(92 days)
The SL 115 Classic Slit Lamp, SL 120 Slit Lamp and SL 130 Slit Lamp are AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. They are used to aid in the diagnosis of disease or trauma which affect the structural properties of the anterior eye segment.
The optional SL cam 5.0 is a digital imaging solution that allows the user to take images and video sequences for documentation purposes of the anterior eye segment during slit lamp examinations.
The SL 115 Classic Slit Lamp, SL 120 Slit Lamp and SL 130 Slit Lamp, combined with SL cam 5.0 are intended for use by physicians and ophthalmologists.
The SL 115 Classic Slit Lamp, SL 120 Slit Lamp and the SL 130 Slit Lamp can perform a wide range of eye care applications. They are used for ophthalmic observation and image documentation of structural properties of the eye. The slit controls of the SL 115 Classic Slit Lamp, SL 120 Slit Lamp and the SL 130 Slit Lamp allow horizontal slit adjustment from either the right or left, vertical slit adjustments with a pinhole-type slit and allow viewing with the slit illuminator in the middle position. The instrument is primarily used by physicians, ophthalmologists, optometrists and eye care providers.
The optional SL cam 5.0 digital imaging solution provides an additional function to capture images and video sequences during an eye examination. It is not a data management system and it is not used for diagnosis. The SL cam 5.0 digital imaging solution does not control the slit lamps.
Here's a summary of the acceptance criteria and the study information based on the provided text for the Zeiss Slit Lamps with SL cam 5.0 digital imaging system:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Compliance) |
|---|---|
| Electrical Safety | Conformance to IEC 60601-1:2007, clauses 10.4, 10.5, 10.6, 10.7 with assessment of hazards caused by optical radiation of the slit lamp with the halogen lamp according to DIN EN ISO 10939:2007, clause 4.4 (cross-references to ISO 15004-2:2007). Additionally, compliance with IEC 60601-1:2005 CORR.1 (2006) + CORR.2 (2007). |
| Electromagnetic Compatibility (EMC) | Conformance to IEC 60601-1-2 (2007-12). |
| Software Validation | Software was tested according to a Carl Zeiss Meditec internal software development procedure that is in compliance with IEC 62304:2006 - Medical device software - Software life cycle processes. It also followed the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. May 11, 2005. |
| Substantial Equivalence | Demonstrated substantial equivalence in electro-optical design and function to predicate devices: ZEISS 20 SL Slit Lamp (K925641), ZEISS 30 SL-L Slit Lamp (K862004), and Righton Zoom Slit Lamp NS-2D (K110129). The SL cam 5.0 specifically was found similar to the optional camera/video of the Righton Zoom Slit Lamp NS-2D. |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical test set or data provenance for the SL 115 Classic Slit Lamp, SL 120 Slit Lamp, SL 130 Slit Lamp, or the SL cam 5.0. The non-clinical tests specified focus on conformance to international standards for safety, EMC, and software development. The primary evidence for performance is demonstrating substantial equivalence to predicate devices, rather than a new clinical study with a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The submission is based on demonstrating compliance with standards and substantial equivalence to existing devices, not on a clinical study requiring expert-established ground truth for a test set.
4. Adjudication method for the test set
Not applicable. There is no mention of a test set or adjudication method for the device's performance in a diagnostic or clinical context.
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 MRMC study was performed. The device is a slit lamp with an optional imaging system for documentation and observation, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. The SL cam 5.0 is an imaging solution for documentation, not an algorithm that performs analysis without human interaction. The text explicitly states, "It is not a data management system and it is not used for diagnosis. The SL cam 5.0 digital imaging solution does not control the slit lamps."
7. The type of ground truth used
Not applicable. The submission relies on adherence to recognized performance standards and comparison to predicate devices, not on ground truth derived from expert consensus, pathology, or outcomes data for a new clinical performance claim.
8. The sample size for the training set
Not applicable. The device is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. The device is not an AI/ML device that requires a training set or associated ground truth.
§ 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.