(128 days)
The iExaminer system with PanOptic Plus, consisting of PanOptic Plus, SmartClip, iExaminer application, and one of the following: iPhone 11 Pro, iPhone 11 Pro Max, iPhone 12 Pro, is intended to be used to capture images as an aid to clinicians in the evaluation, and documentation of ocular health. The images from the iExaminer System with PanOptic Plus are not intended to be used as a sole means of diagnosis.
The iExaminer System with PanOptic Plus is a medical device that allows the user to capture images through the use of a PanOptic Plus ophthalmoscope and a smart device. The iExaminer System with PanOptic Plus consists of (also see Figure 1):
- PanOptic Plus Ophthalmoscope:
a. Ophthalmoscope Head
b. Compatible energy sources (i.e. battery handles or wall units)
c. Optional Patient Eyecup - Smart device attachment instrument (made of SmartBracket and SmartClip);
- Compatible smart device (iPhone X, iPhone 11 Pro, iPhone 11 Pro Max, iPhone 12 Pro).
- iExaminer Pro Software Application.
The iExaminer system with PanOptic Plus is intended to take photographs of the eye and surrounding area.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary:
Acceptance Criteria and Device Performance
The document states that a non-clinical and clinical (image comparison) study was performed to demonstrate that the iExaminer System with PanOptic Plus images are substantially equivalent to the predicate device images in their usefulness for documentation and clinical referrals. The acceptance criteria themselves are not explicitly detailed in a table with specific numerical thresholds for metrics like sensitivity, specificity, or accuracy. Instead, the general acceptance criterion for the clinical study was that the new device's images are "substantially equivalent" in usefulness for documentation and clinical referrals compared to the predicate device.
Given that no specific performance metrics like sensitivity or specificity were reported for the device itself against a ground truth, it's not possible to create a table of acceptance criteria and reported device performance in those terms. The study focuses on comparative usefulness.
However, based on the conclusion, the device did meet the established acceptance criteria:
"The results of the image comparison study demonstrate that the iExaminer System with PanOptic Plus has passed all established acceptance criteria and is as safe and effective as the predicate device for its intended use."
Study Details:
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A table of acceptance criteria and the reported device performance
As noted above, explicit numerical acceptance criteria for performance metrics (sensitivity, specificity) are not provided. The acceptance criterion was "substantially equivalent" usefulness of images for documentation and clinical referrals compared to the predicate device. The study concluded this criterion was met. -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the test set (number of images or patients). It also does not mention the country of origin of the data or whether it was retrospective or prospective. -
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)
The document does not describe the establishment of a "ground truth" by experts for specific pathologies. Instead, the study was an "image comparison study" where the new device's images were compared to the predicate device's images for "usefulness for documentation and clinical referrals." The number and qualifications of experts (if any specific graders were involved in comparing image usefulness) are not detailed. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not provide details on any adjudication method used for comparing images or establishing usefulness. -
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, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with or without AI assistance was not conducted or reported. The study was an "image comparison study" between two devices to show substantial equivalence. The device itself is an image capture system, not an AI-powered diagnostic tool. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The device is a system for capturing images for human clinicians to evaluate, not an automated diagnostic algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The study did not use a traditional "ground truth" in the sense of confirmed diseases (e.g., pathology, outcomes data, or expert consensus on diagnosis). Instead, it focused on the "usefulness for documentation and clinical referrals" of images captured by the proposed device compared to images from the predicate device. The predicate device's images are assumed to be a sufficient and already accepted reference point for "usefulness." -
The sample size for the training set
This information is not applicable. The device is an image capture system, not an AI model that requires a training set. -
How the ground truth for the training set was established
This information is not applicable, as there is no training set for an AI model.
§ 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.