(205 days)
General ophthalmic imaging including retinal, corneal, and external structures of the eye.
The Phoenix Clinical ICON is a battery and AC-powered, cart-based, non-sterile, wide-field, handheld, high resolution, real-time retinal imaging device. It is intended to be used for general ophthalmic imaging including retinal, corneal, and external structures of the eye. The intended users of the Phoenix Clinical ICON are clinical imaging technicians, ophthalmic technicians, nurses, and physicians. The Phoenix Clinical ICON may be used in hospitals, medical clinics, and physician's offices. The Phoenix Clinical ICON is a system comprised of a hand-held camera with an interchangeable LED based light source incorporated into the hand piece that is attached to the cart contains the battery, the keyboard controls, monitor, attached foot pedal, and computer with software. The hand piece is designed such that the glass lens in the tip will come into contact with the cornea. LED light is emitted into the eye to illuminate the retina for image capture. The Phoenix ICON is operated by attaching the appropriate module (white or blue LED) to the handpiece and, after the software is running, placing the camera lens in direct contact with the patient's cornea. The Phoenix Clinical ICON software can capture either video or still images and store them on the cart computer for later review. The Phoenix Clinical ICON may be connected to, under IT supervision, IT networks.
The Phoenix Clinical ICON device is compared to a predicate device (RetCam 3 K102859) to establish substantial equivalence for general ophthalmic imaging. The acceptance criteria and the study that proves the device meets the acceptance criteria are detailed below:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Metric | Acceptance Criteria (Predicate Device K102859) | Reported Device Performance (Phoenix Clinical ICON K170527) |
|---|---|---|
| Intended Use | General ophthalmic imaging including retinal, corneal, and external structures of the eye. | General ophthalmic imaging including retinal, corneal, and external structures of the eye. |
| Observation Light Source Type, Wavelength (White Light) | White light LED | 10W White light LED, 450-675nm |
| Observation Light Source Type, Wavelength (FA Module) | Blue light LED | 10W Blue light LED, 450-460nm |
| Maximum Light Source Output Power (White Light) | 21 mW/cm^2 | 6.1 mW/cm^2 |
| Maximum Light Source Output Power (FA Module) | 85 mW/cm^2 | 28 mW/cm^2 |
| Light Intensity Control | Zero to maximum | Zero to maximum |
| External Fixation Light | None | None |
| Field of View | 30 to 130 degrees | 100 degrees |
| Resolution | Varies with lens between 13 microns and 47 microns | Single lens at 12 microns |
| Frame Rate | 30 frames per second | 30 frames per second |
| Insert Filter (White Light) | No insert filter needed. | No insert filter needed. |
| Insert Filter (FA Module) | Change light source at cart and remove objective lens and insert yellow barrier filter, filters >510nm | Use blue LED module and flip filter on hand piece, barrier filter blocking band 500nm, edge wavelength 515nm |
| Imaging Lens | Flat field inserted | Flat field external camera |
| Eye Contact Materials | Goniosol or GenTeal | Goniosol or GenTeal |
| Imaging Format | .TIF/.JPEG/.AVI/.BMP | .TIF/.JPEG/.AVI |
| Light Safety | Compliant with relevant standards (Implied) | Compliant with ISO 15004-2:2007 Group 2 instrument requirements. |
| Image Quality | Equivalent to predicate based on clinical panel and resolution (Implied) | Supportive of substantial equivalence to the predicate device. |
| Retinal Coverage | Entire retina can be imaged with multiple images. (Implied for predicate) | Can very adequately cover the retina with six images. |
2. Sample Size Used for the Test Set and Data Provenance:
The document doesn't explicitly state the sample size for the test set in terms of cases or patients. However, it mentions that "images from the predicate device and the ICON were presented to a panel." This suggests that the test set consisted of images from both devices.
The data provenance is not explicitly mentioned as country of origin, retrospective or prospective. It appears that images were acquired from both the predicate device and the ICON for comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Five
- Qualifications: "Five clinicians" were used for the comparison of image quality. Specific qualifications (e.g., years of experience, subspecialty) are not provided beyond "clinicians."
4. Adjudication Method for the Test Set:
The document describes that the "images from the predicate device and the ICON were presented to a panel of five clinicians for comparison in four parameters of image quality." This implies a consensus or comparative evaluation method, but no specific adjudication method like 2+1 or 3+1 is mentioned. It seems to be a qualitative comparison by a panel.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A formal MRMC comparative effectiveness study, designed to quantify the improvement of human readers with AI vs. without AI assistance, was not performed. The study involved a panel of clinicians qualitatively comparing images from the new device and the predicate device. There is no AI component mentioned in the context of assisting human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
A standalone algorithm performance study was not performed. The device, Phoenix Clinical ICON, is an ophthalmic camera for image acquisition, not an AI-powered diagnostic algorithm. The testing focused on the device's ability to capture images with comparable quality and safety to a predicate device.
7. Type of Ground Truth Used:
For establishing image quality equivalence, the ground truth was based on:
- Expert Consensus/Qualitative Comparison: A "panel of five clinicians" compared images from both devices in terms of image quality.
- Bench Performance Metrics: ISO standards (ISO 10940:2009 for image quality and ISO 15004-2:2007 for light safety) and objective metrics like "vascular edges as a resolution target" and use of the "NIH analytical tool ImageJ" were used. This suggests a blend of objective measurements and expert assessment.
8. Sample Size for the Training Set:
The document does not mention any "training set." This device is an imaging system, not an AI/ML algorithm that would typically require a training set. The evaluation is for hardware performance and image capture capabilities.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a training set for an AI/ML algorithm.
§ 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.