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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:

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.

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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.

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.

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The Keeler Slit Lamp is an AC-powered Slit lamp biomicroscope 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.

An AC-powered slit lamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into the patient's eye through a control diaphragm a thin, intense beam of light.

This Keeler Slit Lamp has an XYZ translation base that is either mounted onto a custom table top supplied by Keeler or can be mounted on a third parties 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 illumination system rotates around its mounting axis and has a number of filters and graticules allowing the user to control precisely the characteristics of the examination light. The magnification body has a magnification change systems and eyepieces adjustable for the user's individual pupillary distance and distance correction.

The patient is seated in front of the slit lamp with his/her chin in the chin rest and forehead against the forehead rest. The chin rest can be adjusted in height to align the eyes of the patient with the optics/light beam.

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 base unit has a rheostat to control the illumination level.

Various magnifications can be selected on the microscope. For different observations the slit width can be changed, the slit can be tilted horizontally, and the angle between the illumination unit and the microscope can also be varied horizontally.

The Keeler Slit Lamp - H Series is an AC-powered slit lamp biomicroscope 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 affecting the structural properties of the anterior eye segment.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a quantitative sense for performance metrics like sensitivity, specificity, or accuracy, as would be common for AI/diagnostic devices. Instead, the focus is on demonstrating substantial equivalence to a predicate device (Haag-Streit Slit Lamp BQ 900, K100202) through comparison of technical specifications and compliance with recognized safety and performance standards.

The "acceptance criteria" can be inferred to be compliance with relevant safety and performance standards and demonstrating that any differences from the predicate device do not affect safety or effectiveness.

The study that proves the device meets the acceptance criteria is described as the "Summary of Performance, EMC and Safety Testing."

2. Sample size used for the test set and the data provenance

The document does not describe a test set involving patient data or clinical samples for performance evaluation in the context of diagnostic accuracy (e.g., retrospective or prospective studies with a specific sample size). Since this is a hardware device (slit lamp biomicroscope), testing primarily focuses on engineering performance, electrical safety, EMC, and radiation safety.

Therefore, there is no mention of:

• Sample size for a test set.
• Data provenance (e.g., country of origin of the data, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a viewing instrument, and its "performance" is evaluated against technical specifications and safety standards, not against clinical ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or ground truth adjudication process is described for this type of device.

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

Not applicable. This device is an ophthalmic instrument, not an AI-powered diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's acceptance is its compliance with internationally recognized consensus standards for medical electrical equipment and ophthalmic instruments (IEC 60601-1, IEC 60601-1-2, ISO 15004-2, ISO 10939). The testing involved objective measurements against these standards, rather than clinical ground truth like pathology or expert consensus on disease diagnosis.

8. The sample size for the training set

Not applicable. This is a hardware device; there is no training set in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable. As there is no training set mentioned, no ground truth needed to be established for it.

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