(105 days)
The device is intended to be used for taking digital images of the retina of the human eye without a mydriatic.
The DIGITAL RETINAL CAMERA CR-2 is used for taking digital images of retina of human eye without a mydriatic. Canon EOS Digital Camera is mounted to the CR-2. Images can be viewed immediately, making procedures more efficient with 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 DIGITAL RETINAL CAMERA CR-2:
It's important to note that this 510(k) summary is for a medical device, specifically a digital retinal camera, not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study details associated with AI/ML systems (like those for diagnostic accuracy, sensitivity, specificity, reader studies, ground truth establishment for algorithms, etc.) are not present in this document. The focus here is on safety, effectiveness, and substantial equivalence to a predicate device.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Criterion | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC60601-1 | CR-2 was tested in accordance with IEC60601-1 and was found to meet all requirements of this standard. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC60601-1-2 | CR-2 was tested in accordance with IEC60601-1-2 and was found to meet all requirements of this standard. |
| Ophthalmic Instruments Requirements (General) | Compliance with ISO15004-1:2006 | CR-2 was tested in accordance with ISO15004-1:2006 and was found to meet all requirements of this standard. |
| Ophthalmic Instruments Requirements (Specific) | Compliance with ISO15004-2:2007 | CR-2 was tested in accordance with ISO15004-2:2007 and was found to meet all requirements of this standard. |
| Substantial Equivalence | Same imaging principle and intended use as predicate. | The CR-2's imaging principle and intended use are the same as those of CR-1 Mark II. The CR-2 has reduced dimensions and weight compared to the CR-1 Mark II. The optical components, alignment, and most specifications are the same or better than the CR-1 Mark II. The Performance Data demonstrate that CR-2 is as safe and effective as the predicate devices. Based on this, it is considered substantially equivalent to the predicate device (CR-1 Mark II). |
Study Details (Focusing on the type of device and available information)
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify a "test set" in the context of clinical image data for evaluating an algorithm's performance. Instead, the testing described is related to engineering and safety standards.
- Therefore, there is no information on sample size, data provenance, or retrospective/prospective nature for an image-based test set as this is not an AI/ML diagnostic device.
-
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):
- Not applicable. This device is an imaging acquisition device, not an AI/ML diagnostic algorithm that requires expert-established ground truth for performance evaluation of its diagnostic capabilities.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no diagnostic "test set" and thus no adjudication of cases by experts for this type of submission.
-
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:
- Not applicable. This device is a fundus camera, not an AI-assisted diagnostic tool. No MRMC study was performed in this context.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm. The device's "standalone" performance refers to its ability to acquire images and meet technical standards independently.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for this device lies in its adherence to established engineering and safety standards (e.g., electrical safety, EMC, ophthalmic instrument standards) and its functional equivalence to a predicate device in terms of image acquisition. There is no medical "ground truth" (like disease presence/absence via pathology) used in evaluating its performance for this 510(k) submission.
-
The sample size for the training set:
- Not applicable. This device does not involve an AI/ML algorithm that requires a training set. The "training" for such a device would refer to its manufacturing and design process.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of an AI/ML algorithm.
Summary of the Study:
The "study" described in this 510(k) pertains to performance testing against recognized industry standards and direct comparison of specifications to a predicate device, the Canon DIGITAL RETINAL CAMERA CR-1 Mark II (K090466).
- Testing Protocol: The CR-2 underwent testing in accordance with:
- IEC60601-1 (Electrical Safety)
- IEC60601-1-2 (Electromagnetic Compatibility)
- ISO15004-1:2006 (Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments)
- ISO15004-2:2007 (Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection)
- Purpose of Study: To demonstrate that the CR-2 meets all safety and performance requirements set by these standards and is substantially equivalent to its predicate device. This ensures it is as safe and effective for its intended use (taking digital images of the retina of the human eye without a mydriatic).
- Methodology: The device itself was subjected to these standard tests. A direct comparison of its imaging principle, intended use, dimensions, weight, optical components, alignment, and other specifications was made against the predicate device.
- Conclusion: The tests confirmed compliance with the standards, and the comparison showed that the CR-2 maintains the same or better performance than the predicate, leading to a determination of substantial equivalence.
§ 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.