K Number

Device Name

SENSIMED TRIGGERFISH

Manufacturer

SENSIMED AG

Date Cleared

2016-03-04

(668 days)

Product Code

PLZ

Regulation Number

886.1925

Intended Use

The SENSIMED Triggerfish® is a prescription device indicated to detect the peak patterns of variation in intraocular pressure over a maximum period of 24 hours to identify the window of time to measure intraocular pressure by conventional clinical methods. The SENSIMED Triggerfish® is indicated for patients 22 years of age and older.

Device Description

SENSIMED Triggerfish® diurnal recording system (hereinafter "STF") is a small patient-worn electronic device intended for use in the home and clinic settings for recording diurnal patterns of IOP fluctuations. The components of the STF are as follows: a hydrophilic, single-use soft contact lens with a strain gauge sensor, antenna with a telemetry chip embedded within it, allowing for continuous wireless recording of changes in ocular dimension, an external adhesive antenna worn around the eye is used to send power to, and receive measurement data from, the embedded system, a pocket-sized, battery-operated recorder worn by the patient during the 24-hour recording session, which is connected to the external adhesive antenna by a data cable. Additional components: charger to recharge the Recorder, Bluetooth universal serial bus (USB) adapter for communication between Recorder and doctor's personal computer (PC), and software for initiation recording sessions, and retrieval & display of the recorded data. The operating principle of the STF is based on the measurement of circumferential changes of the eye ball at the corneoscleral interface by an active strain gauge embedded into the periphery of a soft silicone contact lens ("ocular telemetry sensor"). During the 24-hour recording session, the sensor wirelessly transfers the data to the recording system. At the end of the recording session, all data can be transferred to the PC for review and analysis by a healthcare professional.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the hardware components and the principle of operation based on a strain gauge sensor. There is no mention of AI, ML, or any algorithms that would suggest their use in data analysis or pattern detection. The analysis of the recorded data is described as being for review and analysis by a healthcare professional.

Therapeutic

No
The device is indicated to "detect the peak patterns of variation in intraocular pressure...to identify the window of time to measure intraocular pressure by conventional clinical methods." It is a diagnostic device that aids in determining when to take measurements, not a device that treats a condition.

Diagnostic

Yes

The SENSIMED Triggerfish® is explicitly indicated "to detect the peak patterns of variation in intraocular pressure over a maximum period of 24 hours to identify the window of time to measure intraocular pressure by conventional clinical methods." This function of detecting patterns and identifying optimal measurement times for a health-related parameter falls under the definition of a diagnostic device.

SaMD (Software as a Medical Device)

The device description clearly outlines multiple hardware components including a contact lens with a sensor, external antenna, recorder, charger, and Bluetooth adapter, in addition to the software.

IVD (In Vitro Diagnostic)

Based on the provided information, the SENSIMED Triggerfish® is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes.
SENSIMED Triggerfish® Function: The SENSIMED Triggerfish® is a patient-worn electronic device that measures in vivo (within the living body) changes in ocular dimension at the corneoscleral interface. It does not analyze specimens taken from the body.
Intended Use: Its intended use is to detect patterns of variation in intraocular pressure in vivo to identify the best time for conventional in vivo IOP measurements.

Therefore, the SENSIMED Triggerfish® falls under the category of a medical device that interacts with the body in vivo, rather than an IVD which analyzes samples in vitro.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

PLZ

Device Description

The components of the STF are as follows:

트 a hydrophilic, single-use soft contact lens with a strain gauge sensor
. antenna with a telemetry chip embedded within it, allowing for continuous wireless recording of changes in ocular dimension

트 an external adhesive antenna worn around the eye is used to send power to, and receive measurement data from, the embedded system.

트 a pocket-sized, battery-operated recorder worn by the patient during the 24-hour recording session, which is connected to the external adhesive antenna by a data cable.

A schematic of the components of the STF worn by the patient is shown in Figure 2 and includes:

1. Ocular Telemetry Sensor
1. Antenna
1. Data Cable
1. Recorder

Additional components: (charger to recharge the Recorder, Bluetooth universal serial bus (USB) adapter for communication between Recorder and doctor's personal computer (PC), and software for initiation recording sessions, and retrieval & display of the recorded data

The operating principle of the STF is based on the measurement of circumferential changes of the eye ball at the corneoscleral interface by an active strain gauge embedded into the periphery of a soft silicone contact lens ("ocular telemetry sensor"). During the 24-hour recording session, the sensor wirelessly transfers the data to the recording system. At the end of the recording session, all data can be transferred to the PC for review and analysis by a healthcare professional.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Eye / Corneoscleral interface

Indicated Patient Age Range

22 years of age and older

Intended User / Care Setting

Prescription device intended for use in the home and clinic settings.
Healthcare professional.

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)

The applicant provided two ex vivo porcine eye studies to validate the measurements of the device. The objective of the studies was to demonstrate the ability of the contact lens sensor to detect dimensional changes in relation to physiological-scaled changes in simulated pressure in enucleated (i.e., ex vivo) pig eyes.

The first study was performed to validate the relationship between the output of the wired contact lens strain gauge sensor and changes in ocular volume in an enucleated pig eye. The study demonstrated a strong correlation (1-0.992) between the sensor output and the control manometric pressure, supporting the conclusion that the contact lens sensor can detect changes in volume in an enucleated pig eye that corresponds to physiological IOP changes b (4) CCI/TS D.

The second study was performed to substantiate the relationship between the output of the telemetric (wireless) contact lens sensor and changes in ocular volume in an enucleated pig eye. This study demonstrated the ability of the STF to detect dimensional changes in relation to physiological-scaled changes in IOP in an enucleated pig eye with both high sensitivity (i.e., ability to detect small simulated pressure pulsations) and high correlation (12 = 0.9935, simulated changes in IOP from b (4) CCI/TS ( D.

The primary data for clinical information are provided by two US studies:

Study TF-1005 - Glaucoma Suspects and Patients with Primary Open Angle Glaucoma (POAG)
- Study Design: Single-center, prospective, open label study. STF recordings were conducted for 24 hours on the same eye of glaucoma suspects and subjects with POAG during two consecutive sessions 6-9 days apart. Ophthalmic examination conducted and subjective comfort level assessed using VAS.
- Objective: To assess the safety and tolerability of the STF Sensor wear during a 24-hour period in glaucoma suspects and subjects with glaucoma.
- Sample Size: 41 subjects enrolled (25 male, 16 female, mean age 54.6 +/- 16.5 years). 22 glaucoma suspects, 19 diagnosed with glaucoma. 40 subjects completed the study for primary and secondary performance analysis. One subject removed the sensor during the first session but wore it for the full 24 hours in the second session.
- Key Results:
  - Mean duration of STF wear: 24.0 +/- 0.5 hours in the first session and 24.0 +/- 0.3 in the second session, equating to 80 24-hour exposures.
  - Six moderate or severe device-related slit lamp findings occurred in 4 subjects (out of 79 evaluable eyes). Ocular hyperemia (severe) was the most common (5.1%, 4/79 study eyes). No symptoms, problems, or complaints reported for the second session.
  - 100% of reported moderate and severe slit lamp findings resolved with no clinical sequelae. Mean time to resolution was 24.5 +/- 11.8 hours. No serious or unanticipated serious adverse device events reported.
  - No significant difference in VAS score between groups over the 2 sessions (p=0.336). No significant correlations between VAS and ocular hyperemia, gender, or use of topical IOP-lowering medication.
  - Mean change from baseline pachymetry was not significantly different. No subjects with abnormal corneal staining values showed corneal erosion.
  - Demonstrated repeatability of the mean 24-hour STF profiles in 31 glaucoma and glaucoma suspect subjects, with a strong intraclass correlation (ICC) (0.99) between the mean profiles from two different sessions one week apart.
Study TF-1009 - Healthy Subjects and Patients with POAG
- Study Design: Single-center, prospective, open label study. IOP pattern recorded for 24 hours using the STF in healthy subjects and subjects with POAG at a sleep laboratory facility.
- Objectives: To assess the safety and performance of STF in recording ocular dimensional profiles.
- Sample Size: Thirty-three subjects were enrolled. Data from all 33 subjects were included for the safety analysis. Data from 29 subjects were included in the primary analysis set for performance.
- Key Results:
  - Safety: 11 device-related slit lamp findings per eye analysis. 7 eyes of 33 (21.2%) showed moderate corneal staining. 1 eye (3.0%) and 3 eyes (9.1%) displayed moderate to severe injection (ocular hyperemia), respectively. No serious adverse events reported.
  - Primary Performance:
    - A positive slope was detected on STF profiles in the transition period from wake to sleep (W/S slope) in the study population.
    - The ocular pulse frequency (OPF) was stated to be within 15% of HR measurements in at least 70% of evaluable cases. The lower margin of the estimated confidence interval (CI) for accuracy of STF to detect the OPF was stated to be 75%. Due to large statistical measurement errors, these results are inconclusive.
    - "Although the study results are inconclusive for quantitative characterization of ocular pulsation profiles or W/S slopes, the results show the ability of the device to qualitatively capture (i) small and fast, and (ii) larger and slower patterns. The existence of predictable STF patterns supports the utility of the device as a tool for monitoring diurnal patterns of the IOP change as related to ocular dimensional changes."
  - Secondary Performance: Average subject tolerability was 3.7 on a 5-point scale (5 high acceptance; 1 low acceptance).
  - Subsequent analysis of TF-1009 dataset: Strong correlation (r=0.956, p

Regulation Number and Section

§ 886.1925 Diurnal pattern recorder system.

(a)
Identification. A diurnal pattern recorder system is a nonimplantable, prescription device incorporating a telemetric sensor to detect changes in ocular dimension for monitoring diurnal patterns of intraocular pressure (IOP) fluctuations.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance data must demonstrate that the device and all of its components perform as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:
(i) Ability of the device to detect diurnal changes.
(ii) Tolerability of the system at the corneoscleral interface in the intended use population.
(2) Nonclinical testing must validate measurements in an appropriate nonclinical testing model to ensure ability to detect changes in intraocular pressure.
(3) Patient-contacting components must be demonstrated to be biocompatible.
(4) Any component that is intended to contact the eye must be demonstrated to be sterile throughout its intended shelf life.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Performance testing must demonstrate the electromagnetic compatibility and electromagnetic interference of the device.
(7) Performance testing must demonstrate electrical safety of the device.
(8) Labeling must include the following:
(i) Warning against activities and environments that may put the user at greater risk.
(ii) Specific instructions for the safe use of the device, which includes:
(A) Description of all device components and instructions for assembling the device;
(B) Explanations of all available programs and instructions for their use;
(C) Instructions and explanation of all user-interface components;
(D) Instructions on all safety features of the device; and
(E) Instructions for properly maintaining the device.
(iii) A summary of nonclinical testing information to describe EMC safety considerations.
(iv) A summary of safety information obtained from clinical testing.
(v) Patient labeling to convey information regarding appropriate use of device.

Summary

DE NOVO CLASSIFICATION REQUEST FOR SENSIMED TRIGGERFISH®

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Diurnal Pattern Recorder System. A diurnal pattern recorder system is a nonimplantable, prescription device incorporating a telemetric sensor to detect changes in ocular dimension for monitoring diurnal patterns of intraocular pressure (IOP) fluctuations.

NEW REGULATION NUMBER: 21 CFR 886.1925

CLASSIFICATION: Class II

PRODUCT CODE: PLZ

BACKGROUND

DEVICE NAME: SENSIMED Triggerfish®

SUBMISSION NUMBER: DEN140017

DATE OF DE NOVO: May 6, 2014

CONTACT: SENSIMED AG Route de Chavannes 37 1007 Lausanne Switzerland

REQUESTER'S RECOMMENDED CLASSIFICATION: Class II

INDICATIONS FOR USE

LIMITATIONS

SENSIMED Triggerfish® is a prescription device intended for use in the home and clinic settings. The clinical utility of SENSIMED Triggerfish® is limited to identifying the potential time period of the diurnal increases of intraocular pressure (IOP) in patients with glaucoma and those suspected of having glaucoma.

SENSIMED Triggerfish® is an adjunctive tool to tonometry. Diagnostic or treatment decisions taken by the healthcare professional shall only rely on traditional tools and methodologies.

Contraindications

Active eye disease, eye injury or eye abnormality affecting the cornea, conjunctiva, or . evelids
. Patient history of eye or eyelid infections including sties or history of adverse events associated with wearing contact lenses, or intolerance, or abnormal ocular response to contact lenses
Active inflammation of the eye ●
Active infection of the eye
Corneal vascularization
Insufficiency of lachrymal secretion ●
Corneal hypoesthesia ●
. Known allergy to silicone

Select Warnings and Precautions

The sensor is intended for use on the surface of the eye. Do not implant the sensor. ●
The sensor is not intended for wear beyond the 24-hour assessment period. ●
The patient should not drive vehicles or handle dangerous machinery while wearing the ● sensor.
The sensor is intended for single-patient, one-time use and should not be re-sterilized.

PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS

DEVICE DESCRIPTION

Image /page/2/Picture/1 description: The image shows a Sensimed Triggerfish device. The device consists of a black rectangular box with the Sensimed Triggerfish logo on the front, a cable, and a sensor. The sensor is attached to a tan-colored contact lens with a circular opening in the center.

Figure 1: STF Diurnal Pattern Recorder System

The components of the STF are as follows:

트 a hydrophilic, single-use soft contact lens with a strain gauge sensor
. antenna with a telemetry chip embedded within it, allowing for continuous wireless recording of changes in ocular dimension

트 an external adhesive antenna worn around the eye is used to send power to, and receive measurement data from, the embedded system.

트 a pocket-sized, battery-operated recorder worn by the patient during the 24-hour recording session, which is connected to the external adhesive antenna by a data cable.
Image /page/2/Picture/9 description: The image shows a person wearing a device on their head with numbers indicating different parts. Number 1 points to the top of the device, while number 2 points to the bottom of the device near the eye. Number 3 points to the strap around the person's neck, and number 4 points to the device hanging from the strap on the person's chest.

Figure 2: Main components of STF

A schematic of the components of the STF worn by the patient is shown in Figure 2 and includes:

1. Ocular Telemetry Sensor
1. Antenna
1. Data Cable
1. Recorder

Image /page/3/Figure/0 description: The image shows patient-wearable components, including an ocular telemetry sensor, right and left antennas, and a portable recorder. The ocular telemetry sensor (1) includes components such as a strain-gauge (passive), microprocessor, three-loop antenna, and strain-gauge (active). There are right and left antennas (2) and a portable recorder (4) labeled SENSIMED Triggerfish.

SUMMARY OF NONCLINICAL/BENCH STUDIES

PERFORMANCE

The experimental setups of both studies used cannulated porcine eves; for each eve, the STF contact lens was placed on the cornea and the cannula was connected to a manometric pressure sensor and a svringe which could effect changes in volume of the solution in the system.

SHELF LIFE/STERILITY

The contact lens with embedded telemetry sensor is packaged in b (4) CCI/TS

) to ensure a Sterility Assurance Level (SAL) of 10 . The process was validated in a small steam sterilizer in accordance with ISO 11737-2:2009 "Sterilization of medical devices – Microbiological methods -Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process."

Shelf life testing was performed following real time storage at ambient conditions to establish a 24-month shelf life. The testing was conducted in accordance with ISO 11607-1:2006 "Packaging for terminally sterilized medical devices - Part 1 : Requirements for materials, sterile barrier systems, and packaging Systems" and ISO 11737-2:2009.

BIOCOMPATIBILITY/MATERIALS

The ocular telemetry sensor is fully embedded in a silicone elastomer. which is widely used in a variety of medical devices. The company provided sufficient evidence that the patient-contacting materials (i.e., silicone elastomer) of the device are biocompatible.

Specifically, the biocompatibility assessment of the silicone elastomer was conducted per ISO 10993-1:2009 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within A Risk Management Process" for mucosal membrane contacting devices with limited contact duration. In addition, the company conducted cytotoxicity (as per ISO 10993-5:2009), irritation, and sensitization tests (ISO 10993-10:2010) to demonstrate that the silicone elastomer is biocompatible. The applicant also conducted chemical analysis of leachables and extractables for the STF final finished ocular telemetry sensor. The extracts were analyzed quantitatively and qualitatively by by b (4) CCITS The amount of organic substances in the extracts was below the limit of quantification ). (4)

The antenna is composed of medical grade foamb (4) CCI/TS ) and hypoallergenic adhesive tape b (4) CCM The foam and the adhesive are not in contact with the eye, only with surrounding skin. The biocompatibility information for the antenna and medical grade adhesive was based on the long history of safe use of these materials for medical devices and cytotoxicity testing conducted per ISO 10993-5:2009. Based on the well-established biocompatibility and common use of these materials, further biocompatibility testing is not necessary.

ELECTROMAGNETIC COMPATIBILITY AND ELECTRICAL SAFETY

Verification testing was performed according to IEC 60601-1-2:2007 "Medical electrical equipment Part 1: General requirements for basic safety and essential performance," including compliance with US National differences. Electromagnetic compatibility of the device was supported by demonstrating compliance with the Electromagnetic Compatibility standard IEC 60601-1-2:2014 tested for the home healthcare environment. This included an evaluation of potential interference to and by the STF device from Bluetooth communication.

MAGNETIC RESONANCE (MR) COMPATIBILITY

The STF device is labeled as "MR Unsafe."

SOFTWARE

The software is considered to be a minor level-of-concern. This software is intended to accomplish the four high-level functions described below:

. Enable the user to configure the STF recorder device for a measurement session
Control the functional operations of the STF device ●
Retrieve measurement data from the recorder device and save the data in an . encrypted format on a PC
. Enable the user to visualize the measurement data using chart plots; enable the user to edit some information in the data and add metadata information to the data

To accomplish the above functions, the sensor contains an embedded microprocessor, the recorder contains firmware, and the desktop computer contains software to operate the Bluetooth service, software to interact with the recorder, and software to display/store data.

The application included the following software-related documents, which are sufficient:

. Software Description
Device Hazard Analysis .
. Software Requirements Specifications
Architecture Design Chart ●
. Design Specifications
Traceability Analysis/Matrix
Verification and Validation testing
Revision Level History ●

SUMMARY OF CLINICAL INFORMATION

The primary data are provided by two US studies:

1. Study TF-1005 - Glaucoma Suspects and Patients with Primary Open Angle Glaucoma (POAG)

Study Design: The study was a single-center, prospective, open label study in which STF recordings were conducted for 24 hours on the same eye of glaucoma suspects and subjects with POAG during two consecutive sessions 6-9 days apart. Upon completion of each recording session, an ophthalmic examination was conducted and subjects were asked to score their subjective comfort level using visual analogue scale (VAS) scale. The study aimed to accrue 20 eligible subjects of each of the two aforementioned populations, equating to a total of 40 subjects.

Objective: The objective of the study was to assess the safety and tolerability of the STF Sensor wear during a 24-hour period in glaucoma suspects and subjects with glaucoma.

Endpoints: Safety endpoints included adverse events, those that were device-related, and categorized by severity, resolution, and whether concomitant medications were employed. The primary endpoint for tolerability was the assessment of ocular discomfort using VAS (0 mm -no discomfort) to 100 mm -very severe discomfort) immediately after the end of the 24hour sensor wear period. The primary endpoint was measured twice for each subject, once after each of 2 sessions. The secondary performance endpoints included best corrected visual acuity (BCVA), pachymetery, corneal staining, and ocular hyperemia.

Data Analysis: For each subject VAS was used to assess comfort.

RESULTS:

A total of 41 subjects (25 male and 16 female, mean age 54.6 ±16.5 years) were enrolled in the study over an 8-month time frame. Out of the 41 subjects enrolled, 22 were glaucoma suspects and 19 were subjects diagnosed with glaucoma.

One subject in the glaucoma suspect group did not complete the study due to improper device fitting on the day of the first monitoring session and therefore, was excluded from the primary and secondary performance analysis sets. Thus, 40 subjects completed the study. One subject in the glaucoma group removed the sensor during the first session, but wore the sensor for the full 24-hour period on the second sessions were included in the analysis for safety, but the first session was excluded from the performance analysis. This occurrence does not affect the validity of the results as the study was designed to assess the safety and tolerability of the device rather than the effectiveness.

The mean duration of STF wear was 24.0 ±0.5 hours in the first session and 24.0±0.3 in the second session, hence equating to 80 24-hour exposures to STF.

Six device-related slit lamp findings of moderate or severe intensity occurred in a total of 79 evaluable eyes in 4 subjects (enrolled). Ocular hyperemia (severe) was the most common slit lamp finding, occurring in 4 (5.1%, 4/79) study eyes. No symptoms, problems and complaints were reported for subjects undergoing a second 24-hour ocular dimension recording session a week after the initial session.

Of all reported moderate and severe slit lamp findings, 100% resolved with no clinical sequelae. The mean time to resolution was 24.5±11.8 hours post utilization of the STF. There were no serious or unanticipated serious adverse device events reported in this study.

Comparison of the VAS score by group over the 2 sessions vielded no significant difference (p=0.336). No significant correlations were found between VAS and presence of ocular hyperemia, gender, or use of topical IOP-lowering medication.

Mean change from baseline pachymetry was not significantly different in both sessions, for each of the groups and for both groups combined. None of the subjects with abnormal corneal staining values showed corneal erosion.

Furthermore, Study TF-1005 demonstrated repeatability of the mean 24-hour STF profiles in 31 glaucoma and glaucoma suspect subjects, with a strong intraclass correlation (ICC) (0.99) between the mean profiles from two different sessions one week apart among all subjects.

2. Study TF-1009 - Healthy Subjects and Patients with POAG

Study Design: The study was a single-center, prospective, open label study in which the IOP pattern was recorded for 24 hours using the STF in healthy subjects and subjects with

POAG. The study was conducted at a sleep laboratory facility. The study aimed to accrue 30 eligible subjects.

Objectives: The objectives of this study were to assess the safety and performance of STF in recording of ocular dimensional profiles. The safety endpoints include all adverse events (AEs), including serious adverse events (SAEs). The primary performance endpoints include: 1) an ability of STF to detect wake-to-sleep (W/S) slope from one hour preceding the time of dark period initiation (going to bed) to one hour after, and 2) percentage difference between frequency of ocular pulsation as recorded by STF and the heart rate (HR) as determined by pulse frequency assessment scored dichotomously at each pair of parallel measurements. 1

The secondary performance endpoints included subject's tolerability (acceptance) of STF, which was measured by questionnaire and presented descriptively on a 5-point analog scale where 5 indicates high acceptance of STF and 1 indicates low acceptance.

Subjects: Thirty (30) eyes of 30 subjects showing at least 3 mmHg difference between wake and sleep IOP were to be enrolled in the investigation. Should some subjects exhibit less than 3 mmHg difference between wake and sleep IOP, additional subjects were enrolled until 30 valid subjects were available. Healthy subjects (including subjects with ocular hypertension) and POAG subjects (including subjects with normal tension glaucoma) were eligible for the study.

Methods: Study subjects remained in a sleep laboratory environment throughout the 24hour STF recording session. All participating subjects received a comprehensive ophthalmic examination before and after STF recordings. Pneumatonometry measurements were taken every 2 hours in the non-STF eye throughout the sleep laboratory housing. HR measurements were collected in the sleep period. Safety was evaluated through the collection of AEs, including serious adverse events (SAEs).

Results: Thirty-three subjects were enrolled in the study. In accordance with the protocol, 4 subjects (out of 33 subjects) were excluded from the primary analysis dataset. The exclusions were made for the following reasons: less than 80% of valid STF measurements were obtained within one hour before/after dark period (n=2), change of IOP from wake/sitting to sleep/supine as measured by tonometry between was less than 3 mmHg (n=1) and invalid STF recording (n=1). The data from all 33 subjects were included for the safety analysis dataset, while data from 29 subjects were included in the primary analysis set for performance.

1 The STF device is not for the detection of the ocular pulse. The comparison of STF output to HR was done to demonstrate the ability of STF to capture small and fast changes by recording a physiologic phenomenon.

Safety:

Per eye analysis of Study TF-1009 reveals that there were a total of 11 device-related slit lamp findings. Seven (7) eyes of 33 (21.2%) displayed moderate corneal staining; and 1 eye (3.0%) and 3 eyes (9.1%) displayed moderate to severe injection (ocular hyperemia), respectively. However, no serious adverse events were reported.

Primary Performance

1. A positive slope was detected on STF profiles in the transition period from wake to sleep (W/S slope) in the study population.
The ocular pulse frequency (OPF) was stated to be within 15% of HR measurements in 2. at least 70% of evaluable cases. In addition, the lower margin of the estimated confidence interval (CI) for accuracy of STF to detect the OPF was stated to be 75%. when using evaluable cases. However, due to large statistical measurement errors, the results are inconclusive.

Although the study results are inconclusive for quantitative characterization of ocular pulsation profiles or W/S slopes, the results show the ability of the device to qualitatively capture (i) small and fast, and (ii) larger and slower patterns. The existence of predictable STF patterns supports the utility of the device as a tool for monitoring diurnal patterns of the IOP change as related to ocular dimensional changes.

Secondary Performance

The average subject tolerability was 3.7 on a 5 point scale (5 high acceptance; 1 low acceptance).

In a subsequent analysis of the TH-1009 dataset, a strong correlation (r=0.956, p