(128 days)
No
The description mentions a "proprietary algorithm" for calculating IOP from probe motion parameters, but there is no mention of AI, ML, or related concepts like training data, neural networks, or adaptive learning. The algorithm appears to be a deterministic calculation based on physical measurements.
No
The device is intended for measuring intraocular pressure, which is a diagnostic function, not a therapeutic intervention.
Yes
Explanation: The device is used to measure intraocular pressure (IOP), which is a key parameter in diagnosing conditions like glaucoma. The stated "Intended Use / Indications for Use" is for "the intraocular pressure of the human eye," clearly indicating its role in providing objective measurements that healthcare professionals use for diagnosis.
No
The device description clearly outlines hardware components including a tonometer, probes, adapter, SmartCradle, power supply, and remote control, which are essential for its function.
Based on the provided information, the iCare ST500 tonometer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- iCare ST500 Function: The iCare ST500 tonometer directly measures the intraocular pressure of the human eye in vivo (within the living body). It does not analyze a specimen taken from the body.
Therefore, the iCare ST500 tonometer is a medical device, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HKY, HKX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human eye / cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing: Bench test to assess accuracy and repeatability using manometrically controlled test corneas with Default Measure and Quick Measure modes. iCare ST500 met predetermined acceptance criteria for accuracy and repeatability. Reproducibility was assessed with two operators performing three measurements with three different ST500 units, showing mean differences between operators of -0.12 mmHg and -0.02 mmHg, and R-squared values of 99.8% for Default Measure and 99.7% for Quick Measure, indicating high reproducibility.
Clinical Performance Testing: Clinical study conducted according to ANSI Z80.10:2014.
Sample size: 165 subjects enrolled, 156 with at least one eligible eye used in analysis.
Study type: Comparison of iCare ST500 measurements against Goldmann Applanation Tonometer (GAT) and iCare IC200.
Key Results: On average, iCare ST500 underestimated IOP by 0.21 mmHg compared to GAT. Underestimation in low and medium IOP groups (0.20 mmHg and 0.49 mmHg respectively), and overestimation in medium IOP group (0.18 mmHg). Regression analyses confirmed good correlation with GAT results (slope and squared Pearson coefficient close to 1: 1.03 and 0.89 respectively). iCare ST500 met the requirements of ANSI Z80.10-2014.
Number of outliers: 4 out of 156 eyes (2.6%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bench Test:
Repeatability (Default Measure): highest standard deviation 0.44 mmHg (CV 1.1 %)
Repeatability (Quick Measure): highest standard deviation 0.78 mmHg (CV 1.9%)
Reproducibility (Default Measure): mean difference -0.12 mmHg, standard deviation 0.75 mmHg, R-squared 99.8%
Reproducibility (Quick Measure): mean difference -0.02 mmHg, standard deviation 0.91 mmHg, R-squared 99.7%
Clinical Study:
Mean GAT – 1st ST500: underestimated IOP by 0.21 mmHg compared to GAT.
IOP Groups:
≤ 16 mmHg: 0 outliers (0.0%)
16 – 23 mmHg: 2 outliers (3.5%)
≥ 23 mmHg: 2 outliers (5.0%)
Total: 4 outliers (2.6%)
Regression analysis: slope 1.03, squared Pearson coefficient 0.89.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 27, 2024
Icare Finland Oy Hannes Hyvönen Regulatory Affairs Manager Ayritie 22 Vantaa. 01510 Finland
Re: K241447
Trade/Device Name: iCare ST500 (TA04) Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer And Accessories Regulatory Class: Class II Product Code: HKY, HKX Dated: August 20, 2024 Received: August 20, 2024
Dear Hannes Hyvönen:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Alexander 2024.09.27
Beylin -S 12:03:30 -04'00'
for Elvin Ng
Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241447
Device Name iCare ST500 (TA04)
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
1.1 Contact Details
Applicant Name: Icare Finland Oy Applicant Address: Äyritie 22 Vantaa 01510 Finland Applicant Contact Telephone: 358 9 8875 1150 Applicant Contact: Mr. Hannes Hyvönen Applicant Contact Email: regulatory@icare-world.com
Prepared on: September 25th, 2024
1.2 Device Name
| Device Trade Name: | iCare ST500 (TA04) |
|---|---|
| Common Name: | Tonometer and accessories |
| Classification Name: | Tonometer, Manual |
| Regulation Number: | 886.1930 |
| Product Code(s): | HKY, HKX |
Premarket Notification 510(k) Number: K241447 This premarket notification type is Traditional 510(k).
1.3 Legally Marketed Predicate Devices
Predicate #: K220852 Predicate Trade Name (Primary Predicate is listed first): iCare IC200 (TA031) Product Code: HKY
1.4 Device Description Summary
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
5
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.
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1.5 | Intended Use / Indications for Use
The iCare ST500 tonometer is a device intended to be used for the measurement of the intraocular pressure of the human eye.
The iCare ST500 tonometer is intended to be used by healthcare professionals.
1.6 Indications for Use Comparison
Indications of use statement is equivalent to the predicate device (see Table 1 below).
1.7 Technological Comparison
The new iCare ST500 tonometer features the same or equivalent technology as in the predicate device iCare IC200 (K220852) such as:
• Automated measurement sequence, where full measurement sequence can be completed by keeping the measurement button pressed down.
- Wireless connectivity with Bluetooth connection to printer and remote control.
• The Quick Measure feature measures the patient's IOP with fewer rebound measurements and a faster measurement cycle.
Differences with respect to the predicate device iCare IC200 (K220852) are:
• Mounted on a slit lamp with the ST500 adapter, allowing the measurement to be performed only in horizontal (sitting) position.
- Automatic eye side recognition system, an automatic IR-based eye side detection and control functionality. Equivalent to reference device iCare HOME2 (K211355).
- · Probe applicator, a funnel shaped applicator used to ease the loading of the probe. Equivalent to reference device iCare HOME2 (K211355).
- Remote control, the tonometer can be operated by using the buttons on the tonometer or by using the wireless battery-operated ST500 Remote control.
- Rechargeable battery, the iCare ST500 tonometer has a rechargeable battery and can be charged in the ST500 SmartCradle powered by a medical power supply.
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| Characteristic | Subject device (K241447) | Predicate Device (K220852) |
|---|---|---|
| Product | ||
| Appearance | Image: iCare ST500 tonometer with a mannequin head | Image: iCare IC200 Tonometer being used on a child |
| Product/Devic | iCare ST500 tonometer | iCare IC200 Tonometer |
| e | (Type: TA04) | (Type: TA031) |
| Identification | ||
| Intended Use / | Equivalent | IOP Measurement |
| Indications for | "The iCare ST500 tonometer is a device | "The iCare IC200 tonometer is intended to be |
| Use Statement | intended to be used for the measurement of the | used for the measurement of intraocular |
| intraocular pressure of the human eye. | pressure of the human eye." | |
| The iCare ST500 tonometer is intended to be | ||
| used by healthcare professionals." | ||
| Intended users | Same | Healthcare professionals |
| Measurement | Same | Rebound tonometry |
| method | ||
| Measurement | Same | 7-50 mmHg |
| range | ||
| Default | Equivalent, | Default measurement mode: 6 |
| measurement | Default measurement mode: 6 measurements | measurements, calculation of median IOP |
| sequence | are averaged | and standard deviation based on 4 |
| measurements (highest and lowest | ||
| excluded) |
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icare
| Measurement
positions | Equivalent
Tonometer must be oriented horizontally (0°,
patient in sitting position), no supine position
measurement possibility, only for slit lamp use
not as a handheld device | Tonometer can be used in any angle between 0°
(sitting, standing) and 90° (patient in supine
position) |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Device Display | Equivalent,
240 x 320 RGB LCD display | 128 x 128 full color OLED display |
| Automatic eye
recognition
system | Difference,
but equivalent to reference device iCare
HOME2 (K211355) | No |
| Design | Equivalent,
Slit-lamp mounted microprocessor based | Handheld microprocessor based |
| Calibration | Same | No maintenance calibration required |
| Contact tip
(probe) | Same | Lightweight, disposable, single use, plastic
probe (TP01s) |
| Contact tip
sterilization | Same | Gamma-sterilized |
| Anaesthesia
required | Same | No |
| Power supply | Difference,
Li-ion rechargeable battery, 3,6 V / 2200-2400
mAh
(not replaceable by the user) | 4 x 1,5V AA Alkaline LR6 batteries |
| Device
dimensions
and weight | Equivalent,
Dimensions:
46 x 70 x 181 mm (L x W x H)
Weight: 226g (including internal power
supply) | Dimensions:
43 mm (W) * 104 mm (H) * 214 mm (L)
Weight: 165g (without batteries) |
| Connectivity
interface | Equivalent,
Bluetooth (ANNA-B112 Module) | Bluetooth (Microchip RN4678 Module) |
| User interface | Difference,
Near Field Communication (NFC) | Audio indications: |
9
| Equivalent | Beeps for device too near or too far situation,
and for other errors. |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Graphical User Interface:
Equivalent,
240 x 320 RGB LCD display | Graphical User Interface:
128 x 128 full color OLED display |
| Probe base light:
Green: same
Red: same
Blinking red: same | Probe base light:
Green: angle correct, device readiness
Red: angle incorrect, measurement not possible
Blinking red: measurement error messages |
The iCare ST500 has the same basic operation principle, underlying technology (rebound tonometry) and device materials as the predicate device. The device performance is substantially equivalent.
Non-Clinical Performance Testing 1.8
The device has been tested based on FDA recognized consensus standards. The following information shows its performance and safety, supporting its substantial equivalence.:
-ISO 15004-1 Second edition 2020-5 (10-123)
-ANSI Z80.36-2021 (10-130)
-IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION (19-49)
-ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] (19-36)
-IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION (5-132)
-ANSI AAMI IEC 62366-1:2015+AMD1:2020 (Consolidated Text) (5-129)
-ANSI AAMI IEC 62304:2006/A1:2016 (13-79)
-ISO 10993-1:2018 (2-258)
-ANSI Z80.10-2014 (10-96)
There were no changes related to sterilization (of probes). Device and software risk analysis has been performed in accordance with ISO 14971:2019 risk management
10
standard. Device firmware and software level of concern was Class B (Basic Documentation).
Summary of bench testing performed is presented below:
The accuracy and repeatability of the Icare ST500 tonometer was assessed in a bench test. The test was done by measuring manometrically controlled test corneas. To assess accuracy and repeatability, measurements were performed with the test tonometer using Default Measure and Quick Measure.
Icare ST500 met the predetermined acceptance criteria for accuracy and repeatability over the measurement range ensuring substantial equivalence to the previously cleared Icare IC200 (K190316) tonometer both for Default Measure and Quick Measure.
For repeatability with Default Measure, the highest standard deviation was 0.44 mmHg (CV 1.1 %). With Quick Measure, the highest standard deviation was 0.78 (CV 1.9%).
Reproducibility was assessed in a test in which two operators performed three measurements with three different ST500 units. Across all the three iCare ST500 units, the mean differences between the operators were -0.12 mmHg and -0.02 mmHg with a standard deviations of 0.75 mmHg and 0.91 mmHg for Default Measure and Quick Measure, respectively. The R-squared value in regression analysis was 99.8% for Default Measure and 99.7% for Quick Measure, which indicates high reproducibility across the operators for both Default Measure and Quick Measure of iCare ST500 tonometer.
The iCare ST500 has two measurement modes: Single and Series. In the Single Mode, the probe is shot every time the measurement button is pressed. In the Series Mode, the measurement button is pressed and held, and the probe is shot consecutively until the measurement is finished or the measurement button is released. The performance of ST500 is not affected the mode used.
Please be advised that bench testing conditions do not cover all the error sources within a clinical setting and thus higher variability is expected in clinical use.
1.9 Clinical Performance Testing
The clinical study was made for iCare ST500 tonometer according to ANSI Z80.10:2014 (in accordance with FDA's extent of recognition). See Table 2 below.
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| Mean GAT – 1st ST500 | ||||
|---|---|---|---|---|
| ≤ 16 mmHg | 16 – 23 | |||
| mmHg | ≥ 23 mmHg | Total | ||
| Number of eyes | 59 | 57 | 40 | 156 |
| Number of outlier | 0 | 2 | 2 | 4 |
| Percentage of | ||||
| outliers | 0.0% | 3.5% | 5.0% | 2.6% |
Table 2 – iCare ST500 1st measurement vs. GAT mean
There were 165 subjects enrolled in the study of which 156 had at least one eligible eye. The measurements were made with iCare ST500 and reference tonometers iCare IC200 and GAT. In case both subject's eyes were eligible, the eye with higher GAT reference pressure was used in the analysis (so the number of eyes included in the analysis was 156). The population of the study consisted of subjects having an appointment to the investigational site and from subjects recruited using a study announcement.
On average iCare ST500 underestimated IOP by 0.21 mmHg compared to GAT. The IOP groups (per standard) were low (≤ 16 mmHg), medium (> 16 to