(141 days)
The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.
The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions.
iCam is indicated for in-vivo viewing of the posterior and external area of the eye and the images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.
iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease.
The iCam is a non-mydriatic fundus camera for capturing, storing and displaying color fundus images with 1.3 MP @ 12 bits per color channel up to 45 degree (axial arc) field of view. It was designed to provide an acceptable area for broad range, high resolution viewing of most retinalbased and optic nerve pathologies. The design allows for the acquisition of high quality images that are of comparable quality to other predicate ocular cameras. The design incorporates the use of an LED light sources providing two advantages over the flash lamp light source of other cameras: 1) longer life expectancy of the LED compared to the typical Xenon flash lamp, and 2) reliability of solid state devices that allow for more reproducible light characteristics over time.
The LED light source provides lower voltage operation, a higher efficiency overall and allows for smaller design of the system based on the relatively small size of the LEDs compared to the Xenon bulb. LED light source has a considerably longer lifespan than a Xenon light source, while emitting minimal heat compared to the heat generating Xenon source.
The LED light source also reliability of solid state devices that allow for more reproducible image quality over time. Solid state devices that function via an on-or-off state are known to maintain light characteristics such as color temperature, lumens of output, and distribution of light. This characteristic of no demonstrable degradation results in more reproducible images over time.
Here's a breakdown of the acceptance criteria and the study details for the Optovue iCam Fundus Camera, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the iCam was "substantial equivalence" to its predicate device (Centervue DRS) in terms of image quality and clinical usefulness.
| Performance Item | Acceptance Criteria (Requirements) | Reported Device Performance (Test Results) |
|---|---|---|
| Clinical Utility (Primary Endpoint) | Non-inferiority margin: The study device (iCam) is considered non-inferior if the probability of a clinically useful image is no worse than 10 percentage points less than that for the predicate (DRS). | Images from the iCam were deemed non-inferior compared to those from DRS. |
| Fundus Image | 45 degree, 36 bit color image | Yes |
| Resolution | 1.3 Million Pixels at 12 bits per color pixel | Yes |
| Resolution on retina | ≥ 60 line pairs/mm at the center of the field; ≥ 40 line pairs/mm at the mid field (r/2); ≥ 25 line pairs/mm at the periphery of the field (r) | Yes (for all three points) |
| Field of view | 45.0 degrees (horizontal) | 44.6 degrees |
| Pixel pitch | 10 µm | 10.24 µm |
| Range of focus | -15 D to + 15 D | -35 D to + 30 D |
| Minimum pupil size | 4.0 mm | 4.0 mm |
| Position of internal fixation targets | CENTRAL, PERI-NASAL, PERI-TEMPORAL, NASAL, TEMPORAL, SUPERIOR, INFERIOR (specific positions relative to fovea) | Actual position (for normally fixating subjects) within ± 1° from expected position |
| Alignment | Manual alignment using split-image technique | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: A total of 120 evaluable subjects were targeted for enrollment. For each subject, images were collected on the study eye (2 central field fundus and 1 external eye) using both the iCam and the DRS.
- Data Provenance: The study was a multi-center, open-label, prospective study. While specific countries are not mentioned, the manufacturer's address (Fremont, CA, USA) suggests it was likely conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Two independent reviewers (graders) were used.
- Qualifications of Experts: Both reviewers were licensed practitioners in optometry.
4. Adjudication Method for the Test Set
The reported method indicates that the best image out of two repeat fundus photos was selected for assessment. Although two reviewers graded the images to assess inter-rater agreement, the text does not explicitly detail a formal adjudication method (like 2+1 or 3+1 consensus) for discrepancies if they occurred. It states: "Agreement between PI and independent graders with regards to clinically usefulness of images was concluded to be at an acceptable level in all cases."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Yes, a multi-reader multi-case (MRMC) comparative effectiveness study was performed. The study aimed to evaluate the non-inferiority of the iCam relative to the predicate (Centervue DRS) regarding image quality.
- Effect Size of Human Reader Improvement (AI vs. without AI assistance): The study design does not involve AI assistance to human readers. It's a direct comparison of images captured by two different devices (iCam vs. DRS), with human readers evaluating the image quality from both devices. Therefore, there's no data to report on how much human readers improve with AI vs. without AI assistance. The study focuses on the inherent quality of images produced by the iCam compared to the predicate, as judged by human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone (algorithm only) performance study was not conducted or reported. The "effectiveness" of the iCam was evaluated by comparing its captured images to the predicate device, with physicians (licensed practitioners in optometry) assessing the clinical usefulness of the images. The iCam "provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease."
7. Type of Ground Truth Used
The ground truth for clinical usefulness was established by expert consensus (or at least expert grading with high inter-rater agreement). Specifically, a 5-point image quality grading scale was used by licensed optometry practitioners, and then dichotomized at a threshold of ≥3 for "clinically useful."
8. Sample Size for the Training Set
The document does not provide information about a separate training set or its sample size. This is a 510(k) for a medical imaging device (camera), not an AI algorithm that requires training data in the traditional sense. The performance evaluation focuses on the image acquisition capabilities of the camera.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned for an AI algorithm, the method for establishing its ground truth is not applicable here. The "ground truth" in this context refers to the expert assessment of the images captured by the device itself.
§ 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.