(303 days)
The EyeQuick Digital Ophthalmoscope Camera is intended for use in capturing approximately eight degrees narrow angle field of view images of the eyelids, retina and the anterior segment of the eye.
The EyeQuick Digital Ophthalmoscope Camera is an ophthalmoscope with an integrated digital camera. The system includes an LCD viewfinder and can be used handheld without any cables. The Digital Ophthalmoscope has on board memory to store images which can be downloaded to a PC via a USB connection.
The provided text describes a 510(k) premarket notification for the EyeQuick Digital Ophthalmoscope Camera (K102412). However, it does not contain detailed information about specific acceptance criteria related to clinical performance or a comprehensive study proving the device meets those criteria, as typically requested for AI/ML-based medical devices.
Instead, the document focuses on:
- Substantial equivalence: Comparing the device to legally marketed predicate devices in terms of intended use, operating principle, and function.
- Compliance with general standards: Stating that the device has been tested and met requirements for ISO 10940, IEC 60601-1, IEC 60601-1-2, and EN55011, and that it meets requirements for safe radiation emission. These are primarily electrical safety, EMC, and ophthalmic instrument-specific safety standards, not typically clinical performance metrics like sensitivity or specificity.
- Intended Use: Defining the device's purpose, which is "capturing approximately eight degrees narrow angle field of view images of the eyelids, retina and the anterior segment of the eye."
Therefore, based on the provided text, I can only provide limited information directly addressing your request.
Here's a breakdown of what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Compliance with ISO 10940 (Ophthalmic instruments - Fundus cameras) | "The EveQuick Digital Ophthalmoscope has been tested and has met all the necessary requirements for ISO 10940." |
| Compliance with IEC 60601-1 (Medical electrical equipment – General requirements for basic safety and essential performance) | "The EveQuick Digital Ophthalmoscope has been tested and has met all the necessary requirements for IEC 60601-1." |
| Compliance with IEC 60601-1-2 (Medical electrical equipment – Electromagnetic compatibility) | "The EveQuick Digital Ophthalmoscope has been tested and has met all the necessary requirements for IEC 60601-1-2." |
| Compliance with EN55011 (Industrial, scientific and medical (ISM) radio-frequency equipment – Electromagnetic disturbance characteristics – Limits and methods of measurement) | "The EveQuick Digital Ophthalmoscope has been tested and has met all the necessary requirements for EN55011." |
| Safe radiation emission | "The device meets the requirements for safe radiation emission." |
| Equivalence to identified predicate devices (K050271, K053425, K950461, K974735) | "The EyeQuick Digital Ophthalmoscope is substantially equivalent to the predicate devices with regard to intended use, operating principle and function." |
Note: The document does not report specific clinical performance metrics such as accuracy (sensitivity, specificity), image quality metrics, or diagnostic agreement rates that would typically be associated with clinical acceptance criteria for AI/ML devices or devices performing an interpretation function. This is a digital ophthalmoscope camera, which is a capture device, and its performance evaluation focuses on safety, electrical, and optical standards rather than diagnostic efficacy based on clinical studies.
Regarding a "study that proves the device meets the acceptance criteria":
The text states, "All testing deemed necessary including requirements set forth in device industry International Standards have been conducted to ensure that the EyeQuick Digital Ophthalmoscope Camera is safe and effective for its intended use..." This indicates that technical compliance testing (for standards like ISO, IEC, EN) was performed, rather than a clinical study with human subjects validating diagnostic performance. The 510(k) summary provided does not detail the methodology or results of these specific compliance tests beyond stating that the device "met all the necessary requirements."
The following information elements are NOT available in the provided text:
- 2. Sample sized used for the test set and the data provenance: Not applicable, as this was not a clinical performance study with a test set of data/patients. The "tests" mentioned are technical compliance tests.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method (e.g. 2+1, 3+1, none) 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: Not applicable. This device is a manual ophthalmoscope with an integrated camera, not an AI/ML diagnostic aid.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable. Equipment performance testing does not involve training sets in the AI/ML sense.
- 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.