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An AC-powered slit-lamp biomicroscope and accessories intended for use in the 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 traumas which affect the structural properties of the anterior eye segment.

An AC-powered slit lamp 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.

The slit lamp illumination is composed of the light source, the slit, collimation and imaging optics, and infrared and ultra violet filters and a dielectric mirror. The slit lamp have the option to combine a background illumination together with the slit illumination.

The patient sits in front of the slit lamp with his chin rest and his forehead against the forehead band. The chin rest is adjusted in height until the eyes of the patient are level with the black mark of the headrest column. The light is switched on and the brightness is controlled with a knob on the power supply. With the joystick 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. 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 provided document describes a 510(k) premarket notification for the Marco Ultra M3 and Marco Ultra M4 slit lamp biomicroscopes. This notification focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical performance or diagnostic accuracy enhancements. Therefore, the document does not contain details about acceptance criteria, a study proving device performance in terms of diagnostic accuracy, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI/diagnostic performance.

Instead, the "acceptance criteria" for this type of submission are primarily related to safety, electrical compatibility, and optical performance in comparison to predicate devices, and the "study" is a series of tests to confirm compliance with recognized standards.

Here's an analysis of the provided information, focusing on what is present:

1. A table of acceptance criteria and the reported device performance

The document doesn't provide a table of acceptance criteria in the context of diagnostic performance or AI accuracy. Instead, it demonstrates compliance with recognized safety and performance standards. The "performance" reported are the characteristics of the device itself and its adherence to these standards.

The document also provides a comparison of technological characteristics between the proposed devices (MARCO ULTRA M3, MARCO ULTRA M4) and their predicate devices (Slit Lamp BM900, Z2 Slit lamp microscope). These comparisons are used to argue for substantial equivalence, implying that the new devices perform safely and effectively within the established range for such devices. Examples of characteristics compared include:

• Brightness Controls: Variable control vs. Light intensity control knob, Maximum brightness (e.g., 240,000 Lux for M3 vs. 450,000 Lux for BM900; 150,000 Lux for M4 vs. 150,000 Lux for Z2).
• Slit image width: 0-14mm continuous for all proposed models vs. 0-8mm for BM900 and 0-14mm for Z2.
• Slit image length: 1-14mm continuous for all proposed models vs. 1-8mm for BM900 and 1-14mm for Z2.
• Illumination field Diameter: Specific discrete values compared (e.g., φ10,φ5, φ3, φ2, φ1, φ0.2 mm for M3 vs. φ8,φ5,φ3,φ2,φ1,φ0.2 mm for BM900).
• Radial movement of the slit light illumination: Horizontal ±90° for all, Vertical 0°,5°,10°,15°,20° for M3 vs. 0-20° for BM900, and Vertical "don't apply" for M4 vs. Z2.
• Light source: LED for all.
• Background illumination: None for M3 vs. Option for BM900; Mounted in Slit lamp unit for M4 vs. None for Z2.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The tests performed are compliance tests against established engineering and safety standards, not clinical trials with patient data.

3. 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)

This information is not provided in the document. As stated above, the "tests" are technical compliance tests, not clinical evaluations requiring expert consensus for ground truth.

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

This information is not provided. The document details technical compliance testing, which does not involve adjudication of expert interpretations.

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 information is not provided. The device in question is an AC-Powered Slit-lamp Biomicroscope, which is a foundational diagnostic instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this submission.

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

This information is not provided. The device is an optical instrument for direct human examination, not a standalone algorithm.

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

This information is not applicable as the document describes technical compliance testing for an optical instrument, not a diagnostic device relying on ground truth for performance evaluation in a clinical sense. The "ground truth" here would be the specifications and requirements defined by the referenced international standards.

8. The sample size for the training set

This information is not applicable as the device is an optical instrument and does not involve machine learning or AI that would require a "training set."

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

This information is not applicable for the same reasons as #8.

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EyeSuite Imaging is a software program intended for use for controlling digital imaging devices and for acceptance. transfer, display, storage and digital processing of documentational ophthalmic images and videos, acquired from computerized diagnostic instruments, through direct connection or through networks.

EyeSuite Basic is a patient and examination management system, acting as a base and communication platform for other EyeSuite software components.

EyeSuite Imaging is a software used by eye care professionals together with imaging systems on Haaq-Streit slit lamps or other devices. EveSuite Imaging requires a computer running Microsoft Windows in one of the following versions:

• Windows XP, SP3 (32 Bit) ●
• Windows Vista, SP2 (32 and 64 Bit) .
• . Windows 7. SP1 (32 and 64 Bit)
• Windows 8 and 8.1 (32 and 64 Bit) .

A slit lamp is an instrument consisting of a light source that can be focused to shine a thin sheet of light into the eye. It is used in conjunction with a biomicroscope. The lamp facilitates an examination of the anterior segment, or frontal structures and posterior segment, of the human eye. With an imaging system a two dimensional image or video of what is seen through the biomicroscope can be recorded into widely used data formats, such as TIFF or JPEG in case of still images or MJPEG in case of a video. These records can be used for documentational purpose or to explain findings to the patient. It is optionally possible to connect the software to a DICOM PACS for storing the recorded image data.

EyeSuite Imaging allows the user to control the Haag-Streit imaging devices attached to the slit lamp or other devices, enables recording of images or videos, allows to view, modify and store the results together with accompanying information such as patient data, information on camera settings or notes of the examiner. The examiner may also highlight significant image features by using the provided draw and measure tools that allow to add predefined overlays, pixel measurements or angle measurements in the image plane. The software is not able and not intended to provide any diagnosis, but it helps the user to examine the visible structures of the eye and enables him to present and store his findings.

EyeSuite Imaging is a software application which is part of the Haag-Streit EyeSuite software product family that is licensed to customers of Haag-Streit Imaging devices. All imaging data acquisition, processing or consistency-check related features are provided by the EyeSuite Imaging Extension component and the EyeSuite Imaging Viewer component. Standard elements such as user management, patient management. database connections, basic settings, installation and backup routines are provided by the EyeSuite Basic component. The architectural decision of isolating standard features into the EyeSuite Basic component was made to reuse these features in other EyeSuite software products.

The imaging modules supported by EyeSuite Imaging are the Haag-Streit IM900 and the Haag-Streit CM900. The EyeSuite Imaging software allows to take control of camera features such as exposure time, camera gain or white balance settings. The release modules supported by EyeSuite Imaging are the Haag-Streit RM01, the Haag-Streit RMX01 and the Haag-Streit Footswitch. These supplementary devices are registered accessory parts to the class II slit lamp microscope (FDA clearance number K100202),

The provided document is a 510(k) summary for the EyeSuite Imaging software. It describes the device's intended use and compares it to predicate devices to establish substantial equivalence. However, it explicitly states that the device is not intended to provide any diagnosis and therefore no clinical or non-clinical performance data was necessary to verify its safety and efficacy in terms of diagnostic performance. The validation primarily focuses on software functionality and compliance with standards.

Therefore, the requested information regarding acceptance criteria for diagnostic performance, details of a study proving such criteria are met, sample sizes for test/training sets, ground truth establishment, expert involvement, or MRMC studies for diagnostic improvement are not applicable or available in this document.

Here's a breakdown of the requested information based on the provided text, highlighting what is (and isn't) present:

1. A table of acceptance criteria and the reported device performance:

Since the device does not provide diagnosis, there are no diagnostic performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics for diagnostic tasks. The document focuses on functional performance and compliance with software standards.

The study that proves the device meets these criteria is the "Software validation testing and image capture testing" mentioned in section 11. Specifically, the test cases listed (e.g., 1182_1021525_06011_Test Case 006) are the documented evidence of this validation.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not applicable/provided. Since the performance validation is focused on software functionality and image handling rather than diagnostic accuracy, specific "test sets" of patient images for diagnostic evaluation, their sample size, or provenance of patient data are not detailed. The testing described appears to be internal software validation.

3. 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. As the software does not provide diagnosis, there's no "ground truth" to establish for diagnostic purposes in the context of patient data. The validation focused on verifying software behavior and compliance with specifications.

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

Not applicable. No diagnostic adjudication method is described as the software does not perform diagnosis.

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. The document explicitly states: "As the software is not able and not intended to provide any diagnosis, no clinical performance data was necessary to verify the safety and efficacy of the device." Therefore, no MRMC study for diagnostic effectiveness or human reader improvement was conducted or reported.

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

Yes, in a sense, the software validation testing documented in section 11 (e.g., "Software validation testing and image capture testing were performed on the EyeSuite Imaging Software") represents the standalone performance evaluation of the software's specified functionalities (capture, display, storage, processing, control). However, this is for functional performance, not diagnostic performance.

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

For the functional software validation, the "ground truth" would be the expected behavior defined by the software's design specifications and the requirements of the standards it aims to comply with. For example, for image capture, the ground truth is that the captured image accurately reflects the input from the device. For DICOM compliance, the ground truth is adherence to the DICOM standard. This is not patient-specific diagnostic ground truth.

8. The sample size for the training set:

Not applicable/provided. This device is not described as an AI/ML diagnostic algorithm that would require a "training set" of data in the common sense. It's an image management and control software.

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

Not applicable, as there is no mention of a training set or an AI/ML model for diagnostic purposes.

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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 Discovery System is intended for use in:

-Mapping the lower and higher order aberrations of the eye which includes measurement of the spherical power, cylindrical power and cylinder axis.

-The measurement and analysis of corneal curvature (comeal refractive power, and cylinder axis of the cornea. The device also maps the display of the corneal shape.

• White-to-white measurements (also called WTW or horizontal corneal diameter).

-Retro-illumination imaging of the anterior segment of the eye including intraocular lens imaging.

• The measurement of pupil diameter.

-In the automated measurement and analysis of refractive errors of the eye including hyperopia and myopia from -25.0 to +15.0 diopters spherical, and astigmatism from 0.0 to ± 10.0 diopters.

The Discovery System combines a corneal topographer and an ocular wavefront aberrometer into a single, efficient system. The Discovery System combines several features to provide clinicians with detailed ophthalmic measurements. The Discovery System is designed to quickly and easily capture:

• Anterior corneal topography .
• Ocular wavefront aberrations .
• Retro-illumination images .
• Iris images .

Using near infrared (NIR) light sources for both the corneal topography and ocular wavefront aberrations permits these measurements to be taken simultaneously along the same optical axis. Retro-illuminated imaging is provided using a NIR light source reflected off the retina and optional white light and/or NIR anterior eye light sources. Iris images are captured during a retro-illumination acquisition and can optionally be captured during all other exam type acquisitions to identify eye rotations between examinations.

The provided text describes a medical device called the "Discovery System," which combines a corneal topographer and an ocular wavefront aberrometer. However, it does not contain information regarding acceptance criteria, a specific study proving the device meets those criteria, or details such as sample sizes, expert qualifications, or ground truth establishment for a study of its performance in a clinical setting.

The "Performance Data" section (Page 2) primarily discusses:

• Light source safety measurements: This involves verifying that the device's light emissions (NIR SLD, NIR LEDs, White LEDs, and combinations) meet specified international safety standards (ANSI 136.1, ISO 15004-2, IEC 62471). This is a safety assessment, not a performance assessment of its clinical diagnostic capabilities.
• System measurement performance evaluation: It states this was "evaluated using bench testing" and involved "designing and producing surfaces on a high-precision contact lens lathe for system calibration. corneal topography measurements, and ocular wavefront measurements." This describes a bench test used for calibration and internal validation of measurement accuracy on controlled targets, not a clinical study with human subjects or a comparison against human experts.

Therefore, I cannot provide the requested table and detailed information because the source document does not contain a description of a clinical study assessing the device's diagnostic performance against established acceptance criteria. The document focuses on regulatory approval (510(k) submission for substantial equivalence) and safety aspects, along with bench testing for calibration and internal performance validation.

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