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The Applanation Tonometer HT-5000 is a manual device intended to measure an intraocular pressure by applanation to aid in the diagnosis of glaucoma.

The Applanation Tonometer HT-5000 is indicated for measurement of intraocular pressure (IOP). Intraocular pressure (IOP) is a very important physiological parameter and has always been an indispensable part of the diagnosis and treatment of ophthalmology, especially for glaucoma.

The Applanation Tonometer HT-5000 is an active medical device, powered by AAA batteries. The device can be used in conjunction with slit lamp microscopes which are commercially available. Components of the tonometer contains applanation tonometer main body, weight bars, connection arms and measuring prisms.

The provided text describes the Huvitz Applanation Tonometer HT-5000, a manual device for measuring intraocular pressure (IOP). The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing studies proving the device meets clinical acceptance criteria for an AI/ML algorithm.

Therefore, many of the requested items related to AI/ML study design (such as human reader improvement with AI assistance, MRMC studies, ground truth establishment for AI training, etc.) are not applicable to this specific device and the information provided. This document describes a traditional medical device (a tonometer) and its physical and electrical performance, not an AI/ML diagnostic or assistive tool.

However, I can extract information related to the acceptance criteria and performance testing conducted for this manual measurement device.

Here's the breakdown of the information available in the provided text:

Device: Huvitz Applanation Tonometer HT-5000

Type of Device: Manual Applanation Tonometer (non-AI/ML device)

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this manual tonometer are primarily defined by adherence to recognized standards and comparative performance with a predicate device, focusing on physical measurement accuracy and safety.

Study Details (Performance Testing)

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

   • Test Set Sample Size: "six different weight values for 10 times in three devices." This indicates 60 measurements per device (6 weights * 10 repetitions), across 3 devices, totaling 180 measurements for the primary bench testing. Additionally, "one investigator measured each weight values in 3 devices and predicate devices" for comparative accuracy.
   • Data Provenance: Not explicitly stated, but implied to be laboratory bench testing conducted by the manufacturer, Huvitz Co., Ltd. (Republic of Korea). The data is retrospective in the context of the 510(k) submission, meaning it was collected prior to submission.

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

   • This is a manual measurement device, not an AI/ML diagnostic tool requiring expert ground truth in the same way. The "ground truth" for the performance testing was established by applying "known pressures" via calibration bars, verified using the calibration procedure described in ISO 8612:2009, and comparing the device's readings against these known values.
   • The bench testing was conducted by "two different experimenters" and "one investigator." Their specific qualifications are not detailed, beyond being capable of performing these technical measurements.

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

   • Not applicable in the context of this device's performance testing. The "ground truth" is physical calibration weights/pressures, not human interpretation requiring adjudication. Performance was assessed by comparing measurements against these known values.

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 is a manual medical device, not an AI-powered one. No human-in-the-loop AI assistance is described or claimed.

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

   • Not applicable. This is not an AI/ML algorithm. The device itself is the "standalone" unit for measurement. Its performance was assessed independently against physical standards and compared to a predicate device.

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

   • For performance testing, the ground truth was known physical forces/pressures applied using calibrated equipment (calibration bars), referencing "known pressures covering the measurement range." This is a metrological ground truth.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense.
   • For the device's internal calibration during manufacturing, "known pressures covering the measurement range are applied to the measurement arm using a calibration arm using calibration bars." This is a factory calibration procedure, not an AI training process.

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

   • Not applicable for the same reason as above. For factory calibration, "ground truth" is established by certified physical standards.

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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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The T170 Applanation Tonometer is indicated for Intraocular Pressure (IOP) measurement.

Not Found

This document is an FDA 510(k) clearance letter for an Applanation Tonometer (K142263). It does not contain the acceptance criteria or a study proving the device meets those criteria. The letter confirms substantial equivalence to a predicate device but does not detail the pre-clinical or clinical studies conducted by the manufacturer for this specific device.

Therefore, I cannot provide the requested information based on the provided text. To answer your questions, the relevant sections of the 510(k) submission, specifically the performance data and testing summaries, would be required.

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The device is a manual tonometer intended to measure intraocular pressure (IOP) by applying a know force to the qlobal of the eye. The device measures the IOP by applanation (application of a small measuring prism to the cornea).The device is intended for use in the diagnosis of glaucoma.

The device is a manual tonometer intended to measure intraocular pressure (IOP) by applying a know force to the qlobal of the eye. The device measures the IOP by applanation (application of a small measuring prism to the cornea).

The provided text is a 510(k) premarket notification letter from the FDA regarding an applanation tonometer. While it confirms the device's substantial equivalence to a predicate device and its intended use, it does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence rather than presenting an exhaustive study report with performance metrics.

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