(102 days)
The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color imaging of a human retina without the use of a mydriatic agent.
The DRSplus is a scanning ophthalmoscope which uses infrared and white light to obtain confocal images of the retina, without pharmacological dilation. The DRSplus operates as a standalone unit, running a dedicated software application, is intended for prescription use only, and includes: 1. an optical head; 2. a patient forehead rest; 3. a display; 4. a base; 5. a stand. The CenterVue DRSplus operates based on the following principles: a) An illumination system consisting of infrared (IR) LEDs, white LEDs and a green LED illuminates the patient eye with the following functions: · the IR LED allows the capture of IR photos, which are used for alignment and focusing purposes. The patient's retina is uniformly illuminated by a line in the horizontal direction. Along the optical path there is an oscillating mirror which scans the line in order to illuminate the retina. · Two IR LEDs are seen from the eye in a free viewing system. The two LEDs are equally shifted with respect to the machine's optical axis. The LEDS are switched on during all exams in order to enable pupil tracking. · The white LEDs allow the capture of color photos. The retina is uniformly illuminated by a line in the horizontal direction. Along the optical path an oscillating mirror scans the line in order to illuminate the retina. · The green LED is used as fixation target. b) An imaging system collects back-reflected light from the retina and creates a high-resolution image. A focusing lens is included in the imaging path to achieve optimal retinal focusing on a CMOS camera. c) An anterior segment alignment system is included, using two cameras and the two IR LEDs. The LEDs illuminate the anterior segment by diffusion, whereas the cameras allow a stereoscopic reconstruction of the pupil's position to be obtained with respect to the instrument's frontlens. The DRSplus interacts with the patient by directing infrared, white (for imaging) and green (for fixation) illumination into the patient's eye. The only part of the only part of the device that contacts the patient.
The provided text describes a 510(k) premarket notification for the CenterVue DRSplus, a confocal scanning ophthalmoscope. The majority of the document focuses on regulatory information, device description, technical specifications, and comparison to predicate devices, demonstrating substantial equivalence based on engineering and safety standards.
However, the provided text does not contain the details required to directly answer all parts of your request regarding acceptance criteria and a specific study proving device performance against those criteria as would typically be found in an AI/ML medical device submission.
The document mentions "Performance data - Clinical" but this section is very brief and describes a qualitative comparison ("similar to those of the mentioned predicate device") rather than a quantitative study with defined acceptance criteria and performance metrics. It also does not describe an AI/ML algorithm within the device that would necessitate ground truth establishment, expert adjudication, or MRMC studies.
Given the information, here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance (Based on provided text)
The document implicitly defines acceptance criteria through compliance with various industry standards and demonstrating substantial equivalence to predicate devices, particularly in terms of image quality for a fundus camera. No specific quantitative performance metrics for a disease detection algorithm are provided.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied/Directly Stated) | Reported Device Performance |
|---|---|
| Electrical Safety: Compliance with EN 60601-1:2006 | Device complies with EN 60601-1:2006. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2:2015 | Device complies with IEC 60601-1-2:2015. |
| Software Verification & Validation: Adherence to FDA Guidance ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices") and IEC 62304 standard for software life cycle. Software classified as "moderate" level of concern. | Software verification and validation testing conducted; documentation provided as recommended by FDA Guidance. Software compiles with IEC 62304 standard. No issues mentioned regarding the "moderate" level of concern. |
| Fundus Camera Standards: Compliance with ISO 10940:2009 | Device complies with ISO 10940:2009. |
| Light Hazard Protection: Compliance with ISO 15004-1:2006 and ANSI Z80.36-2016 | Device complies with ISO 15004-1:2006 and ANSI Z80.36-2016. |
| Image Quality (Qualitative Clinical Comparison): Images similar to predicate device (EIDON) | "The comparison showed that the DRSplus provides images that are similar to those of the mentioned predicate device." (This is a qualitative statement, not a quantitative performance metric against specific acceptance criteria for image quality, such as sharpness, contrast, or resolution in a measurable way beyond the technical specifications listed elsewhere). |
| Safety and Effectiveness: Differences from predicate devices must have no effect on safety and effectiveness. | Differences (IR reflectance imaging for alignment/focusing, smaller field of view, slightly larger minimum pupil diameter, smaller dimensions/lighter weight, different scanning technology) are believed to have no effect on safety and effectiveness. |
Regarding the study proving the device meets acceptance criteria (Clinical Performance Data):
The document describes a very limited qualitative clinical performance assessment, not a robust AI/ML algorithm validation study. Therefore, most of the requested information regarding AI/ML-specific study design is not present in the provided text.
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Sample size used for the test set and the data provenance:
- Test Set Size: "Images from randomly selected normal subjects and subjects with retinal pathologies were acquired." No specific number of subjects or images is provided.
- Data Provenance: "acquired at two different sites" and "patients were imaged without pharmacological pupil dilation." No country of origin is explicitly stated, but the manufacturer is Italian. The study appears to be "prospective" in the sense that images were acquired specifically for this comparison using both devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Mentioned. The "clinical performance data" section describes a qualitative comparison of images between two devices, not a study evaluating an AI/ML algorithm's diagnostic performance against a clinical ground truth. Hence, there's no mention of experts establishing a ground truth for diagnostic purposes.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable / Not Mentioned. As no ground truth for diagnostic performance was established, no adjudication method 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. The provided text does not describe an AI-assisted reading study or an MRMC study. The device is described as an imaging device, not an AI diagnostic algorithm.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The device, as described, is an ophthalmoscope that captures images. It's not presented as a standalone diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for diagnostic ground truth. The "ground truth" implicitly used for the clinical comparison was that the DRSplus should produce images similar to the predicate device (EIDON) for both normal and pathological retinas. There's no mention of a ground truth for disease diagnosis itself in this section.
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The sample size for the training set:
- Not applicable. This device is an imaging instrument, not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As above.
Summary of what's missing and why:
The provided document (K192113) is a 510(k) clearance letter and summary for an ophthalmoscope. This type of device is an imaging hardware device. It is not an Artificial Intelligence/Machine Learning (AI/ML) diagnostic or assistive device. Therefore, the detailed criteria typically required for AI/ML performance validation (e.g., expert reads, ground truth establishment for disease, MRMC studies, training/testing sets for algorithms) are not present and not relevant to this specific submission as described. The performance data presented focuses on demonstrating imaging quality and electrical/software safety compliance in comparison to a predicate device, which is typical for hardware clearances.
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.