(17 days)
General ophthalmic imaging including retinal, corneal, and external imaging.
-Photodocumentation of pediatric ocular diseases including retinopathy of prematurity (ROP).
-Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, without plus disease, or zone 2, stage 3, without plus disease) or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease)* in 35-37 week postmenstrual infants.
RetCam Ophthalmic Imaging Systems utilize a digital camera in a handpiece (with multiple field of view lenses) to capture color ophthalmic images including retinal, corneal, and external images. An on board computer (RetCam 3 Ophthalmic Imaging System) or laptop computer (RetCam Shuttle Ophthalmic Imaging System and RetCam Portable Ophthalmic Imaging System) is used to store, view, retrieve, and export the digital ophthalmic images. A standard Halogen light source is used in all RetCam Ophthalmic Imaging Systems to provide illumination to the eye through the handpiece. An optional Fluorescein light source is also available on the RetCam 3 Ophthalmic Imaging System.
Here's an analysis of the provided text regarding acceptance criteria and study information:
Summary of Device and Changes:
The document describes the Natus Medical Incorporated RetCam Ophthalmic Imaging Systems (RetCam 3, RetCam Shuttle, RetCam Portable). These are digital cameras used for general ophthalmic imaging, photodocumentation of pediatric ocular diseases (including Retinopathy of Prematurity - ROP), and screening for specific types of ROP in 35-37 week postmenstrual infants.
The current submission (K182263) is for modified versions of previously cleared RetCam systems (K090326). The modifications include:
- Upgrade of the camera (due to obsolescence).
- Addition of DICOM communication features.
- Software updates to support these modifications.
The fundamental scientific technology and indications for use remain unchanged from the predicate device.
Acceptance Criteria and Device Performance (as reported):
The document does not detail specific, quantitative acceptance criteria in a tabular format, nor does it present specific performance metrics like sensitivity, specificity, or accuracy.
Instead, it states that the modified devices were tested and found to comply with relevant consensus standards and internal tests. The performance assertion focuses on substantial equivalence to the predicate device due to unchanged indications for use, fundamental scientific technology, operating principle, basic design, and materials.
Based on the provided text, the acceptance criteria are implicitly met by:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Regulatory Compliance (General) | Complies with IEC 60601-1:2005 (basic safety and essential performance) |
| Complies with IEC 60601-1-2:2007/(R) 2012 (electromagnetic disturbances) | |
| Complies with DICOM NEMA PS 3.1-3.20 (2016) | |
| Software Verification & Validation | Software categorized as "moderate level of concern" and verified/validated per FDA guidance (May 11, 2005) |
| Internal Performance Testing | Met defined acceptance criteria for "Image Comparison Test," "Optics verification and Validation Test," and "ISTA Test" (details of these tests and their specific acceptance metrics are not provided in this document). |
| Substantial Equivalence to Predicate (K090326) | "have the same indications for use," "has the same fundamental scientific technology," "uses the same operating principle," "incorporates the same basic design," and "incorporates the same materials." |
Detailed Study Information:
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- This document does not specify a separate test set or its sample size. The performance data section refers to internal testing of the modified devices (Image Comparison Test, Optics verification and Validation Test, ISTA Test) and compliance with standards. There is no mention of patient data (images) being used for a clinical or performance study to determine algorithm efficacy.
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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 / not provided. The document describes a medical device (ophthalmic camera system) that captures images, not an AI algorithm that interprets them. The "screening" indication refers to the device's capability to screen by providing images, not an automated diagnostic capability from the device itself. Therefore, there's no mention of experts establishing a ground truth for an algorithm's performance on a test set.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / not provided. As above, no clinical test set for an algorithm is described.
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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:
- No. This document focuses on the clearance of an ophthalmic imaging system, not an AI-powered diagnostic tool. There is no mention of AI assistance or MRMC studies. The device is a camera system for clinicians to use, not an interpretation algorithm.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. The device is an imaging system; it is not an algorithm for standalone performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth for algorithm performance is discussed. The "ground truth" for the device's function would be its ability to capture clear, diagnostically useful images, which is assessed through the internal tests (Image Comparison, Optics, ISTA) and compliance with imaging and electrical standards.
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The sample size for the training set:
- Not applicable. This device is an imaging system, not an AI algorithm requiring a training set.
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How the ground truth for the training set was established:
- Not applicable. No training set for an AI algorithm is discussed.
§ 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.