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The ophthalmoscope is an AC powered hand-held device containing illumination and viewing optics to examine the cornea, aqueous, lens, vitreous, and the retina of the eye.

AI/ML Overview

This K131939 submission describes a traditional ophthalmoscope, which is a manually operated viewing device, not an AI or algorithm-driven device. Therefore, many of the requested categories related to AI performance, ground truth, and training sets are not applicable.

Here's an analysis based on the provided text, focusing on the device's technical performance and regulatory acceptance:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Substantial Equivalence to Predicate	The applicant device has the same fundamental technological characteristics as the predicate device (K950461 - Welch Allyn Ophthalmoscope). Performance testing verified substantial equivalence in design, materials, and intended use, with no significant differences raising new questions of safety or efficacy. A comparison chart was included in Section 12 (not provided in this excerpt).
Ophthalmoscope Performance Testing	Performance testing was completed per ISO 10942 and ISO 15004-2 requirements, as determined by the FDA Ophthalmoscope Guidance Document (Direct and Indirect) Version 1.0, July 8, 1998. The results (included in Sections 17 and 18, but not provided) demonstrated that the Amico Ophthalmoscope is as safe as or safer than the predicate device for its intended use. (Specific quantitative performance metrics from these ISO standards are not provided in the excerpt.)
Electrical Safety Testing	Electrical safety testing was performed per IEC 60601-1 and UL60601-1-2. The results (included in Sections 17 and 18, but not provided) demonstrated that the Amico Ophthalmoscope is as safe as or safer than the predicate device for its intended use.
Indications for Use	An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous, and retina of the eye. The device met this intended use.
Regulatory Classification and Compliance	Classified as Class II device under 21 CFR 886.1570 (Ophthalmoscope) with Product Code HLI. Received 510(k) clearance based on substantial equivalence, subject to general controls provisions of the Act (e.g., annual registration, device listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration), and potentially additional controls for Class II devices.

Study Details (Non-Applicable/Not Provided for AI Device):

Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI algorithm tested on a dataset. The "test set" would refer to the physical devices themselves and their performance characteristics. The provenance refers to the testing standards (ISO, IEC, UL) and comparison to a legally marketed predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/diagnostic algorithms (e.g., expert consensus on image findings) is not relevant here. Device functionality and safety are evaluated against technical standards.
Adjudication method for the test set: Not applicable. This is not a study assessing diagnostic accuracy of an algorithm requiring adjudication of results.
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 is a standalone physical ophthalmoscope, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical hand-held direct ophthalmoscope, which is inherently used with a human in the loop. There is no "algorithm only" component.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic performance "ground truth." The "ground truth" for this device's acceptance is its conformity to established performance standards (ISO 10942, ISO 15004-2) and electrical safety standards (IEC 60601-1, UL60601-1-2), and its substantial equivalence to a predicate device.
The sample size for the training set: Not applicable. There is no training set for a non-AI physical device.
How the ground truth for the training set was established: Not applicable.

Summary of Acceptance and Study:

The acceptance criteria for the Amico DH-W35 Ophthalmoscope Series were primarily based on demonstrating substantial equivalence to a previously cleared predicate device (K950461 - Welch Allyn Ophthalmoscope) and compliance with relevant performance and safety standards.

The study that proves the device meets these criteria involved:

A performance comparison of the subject device against the predicate device to ensure "the same fundamental technological characteristics" and no "significant differences... that raise new questions of safety or efficacy."
Performance testing conducted according to:
- FDA Ophthalmoscope Guidance Document (Direct and Indirect) Version 1.0, July 8, 1998.
- ISO 10942 (Ophthalmic instruments — Direct ophthalmoscopes)
- ISO 15004-2 (Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection)
Electrical safety testing conducted according to:
- IEC 60601-1 (Medical electrical equipment — Part 1: General requirements for basic safety and essential performance)
- UL 60601-1-2 (Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic disturbances — Requirements and tests)

The results of these tests, as reviewed by the FDA, demonstrated that the Amico Ophthalmoscope is "as safe as or safer than the predicate device for its intended use," leading to its 510(k) clearance based on substantial equivalence. Specific quantitative data from the performance and electrical safety tests are not provided in this summary but were included in Sections 17 and 18 of the original submission.

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