(282 days)
The CSO Cobra Fundus Camera is intended for taking digital images of a human retina with or without the use of mydriatic agent. The retinal image can be stored to an image filing device.
Cobra is intended for taking digital images of a human retina with or without the use of a mydriatic agent. A function for retinal plane capturing is provided. The instrument is furnished with an integrated 5MP CCD camera, and uses one (1) white LED for flashing, one (1) IR led for alignment and Infrared acquisitioning.
Cobra can be used with pupil diameters starting from 2.5 mm, and therefore can be used without the need for a mydriatic agent. Acquisition transfer is performed from the instrument to the accompanying PC via a Firewire cable.
This document is a 510(k) premarket notification for the Cobra Fundus Camera, seeking clearance from the FDA. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent clinical study with specific acceptance criteria in the typical sense for an AI/CADe device.
Therefore, many of the requested sections (e.g., effect size of human readers with AI assistance, detailed sample sizes for test and training sets with ground truth establishment for AI, number of experts for ground truth, adjudication method) are not applicable or not explicitly stated in this type of submission, as the device itself is a fundus camera, not an AI diagnostic system. The "performance test" section refers to engineering and regulatory compliance tests, not a clinical study to evaluate diagnostic accuracy against a ground truth.
Here's the closest interpretation of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1 (International Standard for Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance) | Cobra met all requirements. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 (International Standard for Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests) | Cobra met all requirements. |
| Ophthalmic Instrument Safety | ISO 15004-2 (Ophthalmic instruments — Fundus cameras — Part 2: Requirements for safety) - Specifically "Group 1 instruments" | Cobra met all requirements. |
| Software Validity | FDA Guidance for the content of premarket submissions for software contained in medical devices | Evaluation performed; all functional tests and unit level tests passed, meeting test criteria. Level of concern: Moderate. |
| Biocompatibility | Assessment performed | Materials used are the same as other legally marketed devices in US. |
| Risk Management | ISO 14971:2012 (Medical devices - Application of risk management to medical devices) | Cobra met all requirements; risk management deemed satisfactory. |
| Image Transfer Hardware | Not explicitly stated as a separate standard, but comparison to predicate and impact on safety/effectiveness. | Different from predicate, but not considered critical to intended use or affecting safety/effectiveness. |
| Substantial Equivalence | Equivalence to Kowa nonmyd WX Ophthalmic Camera (K101628) in functionality, design verification, and intended use, with no effect on safety/effectiveness due to differences. | Concluded to be substantially equivalent. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of this 510(k) submission. The "performance tests" mentioned are engineering and regulatory compliance studies, not clinical trials with patient data.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission doesn't describe a clinical study requiring ground truth established by experts.
4. Adjudication method for the test set
- Not applicable.
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
- No. This device is a fundus camera, not an AI/CADe system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware device (fundus camera), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of a clinical performance evaluation. The "ground truth" for the performance tests would be the fulfillment of established engineering standards (e.g., electrical safety, EMC requirements).
8. The sample size for the training set
- Not applicable. This device is a fundus camera, not an AI system that requires a "training set."
9. How the ground truth for the training set was established
- 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.