sample size for the training set:
Not applicable, as this is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable, as this is a physical medical device, not an AI/ML algorithm requiring a training set.
§ 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.