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The Applanation Tonometer AT-2 is intended to measure intraocular pressure for use as an aid in glaucoma screening and diagnosis.

The device consists of a pressurizing force control unit, tonometer tip (hereinafter referred to as measuring prism), section connected to a slit lamp microscope, and accessories. The measuring prism requires disinfection. The device includes no electrical elements. The device is set up to a dedicated support on the slit lamp, and used together with a commercially available slit lamp microscope. The pressurizing force control unit of the device incorporates a measurement dial that indicates pressurizing force, including a pressurizing force control knob, and a prism holder to mount the measuring prism. Also, the pressurizing force control unit includes a connector for a calibrator to check the pressurizing force of the device. The product is a manual medical device.

This document (K182491 510(k) Summary) describes the Applanation Tonometer AT-2 and its substantial equivalence to the predicate device, Haag-Streit AT900. It does not contain information about a study proving the device meets acceptance criteria in the typical sense of a clinical trial or a machine learning performance study with a test set, training set, or ground truth established by experts.

Instead, the "acceptance criteria" here refer to technical specifications and performance characteristics, and the "study" is a performance test conducted according to an international standard.

Here's a breakdown of the requested information based on the provided text:

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

The document compares the new device (AT-2) to the predicate device (AT900) based on shared technical specifications. The "acceptance criteria" can be inferred to be alignment with these specifications, particularly the "Measurement accuracy" and "Repeatability" from the predicate.

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. This is a medical device submission for a physical tonometer, not a study involving patient data or a test set in the context of an algorithm's performance. The "performance testing" refers to mechanical and physical characteristics of the device itself.

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. There is no test set or ground truth established by experts in the context of clinical data for this type of device submission.

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

Not applicable. 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

Not applicable. This device is not an AI-powered diagnostic tool, and no MRMC study of human readers is mentioned.

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

Not applicable. This is a manual medical device with no standalone algorithm.

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

Not applicable. The "ground truth" for this device's performance is tied to metrological standards for measurement accuracy and repeatability, as defined by ISO 8612:2009.

8. The sample size for the training set

Not applicable. This device does not use machine learning, so there is no training set.

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

Not applicable. This device does not use machine learning, so there is no training set or ground truth established for it.

Summary of "Study" Information:

The "study" cited to demonstrate the device meets acceptance criteria is:

• Performance Testing: "Performance of the Applanation Tonometer AT-2 was tested in accordance with ISO 8612:2009-Ophtalmic Instrument-Tonometers, Annex A.2."

This ISO standard outlines the requirements and test methods for applanation tonometers, ensuring they meet specified accuracy and repeatability thresholds. The success of this testing (implied by the conclusion of substantial equivalence) indicates the device's technical performance. No clinical data, patient studies, or expert evaluations of algorithm performance are described in this 510(k) summary.

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The Applanation Tonometer AT-1 is indicated to measure intraocular pressure for use as an aid in glaucoma screening and diagnosis.

The device consists of a pressurizing force control unit, tonometer tip (hereinafter referred to as measuring prism), section connected to a slit lamp microscope, and accessories. The measuring prism requires disinfection. The device is available in two models according to the difference in the method of connecting to a slit lamp microscope, while the pressurizing force control unit and measuring prism are the same for the two models. Each model includes no electrical elements. The device is set up to a dedicated support on the slit lamp, and used together with a commercially available slit lamp microscope. The pressurizing force control unit of the device incorporates a measurement dial that indicates pressurizing force, including a pressurizing force control knob, and a prism holder to mount the measuring prism. Also, the pressurizing force control unit includes a connector for mounting a check weight holder to check the pressurizing force of the device. The product is a manual medical device.

The provided text describes a 510(k) premarket notification for the Applanation Tonometer AT-1, seeking to demonstrate its substantial equivalence to a predicate device, the HAAG-STREIT APPLANATION TONOMETER AT 900.

The document primarily focuses on a comparison of device characteristics and technical specifications rather than providing details of a clinical study or performance data in the context of acceptance criteria and device performance as typically understood for an AI/ML powered device.

Based on the provided text, a comprehensive answer to your request regarding acceptance criteria and a study proving the device meets them, particularly for an AI/ML enabled device, cannot be fully provided because this document pertains to a manual medical device, an Applanation Tonometer, not an AI/ML system.

Here's an attempt to address the points based on the available information, noting where information is missing due to the nature of the device (manual tonometer vs. AI/ML system):

Acceptance Criteria and Device Performance for Applanation Tonometer AT-1

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and adherence to the ISO standard. The "performance" in this context refers to the device's technical specifications and its ability to measure intraocular pressure accurately and repeatably, aligning with established standards for tonometers.

Study Proving Device Meets Acceptance Criteria:

The document states that the performance of the Applanation Tonometer AT-1 was tested in accordance with ISO 8612:2009 - Ophthalmic Instruments - Tonometers, Annex A.2. This standard outlines the specific tests and procedures for evaluating tonometers, including their accuracy and repeatability. The statement "Performance of the Applanation Tonometer AT-1 was tested in accordance with ISO 8612:2009-Ophtalmic Instrument-Tonometers, Annex A.2" implies that the device passed these tests and therefore meets the specified performance criteria (accuracy and repeatability).

2. Sample size used for the test set and the data provenance:
This information is not provided in the document. As this is a physical medical device and not an AI/ML system analyzing data, the concept of a "test set" in the sense of a dataset for an algorithm is not directly applicable. The testing would involve physical measurements and calibration against known standards. The document does not specify the number of devices or measurements performed for this performance testing.

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/provided. Ground truth, in the context of an AI/ML system's diagnostic output, would be established by expert review. For a tonometer, the "ground truth" for calibration and performance testing is established by precision engineering measurements and adherence to metrological standards outlined in the ISO standard.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are relevant for subjective interpretations of images or data by human experts, typical in AI/ML performance studies. For a physical device measuring a quantifiable parameter, performance is assessed through objective, reproducible measurements according to established metrological protocols.

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. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This device is a manual tonometer, 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. This device is a manual tonometer, meaning it inherently requires human operation. There is no "algorithm only" component to test independently.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For the performance testing of the tonometer, the "ground truth" for accuracy and repeatability is based on metrological standards and calibrated reference instruments (e.g., standard weights and measuring devices) as defined by ISO 8612:2009. It is not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set:
This information is not applicable. This is a physical, manual medical device. It does not use machine learning, and therefore there is no "training set" in the context of AI/ML algorithm development.

9. How the ground truth for the training set was established:
This information is not applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply.

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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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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.

Not Found

The provided document describes an FDA 510(k) clearance for the Ellex Slit Lamp, Model 30XL, a medical device. This document is a regulatory approval letter, not a scientific study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications for proving device performance in the context of an AI-powered diagnostic system.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device was cleared based on its substantial equivalence to a predicate device, rather than a de novo clinical study proving performance against pre-defined acceptance criteria with the statistical rigor typically found in AI/ML device evaluations.

Therefore, I cannot provide the requested information from this document. If you have a different document describing a study for an AI-powered device, please provide that for analysis.

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