(74 days)
The IRI™ Integrated Retinal Imager System is a monocular retinal imager designed for routine use. The imager is suitable for documentation of findings in a clinical setting.
Medivision's IRI™ Integrated Retinal Imager System is a retinal camera, which is designed to perform digital fundus imaging. IRI™, as other fundus cameras, uses light photography to obtain clinical information. Using light sources (LEDs of different colours, a set of lenses and filters, and digital camera sensors, an image from the eye's retina is captured and later displayed for review. The device comprises a main console, a PC, a touch screen (as part of the main console) and a monitor. Digital image storage is available to several storage media.
Here's an analysis of the provided text regarding the IRI™ INTEGRATED RETINAL IMAGER SYSTEM, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or a table of reported device performance metrics related to diagnostic accuracy.
Instead, it focuses on general safety, performance, and validation tests, and compliance with industry standards. The statement on "Substantial Equivalence" indicates that its performance is considered similar to predicate devices, but specific quantitative measurements are not provided.
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|
| Device met all its functional specifications | Test performed to ensure compliance |
| Complies with industry and safety standards | Test performed to ensure compliance |
| Light energy outputs within limits set by ISO15004 and other standards | Outputs analyzed to confirm compliance |
| Optical specifications similar to predicate devices | Stated as similar |
| Image processing and storage capabilities similar to predicate devices | Stated as similar |
| Substantially equivalent in safety and efficacy to predicate devices | Stated as "Conclusión" |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for any performance testing, nor does it mention the data provenance (e.g., country of origin, retrospective or prospective) for any clinical or image-based test sets.
3. Number of Experts Used and Qualifications:
The document does not mention the number or qualifications of any experts used to establish ground truth for a test set.
4. Adjudication Method:
The document does not describe an adjudication method for establishing ground truth, as evidence of image-based test sets or expert review is absent.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Therefore, no effect size for human readers' improvement with AI vs. without AI assistance is provided.
6. Standalone (Algorithm Only) Performance Study:
The document does not describe a standalone (algorithm only without human-in-the-loop performance) study. The device is described as an imager, and while it has "image processing," there's no mention of an algorithm making diagnostic decisions independently.
7. Type of Ground Truth Used:
The document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data), as no detailed study on diagnostic performance is described. The device's purpose is "documentation of findings in a clinical setting," implying that ground truth would be what a clinician observes and documents.
8. Sample Size for the Training Set:
The document does not mention a training set sample size. This information would typically be relevant if the device incorporated machine learning or AI algorithms requiring training, which is not explicitly detailed beyond "image processing."
9. How Ground Truth for the Training Set Was Established:
Since no training set is mentioned, the document does not describe how ground truth for a training set was established.
Summary of Device and Study Information from the Provided Text:
The IRI™ Integrated Retinal Imager System is a fundus camera designed for digital imaging of the retina, intended for routine clinical use and documentation. Its regulatory submission (K062295) highlights its substantial equivalence to existing predicate devices (Topcon TRC-NW200, Carl Zeiss VisuCam Lite, Canon CF-60DSi) in terms of safety, efficacy, optical specifications, and image processing/storage capabilities.
The "study" described in the document is a series of "extensive safety, performance testing, and validation" before release, focusing on:
- Ensuring the device met all functional specifications.
- Software validation tests.
- Compliance with industry and safety standards (e.g., IEC/EN-60601-1, IEC/EN 60601-1-2, ISO 15004, ANSI/IESNA RP-27 series).
- Verifying that light energy outputs are within established safety limits.
Crucially, the provided 510(k) summary does not detail any clinical trial, diagnostic accuracy study, or performance evaluation that would typically involve specific acceptance criteria for diagnostic metrics (like sensitivity or specificity), defined test sets, expert ground truth, or comparative effectiveness with or without AI. The primary evidence presented for clearance is the device's functional and safety compliance and its substantial equivalence to predicate devices, which already have established uses as retinal imagers.
§ 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.