(40 days)
The device is intended to be used for taking digital images of retina of human eye with a mydriatic.
CF 1 is an improved model of CF-60DSi. Canon EOS Digital Camera is mounted with CF-1, can be viewed immediately, making procedures more efficient vaniera hand different applications, such as telemedicine and electronic filing. CF-1's intended use is the same as that of CF-60DSi. However, the differences in design are as follows: CF-1 can take images in three modes, such as COLOR, RED FREE, and FLOU. CF-60DSi can take images in four modes, such as COLOR, RED FREE, FLOU and ICG. ICG digital camera cannot be attached to CF-1. CF-1 has 2 variable powers (50//43 degree), where 43 degree is digital magnification. CF-60DSi has 2 optical variable powers (60//40 degree). CF-1 is equivalent to CF-60DSi in the following respect: The optical components and alignment and the mechanical structures of the CF-1 arc almost same as the CF 60DSi.
The provided document is a 510(k) summary for the Canon Digital Retinal Camera CF-1. It primarily focuses on demonstrating substantial equivalence to a predicate device (Canon CF-60DSi) rather than presenting a detailed study proving the device meets specific performance acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and performance study details is not explicitly available in this document.
However, based on the information provided, here's an attempt to answer your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not define explicit "acceptance criteria" as separate measurable thresholds. Instead, it demonstrates "substantial equivalence" by comparing the proposed device (CF-1) to the predicate device (CF-60DSi) across various technical specifications and intended use. The "reported device performance" is implicitly that it performs comparably to the predicate.
| Feature / Criterion (Implicitly "Substantially Equivalent" to Predicate) | Predicate Device (CF-60DSi) Performance | Proposed Device (CF-1) Performance | Notes / Performance Claim |
|---|---|---|---|
| Intended Use | Taking digital images of retina of human eye with a mydriatic. | Taking digital images of retina of human eye with a mydriatic. | Same |
| Angular Field of View | 60/40 degree | 50/43 degree (digital magnification) | Difference noted, but deemed equivalent for intended use. |
| Min. diameter of pupil required | Not specified for predicate | φ5.5mm | Specified for CF-1, implied to be acceptable. |
| Working Distance (WD) | Not specified for predicate | 45mm | Specified for CF-1, implied to be acceptable. |
| Focusing | Not specified for predicate | By aligning the split lines | Specified for CF-1, implied to be acceptable. |
| External Dimensions | Not specified for predicate | W320×D560×H565mm (Main unit), W225×D380×H485mm (Power control unit) | Specified for CF-1, implied to be acceptable. |
| Weight | Not specified for predicate | Approx. 27kg (Main unit), Approx. 27kg (Power control unit) | Specified for CF-1, implied to be acceptable. |
| Energy Consumed | 1000VA | 350VA | Lower consumption for CF-1 – an improvement. |
| Target Population | Ophthalmologist | Ophthalmologist | Same |
| Physical Safety & Compliance with Standards | UL60601-1 | UL60601-1 | Same |
| Biocompatibility | Not Applicable | Not Applicable | Same |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe an independent test set or any clinical study involving patient data to demonstrate performance. The comparison is based on technical specifications and design similarities. This is a 510(k) submission focused on substantial equivalence to a legally marketed predicate device, often relying on engineering and performance testing rather than clinical trials for devices of this type.
- Sample Size for Test Set: Not applicable / Not mentioned.
- Data Provenance: Not applicable / Not mentioned. (No clinical data presented).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no independent test set or clinical study demonstrating diagnostic performance is described, there's no mention of experts establishing ground truth for such a test set. The evaluation is primarily technical.
- Number of Experts: Not applicable / Not mentioned.
- Qualifications of Experts: Not applicable / Not mentioned.
4. Adjudication Method for the Test Set
As there is no clinical test set described, there is no mention of an adjudication method.
- Adjudication method: Not applicable / Not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC study is mentioned. The submission is about the equivalence of an ophthalmic camera, not an AI diagnostic algorithm or a device that impacts reader performance.
- MRMC Study: No.
- Effect size of human readers improve with AI vs without AI assistance: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This device is an ophthalmic camera, which is a physical imaging device, not an AI algorithm. Therefore, "standalone algorithm" performance is not relevant or described.
- Standalone Performance: Not applicable.
7. The Type of Ground Truth Used
Given the nature of the device (an ophthalmic camera) and the 510(k) submission's focus on substantial equivalence, the "ground truth" implicitly relates to the accuracy and quality of the images produced compared to the predicate device, as well as adherence to safety standards. There is no mention of pathology, expert consensus on disease, or outcomes data.
- Type of Ground Truth: Primarily engineering specifications, performance characteristics (e.g., image resolution, field of view, pupil requirements), and safety standards compliance.
8. The Sample Size for the Training Set
This document describes a medical device (an ophthalmic camera), not an AI/ML algorithm. Therefore, the concept of a "training set" for an algorithm is not applicable.
- Sample size for training set: Not applicable / Not mentioned.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned, this question is not applicable.
- How ground truth for training set was established: Not applicable / Not mentioned.
Summary of Device and its Claim:
The Canon CF-1 Digital Retinal Camera is presented as a new model substantially equivalent to the predicate Canon CF-60DSi. The primary evidence for this claim rests on:
- Same Intended Use: Both devices are for taking digital images of the human retina with a mydriatic.
- Similar Optical and Mechanical Components: The CF-1's optical components, alignment, and mechanical structures are "almost same" as the CF-60DSi.
- Compliance with Same Safety Standards: Both adhere to UL60601-1.
- Technical Comparison Table: Highlighting similarities in many specifications and noting differences (like field of view and operating modes) that do not preclude substantial equivalence for the stated intended use. Notably, the CF-1 has a lower energy consumption (350VA vs 1000VA).
The submission argues that despite some differences (e.g., 3 imaging modes vs. 4 for the predicate, different variable powers), the CF-1 retains the fundamental features and performance necessary to achieve its intended use safely and effectively, comparable to the predicate device. It does not contain information about clinical studies or performance studies as one might expect for a diagnostic AI 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.