(280 days)
General ophthalmic imaging including retinal, corneal, and external structures of the eye.
The Phoenix ICON system is an updated cart based retinal imaging system covering the design changes to date on the predicate device, Phoenix ICON. The Phoenix ICON GO retinal imaging system is a portable version of the predicate device, Phoenix ICON (K170527) including the design changes in the Phoenix ICON system.
Both the Phoenix ICON and Phoenix ICON GO are wide-field, handheld, high resolution, real-time retinal imaging devices. They are intended to be used for general ophthalmic imaging including retinal, corneal, and external structures of the eye. The intended users of the Phoenix ICON and Phoenix ICON GO are clinical imaging technicians, ophthalmic technicians, nurses, and physicians. The devices may be used in hospitals, medical clinics, and physician's offices.
The Phoenix ICON platform consists of either a cart based (Phoenix ICON) or portable (Phoenix ICON GO) control box used in conjunction with a hand-held camera (Handpiece) using interchangeable LED based light sources (White and Blue light). The Phoenix ICON cart contains an AC mains power attachment, a battery module, a keyboard interface, a monitor, and a computer with Phoenix ICON software. The Phoenix ICON GO contains a portable control box with battery function and has an interface for attachment to a specified laptop computer which runs the Phoenix ICON software. Both systems may be used with a Foot Pedal, White Light Module (standard), Blue Light Module (FA) and/or Diffuser accessory.
The Phoenix ICON Handpiece contains a wide-field, high resolution camera is used in three (3) modes, External Imaging (White Light), Retinal Imaging (White Light), and Fluorescein Angiography (Blue Light). For external imaging, the Diffuser accessory is placed over the lens tip to diffuse the light and provide for images of the outer surfaces of the eye. Both Retinal Imaging and Fluorescein Angiography are performed with the glass lens of the Handpiece coupled to the cornea via an imaging gel. In these imaging methods, LED light is emitted into the eye to illuminate the retina for image capture.
Both the Phoenix ICON and Phoenix ICON GO are software-controlled systems which can capture either video or still images and store them on the control box (Cart computer or GO laptop) for later review. The Phoenix ICON system may be connected to IT networks under IT supervision.
The provided document does not contain details about specific acceptance criteria for a device's performance in a clinical study or a study proving that the device meets those criteria. Instead, it is a 510(k) summary for the NeoLight Phoenix ICON and Phoenix ICON GO ophthalmic cameras, aimed at demonstrating substantial equivalence to a predicate device (K170527, Phoenix ICON by Phoenix Technology Group, LLC).
The document focuses on comparing technological characteristics and safety testing, not on clinical performance acceptance criteria or a study to demonstrate such.
However, based on the Performance Testing section (Table 5.3) related to Simulated Use, it states:
Characteristic: Image Clarity - Comparison between subject and predicate images to ensure equivalent visual quality of the captured images.
Results: Pass.
While this indicates some form of performance assessment related to image quality, it does not provide the specific acceptance criteria (e.g., quantitative metrics, thresholds) or the detailed methodology of the study. It also doesn't present the "reported device performance" in a manner typical for clinical trials (e.g., sensitivity, specificity, or reader agreement scores).
Therefore, a table of acceptance criteria and reported device performance, as well as several other requested details, cannot be fully extracted from the provided text.
Here's an attempt to answer the questions based only on the available information, noting where information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Visual quality of captured images is equivalent to predicate device | Passed (Equivalent visual quality of captured images) |
Note: The document only provides a high-level "Pass" result for "Image Clarity - Comparison between subject and predicate images to ensure equivalent visual quality of the captured images." It does not specify quantitative acceptance criteria or detailed performance metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Simulated Use" testing for "Image Clarity - Comparison between subject and predicate images." However, it does not specify the sample size used for this comparison, nor does it provide any information on data provenance (e.g., country of origin, retrospective/prospective nature).
3. 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 provide any information about the number or qualifications of experts used for establishing ground truth or evaluating image clarity.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not specify any adjudication method used for the image clarity comparison.
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
The document describes the device as an "Ophthalmic Camera" for "General ophthalmic imaging." It is a imaging acquisition device and does not include AI functionality. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not relevant to this submission, and no such study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device is an ophthalmic camera. Its function is to capture images. It does not appear to incorporate an algorithm that independently processes or interprets images to provide a diagnosis or finding, nor does it claim AI capabilities. Therefore, a standalone algorithm performance study is not applicable and not mentioned. The "Simulated Use" test assesses the visual quality of the captured images, not the performance of an interpretive algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "Image Clarity" assessment, the implicit "ground truth" was a visual comparison to the predicate device's images to ensure equivalent visual quality. The document does not specify a separate, independent ground truth method like expert consensus on pathology, or outcomes data.
8. The sample size for the training set
The document concerns an ophthalmic camera, not an AI/ML algorithm requiring a training set. Therefore, this question is not applicable.
9. How the ground truth for the training set was established
As the device is an ophthalmic camera and not an AI/ML algorithm, there is no training set and therefore no ground truth for a training set.
§ 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.