(113 days)
The EAS-1000 "Anterior Eye-Segment Analysis System" is intended to take photographs of the eye and surrounding area, for non-invasive illumination, magnification, observation, analysis and photography of the anterior segments of the eye, which include the cornea, aqueous, lens, vitreous and retina of the eye. To evaluate and analyze conditions of lens (opaque crystalline lens), lens position (pre and post Intraocular Lens Transplant), anterior or posterior cortical opacity, cataracts (nuclear, subcapsular and or cortical) using cross slit imaging or retro-illumination, or both with densitometry and biometry analyses where applicable.
This DEVICE is a non-invasive, table mounted, AC powered diagnostic sytem intended to take photographs of the eye and surrounding area. The system contains a illumination device, viewing optics, a computer (CPU), image capturing devices, and is based on the Scheimpflug Principle for Slit Image photography. The system uses a Xenon flash lamp for Flash Photography, and an Infrared LED for Retro-Illumination.
The provided 510(k) summary for the Nidek EAS-1000 Anterior Eye-Segment Analysis System does not include acceptance criteria or a study that proves the device meets specific performance criteria.
Instead, the submission relies on demonstrating substantial equivalence to predicate devices already on the market. This means the manufacturer is asserting that their new device is as safe and effective as pre-existing, legally marketed devices, rather than proving performance against quantified metrics.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: The 510(k) submission does not define specific performance acceptance criteria for the EAS-1000. It focuses on comparing the new device's features and intended use to those of predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not applicable, as no dedicated test set or clinical study with a specified sample size is described for the EAS-1000's performance validation against specific criteria.
- Data provenance: Not applicable. The submission refers to "Published Journal Articles" to support claims for use, accuracy, safety, and effectiveness, but it doesn't describe a specific study conducted for this device with a given test set and provenance.
3. 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. Since no specific test set or ground truth establishment process is described for the EAS-1000's performance validation, information about experts and their qualifications is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is described as there is no specific test set and ground truth process provided for the EAS-1000.
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. An MRMC comparative effectiveness study was not done. The device is a diagnostic imaging system, not an AI-assisted diagnostic tool, and the submission does not mention any AI components or human-in-the-loop performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The EAS-1000 is a hardware device for taking photographs; it does not explicitly describe an algorithm operating in standalone mode that would require such testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The submission refers to "Published Journal Articles," implying that the claims are supported by existing scientific literature and general clinical understanding of similar devices, rather than a specific ground truth set up for this device.
8. The sample size for the training set
- Not applicable. This device is a camera system, not an algorithm that requires a training set in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. As described above, there is no mention of a training set for this device.
Summary of Device Acceptance:
Instead of demonstrating a device meeting specific acceptance criteria through a dedicated study, the Nidek EAS-1000 gained acceptance (510(k) clearance) by demonstrating substantial equivalence to predicate devices already on the market.
The key arguments for substantial equivalence were:
- General Intended Uses: All three devices (EAS-1000, Nidek 3-DXF Stereo Fundus Camera, KOWA SC-1200 Slit Lamp) share the general intended use "to take photographs of the eye and surrounding area."
- Operating Principles: They utilize similar operating principles, including optical systems, illumination sources for observation and photography, and photographic mediums.
- Device Features: They share common device features such as a head stabilizing device, external fixation target, joystick/control mechanism, and exposure control.
- Illumination and Safety: All use illumination sources and flash output sources, and photo toxicity is not an issue for these devices. They are considered non-invasive and "Non Significant Risk" devices.
- Safety and Effectiveness: The manufacturer states the EAS-1000 is non-invasive, does not pose new risks, meets electrical safety requirements, and is proven effective through "internal company and independent international clinical studies" (though no specifics of these studies are provided in the summary).
The FDA concurred with the claim of substantial equivalence, allowing the device to be marketed.
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.