(224 days)
The iExaminer is an attachment and software used only with the iPhone 4 and iPhone 4S in conjunction with the Welch Allyn PanOptic Ophthalmoscope to allow users to capture, send, store and retrieve images of the eye. The device is intended to be used by trained personnel within a medical or school environment.
The Welch Allyn iExaminer is comprised of the adapter, the iPhone and the software application. The adapter is specifically designed to hold the iPhone 4 and iPhone 4S in a fixed position in order to align the camera in the iPhone with the optics of the Welch Allyn PanOptic. The software application allows the user to capture, store, send, and retrieve images of the eye as seen through the PanOptic.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Welch Allyn iExaminer, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the comparative technical specifications and the "Summary of ISO 10940 performance" table. The device's performance is listed for the iPhone 4 Standard res, iPhone 4 High res, iPhone 4S Standard res, and iPhone 4S High res. Since the document states "The transferred images were determined to be at least as accurate and adequate (carry sufficient imaging details) to discern important clinical information as the predicate Optomed device, and thus substantially equivalent," the implicit acceptance criteria is 'performs at least as well as the predicate device (Optomed Smartscope M5 EY3) for clinical utility.'
| Acceptance Criteria (Predicate: Optomed Smartscope M5 EY3/General Standards) | Reported iExaminer Performance (iPhone 4 / 4S) | Notes |
|---|---|---|
| Resolving power on fundus camera |
- Centre: ≥ 80 lp/mm
- Middle (r/2): ≥ 60 lp/mm
- Periphery (r): ≥ 40 lp/mm | iPhone 4 High res:
- Centre: 82.94 lp/mm
- Middle (r/2): 74.12 lp/mm
- Periphery (r): 58.82 lp/mm | iExaminer (iPhone 4 High res) meets/exceeds all resolving power criteria. Predicate "Not possible to observe" for these. |
| Tolerance of angular field of view
+/- 5% (against 25° claim) | -1.16 % (Measured 24.71° against 25° claim) | iExaminer (all iPhone versions) meets this criterion. Predicate (+10.5%) does not meet this specific tolerance. |
| Tolerance of pixel pitch on fundus
+/- 7% (Implicit from predicate comparison) | iPhone 4: 16.25 um/pixel
iPhone 4S: 4.25 um/pixel
(Predicate: 8.77 um/pixel) | The document explicitly states "N.A. (Fundus camera on a digital sensor)" for magnification tolerance, and then introduces "Tolerance of pixel pitch on fundus" with a +/- 7% criterion. The various iPhone models show different pixel pitch values. To meet the tolerance, the measured pixel pitch should be within +/- 7% of an expected value, or be comparable to the predicate. With the predicate at 8.77 um/pixel, and the iExaminer at 5.37 um/pixel (iPhone 4 High res) and 4.25 um/pixel (iPhone 4S High res), these are different but not necessarily failing. The raw pixel pitch values alone don't directly indicate compliance without a target pixel pitch. However, the document's structure implies these are presented for comparison and general compliance. |
| Range of diopter adjustment of the optical finder
-5D to +5D (General Standard) | -20D to +20D | iExaminer meets/exceeds the range. Predicate "At least -20D to +20D". |
| Range of focus adjustment for compensation of patient's refractive
-15D to +15D (General Standard) | -20D to +20D | iExaminer meets/exceeds the range. Predicate "At least -20D to +20D". |
| Image Quality for Clinical Information
"at least as accurate and adequate (carry sufficient imaging details) to discern important clinical information as the predicate Optomed device." | "images... are accurate enough and carry sufficient imaging details to discern important clinical information." | This is met based on the conclusion of the clinical trial. |
| Compliance to applicable standards: ISO 14971, Guidance on OTS Software, Guidance for Premarket Submission for software, ISO 10940, ISO 15004-1, ISO 15004-2, IEC 60601-1, IEC 60601-1-2 | "tested and found to be in compliance to applicable industry standards." | This is stated as met based on non-clinical tests. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of patients or images for the clinical trial. The text says "Clinical data were collected" and refers to "the clinical trial data," but no specific sample size in terms of cases or participants is provided.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The study is referred to as "the clinical trial," suggesting it was a prospective study conducted for the purpose of this submission, but its geographical location is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The document states that the test established images had "sufficient detail to allow a trained professional to discern clinically important information," but it does not detail how many professionals were involved or their qualifications.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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
- MRMC Study: No, this does not appear to be an MRMC comparative effectiveness study involving AI assistance for human readers. This device is an ophthalmic camera attachment and software. Its primary function is to capture and transmit images, not to provide AI interpretation or assist human readers with diagnosis in a comparative effectiveness setting.
- Effect Size: Not applicable as it's not an AI-assisted diagnostic device in the context of improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the traditional sense of an AI algorithm providing diagnostic output. The device itself (iExaminer) is a standalone imaging and image management system. The "clinical study" confirmed the image quality was sufficient for a trained professional to discern clinical information. It does not suggest an AI algorithm was evaluating images without human-in-the-loop.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth is indirectly implied as expert assessment of image quality for clinical utility. The clinical trial aimed to confirm that "images... are accurate enough and carry sufficient imaging details to discern important clinical information." This suggests that human experts, likely clinicians (ophthalmologists or similar specialists), evaluated the captured images to determine if they contained enough detail for clinical decision-making. There is no mention of pathology or outcomes data as ground truth.
8. The Sample Size for the Training Set
This information is not applicable/not provided for a traditional training set as this is not an AI/Machine Learning diagnostic device at the time of FDA submission. The software's function is image capture, storage, and transfer, not automated interpretation.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided for a traditional training set as this is not an AI/Machine Learning diagnostic device.
§ 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.