(134 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 3, with plus disease), 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.
The RetCam Envision system is a contact type wide-field fundus ophthalmic imaging system used for 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 3, with plus disease), 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. A fundus camera comprised of handpiece, detachable lens piece, LED light sources, control panel, footswitch and application software running on a PC are used to acquire still images and video of the eye. The LED light is used to illuminate the retina uniformly and the image is transferred from the handpiece to the PC for display storage, review & transfer. The camera focus and image light intensity as well as the image capture is controlled by the user via a button panel on the cart or a footswitch. Controls are also available via the keyboard mouse and touchscreen.
The provided text describes a 510(k) premarket notification for the RetCam Envision ophthalmic camera, outlining its indications for use, technological characteristics, and comparison to a predicate device. However, it does not include a study specifically designed to demonstrate the device's performance against detailed acceptance criteria for its clinical indications (e.g., screening for ROP using a defined metric like sensitivity/specificity). Instead, the document focuses on demonstrating substantial equivalence to a predicate device through engineering and safety testing.
Therefore, many of the requested details about a study proving the device meets clinical acceptance criteria cannot be extracted from this document. The information primarily relates to electrical safety, electromagnetic compatibility, packaging, and internal performance verification against specifications, rather than clinical performance for its stated indications for use.
Here's an attempt to answer based on the provided text, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance
The document provides acceptance criteria in terms of compliance with various engineering and safety standards, and internal performance specifications. It does not provide quantitative clinical acceptance criteria (e.g., specific sensitivity, specificity, or image quality metrics for ROP screening) nor a study demonstrating performance against such criteria.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1-6: 2010, Am1: 2013; IEC 62366: 2007, Am1: 2014 | Verified for performance in accordance with the standard. |
| Electromagnetic Compatibility | IEC 60601-1-2 Edition4.0: 2014-02 | Verified for performance in accordance with the standard. |
| Packaging and Handling | ISTA-2B: Packaged Products weighing over 150 lbs (68 kg) | Successfully passed packaging and handling verification. |
| Performance Verification & Validation (Bench Testing) | Internal requirements and specifications (functional and performance characteristics), including: Image Comparison Test, Optics verification and Validation Test, Software Test, Mechanical design Test, Light Safety Test, EMC and Electrical Safety Test, Biocompatability Test, Packaging ISTA Test | Successfully passed performance verification and validation; met defined acceptance criteria. |
| Clinical Indication Performance | (Not specified in terms of quantitative metrics like sensitivity/specificity for ROP screening) | (Not a clinical study; document states "Verification and Validation were performed to ensure no new questions of safety or effectiveness are raised. The results of these activities demonstrate that the RetCam Envision is as safe, as effective, and performs as well as or better than the predicate device.") |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes engineering bench testing and internal verification/validation. It does not mention a clinical test set sample size, data provenance, or whether it was retrospective or prospective. The "Performance Testing – Bench Verification & Validation" refers to internal testing of the device itself.
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)
Given that no clinical test set for ROP screening performance is described, there is no information provided on experts or ground truth establishment relevant to clinical indications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical test set is detailed, no adjudication method for a clinical ground truth is specified.
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
The document makes no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss AI assistance or improvement of human readers. The device described is an ophthalmic camera, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an imaging system; it does not feature an AI algorithm for standalone diagnosis based on the provided text. Therefore, no standalone algorithm performance study was reported.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical performance aspects, the "ground truth" was likely established by reference to engineering specifications and standard requirements (e.g., electrical safety standards, packaging standards). For clinical ground truth for indications like ROP screening, this information is not provided because a clinical performance study is not described.
8. The sample size for the training set
Since no AI algorithm is detailed, there is no mention of a training set or its sample size.
9. How the ground truth for the training set was established
As there is no training set described, this information is not applicable.
Summary of what the document does provide regarding "studies":
The document primarily describes a comprehensive set of engineering and safety verification and validation activities to demonstrate that the RetCam Envision meets its predetermined specifications and applicable standards, and that it is substantially equivalent to existing predicate devices. These activities include:
- Electrical Safety testing: Compliance with IEC 60601-1-6 and IEC 62366.
- Electromagnetic Compatibility testing: Compliance with IEC 60601-1-2.
- Packaging and Handling Verification: Compliance with ISTA-2B.
- Bench Testing (Verification & Validation): Internal testing covering Image Comparison, Optics, Software, Mechanical design, Light Safety, EMC, Electrical Safety, Biocompatibility, and Packaging.
The "study that proves the device meets the acceptance criteria" in this context refers to these internal engineering and safety tests, which concluded that "the RetCam Envision system complies with its predetermined specifications and the applicable standards." The document does not present a clinical performance study with defined clinical acceptance criteria for its ROP screening indications.
§ 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.