(137 days)
The Keeler Slit Lamp is an AC-powered slit lamp bio-microscope 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 authorised healthcare professionals.
The Keeler Slit Lamp H-Series device is AC-powered slit lamp bio-microscope intended for use in eye examination that projects into the patient's eye through a control diaphragm a thin, intense beam of light. It is mounted on an XYZ translation base that is either mounted onto a custom table top supplied by Keeler or can be mounted on a third party's table top {refraction unit} by suitably trained technicians.
Fitted to the XYZ base is the illumination and observation system; fitted to the table top is the chinrest assembly with fixation target. The patient is seated in front of the slit lamp with his/her chin in the adjustable chin rest and forehead against the forehead rest. With the control lever the instrument can be moved back and forward until the slit appears in focus on the cornea. The image can be observed through the microscope.
The digital option for the H-Series Slit Lamp enables digital photographs to be taken to capture the image being observed, for further viewing and record purposes. It comprises an additional USB camera module that can be fitted by the user between the binocular eyepiece assembly and the main body of the microscope, which is connected to a powered USB3 hub enclosed within the microscope base, for onward connection to a medically approved PC.
Addition of this option necessitates modifications to the illumination tower to provide background lighting via a fibre optic light tube when capturing digital images.
There are two variants of the H-Series Digital Slit lamp. The first variant uses an incandescent light source, which is used to illuminate the eye during examination and provide background illumination to aid digital photography.
The bulb is more powerful than the bulb sited in the predicate 510(k) [K131589] due to the requirement for additional background illumination for digital photography. The quantity of light for illuminating the eye is comparable to the product sited in K131589, and therefore posses no additional risk to the safety and effectiveness of the product.
The second product variant is an LED illumination option, which again provides light to illuminate the eye during examination and provides background illumination for digital photography. Both variants are factory fitted and comply with ISO 15004-2:2007.
The provided 510(k) summary for the Keeler Slit Lamp H-Series Digital does not contain information about specific acceptance criteria or a study proving the device meets performance criteria in the way typically expected for AI/ML-driven devices (e.g., sensitivity, specificity, accuracy against a recognized standard).
This document describes a traditional medical device (a digital slit lamp biomicroscope), which primarily focuses on substantial equivalence to predicate devices rather than novel performance metrics. The "device performance" in this context refers to its
functional capabilities and safety compliance, not diagnostic accuracy in the way AI algorithms are evaluated.
Therefore, many of the requested details about acceptance criteria for AI models, sample sizes for training/test sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable or not present in this type of submission.
However, I can extract the relevant information regarding what constitutes "acceptance" for this device, which relies on demonstrating substantial equivalence and compliance with established standards.
Here's an attempt to answer your request based on the provided document, adapting where necessary due to the nature of the device:
Acceptance Criteria and Device Performance for Keeler Slit Lamp H-Series Digital (K140451)
Given that the Keeler Slit Lamp H-Series Digital is an AC-powered slit lamp biomicroscope with an added digital camera module, the "acceptance criteria" discussed in this 510(k) submission primarily revolve around demonstrating substantial equivalence to a predicate non-digital slit lamp and a predicate digital camera option, and compliance with relevant safety and performance standards. There are no specific diagnostic or AI performance metrics (like sensitivity, specificity, or AUC) as the device is an imaging tool, not a diagnostic algorithm.
The "study" proving the device meets the acceptance criteria is the 510(k) submission itself, which presents a comparison of features and compliance with standards.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a traditional medical device submission, the "acceptance criteria" are derived from the substantial equivalence comparison and compliance with recognized standards. "Device performance" refers to its technical specifications and demonstrated compliance.
| Acceptance Criterion (Based on Substantial Equivalence & Standards) | Reported Device Performance (Keeler Slit Lamp H-Series Digital) |
|---|---|
| Intended Use (Substantially equivalent to predicate) | "AC-powered slit lamp bio-microscope... for use in eye examination of the anterior eye segment... to aid in the diagnosis of diseases or trauma... used only by suitably trained and authorized healthcare professionals." (No change from predicate). |
| Bio-microscope Components (Similar to predicate) | Galilean converging binoculars with detachable eyepiece head. |
| Digital Camera Module Functionality (Similar to predicate) | Optional fitment, Image Capture Button fitted to joystick, Camera Exposure Buttons adjacent to joystick, Internal USB3 Hub. Captures digital photographs and video for documentation. |
| Slit Lamp Illumination Options (Safe and effective) | 12VDC 30W halogen bulb or LED option. Provides slit lamp illumination and background lighting. (Increased power for halogen bulb compared to non-digital predicate, but quantity of light for illuminating the eye is comparable and poses no additional risk). Both variants comply with ISO 15004-2:2007. |
| Background Illumination Control and Source | Fitted to top of illumination tower for optimum lighting for digital photography. 12VDC 30W halogen bulb or LED. |
| Phototoxicity (Halogen Bulb Option) | Limited to 6 minutes for 50% duty cycle at maximum brightness. Maximum exposure increased from 13 to 17 minutes based on testing to ISO 15004-2 (LED maximum exposure unchanged at 12.5 minutes). (Ensures body of light source does not exceed 62.3ºC limit demanded by IEC 60601-1 compliance). |
| Electrical Ratings | AC 100-240 V, 50/60Hz input voltage. 52VA (2.2A) power output. 24V DC output voltage for bulb option, 12V DC for LED option. |
| Compliance with Safety Standards | IEC60601-1, IEC60601-1-2, ISO 15004-1, ISO 15004-2, ISO 10939. |
| Digital Camera Specifications (Similar to predicate Haaf Streit) | Sony ICX274 CCD sensor, 1600x1200 pixels resolution, 1/1.8" (7.04x5.28mm) sensor dimensions, 12 fps frame rate. |
| Computer Specifications | Intel Core i5, 2 GHz or higher, with at least 4GB RAM and Windows OS required for image display. Complies with IEC 60601-1 or operated with transformer to isolate PC from mains. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable in the traditional sense of an AI/ML test set. This submission does not describe a "test set" of images to evaluate an algorithm's diagnostic performance. Instead, it relies on engineering testing and comparisons to predicate devices.
- Data Provenance: The document refers to compliance with international standards (e.g., ISO, IEC) and comparisons to existing devices on the market (UK for Keeler's non-digital, and Haag Streit for a digital camera module, which operates in the US market). The engineering tests conducted would typically occur in the manufacturer's facilities (UK).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. As there is no "test set" for an AI algorithm's diagnostic performance, there were no experts establishing ground truth for such a purpose. The device's safety and effectiveness are evaluated through engineering tests and comparison to predicates, which would involve qualified engineers and regulatory affairs personnel but not clinical "ground truth" experts in this context.
4. Adjudication Method for the Test Set
- Not Applicable. Without a test set for an AI algorithm, there is no adjudication method described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is typically performed for diagnostic devices, especially those incorporating AI, to assess the impact of the AI on human reader performance. This device is an imaging system, not a diagnostic algorithm, and therefore such a study was not performed or necessary for this 510(k) submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a hardware imaging system. There is no standalone algorithm being evaluated for diagnostic performance. The digital camera module captures images, which are then viewed by a human operator, making it inherently "human-in-the-loop."
7. The Type of Ground Truth Used
- Not Applicable in the context of diagnostic performance. The "ground truth" for this device relates to:
- Functional specifications: Whether the camera captures images at the stated resolution and frame rate.
- Safety compliance: Ensuring the device meets phototoxicity limits (ISO 15004-2), electrical safety standards (IEC 60601-1, IEC 60601-1-2), and other relevant standards.
- Substantial equivalence: Demonstrating that its features and performance are acceptably similar to legally marketed predicate devices without raising new questions of safety or effectiveness.
8. The Sample Size for the Training Set
- Not Applicable. This device does not employ machine learning or AI algorithms that would require a training set of data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, there is no ground truth establishment for it.
§ 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.