(103 days)
CR6-45NM is intended to be used for taking pictures of retina of human eye without a mydriatic.
Taking pictures of retina of human eye.
CR6-45NM is an improved model of CR5-45NM. CR6-45NM has employed Auto Flash Adjustment and Advanced Internal Fixation Lamp, making operation easier.
The provided 510(k) summary for K980246 describes a new non-mydriatic retinal camera, the Canon CR6-45NM, and compares it to a predicate device, the Canon CR5-45NM. The submission focuses on demonstrating substantial equivalence rather than reporting on a study with specific acceptance criteria and performance metrics for a novel AI/software device.
Therefore, the requested information elements related to AI/software performance, such as sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance, are not explicitly provided or relevant in this context.
However, I can extract and present the available information regarding the device's characteristics and the comparison to the predicate device, which implies the "acceptance criteria" were met by demonstrating substantial equivalence based on technological characteristics and intended use.
Here's the breakdown of the information as requested, with "N/A" for elements not applicable to this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
This submission focuses on demonstrating substantial equivalence to a predicate device (Canon CR5-45NM). The "acceptance criteria" implicitly revolve around ensuring the new device's technological characteristics and intended use are sufficiently similar to the predicate device, and that any differences do not raise new questions of safety or effectiveness.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | CR5-45NM (Predicate) Performance/Characteristics | CR6-45NM (New Device) Performance/Characteristics | Differences/Improvements (New Device) |
|---|---|---|---|
| Angle of View | 45° (37° with S.P switch ON) | Same | None |
| Actual Image Size | $\phi$ 22mm (35mm film), $\phi$ 74mm (Polaroid film) | Same | None |
| Min. Diameter of Pupil Required | 4.0mm (3.7mm with S.P switch ON) | Same | None |
| Working Distance (WD) | 45mm | Same | None |
| Focusing Method | By aligning the split lines | Same | None |
| Data to be Printed | Hand-written data | Same | None |
| Eye Fixation Lamp | Internal (during observation of retinal image) | Internal (during observation of eye front image and retinal image) | Advanced Internal Fixation Lamp (supports eye front image observation) |
| Light Source for Photography | Max. 300WS | Same | None |
| Working Range (Vertical) | 37mm | Same | None |
| Working Range (Forward & Back) | 40mm | Same | None |
| Working Range (Right & Left) | 100mm | Same | None |
| Chin Rest (Vertically) | 70mm | Same | None |
| External Dimension | W325xL480xH585mm | W325xL496xH570mm | Minor dimensional variations |
| Weight | Approx. 24kg | Same | None |
| Intended Use | Taking pictures of retina of human eye | Same | None |
| Energy Used | 300VA | Same | None |
| Target Population | General Population | Same | None |
| Physical Safety Standards | UL544 | Same | None |
| Compliance with Standards | UL544 | Same | None |
| Biocompatibility | NA (Not Applicable/Not Assessed) | Same | None |
| Key Material Differences | Aluminum casting AC2A (Component 5), PBT resin (Component 6) | Aluminum die cast ADC10 (Component 5), PC resin (Component 6) | Material change for two components |
| Software | Exclusive pre-installed software | Same | None |
| Operational Improvement | N/A | Auto Flash Adjustment | New feature for easier operation |
Summary of "Study" Proving Acceptance:
The "study" or justification for acceptance is a 510(k) Pre-market Notification which aims to demonstrate substantial equivalence to a legally marketed predicate device (Canon CR5-45NM). The submitter, Canon USA, Inc., stated that "CR6-45NM is an improved model of CR5-45NM. CR6-45NM has employed Auto Flash Adjustment and Advanced Internal Fixation Lamp, making operation easier." The FDA reviewed the comparison chart and other information and concluded that the device is substantially equivalent for its stated indications for use.
2. Sample size used for the test set and the data provenance
N/A. This 510(k) submission for a non-mydriatic retinal camera (a hardware device with some software) does not detail a "test set" in the context of performance evaluation for an AI/software algorithm. The substantial equivalence argument relies on comparing the technical specifications and intended use to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. Not applicable to this type of hardware device submission. No "ground truth" establishment by experts is described for performance evaluation.
4. Adjudication method for the test set
N/A. Not applicable for this hardware device submission.
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. This is a hardware device (retinal camera) and not an AI-assisted diagnostic tool in the sense of an algorithm interpreting images for human readers. No MRMC study was performed or required for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. Not applicable. This device is a camera and its function is to capture images, not to perform standalone diagnostic interpretations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
N/A. Not applicable. The "ground truth" in this context would likely refer to established engineering and medical standards for retinal imaging, satisfied by the performance of the predicate device and the new device's comparable or improved features.
8. The sample size for the training set
N/A. Not applicable. There is no information about a "training set" as this is not an AI/machine learning algorithm seeking to be cleared.
9. How the ground truth for the training set was established
N/A. 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.