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The Chongqing Sunkingdom Slit Lamp LS-1A, LS-1B are AC --- powered slit lamp Biomicroscopes 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.

Sunkingdom slit lamp LS-1A, LS-1B are an AC-powered slit lamp biomicroscope 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. An AC-powered Slit lamp Bio-microscope 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. Components: The optical body, movement mechanism, illumination system, portable handle, power supply.

The given text is a 510(k) Pre-market Notification for the Sunkingdom Slit Lamp LS-1A, LS-1B. It details the device's technical characteristics and performance testing conducted to demonstrate substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance:

The document primarily relies on demonstrating compliance with relevant industry standards and showing that the proposed device's performance characteristics are comparable to or better than the predicate device. The acceptance criteria are implicitly defined by these standards and the comparison table.

Study Information:

1. Sample size used for the test set and the data provenance:

   • The document does not explicitly state a "test set" in the context of clinical data for performance evaluation. The performance data provided is primarily from bench testing and compliance with standardized tests (Biocompatibility, Electrical safety, EMC, Performance testing according to ISO 10939, Light Hazard Protection according to ISO 15004-2).
   • For biocompatibility, the tests were conducted with specific samples (e.g., "Chinrest pat and Forehead band extract," "rabbitskin," "guinea pig," "L-929 cells").
   • The data provenance is not specified beyond the tests being conducted on the "Sunkingdom Slit Lamp LS-1A, LS-1B" and under recognized FDA standards and Good Laboratory Practice (21 CFR 58). This suggests the tests were carried out by the manufacturer or a contracted lab. There's no indication of retrospective or prospective human clinical data.

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

   • This question is not applicable as the study did not involve human expert interpretation of clinical cases to establish ground truth. The "ground truth" for the performance claims were objective measurements and adherence to technical specifications and international standards.

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

   • Not applicable, as no human adjudication of clinical cases was performed.

4. 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 comparative effectiveness study was done. This device is a traditional medical instrument (slit lamp biomicroscope), not an AI-powered diagnostic tool.

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

   • Not applicable, as this is a medical device for direct human use in eye examination, not an algorithm.

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

   • The ground truth is established by objective measurements against engineering specifications and compliance with international standards for medical device safety and performance (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety/EMC, ISO 10939 for slit lamps, ISO 15004-2 for light hazard).

7. The sample size for the training set:

   • Not applicable. This device does not use an AI component requiring a training set.

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

   • Not applicable. This device does not use an AI component or a training set.

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Portable Slit Lamp Microscope Model KJ5S is intended for use in the anterior and posterior segment of the eye.

The Portable Slit Lamp Microscope is a hand held converging stereomicroscope system powered by rechargeable batteries.

This document describes the FDA 510(k) clearance for the Portable Slit Lamp Microscope Model KJ5S by Suzhou Kangjie Medical Inc.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the typical sense of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity). Instead, the performance evaluation for this device is based on non-clinical tests to ensure safety and functionality, and a comparison to a predicate device to demonstrate substantial equivalence.

The comparative table on pages 6-7 serves as the primary method to show the device's technical characteristics meet acceptable standards by demonstrating similarity to a legally marketed device.

2. Sample Size Used for the Test Set and Data Provenance

• No clinical test set was used. The document explicitly states: "Discussion of Clinical Tests Performed: None".
• The "test set" for this device largely consists of its physical specifications and performance against recognized electrical, safety, and optical standards (IEC, ISO). The data provenance for these non-clinical tests is internal to the manufacturer's testing and compliance processes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. Since no clinical studies were performed, there was no need for experts to establish ground truth for a clinical test set. The validation relies on engineering and safety standards.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set or subjective interpretations requiring adjudication were involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. The document explicitly states: "Discussion of Clinical Tests Performed: None". Hence, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

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

• No. This device is a hardware medical device (a slit lamp microscope), not an AI algorithm. Therefore, "standalone" algorithm performance is not applicable.

7. The Type of Ground Truth Used

• For the non-clinical tests, the "ground truth" is defined by the specifications and requirements outlined in the international standards (IEC, ISO) referenced (e.g., IEC 60601-1 for basic safety, ISO 10939 for slit-lamp microscope specific requirements). The device's performance characteristics (e.g., light intensity, dimensions, temperature) were measured and compared against these established engineering and safety benchmarks.
• For biocompatibility, the ground truth is established by the ISO 10993 series of standards.

8. The Sample Size for the Training Set

• Not applicable. Since this is not an AI/Machine Learning device, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. No training set was used.

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The SLIT LAMP SL-2000 is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. This device is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

The SLIT LAMP SL-2000 is used to magnify the eyeball, eyelid, and eyelash of patients for observation, using slit illumination light.

The SL-2000 comprises the main unit that incorporates the microscope unit, illumination unit, base plate unit, and power supply box.

This document is a 510(k) premarket notification for the Nidek Co., Ltd. Slit Lamp SL-2000. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria. Therefore, much of the requested information regarding specific performance metrics, clinical study design, and ground truth establishment is not present in this document because it is not typically required for a 510(k) submission for a device like a slit lamp.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) for the slit lamp, as it is a diagnostic tool observed by a human, not an automated diagnostic system. Instead, it focuses on demonstrating that the device meets safety and performance standards equivalent to predicate devices. The "performance" mentioned primarily refers to compliance with international standards for ophthalmic instruments and electrical safety.

2. Sample Size Used for the Test Set and Data Provenance

The document does not detail specific "test set" sample sizes in the context of clinical performance data for diagnosis of diseases. The testing described is primarily limited to bench testing and compliance with engineering and safety standards. There is no mention of clinical data or patient samples being used in the validation tests outlined.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as a clinical test set with ground truth established by experts is not described in this document for a device like a slit lamp in a 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable, as a clinical test set with expert adjudication is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

Not applicable. The Slit Lamp SL-2000 is a manual observation device, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI improvement metrics are relevant or discussed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is a manually operated medical device without an AI algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of clinical diagnostic accuracy. The "ground truth" for the tests performed would be the specifications and requirements outlined in the referenced ISO, IEC, and AAMI/ANSI standards (e.g., a specific light intensity, magnification, or electrical characteristic).

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is not an AI/machine learning device.

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The SLIT LAMP is an AC-powered slit lamp biomicroscope that is intended for use in examining the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye.

The slit lamp is an instrument consisting of a high-intensity light source that can be focus to shine a thin sheet of light into the eye. The binocular slit-lamp examination provides a stereoscopic magnified view of the eye structure in detail, enabling diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye. The device consists of a base plate, chin rest, fixation light, illumination light, slit project, focusing ring and other accessories that in aid of examination. The patients can rest their chin and forehead on a support to keep the head steady.

It is powered by the specified adapter (model: MDS-060BAS12A) which is certificated by ANSI/AAMI ES 60601-1 and considered as part of this equipment. Appliance coupled with US Plug.

The provided document is a 510(k) summary for a medical device called "SLIT LAMP, Model: YF-100." This document outlines the device's technical specifications, intended use, and its comparison to a legally marketed predicate device to demonstrate substantial equivalence.

However, the document describes a traditional medical device (a physical slit lamp biomicroscope), not an AI/ML-driven device. As such, it does not contain information about acceptance criteria or a study proving an AI device meets those criteria. The testing performed is related to electrical safety, EMC compliance, environmental tolerance, and photo-biological safety of the hardware, not the performance of an algorithm or AI model in diagnostic tasks.

Therefore, I cannot extract the specific information requested regarding AI/ML device acceptance criteria and study data because the provided text does not describe such a device or study.

To address your request, if this were an AI/ML device, the sections would typically describe:

1. A table of acceptance criteria and the reported device performance: This would involve metrics like sensitivity, specificity, accuracy, AUROC, positive/negative predictive values, or agreement rates for a diagnostic task. The document would list the target values for these metrics and the actual achieved values from the study.
2. Sample size used for the test set and the data provenance: Details on the number of cases (e.g., images, scans, patient records) in the test set, and whether the data was collected retrospectively or prospectively, and its geographic origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For AI in medical imaging, this would involve radiologists, ophthalmologists, pathologists, etc., with specified experience levels (e.g., board-certified, years of experience).
4. Adjudication method for the test set: How disagreements among experts were resolved to establish the final ground truth (e.g., majority vote, senior expert arbitration, additional expert review).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: An MRMC study assesses the performance of human readers with and without AI assistance to quantify the improvement. The effect size (e.g., increase in sensitivity, decrease in false positives) would be reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Performance metrics of the AI algorithm operating independently, without human interaction.
7. The type of ground truth used: Whether it was expert consensus, pathology confirmation, clinical outcomes data, or a combination.
8. The sample size for the training set: The number of cases used to train the AI model.
9. How the ground truth for the training set was established: The process for labeling or annotating the training data to provide the AI with correct answers to learn from.

Given the content of the provided document, I must state that it does not contain the information necessary to fulfill your request for an AI/ML device.

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The Slit Lamp SL-D301 is an AC-powered slitlamp 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 which affect the structural properties of the anterior eye segment.

This instrument is a slit lamp to observe, examine and photograph the eyeball and appendage of the eye. The slit lamp has the illumination unit for illumination and the binocular stereo microscope, and allows for stereoscopic observation. This instrument allows users to photograph and save the observed images by combining with an accessory, the digital camera unit DC-4. This instrument consists of the main body and accessories.

The document is a 510(k) summary for the Topcon Slit Lamp SL-D301, which is an AC-powered slitlamp biomicroscope.

Here's an analysis of the provided text in relation to your request:

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

The document does not provide a table with specific acceptance criteria (e.g., numerical thresholds for performance metrics) or directly compare the device performance against such criteria in a quantitative manner. Instead, it states that the device was found to be "substantially equivalent" to a predicate device based on its intended use, indications for use, and similar technological characteristics, and compliance with recognized consensus standards.

The closest to "acceptance criteria" and "reported device performance" are statements of compliance with standards:

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

The document explicitly states "The following bench testing was conducted...". This indicates that the study primarily involved laboratory-based evaluations against engineering and safety standards, rather than clinical studies using patient data. Therefore, concepts like "sample size for the test set" or "data provenance (country of origin, retrospective/prospective)" in the context of patient data do not apply here.

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)

Given that the study was bench testing for compliance with technical standards, there were no "experts" in the sense of clinical specialists establishing ground truth on patient data. The "ground truth" was defined by the requirements of the recognized consensus standards themselves.

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

Not applicable, as this was bench testing against technical standards, not a clinical study requiring 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

No such study was performed or mentioned. This device is a Slit Lamp, a diagnostic instrument for direct observation by clinicians, and does not involve AI or human-in-the-loop assistance in the diagnostic aid sense that would warrant an MRMC study.

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

Not applicable. The device is a physical instrument for observation. It does not perform an "algorithm only" task in the absence of a human operator.

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

The "ground truth" in this context refers to the requirements and specifications set forth in the recognized consensus standards (e.g., IEC 60601-1, ISO 10939, etc.). The device was tested to ensure it met these predetermined engineering and safety specifications.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI that would require a training set.

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

Not applicable, as there is no training set for this type of device.

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The BL-5000 portable slit lamp is an AC-powered slit lamp biomicroscope that is intended for use in examining the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye

The BL-5000 portable slit lamp 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 BL-5000 portable slit lamp is composed of the following components: microscope unit, illumination unit, base unit and power unit. The slitlamp biomicroscope is used for the observation of the eye. It has an illumination unit to illuminate the eye, and a binocular stereoscopic microscope to zoom and observe patient's eyes.

The provided text describes a 510(k) premarket notification for the BL-5000 Portable Slit Lamp, a medical device. The document primarily focuses on establishing substantial equivalence to a predicate device (PSL Portable Slit Lamp, K061330) based on technological characteristics and non-clinical testing.

However, the document does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in terms of diagnostic accuracy or clinical effectiveness. Instead, it relies on demonstrating that the device's technical specifications and safety comply with relevant international standards and are comparable to its predicate.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test/training set, training set sample size) are not available in the provided text, as these are typically associated with performance studies, especially those involving AI or diagnostic accuracy, which is not the focus of this 510(k) submission for a slit lamp.

Here's an attempt to answer the questions based only on the provided text, highlighting the missing information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the context of clinical performance thresholds. Instead, it relies on compliance with international standards and similarity to the predicate device's specifications.

Study to prove device meets acceptance criteria:

The study proving the device meets the "acceptance criteria" (which are primarily regulatory and technical compliance, and comparability to the predicate) consisted of bench testing against the listed international standards (IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ISO 15004-2, ISO 10939). The results of these tests indicated that the product met the requirements of these standards. Additionally, a comparison table was used to demonstrate the technological equivalence of the BL-5000 Portable Slit Lamp to the predicate device (PSL Portable Slit Lamp, K061330).

Detailed breakdown for remaining items:

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 / Not provided. The document describes bench testing of the device itself against technical standards, rather than testing on a dataset of clinical cases. There is no mention of a clinical "test set" in the context of diagnostic accuracy.

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 / Not provided. No clinical test set or ground truth determination by experts is described.

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

   • Not applicable / Not provided. No clinical test set or adjudication process is described.

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 device is a "portable slit lamp" for eye examination, not an AI-powered diagnostic system. No MRMC study or AI assistance is mentioned.

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

   • Not applicable / No. The device is a physical diagnostic instrument and does not involve an algorithm for standalone performance evaluation in the context of this submission. The document explicitly states "All controls are manual. Neither the BL-5000 nor its predicate device has data collection, display systems, motors, or software."

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

   • Not applicable / Not provided. For the bench testing, the "ground truth" was compliance with the specified international standards. No clinical ground truth (like pathology or expert consensus on patient cases) was used.

8. The sample size for the training set:

   • Not applicable / Not provided. As this is not an AI/machine learning device, there is no concept of a "training set."

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

   • Not applicable / Not provided. No training set exists for this device.

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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 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.

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

The provided document is a 510(k) premarket notification for a Class II medical device, the Z5 and Z2 Slit Lamp Microscopes. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study with acceptance criteria for device performance in diagnosis or treatment.

Therefore, the document does not contain information related to acceptance criteria or studies that prove the device meets such criteria in the context of diagnostic accuracy, which is typically seen for AI/ML devices.

Instead, the performance data provided relates to the physical and technical specifications of the slit lamps and compliance with recognized safety and performance standards.

Here's the breakdown based on the information available:

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

Since this is not a diagnostic AI/ML device, there are no diagnostic accuracy acceptance criteria or performance metrics in that sense. The "performance" described relates to technical specifications and safety standards.

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

This information is not applicable or not provided in this 510(k) submission. No clinical test set of patients or medical images is described for performance evaluation of diagnostic accuracy. The "tests" mentioned are engineering and safety compliance tests on the physical device.

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 applicable or not provided. There is no ground truth, as typically understood for diagnostic AI/ML devices, described in this submission. The device is a traditional medical instrument.

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

This information is not applicable or not provided.

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 applicable or not provided. The device is a conventional slit lamp microscope, not an AI-assisted diagnostic tool.

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

This information is not applicable or not provided. The device is an optical instrument requiring human operation.

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

This information is not applicable or not provided.

8. The sample size for the training set

This information is not applicable or not provided.

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

This information is not applicable or not provided.

Summary of why the requested information is largely absent:

The document describes a traditional medical device (slit lamp microscope) and its premarket notification (510(k)) to the FDA. The purpose of a 510(k) for such a device is to demonstrate substantial equivalence to existing, legally marketed predicate devices. This typically involves comparing technical specifications, materials, safety features, and compliance with recognized industry standards (e.g., electrical safety, EMC, radiation hazards). It does not require clinical studies for diagnostic accuracy, particularly those involving "acceptance criteria" or "ground truth" derived from expert consensus on patient data, which are common requirements for AI/ML-driven diagnostic software. The "performance" referred to in this document relates to the physical and technical functionality of the instrument itself.

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The MediWorks Model S series Slit Lamps are AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. They are used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.

AC-powered slit lamp biomicroscopes

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Shanghai Mediworks Precision Instruments Co., Ltd. for a Slit Lamp Microscope. This document does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or study details. It primarily focuses on the FDA's determination of substantial equivalence to a predicate device and regulatory requirements. Therefore, I cannot fulfill your request based on the given input.

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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 Xcel 455 Slit Lamp is an AC-powered slit lamp biomicroscope that is intended for use in examining the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye.

The Xcel 455 slit lamp is a general purpose examination instrument used in a wide range of eye care practices. Slit lamps are used for ophthalmic observation of the structures of the eye. By controlling the light source, nature of slit, and filters, physicians, optometrists, ophthalmologists and eye care technicians can observe various structures in the eye. The Xcel 455 can be used on any patient; there are no contraindications.

Ophthalmic slit lamp design has not changed in decades, and like most, including the predicate Xcel 255, the Xcel 455 slit lamp consists of two fundamental subsystems, the illumination source to illuminate the eye to be examined, and the microscope to enable the practitioner to view the structures of the eye under magnification.

The Xcel 455 uses a low voltage (6 Volt, 20 Watt) dimmable halogen lamp, and a selection of 4 color filters, or none, to illuminate the eye. The device uses a stereo microscope with 5 selections of magnification ranges, from 6.5x to 40x, to view the structure. There is a mount that allows other devices to attach in line with the optical path, such as a prism type contact tonometer.

Like the predicate Xcel 255 device, the Xcel 455 device uses a steel body and glass lenses. The scientific principle of all slit lamps is to project light onto a patient's eye, so that a doctor may view the eye and its structures through a microscope.

The document describes the Reichert Xcel 455 Slit Lamp, an AC-powered slit lamp biomicroscope intended for examining the anterior eye segment to aid in diagnosing diseases or trauma affecting its structural properties. The submission claims substantial equivalence to the Reichert Xcel 255 Slit Lamp (K063750).

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list acceptance criteria in a quantitative table with corresponding device performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it states that the device was evaluated against several international standards and "passed" them.

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

This information is not provided in the document. The tests performed are engineering and safety standard compliance tests, not clinical performance studies involving a test set of patient data.

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

This information is not applicable as there was no test set involving patient data requiring expert ground truth.

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

This information is not applicable as there was no test set involving patient data.

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 applicable. The device is a physical slit lamp, not an AI-powered diagnostic tool, and no MRMC study was mentioned. The determination of substantial equivalence was based on nonclinical performance data, and did not include clinical data.

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

This information is not applicable. The device is an ophthalmic examination instrument, not an algorithm.

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

This information is not applicable as the studies conducted were engineering and safety compliance tests, not clinical performance studies. The "ground truth" for these tests would be the established specifications and requirements of the various IEC and ISO standards.

8. The sample size for the training set:

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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