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DIGITAL FUNDUS CAMERA CF-60DSi is intended to be used for taking digital images of retina of human eye with a mydriatic.
CF-60DSi is an improved model of CF-60UVi. The DIGITAL FUNDUS Doorfpack CF-60DSi is used for taking digital images of retina of human eye without a mydriatic. Canon EOS Digital Camera is mounted with CF-60DSi, can be viewed immediately, making oundly 200 Digitiont and many different applications, such as telemedicine and electronic filing.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Canon CF-60DSi Digital Fundus Camera:
This 510(k) submission (K041546) is for a modified device, the Canon CF-60DSi, which is being compared to its predicate device, the Canon CF-60UVi. The core of this submission is to demonstrate substantial equivalence rather than defining and proving acceptance criteria for a novel device. Therefore, a traditional "acceptance criteria and study that proves the device meets the acceptance criteria" in the sense of a new, groundbreaking AI-powered diagnostic device with specific performance metrics (like sensitivity, specificity, AUC) is not present. Instead, the focus is on a comparison table highlighting the similarities and minor differences between the new model and the previously cleared predicate device.
The "acceptance criteria" here are implicitly tied to the performance and safety profile of the predicate device, CF-60UVi, which has already been deemed safe and effective. The study proving equivalence is the detailed comparison provided in the 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
As noted, explicit quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) for the CF-60DSi itself are not stated in this 510(k) summary because it's a device modification submission rather than a new technology validation. The "performance" being evaluated is its equivalence to the predicate device.
| Aspect | Acceptance Criteria (Implied by Predicate) | Reported CF-60DSi Performance |
|---|---|---|
| Intended Use | Taking pictures of the retina of the human eye (with a mydriatic) | Same (Taking digital images of retina of human eye with a mydriatic) |
| Optical Components & Alignment | Equivalent to CF-60UVi | Same |
| Mechanical Structures | Almost same as CF-60UVi | Almost same |
| Angle of View | 60/40/30° (CF-60UVi) | 60/40° (CF-60DSi) |
| Actual Image Size | φ29x22 (on 35mm film); φ7.5x5.7 (Type 1: on sensor array) | Same (on monitor / on sensor array) |
| Min. Pupil Diameter Required | φ5.5mm (60/40/30°); φ4.0mm (with S.P switch ON in 30°) (CF-60UVi) | Same (60/40°); φ4.0mm (with S.P switch ON in 40°) (CF-60DSi) |
| Working Distance (WD) | 45mm | Same |
| Focusing | By aligning the split lines | Same |
| Eye Fixation Lamp | External | Same |
| Filter Set | Automatic/Manual | Same |
| Light Source for Photography | Max. 300WS | Same |
| Image Unit Integration | EOS Digital Camera (with Adapter) (CF-60UVi) | EOS Digital Camera (Directly) |
| Physical Safety | UL544 (CF-60UVi) | UL60601-1 (CF-60DSi) |
| Compliance with Standards | UL544 (CF-60UVi) | UL60601-1 (CF-60DSi) |
Explanation of Deviations/Differences:
The CF-60DSi is an improved model primarily in its integration of the EOS digital camera directly, simplifying the process. It also has two variable powers (60/40 degrees) compared to the CF-60UVi's three (60/40/30 degrees), and it uses the updated medical safety standard UL60601-1 instead of UL544. These differences are presented to FDA for review, and the conclusion of substantial equivalence indicates these differences do not raise new questions of safety or effectiveness.
Regarding AI/ML Specifics (as per your prompt structure):
This device (Canon CF-60DSi Digital Fundus Camera, submitted in 2004) is a conventional medical imaging device. It does not employ AI or Machine Learning (ML) functionalities. Therefore, the following points related to AI/ML specific studies are not applicable (N/A) to this 510(k) submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This is not an AI/ML device that generates diagnostic output based on a test set. The "test" for this device involved comparing its physical and performance specifications to a predicate device.
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)
- N/A. No diagnostic "ground truth" establishment by experts is described as this is not an AI/ML diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No adjudication method for diagnostic results from an AI/ML algorithm.
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
- N/A. No MRMC study was conducted as this device does not provide AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. No standalone algorithm performance study was done as there is no algorithm for diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. No diagnostic ground truth is mentioned. The "ground truth" for comparison is the established performance and safety of the predicate device (CF-60UVi).
8. The sample size for the training set
- N/A. No training set exists for this conventional imaging device.
9. How the ground truth for the training set was established
- N/A. No training set ground truth to establish.
Summary Conclusion for K041546:
The Canon CF-60DSi is a modified conventional fundus camera. Its "acceptance criteria" are implicitly met by demonstrating substantial equivalence to its predicate device, the CF-60UVi, which was already cleared for market. The study proving this "acceptance" is the detailed comparison in the 510(k) summary, which outlines the specifications and features of both devices. The FDA's clearance (JUN 23 2004) confirms this substantial equivalence. As this is not an AI/ML-powered device, the AI-specific questions are not applicable.
§ 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.