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The VS Tabletop Tonometer is a digital tonometer intended to measure intraocular pressure of the human eye.

The VS Tabletop Tonometer (VS TT) is a non-contact, table-top tonometer used to measure intraocular pressure of the eye. The tonometer is based on the previously cleared MiiS tonometer, the Horus Scope DPT 100 (K181260). The core technology element of the VS TT is the air puff module, which is equivalent to the air puff module used in the DPT 100 predicate device. The measurement method and measurement algorithm of the VS TT and DPT 100 devices are the same. The main technological difference between the VS TT and the predicate DPT 100 is that the VS TT features an auto-alignment system that automatically brings the air puff module within a positional range with respect to the patient's cornea such that the air puff module is able to perform the IOP measurement. The auto-alignment system of the subject device performs the same pre-positioning adjustments that are performed manually by clinical staff with the DPT 100. Hence, the consequence of these design modifications is that a clinical staff member is not required to perform an intermediary, non-critical step in measurement acquisition. The VS TT device is intended to be used by patients in doctor's office with the assistance from eye care professional. Patients are first trained on how to use the device. The VS TT measures IOP in the range of 7-55 mmHg. It contains a graphical user interface on a color LCD touchscreen display where the IOP results are displayed. The device is powered by a rechargeable lithium-ion battery. It can either be used alone (i.e. not plugged in) or connected to a power adapter.

The information provided describes the VS Tabletop Tonometer (VS TT) and its substantial equivalence to predicate devices, but it does not include a detailed study proving the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy against a gold standard).

The text focuses on demonstrating that the VS TT is substantially equivalent to existing devices based on technological characteristics and general performance/safety testing, rather than presenting a clinical study with detailed acceptance criteria for diagnostic accuracy.

However, based on the provided text, here's what can be extracted and inferred regarding performance and its supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" in a quantitative diagnostic sense (e.g., a target sensitivity or specificity). Instead, it refers to performance specifications and the outcome of equivalence testing. The "reported device performance" primarily focuses on the device's measurement range, accuracy, and the auto-alignment feature.

2. Sample Size for Test Set and Data Provenance

The document does not specify a distinct "test set" sample size for diagnostic performance.

• Sample Size for Auto-Alignment Clinical Validation: Not explicitly stated, but it was a "clinical validation performed on the VS TT" to demonstrate the auto-alignment feature.
• Data Provenance: Not explicitly stated. The submitter is from Hsinchu, Taiwan, which might suggest data could originate from there, but this is not confirmed. The study appears to be prospective for the auto-alignment feature.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The document does not describe a study involving expert readers establishing ground truth for diagnostic performance of the tonometer. The device's "accuracy" is described as being "within 5 mmHg" and is likely assessed against a reference tonometer rather than expert interpretation of images or symptoms.

4. Adjudication Method

Not applicable, as no expert-based ground truth establishment is described.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done or reported in this document. The focus is on the device's intrinsic measurement capabilities and the effectiveness of its auto-alignment feature, not on human-in-the-loop performance improvement with AI assistance.

6. Standalone Performance (Algorithm Only)

Yes, the performance discussed seems to be primarily standalone (algorithm only for IOP measurement and auto-alignment). The device performs the IOP measurement autonomously once aligned. The document states: "The measurement method and measurement algorithm of the VS TT and DPT 100 devices are the same." and "Obtaining the IOP measurement: Automatic. Once air puff module detects that the center of the eye is in the right position, pneumatic and applanation systems are automatically activated."

7. Type of Ground Truth Used

For IOP Measurement Accuracy: Not explicitly stated, but typically a reference tonometer (e.g., Goldmann Applanation Tonometer) would be used as the ground truth or reference standard for calibrating and validating non-contact tonometers to achieve "within 5 mmHg" accuracy.

For Auto-alignment Feature: The ground truth was likely determined by the successful physical alignment of the device to the human eye within the specified time, confirmed by observation or internal sensors.

8. Sample Size for the Training Set

Not applicable. The device's core IOP measurement algorithm is stated to be the same as the predicate DPT 100, implying it was previously developed and validated. The auto-alignment system is a new feature, but the document does not discuss a "training set" for it in the context of machine learning, rather its successful operation in clinical validation.

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

Not applicable, as no training set for a machine learning algorithm is discussed.

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The Tonometer Easyton is indicated for the measurement of intraocular pressure in human eyes.

The principle of EASYTON measurement is based on simultaneous use of the two types of measuring actions – static and dynamic. Both actions are carried out by the vibrator's rod on the eyelid. Static action is carried out during the time of measurement and determined by the weight of the vibrator. Dynamic exposure represents itself during the vibrating action with frequency: about 150 HZ and amplitude: the millimeter hundredth parts and tactile is felt as soft vibration. Vibrator's rod is elastically movable in its axial direction and is set in oscillatory motion by electromagnetic way. While carrying out the measurement, the rod is put up on the eyelid, sagging (pressing the eyelid down with its weight about 10g and is fixed on sclera or an eye cornea forming elastic system of eye-vibrator with total mechanical rigidity. This system is disturbed from the equilibrium state by the rod's short term electromagnetic removal. In a system within tan equilibrium state restoration there are arising free damped vibration. Functional connection between elastic system rigidity and the period of is own vibration is known. This period is measured by the tonometer and is used for IOP calculation being shown on the display.

The information provided describes the performance study for the Intraocular Pressure Tonometer EASYTON.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the statement "not more than 5% of the paired differences between the reference tonometer reading and the test tonometer reading for each pressure range are greater than the tolerance for that range," where the tolerance is defined as ±2 mmHg for IOP from 7 to 23 mmHg and ±5 mmHg for IOP more than 23 mmHg (as stated in the technical specifications).

Here's a summary of the reported device performance from the provided text:

Summary of Studies and Performance (from table on page 15):

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

The studies were prospective comparative studies using human subjects.

• "Low stiffness eyelids study" (Caucasian population): 156 patients (eyes)
• "Epicanthus study" (Asian population): 150 patients (eyes)
• "Rigid stiffness eyelids study" (Indian population): 78 patients (155 eyes) - Note: The discrepancy between patients and eyes might indicate bilateral measurements or a typo. Assuming 155 eyes were tested.

Data Provenance:

• Russia (Moscow, Russia): Glaucoma Community of Russia, IPO (Caucasian population with low stiffness eyelids)
• Kazakhstan (Karaganda, Kazakhstan): Regional Medical Center and TENSV Clinic, LLP (Asian population with epicanthal fold of the eyelid)
• India (Gurgaon, New Delhi, India): Hospital Park (Indian population with rigid stiffness of eyelids)

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

The document does not explicitly state the number or qualifications of experts involved in establishing the ground truth measurements for the test set. However, the ground truth was established using the Goldman Applanation Tonometer, which is a widely recognized standard in ophthalmology and would typically be operated by ophthalmologists or trained technicians.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The study compares the Easyton measurements directly against the Goldman Tonometer measurements.

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

No multi-reader multi-case (MRMC) study is described. The studies focus on comparing the device's measurements against a reference standard across different patient populations and anatomical features, rather than evaluating human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The provided information describes the performance of the device itself (Easyton Tonometer) against a reference standard (Goldman Tonometer) in human subjects. This is a standalone performance study of the device.

7. Type of Ground Truth Used

The ground truth used was comparative measurements from a reference device, specifically the Goldman Applanation Tonometer. This is considered a clinical reference standard for intraocular pressure measurement.

8. Sample Size for the Training Set

The document does not provide information about a separate training set or its sample size. The studies described appear to be testing (validation) studies. The device's measurement principle (functional connection between elastic system rigidity and the period of its own vibration, with IOP calculation based on measured vibration frequency) suggests a physical-based measurement rather than a machine learning model that would require a distinct training set. If machine learning was involved in the device's core algorithm, details about its training set are not provided.

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

As no training set is described, the method for establishing its ground truth is not provided.

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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 Keeler TonoCare Tonometer is a hand-held, battery operated, non-contact tonometer intended to be used for measuring intraocular pressure (IOP) of the human eye with less than 3D in corneal astigmatism.

The Keeler TonoCare Tonometer is designed to measure Intra Ocular Pressure (IOP) to aid in the screening and diagnosis of glaucoma without contacting the eye. The Keeler TonoCare Tonometer has been designed using the same ergonomics as the predicate device described in 510(k) submission K093298. Both products consist of an air generation system in the form of a vacuum Diaphragm pump, an air reservoir, a solenoid valve, a light source and an opto-electronic platform which is used for position detection and IOP measurement. The basic concept of operation is the same. The user positions the instrument close to the patient's cornea using a targeting system. As the user moves the instrument closer to the patient, the reflection off the cornea from the built-in light source increases until the predefined firing thresholds on the built-in photodiodes have been met. Once this condition has been met, a quantized puff of air is automatically projected toward the patient's cornea. As the cornea flattens due to the force of the puff of air, the light being reflected off of the cornea changes shape which in turn changes the profile of the light being reflected back onto the photodiodes. The rate of change of this reflection is monitored by the photodiodes and converted into intraocular pressure in units of mmHg by the on-board microprocessor.

The document provided describes performance testing for the Keeler TonoCare Tonometer, primarily focusing on its equivalence to a predicate device and a reference standard tonometer. However, it does not detail acceptance criteria or a study that proves a device meets those acceptance criteria in the context of an AI/algorithm's performance. The document is for a physical medical device (a tonometer for measuring intraocular pressure), not an AI or algorithm.

Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance) was done," or "sample size for the training set," are not applicable to this document as it does not describe an AI medical device.

I will interpret the request as asking for the acceptance criteria and the study that proves the Keeler TonoCare Tonometer (a physical device) meets its performance requirements, based on the provided text.

Here's a breakdown based on the provided text, adapted to the context of a physical medical device:

Device: Keeler TonoCare Tonometer
Intended Use: Measuring intraocular pressure (IOP) of the human eye with less than 3D in corneal astigmatism.

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

The acceptance criterion is derived from ISO 8612 (comparable to ANSI Z80.10) for comparison with a reference tonometer.

*   **Data Provenance:** The study was a "single visit, single-center" study. While the document mentions "Keeler Ltd, Clewer Hill Road, Windsor, Berkshire, United Kingdom" as the manufacturing location, the specific country of origin for the clinical data is not explicitly stated, but implies a UK or European context given the European market launch mentioned. It was a **prospective** study ("Subjects were recruited according to the following inclusion and exclusion criteria").

• Repeatability/Reproducibility Bench Test:
  • Sample Size:
    • Repeatability: Approximately 50 individual readings for each of 5 pressure values on a manometrically controlled test eye.
    • Reproducibility: Measurements from three different TonoCare units by two different operators across 5 pressure values.
  • Data Provenance: Bench testing. Location not specified, but likely at the manufacturing facility.

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

• Number of Experts: Two experienced observers.
• Qualifications of Experts: Described as "experienced observers." No further detail (e.g., specific clinical specialty, years of experience) is provided.

4. Adjudication method for the test set:

• The study design was a "paired crossover study" comparing the TonoCare NCT to the Perkins Applanation Tonometer (AT). The "ground truth" for IOP measurements in this context was established by the reference standard Perkins AT (which itself is described as using the same basic principle as the Goldmann AT, a recognized reference).
• There's no mention of an adjudication process between the "two experienced observers" for the clinical measurements. It's implied that both observers took measurements using both devices.

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:

• N/A. This was a study for a physical tonometer device, not an AI or algorithm. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or is relevant to this submission.

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

• N/A. This was a physical device, not an algorithm. The device measures IOP. Human operators are required to use the device.

7. The type of ground truth used:

• Clinical Performance Study: The ground truth for IOP measurement was established by comparison to a reference standard clinical device, specifically the Perkins Applanation Tonometer (AT), which is considered an "established, gold standard" comparable to the Goldmann Tonometer.
• Repeatability/Reproducibility Study: The ground truth was a manometrically controlled test eye with known pressure values.

8. The sample size for the training set:

• N/A. This refers to a physical device, not an AI/ML algorithm that requires a training set. The device was likely designed and calibrated, not "trained" in the typical ML sense.

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

• N/A. As above, no training set in the AI/ML sense.
• However, the document mentions:
  • "The TonoCare Tonometer unit was initially cross calibrated on several rubber eyes against Keeler Pulsair IntelliPuff (K093298)."
  • "In addition, a mini trial on volunteers have been conducted to further refine the calibration of the TonoCare Tonometer in order to minimize the error between the devices."
  • The "ground truth" for calibration appears to be mechanical phantom eyes and real-world "mini trial" data compared against a known predicate device (Keeler Pulsair IntelliPuff) and the reference Perkins/Goldmann AT.

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The TonoVue is a non-contact tonometer that is intended to measure the intraocular pressure of the human eye in vivo.

The TonoVue is a non-contact tonometer that intended to measure the intra-ocular pressure of the eye in patients with less than 3 diopters of corneal astigmatism.

TonoVue Tonometer is designed to non-contact tonometer (NCT) that measures the intraocular pressure (IOP) by delivering a soft air puff without contacting eyes directly. It's designed as a full auto-alignment and All-In-One desktop type medical device with built-in thermal line printer. The dimensions of whole device are about 500mm (H) x 260mm (W) x 500mm (L). The AC power input port and a USB port are set at the bottom side of the device, but the USB port only for engineering use. Based on the Imbert-Fick principle, the IOP is calculated by dividing the amount of air pressure into the area of applanated surface. TonoVue utilizes a rapid air puff to apply force for flattening the cornea of human eye, and an advanced electro-optical system to monitor its deformation. The puff force increases until the cornea is applanated over the predetermined area and detected by the pressure sensor inside TonoVue, and the IOP can be calculated.

The provided text describes the acceptance criteria and a clinical study conducted for the TonoVue Non-Contact Tonometer.

Here's an analysis of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Additional performance claims:

• Accuracy and Reproducibility: Bench testing proved that the TonoVue non-contact tonometer's IOP measurement result meets product specifications.
• Electrical Safety & EMC: Complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC).
• Biocompatibility: Complies with ISO 10993-1 standard.
• Software Validation: Software verification and validation testing were conducted as recommended by FDA Guidance- "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

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

• Sample Size: 120 patients.
• Data Provenance: The text does not explicitly state the country of origin or whether the study was retrospective or prospective. Given it's a clinical testing section and refers to "patients," it's implicitly a prospective clinical study.

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

The document does not specify the number of experts or their qualifications for establishing ground truth, nor does it explicitly mention "experts" in the context of ground truth for the clinical study. It refers to a "reference tonometer reading," which would imply an accepted standard for measuring IOP.

4. Adjudication method for the test set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The criteria focus on the agreement between the test tonometer and a "reference tonometer."

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, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. The device is a standalone non-contact tonometer, not an AI-assisted diagnostic tool for human readers.

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

Yes, the clinical testing describes the standalone performance of the TonoVue Non-Contact Tonometer, comparing its readings to a "reference tonometer." This is an algorithm-only performance assessment in measuring IOP.

7. The type of ground truth used

The ground truth was established by readings from a "reference tonometer" as per the ISO 8612:2009 standard. This implies a standard, accepted method for measuring intraocular pressure.

8. The sample size for the training set

The document does not mention a "training set" or any machine learning/AI components that would require one. The validation described is for a medical device that mechanically measures IOP.

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

Not applicable, as no training set for a machine learning model is mentioned.

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Measuring the refraction of the eye giving both lower and higher order aberrations
Measurement of the shape of the cornea
Retro-illumination imaging of the eye
Measuring the intraocular pressure without contacting the eye for glaucoma evaluation.
Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea.
Full corneal thickness map.
Scheimpflug imaging.
Anterior chamber imaging.
Pupil image.
Image of the cornea relative to the iris.

The VX130 is a multifunctional ophthalmic diagnostic device.
The VX130 combined wavefront aberrometer, corneal topographer, cataract screening device, Scheimpflug pachymeter, and non-contact tonometer is a single platform that contains five different measurement units.
The wavefront aberrometer works on the Shack-Hartmann principle and is used as an advanced autorefractometer that measures both lower and higher order aberrations of the eye. Retro illumination is used to image ocular opacities. The corneal topographer uses a Placido disk to measure keratometry and the detailed shape of the cornea. A linear scanning Scheimpflug pachymeter measures the thickness of the cornea by illuminating it with a slit of light and photographing it using the Scheimpflug technique. Anterior and posterior corneal shape are also measured from the Scheimpflug images. An air puff non-contact tonometer is included for measurement of the intraocular pressure. The device is fully automated and a number of different measurements can be performed by a single command including alignment and focusing.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

Device: VX130 Ophthalmic Diagnostic Device
Primary Function under review (for the comparison study): Pachymetry (corneal thickness measurement)

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state formal "acceptance criteria" in terms of specific thresholds for performance metrics. Instead, the approach is one of demonstrating substantial equivalence to a predicate device (Galilei G4). The implicitly accepted performance is that the VX130's measurements are not significantly different from those of the predicate device, across various anterior segment parameters, and that it demonstrates sufficient repeatability.

Interpretation of Performance: The average differences between the VX130 and Galilei G4 are quite small (e.g., -0.43 µm for CCT), and the 95% confidence intervals (not explicitly provided for CCT, but -15.03 to 14.16 µm for CCT suggests the differences are within a clinically acceptable range for equivalence, especially considering the standard deviations). The repeatability standard deviations for the VX130 are also small, indicating consistent measurements.

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

• Comparison Study (VX130 vs. Galilei G4):

  • Sample Size: Not explicitly stated, however, Table 2 (Repeatability of VX130) mentions "42 eyes were measured 3 times each". It is highly probable that the comparison study (Table 1) also used these 42 eyes, or a similar sample size, as it's part of the same "Tests for pachymetry" section. Assuming 42 subjects, likely n = 42 eyes.
  • Data Provenance: Not specified; retrospective or prospective is not mentioned. Country of origin not mentioned.

• Repeatability Study (Table 2 - Std dev 1):

  • Sample Size: "a single eye was measured ten times".

• Repeatability Study (Table 2 - Std dev 2):

  • Sample Size: "42 eyes were measured 3 times each".

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

The document does not mention the use of experts to establish ground truth for the test set. The study design is a comparison between two devices (VX130 and Galilei G4) and a repeatability assessment of the VX130 itself. The Galilei G4's measurements serve as the reference for comparison, not an expert-derived ground truth.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as there were no human readers/interpreters involved in establishing the ground truth for the measurement comparison. The comparison is between automated device measurements.

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

No MRMC study was done. This study focuses on device performance for automated measurements, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done for the pachymetry function of the VX130 in two ways:

• Comparison to a predicate device: This evaluates the VX130's agreement with an established device (Galilei G4). The results are presented in Table 1, showing "small differences between the devices."
• Repeatability study: This demonstrates the consistency of the VX130's own measurements. The results are presented in Table 2, showing low standard deviations for repeated measurements.

7. Type of Ground Truth Used

The ground truth for the comparison study was the measurements obtained from a legally marketed predicate device (Galilei G4). This is a common approach for demonstrating substantial equivalence for quantitative diagnostic devices. For the repeatability study, the "ground truth" is inferred from the consistency of the device's own measurements over multiple trials.

8. Sample Size for the Training Set

The document does not mention a training set. This is not an AI/Machine Learning device that requires a training set in the conventional sense. The device's functionality is based on established optical and measurement principles (Shack-Hartmann, Placido disk, Scheimpflug), and its performance is evaluated against a predicate device and through repeatability.

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/ML algorithm.

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The VX120 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for:

Measuring the refraction of the eye giving both lower and higher order aberrations

Measuring the shape of the comea

Retro-illumination imaging of the eye

Measuring the intraocular pressure without contacting the eye for glaucoma evaluation

Photographing the eye and taking images of the eye to evaluate the thickness of the cornea.

The VX120 is a multifunctional ophthalmic diagnostic device.

The VX120 combined wavefront aberrometer, corneal topographer, retro illumination device, Scheimpflug pachymeter, and non-contact tonometer is a single platform that contains five different measurement units.

The wavefront aberrometer works on the Shack-Hartmann principle and is used as an advanced autorefractometer that measures both lower and higher order aberrations of the refraction of the eye.

Retro illumination is used to image ocular opacities.

The corneal topographer uses a Placido disk to measure keratometry and the detailed shape of the cornea.

The Scheimpflug pachymeter measures the thickness of the central cornea by illuminating it with a slit of light and photographing it using the Scheimpflug technique. An air puff non-contact tonometer is included for measurement of the intraocular pressure.

The device is fully automated and a number of different measurements can be performed by a single command including alignment and focusing.

The provided text describes the 510(k) summary for the VX120 Ophthalmic Diagnostic Device, focusing on its tonometry and pachymetry functions for substantial equivalence to predicate devices. It outlines performance data including bench and clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the performance claims and the standards the device was tested against. The text explicitly states that the device meets the requirements of the specified standards.

Here's a breakdown of the study details based on the provided text:

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

   • Tonometry: The text mentions "clinical evaluation" and "bench testing." It does not specify the sample size for either.
   • Pachymetry: The text mentions a "comparison study" with Pentacam. It does not specify the sample size for this study.
   • Data Provenance: The text does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The manufacturer, Luneau SAS, is based in France. The predicates are from the UK (Keeler) and Germany (Oculus), implying international standards and potentially international data, but this is not confirmed.

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

   • The document describes performance testing against standards (ISO, ANSI) and predicate devices. It does not mention the use of human experts or human readers to establish ground truth for the test sets for tonometry or pachymetry performance. The "ground truth" for tonometry appears to be established by the performance of the predicate device and the specified accuracy and repeatability limits from the standards. For pachymetry, the ground truth is implicitly the measurements from the Pentacam predicate.

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

   • Not applicable, as ground truth was not established by human experts requiring adjudication.

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 or human-in-the-loop study comparing human readers with and without AI assistance is described. The device is referred to as a "diagnostic device," but the performance studies focus on its intrinsic measurement accuracy and comparison to predicate devices, not its assistance to human interpretation or diagnosis.

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

   • Yes, the performance data presented (bench testing, clinical evaluation against standards, and comparison studies for tonometry and pachymetry) appear to represent the standalone performance of the VX120 device/algorithm. The focus is on the device's output accuracy and consistency.

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

   • Tonometry: The ground truth for the tonometry function appears to be established by:
     • Benchmarking against industry standards: ISO8612:2010 and ANSI Z80.10-2009 for clinical evaluation, and internal specifications for accuracy (±2mmHg) and repeatability (±1.2mmHg) from bench testing.
     • Comparison to predicate device performance: The "Pulsair tonometer" is also stated to have an accuracy of ±2 mmHg.
   • Pachymetry: The ground truth for the pachymetry function is established by comparison to a legally marketed predicate device, the Pentacam, noted as demonstrating "no significant statistical difference."

7. The sample size for the training set:

   • The document is a 510(k) summary, not a detailed technical report on the algorithm development. It does not mention a "training set" or specify its size. The device relies on established physical measurement principles (Shack-Hartmann, Placido disk, Scheimpflug, air puff tonometry) rather than machine learning that typically requires training data.

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

   • Not applicable, as a "training set" is not mentioned or implied for this type of device and its described validation. The device's operation is based on fundamental physics and established optical/measurement techniques rather than trained algorithms in the sense of AI/machine learning.

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The Corvis ST is intended to measure the intra-ocular pressure of the eye in patients with less than 3 diopters of corneal astigmatism. In addition, the Corvis ST is designed to photograph the eye and take Scheimpflug images of the anterior segment of the eye to evaluate the thickness of the cornea.

The Corvis ST performs the following two functions: Tonometry and Pachymetry. The Corvis ST measures intraocular pressure without contact with the eye by applying an air puff to the eye. The eye is illuminated and during the air puff, a high-speed camera records the movement of the eye with more than 4000 images per second. The high-speed camera analyzes a sequence of 140 Scheimpflug images of the cornea to determine intra-ocular pressure. The Corvis ST measure corneal thickness and shape based on sectional images when the cornea is not influenced by the air puff. The pachymetry measurements of the Corvis ST and the cleared Oculus predicate use the same image processing routine for analysis to obtain corneal thickness measurements. Tonometry and pachymetry functions can be performed during the same evaluation or separately.

Here's a breakdown of the acceptance criteria and study details for the Corvis ST, based on the provided document:

Acceptance Criteria and Device Performance:

Study Details:

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

   • Pachymetry (Clinical):
     • Test Set Size: 51 subjects (102 eyes).
     • Data Provenance: Internal study (implies data was collected by the manufacturer, likely prospective). No specific country of origin is mentioned, but the manufacturer is based in Germany.
   • Tonometry (Clinical):
     • Test Set Size: 120 eyes (40 eyes per IOP group).
     • Data Provenance: Not explicitly stated if internal, but likely collected prospectively for the purpose of the study. No specific country of origin is mentioned.
   • Pachymetry (Bench):
     • Test Set Size: "Several glass plates with several known thicknesses." Not a human sample size.
     • Data Provenance: Internal study.
   • Tonometry (Bench):
     • Test Set Size: Manometric controlled test eye (phantom). Not a human sample size.
     • Data Provenance: Internal study.

2. 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)

   • Pachymetry (Clinical): Ground truth was established by comparing to measurements from the FDA-cleared predicate device, Pachycam (K041841). No human experts were explicitly mentioned for ground truth.
   • Tonometry (Clinical): Ground truth was established using the Goldmann applanation tonometer (Haag-Streit), which is considered a clinical standard. No human experts were explicitly mentioned for ground truth.
   • Bench Testing (Pachymetry & Tonometry): Ground truth was established by known physical standards (calibrated glass plates for pachymetry, manometrically controlled pressure chamber for tonometry).

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

   • No adjudication method involving human readers for the test set was mentioned or implied for either pachymetry or tonometry. The comparison was directly against established reference devices or physical standards.

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 mentioned.
   • The Corvis ST is a diagnostic measurement device (tonometer/pachymeter), not an AI-assisted diagnostic aid for human readers. Its performance is evaluated on the accuracy of its direct measurements against a reference, not on how it assists human interpretation.

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

   • Yes, the performance studies described are for the standalone device. The device takes measurements directly, and its output (IOP, corneal thickness) is compared to a reference standard. There is no human-in-the-loop component for the measurement process itself in these evaluations.

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

   • Pachymetry (Clinical): Ground truth based on measurements from an FDA-cleared predicate device (Pachycam).
   • Tonometry (Clinical): Ground truth based on measurements from a widely accepted clinical standard device (Goldmann applanation tonometer).
   • Bench Testing (Both): Ground truth based on known physical standards (calibrated glass plates, manometrically adjusted pressure chamber).

7. The sample size for the training set

   • The document describes performance studies, which are typically test sets. It does not provide information about a training set for the device's algorithms. The device's image processing routines are mentioned, and for pachymetry, it states they use the "same image processing routine" as the cleared predicate, implying established algorithms rather than ones newly trained for this submission.

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

   • Not applicable as no training set information is provided in the document. The device's underlying technology seems to rely on established image processing techniques and comparison against predicate devices rather than a de novo AI model that requires a distinct training phase.

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The Canon Full Auto Tonometer TX-20 is intended to be used for the measurement of intraocular pressure of the human eye.

The Canon Full Auto Tonometer TX-20 is a tonometer designed using a non-contact measurement system. Air puff gently measures the intraocular pressure with the help of a full auto-alignment system.

The provided text is a 510(k) summary for the Canon Full Auto Tonometer TX-20. It states that the device is substantially equivalent to a predicate device (Canon Full Auto Tonometer TX-F) and details its intended use, but it does not contain specific acceptance criteria, a detailed study design with sample sizes, expert qualifications, or comparative effectiveness results. The document emphasizes substantial equivalence based on performance testing (electrical safety, electromagnetic compatibility) and design control activities, rather than a clinical study establishing new performance metrics.

Therefore, for aspects of your request related to specific acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness (MRMC study), the provided text does not contain this information. The response will reflect the information that is present in the document.

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

Acceptance Criteria and Device Performance

The provided document does not explicitly list specific numerical acceptance criteria (e.g., accuracy, precision targets) for the Canon Full Auto Tonometer TX-20, nor does it report detailed performance data against such criteria. Instead, it relies on demonstrating substantial equivalence to an existing predicate device (Canon Full Auto Tonometer TX-F, K023816). The "Performance testing" section vaguely states that "Evaluation performed on the TX-20 demonstrated that it's safe and effective."

Study Information

The document does not describe a clinical study in the traditional sense with a test set, training set, or ground truth data. Instead, it refers to "Performance testing" to demonstrate substantial equivalence.

1. Sample size used for the test set and the data provenance: Not specified. The document mentions "Performance testing" but does not detail the sample size (e.g., number of subjects or measurements) used for any such testing. No data provenance (e.g., country of origin, retrospective/prospective) is provided.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth establishment for a test set is described. The device's performance is asserted through comparison to a predicate and compliance with technical standards.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical study or ground truth establishment requiring adjudication is described.

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: Not applicable. The device is a tonometer, which directly measures intraocular pressure, not an AI-assisted diagnostic tool for human readers. There is no mention of an MRMC study or AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The TX-20 is described as a "Full Auto Tonometer," implying standalone (automated) operation to measure intraocular pressure. However, no specific standalone performance metrics (e.g., accuracy against a gold standard) are detailed beyond the claim of substantial equivalence to the predicate.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified. For a tonometer, "ground truth" would typically refer to measurements taken by a highly accurate reference method, but no such reference or ground truth method is detailed in this submission. The basis for safety and effectiveness is substantial equivalence to the predicate.

7. The sample size for the training set: Not applicable. This document pertains to a medical device (tonometer) which does not appear to involve machine learning models that require a "training set" in the context of data-driven AI.

8. How the ground truth for the training set was established: Not applicable, for the reason stated above.

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The Pulsair IntelliPuff Non-Contact Tonometer is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

The Pulsair Desktop Tonometer is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

The Keeler Pulsair Tonometer product family are non-contact tonometers and are used to measure intraocular pressure without contacting the eye to aid with the screening and diagnosis of glaucoma. The product family consists of the Pulsair Intellipuff (Hand Held device) and the Pulsair Desktop which is mounted on a desk. The Pulsair Intellipuff Tonometer has been designed using the same ergonomics as the predicate device described in 510(k) submission K990257 whilst the Pulsair Desktop Tonometer ergonomics have been adapted to suite the Desktop mounted market place. Both products use the same concept of measurement as the predicate device and contain many common components. All of the products consist of an air generation system in the form of a vacuum Diaphragm pump, an air reservoir, a solenoid valve, a light source and an opto-electronic platform which is used for position detection and IOP measurement.

The basic concept of operation is the same. The user positions the instrument close to the patient's cornea using a targeting system. As the user moves the instrument closer to the patient, the reflection off the cornea from the built in light source increases until the predefined firing thresholds on the built in photodiodes have been met. Once this condition has been met, a quantised puff of air is automatically projected toward the patient's cornea. As the cornea flattens due to the force of the puff of air, the light being reflected off of the cornea changes shape which in turn changes the profile of the light being reflected back onto the photodiodes. The rate of change of this reflection is monitored by the photodiodes and converted into intraocular pressure in units of mmHg by the on board microprocessor.

The Keeler Pulsair IntelliPuff and Pulsair Desktop Tonometers are non-contact tonometers used to measure intraocular pressure (IOP) to aid in the screening and diagnosis of glaucoma.

Here's an analysis of their acceptance criteria and the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:

• Pulsair IntelliPuff Tonometer: The document does not explicitly state the exact sample size for the "new independent clinical study" used to show design compliance. It only mentions "over 95% of the eyes tested," implying a statistically significant number of eyes were included to meet the 5% tolerance criterion.
  • Data Provenance: The study was "new," "independent," and conducted to ISO 8612:2001, which is an international standard. No specific country of origin is mentioned, but the manufacturing location is the UK, suggesting the study likely occurred in Europe or the UK. It was a prospective clinical trial.
• Pulsair Desktop Tonometer: "An additional small scale trial was conducted within a clinical environment on 28 eyes."
  • Data Provenance: Conducted within a "clinical environment." No specific country is mentioned, but likely similar to the IntelliPuff. This was also a prospective study.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications for the test sets. However, the ground truth standard was the Goldmann Tonometer, which is considered the "gold standard" for IOP measurement, implying its use by trained clinicians.

4. Adjudication Method for the Test Set:

Not explicitly stated. The studies describe comparing device readings directly to Goldmann Tonometer readings and to each other, but not a consensus-based adjudication process for discrepancies.

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

No, an MRMC comparative effectiveness study was not explicitly mentioned. The studies focus on comparing the device's readings to a "gold standard" (Goldmann Tonometer) or to another version of the device, rather than assessing human reader improvement with or without AI assistance. The device is a measurement instrument, not an AI diagnostic aid requiring human interpretation to improve.

6. Standalone Performance Study (Algorithm Only):

Yes, the described clinical trials for both the Pulsair IntelliPuff and the Pulsair Desktop effectively demonstrate their standalone performance. The devices directly output an IOP measurement, and this output was compared against the Goldmann Tonometer, representing the algorithm's performance without specific human-in-the-loop steps designed to alter the measurement itself. The "IntelliPuff readings tended to fall slightly below the Goldmann readings at IOP's exceeding 30mmHg" is an observation about its standalone performance.

7. Type of Ground Truth Used:

The primary ground truth used was measurements obtained from a Goldmann Tonometer, which is the clinical "gold standard" for intraocular pressure measurement.

8. Sample Size for the Training Set:

The document does not provide information on the sample size used for the training set. It mentions the "algorithm for IOP calculation remains the same" as the predicate Pulsair 3000 and that the software was "sub-contracted for further development" based on a "Product Design Requirements Specification." This implies the algorithm was developed and refined, but the training data specifics are not detailed.

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

The document does not explicitly detail how the ground truth for the training set (if a distinct training set was used for the algorithm's development) was established. Given the algorithm's continuity from the predicate device (Pulsair 3000), it's implied that it was originally developed and validated against a known standard, likely the Goldmann Tonometer, similar to how the current devices were tested. The development involved functionality and usability improvements rather than a complete re-training of a new core IOP calculation algorithm.

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