(247 days)
An AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
The SL 220 can be used in performing a wide range of conventional eye care applications. It is used for ophthalmic observation of structural properties of the eye. The illumination can be adjusted from slit type illumination to a full-field type illumination by beam forming elements. The instrument is primarily used by ophthalmologists, opticians and optometrists.
This document is a 510(k) summary for the Carl Zeiss Meditec SL 220, an AC-powered slit lamp biomicroscope.
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Acceptance Criteria and Reported Device Performance
The provided document does not contain a table of acceptance criteria nor reported device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC). This is a submission for a Slit Lamp Biomicroscope, which is a diagnostic tool that physicians use, not an AI or algorithm-driven diagnostic device that would typically have such performance metrics.
Instead, the "acceptance criteria" for a device like this are compliance with recognized performance standards related to safety and effectiveness, and then a comparison to predicate devices for substantial equivalence.
Here's what is presented:
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance (Compliance) |
|---|---|
| IEC 60601-1: 2005 + CORR. 1 (2006) + CORR.2 (2007) + AM 1 (2012) (Medical electrical equipment - General requirements for basic safety and essential performance) | Demonstrated conformance |
| IEC 60601-1-2: 2007 (Third edition) (Medical electrical equipment - Electromagnetic compatibility) | Demonstrated conformance |
| ISO 15004-2:2007 (Ophthalmic instruments - Slit-lamp biomicroscopes - Part 2: Ophthalmic instruments and fundamental requirements and test methods) | Demonstrated conformance |
Study Information (as per the document)
The document describes non-clinical tests to demonstrate compliance with standards and a comparison to predicate devices. It does not describe a clinical study of diagnostic accuracy or comparative effectiveness in the way an AI/CADe/CADx device would.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device submission. There is no "test set" in the context of diagnostic accuracy.
- 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. Ground truth for diagnostic accuracy is not discussed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-only device. It's a medical instrument used directly by a human.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic accuracy. The ground truth for this device's performance is adherence to engineering and safety standards.
- The sample size for the training set: Not applicable. This is not a machine learning device.
- How the ground truth for the training set was established: Not applicable.
Summary of the Device and Submission:
The SL 220 is a conventional slit lamp biomicroscope intended for eye examination of the anterior eye segment to aid in the diagnosis of diseases or trauma. The submission focuses on demonstrating substantial equivalence to existing predicate devices (Carl Zeiss Meditec (CZM) Slit Lamp SL 130 and C.S.O. SL990) and compliance with relevant international safety and performance standards (IEC 60601-1, IEC 60601-1-2, ISO 15004-2). The main technological differences highlighted are top-illumination versus bottom-illumination and Halogen versus LED illumination. The document concludes that the SL 220 is safe and effective and substantially equivalent to the predicate devices.
§ 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.