(107 days)
The Keeler Slit Lamp Z-series and Keeler Slit Lamp Z-series Digital are AC-powered Slit lamp bio-microscopes and 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 affects the structural properties of the anterior eye segment This device is intended to be used only by suitably trained and authorized healthcare professionals
The Keeler Slit Lamp Z-series (modified device) exists in two variants: non-digital and digital. The Z-series variant of the product is introduced as a lower cost alternative of the H-series to meet expectations of the optometry market. The Keeler Slit Lamp Zseries includes bottom-illuminating tower assembly instead of top-illuminating Haagtype illuminating tower. The high percentage of components/assemblies used on cleared Keeler Slit Lamp H-series (unmodified device) will be utilized on the Z-series slit lamp.
The modified device will come in a few different configurations assembled from the same components (022 Configurations of the Modified Device). High percentage of components shared between H-series and Z-series slit lamps are used on the cleared H-series device.
Similar to the H-series slit lamp, the Z-series will offer a digital option for recording and storing images and a range of magnifications from x6 to x40. The Z-series slit lamp will only come with LED as a light source, the same as in cleared H-series device, but unlike the H-series slit lamp the bulb version will not be available for the Z-series. The modified device will offer converging and parallel viewing optics, the same options as available on the unmodified device.
The provided document is a 510(k) premarket notification for the Keeler Slit Lamp Z-series and Keeler Slit Lamp Z-series Digital. It focuses on demonstrating substantial equivalence to a previously cleared device (Keeler Slit Lamp H-series). The document does not describe a study that establishes acceptance criteria for diagnostic performance or compares the device's diagnostic abilities against a ground truth.
Instead, the document details engineering, safety, and performance testing related to the physical device itself, primarily to ensure it meets recognized medical device standards and is safe for use.
Here's an analysis based on the information provided, highlighting why it doesn't fit the requested criteria for diagnostic performance evaluation:
1. A table of acceptance criteria and the reported device performance
This document does not provide acceptance criteria or reported performance for diagnostic accuracy (e.g., sensitivity, specificity) as it is not a study evaluating the diagnostic capability of the device.
The "performance" described pertains to engineering and safety standards:
| Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|
| ISO 15004-2 / ISO 10939: Optical Radiation Hazard | Compliant (new exposure safety limits added to IFU) |
| IEC 60601-1: Electrical Safety | Compliant |
| IEC 60601-1-2: Electromagnetic Compatibility (EMC) | Compliant |
| Functionality (e.g., magnification, illumination) | Performs as intended (e.g., offers x6 to x40 magnification, LED light source, converging/parallel optics) |
2. Sample size used for the test set and the data provenance
This is not applicable as the document describes engineering and safety testing on device prototypes/configurations, not a diagnostic study using patient data. The "test set" in this context refers to the device configurations themselves. The provenance of raw patient data is not mentioned because no such data was used for diagnostic performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The evaluations conducted relate to device safety and functionality based on engineering standards and design specifications, not expert interpretation of diagnostic output.
4. Adjudication method for the test set
This is not applicable. No expert adjudication of diagnostic outcomes was performed.
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
This is not applicable. This document describes a physical medical device (slit lamp) and not an AI or software-as-a-medical-device (SaMD) product. Therefore, no MRMC study, AI assistance, or effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical diagnostic tool for human operators, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the engineering and safety tests, the "ground truth" or reference was the established requirements and limits of the relevant international standards (e.g., ISO 15004-2, IEC 60601-1, IEC 60601-1-2).
8. The sample size for the training set
This is not applicable as no AI or machine learning model was developed or trained.
9. How the ground truth for the training set was established
This is not applicable as no AI or machine learning model was developed or trained.
In summary: The provided document is a regulatory submission for a physical medical device. It demonstrates the device's adherence to safety and operational standards and its substantial equivalence to a predicate device. It does not contain information about studies evaluating diagnostic performance, human-in-the-loop performance, or AI-driven diagnostic accuracy, as these are outside the scope of this type of submission for this particular device.
§ 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.