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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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MiiS Horus Scope DPT 100 is a digital portable tonometer used to measure intraocular pressure of eyeball.

MiiS Horus Scope DPT 100 is a Li-ion battery-powered device. The Li-ion battery is rechargeable. It is a digital portable tonometer used to measure intraocular pressure of eyeball.

The device uses a white LED for illumination and capture image. The device has been tested according to the ISO 15004-2 (first edition, 2/15/2007) and been classified as Group I device.

The device has a CMOS sensor. The sensor accomplishes a task of capturing light and converting it into electrical signals.

The device store images to a SD card and have connectivity towards PC. The device uses an USB 2.0 interface to transfer data or picture to PC when connected.

The operation method of the device is described step by step in the attachment A1 "User manual". There is a graphical user interface color TFT display and keypad that is used for making adjustments before and during measure intraocular pressure of eyeball. Its' measure rang is 7-55 mmHg.

The MiiS Horus Scope DPT 100 is a digital portable tonometer used to measure intraocular pressure of the eyeball. The following information details its acceptance criteria and the study proving its performance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document primarily focuses on overall compliance with standards rather than specific numerical targets for all performance metrics. For "Accuracy," "Repeatability," and "Reproducibility," the text states "The units under test met the acceptance criteria," indicating successful conformance without providing the specific numerical criteria or results.

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

• Sample Size for Human Eye Clinical Performance Test: The document does not specify the exact number of human subjects or measurements used in the clinical performance test. It only states that "Data was collected" in comparison to the predicate device.
• Data Provenance: Not explicitly stated. The manufacturer is based in Taiwan (R.O.C.), but the country of origin for the clinical test data is not provided. The study appears to be prospective as it's a "Clinical Performance Test" conducted to evaluate the device against a predicate.

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

The document does not mention the use of experts to establish ground truth for the test set. Instead, it relies on a predicate device (Goldmann applanation tonometry (GAT) Keeler Digital Applanation Tonometer (D-KAT) (K133234)) as the comparative standard for the human eye clinical performance test.

4. Adjudication Method

Not applicable. The study compares the device's measurements directly to a predicate device, not against an adjudicated expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. The study focused on the device's technical performance and its direct comparison to a predicate tonometer. There is no mention of human readers or AI assistance.

6. Standalone Performance

Yes, a standalone performance evaluation of the algorithm (or device in general, as it's a tonometer, not specifically an AI algorithm for image interpretation) was conducted. The "bench test" evaluated the operating range, accuracy, repeatability, and reproducibility with a manometer-controlled model. The "Clinical Performance Test" also assessed the device's standalone performance by comparing its measurements to a predicate device on human eyes.

7. Type of Ground Truth Used

• For bench testing: A manometer-controlled model was used as the ground truth for evaluating operating range, accuracy, repeatability, and reproducibility.
• For clinical performance testing: Measurements from a Goldmann applanation tonometry (GAT) Keeler Digital Applanation Tonometer (D-KAT) (K133234) served as the comparative standard (ground truth) for human eye measurements. Goldmann Applanation Tonometry (GAT) is widely considered the gold standard for intraocular pressure measurement.

8. Sample Size for the Training Set

Not applicable. The MiiS Horus Scope DPT 100 is presented as a tonometer device for direct measurement of intraocular pressure, not an AI-based system that requires a "training set" in the context of machine learning. The document does not mention any AI components or machine learning models that would necessitate a training set.

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

Not applicable, as there is no mention of a training set for an AI-based system.

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The Z-type Digital Keeler Applanation Tonometer is indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma.

The Z-type Digital Keeler Applanation Tonometer is a screening device used to measure intraocular pressure which is one of the factors considered in diagnosing glaucoma. The product is an active medical device, powered by a single AA battery. The operation principal is based on Goldmann applanation method.

The provided text is a 510(k) summary for a modified medical device, the Z-type Digital Keeler Applanation Tonometer. The primary focus of this document is to demonstrate "substantial equivalence" to a predicate device, rather than to establish new performance criteria for a novel device. As such, it relies heavily on the fact that existing performance characteristics (like measurement deviation, range, and technique) remain unchanged.

Here's an analysis of the acceptance criteria and study information available in the document:

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

Since this is a submission for a modified device claiming substantial equivalence, the "acceptance criteria" are essentially the performance characteristics of the predicate device, which the modified device is expected to match. The document explicitly states "No change" for most performance-related characteristics when comparing the modified device to the predicate device.

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

The document mentions "Verification tests have been carried out in accordance to the FDA guidelines 'Tonometers - Premarket Notification [510(k)] Submissions'." However, it does not specify the sample size for any clinical or performance test set, nor does it provide details about data provenance (country of origin, retrospective/prospective). The tests mentioned are primarily engineering verification tests (electrical safety, EMC, software).

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)

No information is provided regarding the number or qualifications of experts used to establish ground truth for any clinical test set. Given it's a 510(k) for a modification and claims substantial equivalence based on engineering verification, explicit clinical ground truth establishment with experts is not detailed.

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

No information is provided regarding an adjudication method.

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 device is not an AI-assisted diagnostic tool. It is a physical tonometer. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

The device is a manual contact tonometer that requires a human operator for its use. It is not an algorithm-only standalone device.

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

For the mechanical and electrical verification mentioned, the ground truth would be based on established engineering standards (e.g., ISO 8612:2009 for tonometer calibration, BS EN 60601-1 for electrical safety, BS EN 60601-1-2 for electromagnetic compatibility). For the primary function of measuring IOP, the gold standard is stated as the "Goldmann tonometer." The document indicates that the device's operating principle is based on the Goldmann method, and its measurement deviation aligns with previous models.

8. The sample size for the training set

This is not an AI/machine learning device, so there is no concept of a "training set" in the traditional sense. The device's "training" or calibration is factory-based using known pressures and a calibration arm.

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

For the calibration process, the ground truth is established by "known pressures covering the measurement range applied to the measurement arm using a calibration arm verified using the calibration procedure outlined in the Tonometer standard ISO 8612:2009." This means the ground truth for the device's accuracy is derived from international standards for tonometer calibration.

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