(60 days)
The Optronics EPIC System is intended for use as an accessory to a slit lamp biomicroscope, providing enhanced imaging of the eye for opthalmic examination, diagnosis, treatment definition and clarification, and patient education/proof of treatment need
The Optronics EPIC System consists of a camera and a video processor. The camera consists of a camera head with eyepiece and beamsplitter and an integral cable for electronic transmission of signals and power. The camera head consists of an outer aluminum shell housing the video sensor and optical elements. The cable is permanently attached to the camera head and connects to the processor. The processor consists of a finished aluminum housing containing the power supply, circuit boards, and interconnections necessary to process the video image.
The provided text describes a 510(k) summary for the Optronics EPIC Color Television Camera System. It focuses on the device's description, intended use, and a comparison to predicate devices, particularly regarding video system performance.
However, the document does not contain information typically found in a study designed to demonstrate how a device meets specific acceptance criteria. Specifically, it lacks:
- Explicit Acceptance Criteria: The document does not define specific performance thresholds (e.g., "the device must achieve a resolution of X TV lines"). While it provides performance characteristics like resolution and sensitivity, these are presented as descriptive specifications rather than pass/fail criteria.
- A "Study" Proving Acceptance: There is no mention of a formal study (e.g., a clinical trial, a laboratory validation study) where the device was tested against predefined criteria. The comparison table merely lists the device's specifications alongside those of predicate devices.
- Details about Test Sets, Ground Truth, Experts, or Adjudication: These elements are crucial for any study demonstrating a device's performance, especially for medical imaging where diagnostic accuracy is paramount. This document is a technical summary, not a clinical validation report.
- MRMC or Standalone Performance Data: There's no discussion of multi-reader multi-case studies or standalone algorithm performance, as this device is a camera system and not an AI-powered diagnostic tool.
- Training Set Information: Since no AI algorithm is described, there's no training set or ground truth establishment relevant to AI.
Despite the lack of the requested information, I can extract and present the available performance characteristics in a table format, interpreting them as specifications rather than "acceptance criteria" met by a formal study.
Table of Device Specifications and Predicate Device Performance:
| Characteristic | Optronics EPIC (Reported Device Performance) | Predicate Device 1 (Haag-Streit 900 BQ) | Predicate Device 2 (Haag-Streit 900 BM) |
|---|---|---|---|
| CCD Type | 1/4 inch | 1/2 inch | 1/2 inch |
| Resolution | 470 TV lines | 450 TV lines | 450 TV lines |
| Sensitivity | 2 lux | 10 lux | 10 lux |
| Beam splitter | 50/50 | 50/50 or 70/30 (selectable) | Video adaptor is a separate microscope |
| Eyepiece magnification | 10X | 6.3, 10, 16, 25, 40X | 6.3, 10, 16, 25, 40X |
Since the document does not describe a study to prove acceptance criteria, the following points cannot be answered based on the provided text:
- Sample size used for the test set and the data provenance: Not applicable; no test set described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no ground truth or experts described.
- Adjudication method for the test set: Not applicable; no test set described.
- 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 camera system, not an AI diagnostic tool, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this device is a camera system, not an AI algorithm.
- The type of ground truth used: Not applicable; no ground truth described.
- The sample size for the training set: Not applicable; no AI algorithm or training set described.
- How the ground truth for the training set was established: Not applicable; no AI algorithm or training set described.
In summary, the provided document is a 510(k) summary focusing on device specifications and substantial equivalence, not a detailed study report demonstrating performance against predefined acceptance criteria using clinical or laboratory test sets.
§ 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.