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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 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 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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The Icare ic200 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.

The Icare ic200 (TA031) tonometer is a hand-held, battery operated device, which measures intraocular pressure (IOP) without the need for topical anesthesia. The Icare ic200 tonometer measures the IOP by utilizing the rebound method, where a small (1.8 mm diameter), light (26.5 mg) probe makes brief contact with the eve. The Icare ic200 probes are sterile (gamma sterilized), single-use accessories of the device. All other accessories of the Icare ic200 are non-sterile and do not have direct patient contact.

Icare ic200 allows IOP measurement of patients in all positions between sitting position (direction of probe movement 0°) and supine position (direction of probe movement 90°).

Identical to the predicate device, the Icare ic200 (TA031) tonometer records the speed of the probe upon initiation of a measurement sequence. When the moving probe contacts the cornea, the probe decelerates at a rate which depends on the intraocular pressure. The tonometer measures the deceleration of the magnetized probe and the rebound time during contact with the eye and calculates the IOP from these parameters.

A single measurement sequence includes six measurements. After the six measurements are completed, the tonometer calculates the final IOP and the result is provided on the display. JOP measurement result can be transferred to printer or to a PC via Bluetooth® connection.

The measurement method, the IOP measurement algorithm and rebound technology (including sterile, single-use probe) of Icare ic200 are identical to the predicate device Icare ic100 (TA011, K153694).

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Icare ic200 Tonometer

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document explicitly states that the Icare ic200 met the predetermined acceptance criteria for accuracy and bias over the measurement range, ensuring substantial equivalence to the previously cleared Icare ic100 tonometer. While the exact numerical acceptance criteria for bench testing (beyond matching the predicate) are not fully detailed for all parameters, the reported performance indicates that they were met. For clinical performance, the ANSI Z80.10:2014 standard's criteria were used, and the device conformed to them.

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

• Clinical Test Set:

  • Sample Size: 152 eyes
  • Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "clinical study" and "performed as intended," implying prospective data collection for this submission.

• Bench Test Set:

  • Sample Size:
    • Accuracy and bias: Not explicitly stated, but performed with a "simulated IOP model."
    • Repeatability: 10 measurements were performed (with 3 different angles for the tonometer).
    • Reproducibility: Two operators performed three measurements with three different ic200 units in each measurement setup, resulting in 162 measurements per operator.
  • Data Provenance: Laboratory bench testing.

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

• Clinical Study: The ground truth was established by comparator devices:

  • Goldmann Applanation Tonometer (GAT) for sitting position.
  • Tonopen Avia and Perkins for supine position.
  • No information is provided on the number or qualifications of the operators for these reference devices in the clinical study.

• Bench Testing:

  • The ground truth was established by a "manometrically controlled test cornea" (i.e., a physical reference standard).
  • No human experts were involved in establishing the ground truth directly for this bench test.

4. Adjudication Method for the Test Set:

• Clinical Study: Not explicitly mentioned, but the comparison was against established reference devices (GAT, Tonopen Avia, Perkins) for IOP measurement. There's no indication of a separate expert adjudication process for the clinical data itself beyond direct measurement comparisons.
• Bench Testing: No adjudication method mentioned; the comparison was against a known manometric pressure.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• No, an MRMC comparative effectiveness study was not done.
• This device is a tonometer, a measurement device, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images with or without AI assistance. The study focused on the device's accuracy and performance compared to established tonometry methods.

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

• Yes, a standalone performance assessment was conducted for the device's measurement algorithm. The device itself performs the IOP measurement and provides a numerical result without human interpretation of raw data. The bench testing (comparing to manometric pressure) and the clinical study (comparing to reference tonometers) are effectively standalone assessments of the device's measurement capabilities. The software calculates the IOP from probe speed during impact.

7. The Type of Ground Truth Used:

• For Bench Testing: Manometric pressure from a controlled test cornea.
• For Clinical Testing: Intraocular pressure measurements from legally marketed predicate and reference devices: Goldmann Applanation Tonometer (GAT), Tonopen Avia, and Perkins tonometer.

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided. The document describes a 510(k) submission for a rebound tonometer, which uses a physical measurement (rebound method) and an "IOP measurement algorithm" that is stated to be identical to its predicate device. This typically implies a deterministic algorithm or one trained on historical data, but the document does not detail a specific "training set" in the context of machine learning. The focus is on verifying and validating the device's performance, not on a new algorithm's training.

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

• Not Applicable / Not Provided. As mentioned above, the concept of a "training set" and its ground truth is not detailed in this submission because it's for a traditional medical device's performance verification, not necessarily a machine learning model requiring a distinct training phase in the context of this document. The "IOP measurement algorithm" and rebound technology are identical to the predicate, suggesting it was established previously.

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Sunkingdom Applanation Tonometer is a manual device intended for measurement of intraocular pressure by applanation (applying a small flat disk to the cornea) to aid in the diagnosis of glaucoma.

Sunkingdom SK-R, SJ-T, SK-Q are applanation tonometers, which are 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 operation principle is based on Goldmann applanation method, which is considered as the gold standard for measuring intraocular pressure. Therefore the applanation tonometer plays an important role in the diagnosis and treatment of ophthalmic diseases.

Sunkingdom series of Applanation tonometer are active medical devices powered by 3V button battery. In practice, it provides two ways to read the measured intraocular pressure value, one from the dial indicator in mmHg unit, the other from the LCD display in mmHg and KPa units. It is used in conjunction with a slit lamp, and the only difference among the SK- R, SK-T, SK-Q is the connection part. Each model differs from each other depending on the type of slit lamp to be used with it as shown in the figure below. All the other technical specifications are the same for these three models.

Model SK-Q is especially for the slit lamp with a large head size that cannot be configured for SK-R. Model SK-R can be left on the slit lamp permanently. It is fixed to the microscope on a mounting base and can be rotated in front of the microscope for examination. Model SK-T is mounted on the guide plate over the slit lamp axis for measurement purposes.

Components of the tonometer include applanation tonometer main body, Connection mechanical parts and screws, calibration rod, and applanation prism.

The provided text describes a medical device, the Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q, and its substantial equivalence determination by the FDA. However, the document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information on the specific acceptance criteria for device performance or a comprehensive study report with the level of detail requested in your prompt.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states that the testing was carried out in accordance with ANSI Z80.10-2014, Ophthalmic Instruments-Tonometer. This standard would define the specific acceptance criteria for performance (e.g., accuracy, repeatability). However, the document does not explicitly list those criteria or the detailed reported performance data against them. It only states that the devices "are in compliance with above FDA recognized standards."

Detailed Breakdown of Missing and Available Information:

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

• Sample Size: The document mentions "3 devices" were used for performance testing. For verification bench testing, it states an "experimenter measured each weight value for 10 times and by 2 experimenters measured 3 weight values for 2 times in 3 devices." This refers to specific test procedures and not necessarily a clinical test set in the traditional sense of patient data.
• Data Provenance: Not specified. The performance testing appears to be bench testing conducted by the manufacturer.

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. The performance testing described is bench testing against known physical forces/weights, not a clinical study involving experts establishing ground truth for patient outcomes.

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

• This information is not applicable/not provided as there is no human-involved "test set" or clinical study described in the provided text that would require adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This information is not provided. The device is an applanation tonometer, a measurement instrument. There is no mention of AI assistance or human reader involvement in the context of improving diagnostic effectiveness.

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

• This information is not applicable. The device is a manual tonometer that requires a human operator for its use. It's not an automated diagnostic algorithm.

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

• For the performance testing, the "ground truth" was established by known physical forces/weights applied using a balance system, as described in the calibration section and performance testing details. The principle is based on the Goldmann method's physics.

8. The sample size for the training set

• This information is not applicable/not provided. The device is a mechanical/electronic measurement instrument based on physical principles, not a machine learning or AI-driven system that requires a "training set."

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

• This information is not applicable/not provided for the reasons mentioned in point 8.

In summary, the provided FDA document focuses on demonstrating substantial equivalence through comparison with a predicate device and compliance with recognized safety and performance standards for a medical measurement instrument. It lacks the detailed clinical study information and specific performance metrics often associated with AI-driven diagnostic devices or devices requiring human expert interpretation that your prompt implies. The "performance data" section primarily highlights biocompatibility, electrical safety, EMC, and a brief description of bench testing for measuring force.

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