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The iCare ST500 tonometer is a device intended to be used for the intraocular pressure of the human eye.

The iCare ST500 tonometer is intended to be used by healthcare professionals.

The iCare ST500 tonometer is based on a patented, induction-based rebound method, which allows intraocular pressure (IOP) to be measured by a healthcare professional accurately, rapidly and without an anesthetic. The iCare ST500 tonometer measures a patient's IOP while he or she is in an upright (sitting) position. It is attached to a slit lamp with the ST500 Adapter, making it easy to use during a standard eye exam. This tonometer is designed only for use with a slit lamp not as a handheld device. The tonometer is compatible with most of the common slit lamp models on the market.

The tonometer system consists of the iCare ST500 tonometer (together with ST500 Remote and ST500 Adapter, ST500 SmartCradle and a medical power supply used with ST500 SmartCradle), and a compatible printer and slit lamp.

With the iCare rebound measurement method, a miniature, lightweight, single-use probe is launched in a direction perpendicular to the surface of the center of the cornea of the eye. The probe is composed of a medical grade plastic tip and a metal shaft. The metal shaft is magnetized prior to the measurement. During the measurement, the probe can be considered to act like a moving magnet that induces an electric signal in the surrounding coil allowing for a highly accurate measurement of the probe's motion. After launching. the probe briefly contacts the cornea and bounces back. The tonometer records multiple parameters covering the motion of the probe, including deceleration, and rebound time. Using a proprietary algorithm, the device can calculate the eye's IOP.

The displayed IOP reading is derived from the results from a sequence of six individual probe rebounds. The displayed IOP measurement is also stored in the tonometer's memory for later retrieval.

The iCare ST500 tonometer has a rechargeable battery and can be charged in the ST500 SmartCradle powered by a medical power supply. The tonometer can be operated by using the buttons on the tonometer or by using the wireless battery-operated ST500 Remote control.

Here's a breakdown of the acceptance criteria and study details for the iCare ST500 (TA04) tonometer, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Clinical Test Set Sample Size: 156 eligible eyes from 165 enrolled subjects. In cases where both eyes were eligible, the eye with the higher GAT reference pressure was used for analysis.
• Data Provenance: Not explicitly stated from which country the data originated. It mentions "subjects having an appointment to the investigational site and from subjects recruited using a study announcement," implying a prospective study conducted at one or more clinical sites, likely in Finland where the applicant is based.

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

• The document implies that Goldmann Applanation Tonometer (GAT) measurements were used as the reference standard (ground truth) in the clinical study. It does not specify the number of expert ophthalmologists or optometrists who performed the GAT measurements, nor their detailed qualifications (e.g., years of experience). Healthcare professionals would typically perform GAT measurements.

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method for the test set. Given that GAT is considered a clinical gold standard, it's possible that a single GAT measurement was taken as truth, or if multiple readings were taken, the average was used without formal adjudication by additional experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done concerning AI assistance. This device is a tonometer with an AI-like algorithm for IOP calculation, but the focus of the clinical study was on its standalone accuracy against an established reference (GAT), not on human reader improvement with or without AI assistance. The "AI" here refers to the proprietary algorithm used to calculate IOP from probe motion, not a diagnostic AI system assisting human interpretation.

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

• Yes, a standalone performance study was done for the iCare ST500 tonometer. The clinical study compares the device's measurements directly to GAT, indicating its standalone performance without human interpretation or adjustment of the device's numerical output. The "algorithm only" aspect is embedded within the device's functionality to calculate IOP.

7. The Type of Ground Truth Used

• Clinical Ground Truth: Goldmann Applanation Tonometer (GAT) measurements. GAT is widely considered the clinical gold standard for intraocular pressure measurement.

8. The Sample Size for the Training Set

• The document does not provide information about a separate training set or its sample size. The device uses a "proprietary algorithm" to calculate IOP, but details on how this algorithm was developed, trained, or validated (if machine learning was used) are not disclosed in this summary. The provided clinical and bench testing data refer to the validation of the finalized device.

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

• As the document does not mention a specific training set, it does not provide details on how ground truth for such a set would have been established. If the proprietary algorithm involved machine learning, its training data and ground truth establishment would be a separate, undisclosed process. The current document focuses on the regulatory validation of the final product.

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The Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes is intended to be used for the measurement of intraocular pressure of the human eye.

The Reichert Tono-Vera® Tonometer is a hand-held, battery powered instrument that utilizes rebound methodology to measure the intraocular pressure (IOP) of the eye. The tonometer propels a small, plastic-tipped measurement probe in a controlled manner against a patient's unanesthetized eye in order to calculate IOP. The device has a simple, four-button control system and an LCD that provides information to the operator and displays measurement results.

There are two Tono-Vera Tonometer models:
· Tono-Vera Tonometer Starter Kit, AA Battery, Model 16305; and
• Tono-Vera Tonometer Starter Kit, Rechargeable, Model 16306.

Both models of the Tono-Vera Tonometer have a required accessory, the Ocu-Dot® Tonometer Probe, model 16318. The Ocu-Dot Tonometer Probe is a sterile, single-use, disposable accessory.

The Tono-Vera Tonometer utilizes a camera-based alignment system, called ActiView™ to improve alignment with the apex of the cornea and reduce measurement variability caused by operator technique. The measuring process starts automatically once alignment conditions are fulfilled.

The device has two measurement options: 3+ (Quick) Measurement Option and 6 Measurement Option. Both the 3+ (Quick) Measurement Option and 6 Measurement Option use the same calculation for the IOP result. The 3+ (Quick) Option can calculate a final IOP result with as few as three measurements. The 6 Measurement Option always uses six measurements to calculate the final IOP result.

The Tono-Vera Tonometer can be connected to a computer with ReichertSync® installed on it. Data from ReichertSync can be imported by an EMR system.

The Tono-Vera Tonometer determines IOP by detecting and analyzing the motion of the measurement probe as it briefly contacts the cornea.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text primarily focuses on demonstrating substantial equivalence to a predicate device (Icare Ic100) and meeting an industry standard (ANSI Z80.10-2014) for tonometry. Specific numerical acceptance criteria for a direct comparison study between the Tono-Vera Tonometer and the Goldmann Applanation Tonometer are not explicitly stated as a table within the document. However, the performance metrics reported against the predicate device give us an indication of the performance expected and validated.

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The CATS-L® Tonometer Prism is intended to be used with Goldmann type tonometers for the measurement of intraocular pressure of the human eye.

The CATS-L Tonometer Prism is used as an optical image prism for Goldmann applanation style tonometers. The CATS-L prism is made of PMMA, the corneal contact diameter is 6.28 mm, and the total length of the prism is 29.28 mm.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Five samples of the CATS-L tonometer prisms were evaluated.
• Data Provenance: The document does not specify the country of origin. The study is described as "design verification bench testing," implying a prospective, controlled laboratory setting rather than retrospective patient data.

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

This information is not provided in the document. The testing described is bench testing against specified engineering standards, not a clinical study involving human experts establishing ground truth from patient data.

4. Adjudication method for the test set:

This information is not applicable as the testing was bench testing against engineering standards, not a clinical study requiring expert adjudication of results.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a tonometer prism, which is a physical accessory for measuring intraocular pressure, not an AI or imaging diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this device.

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

A standalone performance study of an algorithm was not done. This device is a physical medical device accessory, not a software algorithm. The "performance data" refers to bench testing of the physical properties against engineering standards.

7. The type of ground truth used:

The ground truth used was based on engineering standards specified in ANSI Z80.10-2018. Specifically, sections A1.1, A1.2, and A1.6 for various physical and optical properties of the tonometer prism.

8. The sample size for the training set:

This information is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable as there is no training set for this device.

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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 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 iCare IC200 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.

The iCare IC200 tonometer (model TA031) is a hand-held, battery-operated device which measures intraocular pressure (IOP) without the need for topical anaesthesia by rebound tonometry. The tonometer is to be used by a healthcare professional. The tonometer uses the rebound method. A small and light, sterile, single-use probe makes brief contact with the eye. The device measures the deceleration of the probe and the rebound time and calculates the IOP from these parameters. Deceleration of the probe is slower at low IOP compared to high IOP. The measurement method, the IOP measurement algorithm and rebound technology (including disposable probe) are identical with the predicate device. iCare IC200 tonometer can obtain IOP measurements in all angles between horizontal and supine directions. External design has not been modified. The user interface menu has been updated to contain a Quick Measure mode. The new Quick Measure feature is used to measure patient's IOP with fewer rebound measurements and faster measurement cycle. Quick Measure takes two or three rebound measurements; two if both results are within 2 mmHg and third if the difference between the first two measurements is greater than 2 mmHg.

The provided document, a 510(k) Premarket Notification review for the iCare IC200 tonometer, outlines the acceptance criteria and the study performed to demonstrate substantial equivalence to a predicate device. This submission focuses on a new feature of the device, the "Quick Measure" mode, rather than the entire device itself, as the underlying technology remains the same as the predicate.

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

Acceptance Criteria and Reported Device Performance

The acceptance criterion for the Quick Measure mode's performance is its ability to meet the performance goals of the ANSI Z80.10:2014 standard for ophthalmic tonometers, specifically regarding agreement with reference tonometers (GAT and Perkins) within ±5 mmHg. This is presented across different Intraocular Pressure (IOP) subgroups.

Table 1: Acceptance Criteria and Reported Device Performance for iCare IC200 Quick Measure Mode

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The iCare HOME2 tonometer is a prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.

The iCare HOME2 tonometer (model TA023) is a hand-held, battery operated device which measures intraocular pressure (IOP) without the need for topical anaesthesia by rebound tonometry. The tonometer is to be used by the patients themselves. The tonometer uses the rebound method. A small and light, sterile, single-use probe makes brief contact with the eye. The device measures the deceleration of the probe and the rebound time and calculates the IOP from these parameters. Deceleration of the probe is slower at low IOP compared to high IOP. The measurement method, the IOP measurement algorithm and rebound technology (including disposable probe) are identical with the predicate device. iCare HOME2 tonometer is a further developed version of iCare HOME tonometer. It features enhancements such as possibility to measure IOP in any angle between 0° and 90° (horizontal to supine patient position) and possibility for wireless measurement result transfer to mobile device or to PC. External design and user interface have been modified for better usability and ergonomics. The measurement data can be uploaded to iCare CLINIC for further analysis using either iCare EXPORT (desktop application) or iCare PATIENT2 (mobile application). iCare PATIENT2 is a mobile app intended for transferring eye pressure measurement data from the iCare tonometer to the iCare CLINIC cloud service or an external system. The app displays the eye pressure measurement results and helps in glaucoma management. It is indicated for use by healthcare professionals and patients. Measurement results can be transferred to iCare CLINIC with either through a Bluetooth connection or by connecting the USB C type connector to the device and mobile phone, depending on the user's mobile phone operating system.

The iCare HOME2 tonometer is intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document for iCare HOME2 (K211355) does not explicitly list "acceptance criteria" in a bulleted or numbered format with specific thresholds. However, based on the provided "Performance and Safety Data" and "Clinical Performance Testing" sections, we can infer the implied acceptance criteria were related to accuracy, repeatability, and reproducibility compared to existing tonometers, as well as safety.

The key performance metric presented is the agreement between the iCare HOME2 and a reference tonometer (iCare IC200).

• Mean paired difference (iCare HOME2 - iCare IC200): 0.55 mmHg
• Standard deviation of the difference: 2.69 mmHg
• 95% CI for Mean Difference: -0.86, -0.23 mmHg (Note: This range seems incorrectly transcribed in the original document as it does not align with the mean paired difference, it may be a typo. Usually, it would encompass the mean diff. Assuming the mean diff is correct.)
• 95% Limits of Agreement (LOA) for Mean Difference: -5.82, 4.72 mmHg (This indicates that 95% of the differences between the two devices fall within this range). |
  | Repeatability (Variability of repeat measurements) | For each patient, variability (difference of repeat measurements) for all IOP ranges was ~7.9%. |
  | Reproducibility (Agreement regardless of device, operator, or measurement angle) | Demonstrated high agreement with manometric pressure regardless of the device, operator, or the measurement angle (from bench testing). |
  | Safety | No adverse events (including corneal abrasions) were recorded in the study population. |

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

• Sample Size: 47 patients.
• Data Provenance: Prospective clinical study performed at East West Eye Institute, CA 90013, USA. The patients were either diagnosed glaucoma patients or 'glaucoma suspects'.

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 of experts used or their qualifications for establishing the ground truth. The ground truth was established by comparison to a "reference tonometer (iCare IC200)," which is a cleared medical device. While healthcare professionals (likely ophthalmologists or technicians) would have operated both devices during the clinical study, their role in establishing a "ground truth" (beyond operating the reference device) for each patient's IOP is not detailed. The iCare IC200 itself is considered a "reference" for comparison.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It appears a direct comparison between the iCare HOME2 measurements and the iCare IC200 measurements was performed. A "random eye was selected as the study eye for each patient."

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

The study described is not a Multi-Reader Multi-Case (MRMC) comparative effectiveness study involving human readers with and without AI assistance.** This device is a tonometer, a measurement device, not an AI-powered diagnostic imaging tool that assists human readers.** Therefore, this question is not applicable to the submitted document.

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

The iCare HOME2 is a physical tonometer device that performs measurements. It has an "IOP measurement algorithm" that calculates IOP from probe deceleration and rebound time. The clinical study evaluated the performance of this device (which includes its internal algorithm) when used by patients (self-measurement) compared to a reference tonometer (likely operated by a healthcare professional). Therefore, in a sense, the measurement output itself is "standalone" from direct human interpretation of raw data, but it's a device measurement, not an AI algorithm assisting human interpretation.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established by comparison to a legally marketed reference medical device: the iCare IC200 tonometer (cleared in K190316). In addition, bench testing used "manometrically controlled artificial cornea" for accuracy and reproducibility assessment, implying manometric pressure served as a higher-level ground truth in those tests. For the clinical study, the IC200 served as the comparative standard.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" in the context of machine learning or AI. The iCare HOME2 tonometer uses a "rebound method" and an "IOP measurement algorithm," which are stated to be "identical with the predicate device." This suggests the core measurement algorithm was likely developed and validated prior to this submission (possibly with data from the predicate device iCare HOME), and this submission focuses on the safety and effectiveness of the new device iteration. No specific training set for a machine learning model is mentioned.

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

As no specific training set for an AI/machine learning model is mentioned for iCare HOME2, information on how its ground truth was established is not available in the provided document. The device's measurement principles are inherited from the predicate device.

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The CATS®-D Tonometer Prism is intended to be used with Goldmann type tonometers for the measurement of intraocular pressure of the human eye.

The CATS®-D Tonometer Prism is used as an optical image prism for Goldmann applanation style tonometers. It is made of PMMA, the corneal contact diameter is 6.5 mm and the total length of the prism is 30 mm.

This document does not contain information related to AI/ML device performance or clinical studies typical for AI/ML-based medical devices. The submission (K203850) is for a CATS®-D Tonometer Prism, which is a physical accessory for Goldmann type tonometers, not an AI/ML algorithm.

The core of the submission focuses on demonstrating substantial equivalence to a predicate device (CATS® Reusable Tonometer prism K173904) through performance data related to:

• Design verification: Ensuring the device meets its design specifications.
• Sterilization validation and shelf-life testing: Confirming the sterility and stability of the disposable prism.
• Biocompatibility testing: Cytotoxicity, sensitization, and irritation tests according to ISO 10993 standards.

There is no mention of:

• Acceptance criteria for an algorithm's performance (e.g., accuracy, sensitivity, specificity).
• A test set with ground truth or expert annotations.
• Sample sizes for AI/ML model testing or training.
• The number or qualifications of experts.
• MRMC studies or human reader improvement with AI assistance.
• Standalone algorithm performance.

Therefore, I cannot provide a response to the prompt's specific requirements, as they are geared towards AI/ML device evaluations, which are not relevant to this 510(k) submission.

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The VX650 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 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 cornea thickness map
• · Scheimpflug imaging
• · Anterior chamber imaging
• · Pupil Image
• · Image of the cornea relative to the iris
• · Automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatio agent

The VX650 is based on the VX130 (already cleared 510(k), number K162067) which is a combined wavefront aberrometer, corneal topographer, Scheimpflug pachymeter, non-contact tonometer and cataract screening device in a single platform that contains five different measurement units. The VX650 also contains a non-mydriatic fundus camera for retinal photography. The wavefront aberrometer uses 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.

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, there is also a scanning mode that allows measurement of the whole corneal surface and can provide detailed tomography maps of both corneal surfaces and the corneal thickness.

An air puff non-contact tonometer is included for measurement of the intraocular pressure and retro illumination is present for cataract screening.

The fundus camera contains an infra-red LED for alignment and focusing and a white LED flash for the photography to give colour images. The fundus image covers an angle of 45° on the retina so a regular image will contain both the macula and the optic nerve. The fundus camera also has a seven-position fixation target to increase the field of view as the patient can fixate in different directions.

The device is fully automated and a number of different measurements can be performed by a sinqle command including alignment and focusing. The fundus imaging function is also fully automatic including automatic alignment, focusing and image capture.

The provided document describes the VX650, a multi-function diagnostic device. The bulk of the submission focuses on demonstrating substantial equivalence to predicate devices through comparison of technical characteristics and compliance with standards. However, the document does not describe specific acceptance criteria and a study proving the device meets those criteria for clinical performance.

Instead, it relies on:

• Bench tests and compliance with recognized standards: This demonstrates the device's adherence to general safety and performance requirements for ophthalmic instruments and software.
• Comparison to predicate devices: The manufacturer argues that the VX650 is substantially equivalent to existing devices (VX130 for core functions, and Nexy/CenterVue DRS for the fundus camera module) which are already cleared for market. The claim is that the differences are minor and do not raise new questions of safety or effectiveness.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance (as no specific performance metrics with acceptance limits are defined and reported from a clinical study).
• Sample size for the test set or data provenance (as no clinical test set is described).
• Number and qualifications of experts for ground truth (as no ground truth establishment for a test set is described).
• Adjudication method.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done or the effect size of human readers with/without AI assistance.
• If a standalone (algorithm only) performance was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

Summary of what the document does provide regarding testing:

1. Bench Tests and Standard Compliance:

   • Acceptance Criteria (Implicit): Compliance with various ISO and IEC standards related to medical devices, ophthalmic instruments, electrical safety, electromagnetic compatibility, and software verification/validation.

   • Reported Device Performance: The device "complies with" and "meets" these standards. The collective performance testing "demonstrates that the VX650 device does not raise any new questions of safety or effectiveness when compared to the predicate devices" and "performs as intended."

   • Specific Standards Mentioned:

     • ISO 14971 (Risk Management)
     • AAMI ANSI ES60601-1 (Electrical Safety)
     • IEC 60601-1-2 (EMC)
     • ISO 15004-1 (Ophthalmic instruments - Fundamental requirements and test methods)
     • ISO 10940 (Ophthalmic Instruments - Fundus Cameras)
     • IEC 62471 (Photobiological safety of lamps and lamp systems)
     • IEC 60825-1 (Safety of laser products)
     • ISO 10993-1 (Biological evaluation of medical devices)
     • IEC 62366-1 (Usability)
     • IEC 60601-1-6 (Usability for medical electrical equipment)
     • IEC 62304 (Medical device software - Software life cycle processes)
     • ANSI Z80.36-2016 (Light Hazard Protection)
     • ISO 8612:2009 (Tonometers)
     • ISO 10342:2010 (Eye refractometers)
     • ISO 10343:2014 (Ophthalmometers)
     • ISO 19980:2012 (Corneal topographers)
     • ISO 24157:2008 (Reporting aberrations of the human eye)
     • ISO 15004-2 (Ophthalmic Instruments - Requirements and test methods for fundus cameras)

2. Software Verification and Validation:

   • Level of Concern: "Moderate" based on FDA's guidance for software in medical devices.
   • Proof: Performed "per AAMI/ANSI/IEC 62304."

In conclusion, the document provides evidence of engineering and regulatory compliance testing rather than clinical performance studies with specific acceptance criteria. The substantial equivalence argument negates the need for new clinical performance studies by demonstrating that the new device is fundamentally similar to already cleared devices and performs as intended according to established technical standards.

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The Icare HOME tonometer is a prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.

The Icare HOME tonometer is a home-use handheld, battery operated device that measures the intraocular pressure (IOP) without the need for topical anaesthesia. It is for prescription use only and to be used under the supervision of a healthcare professional. The device is intended to be used by patients at home.

The tonometer uses the rebound method. A small and light, sterile, single-use probe makes brief contact with the eye. The device measures the deceleration of the probe and the rebound time and calculates the IOP from these parameters. Deceleration of the probe is slower at low IOP compared to high IOP.

The measurement sequence includes six measurements. The probe moves to the cornea and back during every measurement. The tonometer stores information on every complete measurement sequence of six measurements. The stored information includes the calculated final IOP, time and date of the measurement, identification of the eye (right or left) and the quality level of the measurement (i.e. the standard deviation of the six individual measurements).

The measurement data can be uploaded to Icare CLINIC for further analysis using either Icare EXPORT (desktop application) or Icare PATIENT (mobile application). Icare CLINIC is a browser-based software designed for managing patient information and the IOP measurement data.

The provided text does not contain detailed information about specific acceptance criteria related to a performance study for the Icare HOME tonometer, nor does it describe a study that explicitly proves the device meets such criteria in terms of clinical accuracy or diagnostic performance. Instead, this document is a 510(k) summary for a premarket notification, focusing on demonstrating substantial equivalence to a predicate device.

The document highlights:

• Changes: The modifications are primarily related to software (Icare LINK replaced with Icare CLINIC, Icare EXPORT, and Icare PATIENT) and connectivity (added Android support). There are also minor changes to user interface sounds and product appearance.
• Performance and Safety Data: The document states that the device has been tested according to relevant FDA recognized consensus standards for electrical safety, ophthalmic instruments, usability, software lifecycle processes, and photobiological safety.
• No Clinical Studies: Crucially, it explicitly states: "No clinical studies were performed to test this device modification." This means there is no new clinical data presented here to establish performance metrics (like accuracy, sensitivity, specificity, etc.) against a ground truth in a clinical setting for this specific modification. The substantial equivalence is based on the argument that the technological changes do not raise new issues of safety or effectiveness, and therefore, the performance is assumed to be equivalent to the predicate device.

Given this, I cannot extract the detailed information requested in the prompt (acceptance criteria, reported device performance, sample size for test set, expert qualifications, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, how training set ground truth was established) as this information is not present in the provided document for this specific 510(k) submission. The document focuses on demonstrating that the modified device is substantially equivalent to the predicate device without requiring new clinical performance data.

However, based on the general context of medical device regulatory submissions and the information provided, here's what can be inferred or stated regarding the lack of such information:

In summary, this 510(k) document is a "Special 510(k)" for a device modification, and the strategy is to demonstrate substantial equivalence to a predicate device without new clinical performance data, relying on the argument that the changes do not affect the fundamental safety and effectiveness of the IOP measurement.

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