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The FSYXTM Ocular Pressure Adjusting Pump is indicated for the reduction of Intraocular Pressure (IOP) during sleep in adult patients with open-angle glaucoma and IOP ≤ 21 mmHg who are currently using or have undergone another IOP-lowering treatment.

Device Description

The FSYX™ Ocular Pressure Adjusting Pump System is comprised of two distinct elements, the programmable pump and the goggles with tubing. The FSYX™ Ocular Pressure Adjusting Pump System is designed to allow the application and monitoring of bilateral negative pressure (NP) in the microenvironment in front of a patient's eves.

The FSYX™ Ocular Pressure Adjusting Pump System goggles are designed to fit and seal around the eyes of patients, creating an air-tight chamber in which NP can be created and maintained. A headstrap is included with the goggles to facilitate reliable positioning on the patient's face during sleep. The goggles can be connected and disconnected from the FSYXM Ocular Pressure Adjusting Pump to allow for daily cleaning. FSYX™ Ocular Pressure Adjusting Pump System goggles should be replaced every 30 days.

The FSYX™ Ocular Pressure Adjusting Pump houses 2 miniature diaphragm pumps that produce programmable NP pressure levels independently for each eye. The pumps are connected to a manifold that pneumatically interfaces the connector integral to the tubing system of the goggles. The manifold also mechanically and pneumatically connects a plurality of pressure sensors and relief valves. To create NP for each goggle lens, a pump extracts air from the cavity created by the goggle and the patient's face. The pump is pneumatically connected to the goggle through a negative pressure line comprised of a tube, a portion of the connector, and a portion of the manifold. The air extracted from the goggle is evacuated from the FSYX™ Ocular Pressure Adjusting Pump through a pneumatic path integral to the manifold. For each individual gogle. there is a separate pump and NP line, which allows independent NP application treatments for each eye.

The NP inside each goggle is monitored by a pressure sensor that is pneumatically connected to the respective goggle through a sense line. The NP and sense lines for each goggle are pneumatically connected proximal to the goggle cavity; this ensures that creation and monitoring of the NP level in each goggle can occur independently. The signal from each sensor is used in a separate Proportional-Integral-Derivative (PID) control loop for each pump so that the applied NP matches the value entered by the treating physician. If leaks exist at the interface between the seal and the patient's skin. NP is reduced and the PID controller increases rotational speed of the pump to counterbalance the leak and reestablish the prescribed NP level.

An additional differential pressure sensor is connected to each of the two independent sense lines to ensure that the differential signal matches the arithmetic difference between the NP levels set for the treatment of each eye and the actual NP levels sensed in each eye. An alarm is generated if the measured difference substantially departs from the arithmetic one.

For each independent NP line, a relief valve is also provided to mechanically limit the maximum allowable applied NP to a level

AI/ML Overview

Here's a detailed breakdown of the FSYX Ocular Pressure Adjusting Pump System's acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion	Reported Device Performance
Clinical Performance - Efficacy	Primary Endpoint: Proportion of eyes with IOP reduction of 20% or greater at 52 weeks (Visit 8) as measured via pneumotonometry with Excursion goggles worn from "before" to "during" application of negative pressure during in-clinic visit in the treated group compared to the control group. (Pre-specified hypothesis: treated group higher than control group at a one-sided alpha level of 0.025).	With all missing values imputed as "non-responders," 58.1% (54/93) of study eyes achieved ≥ 20% reduction in IOP during NP application, as compared to 1.1% (1/93) of control eyes. This difference was **statistically significant (p 2.5 dB in 7 participants at Week 26 (4 study eyes, 5 control eyes) and 4 participants at Week 52 (3 study eyes, 3 control eyes). Many VF data points were insufficient for analysis. Glaucoma progression was not determined in remaining analyzable eyes.
Retinal Nerve Fiber Layer (RNFL) thickness: Unchanged between baseline and Week 52 in study eyes. Thinning >5 um in 8% study eyes, 11% control eyes, with no associated VF loss. No signs or symptoms of hypotony were reported. Higher programmed NP levels contributed to a higher incidence of AEs.
Non-Clinical Performance	Device performs as intended under anticipated conditions of use. Includes:

Independent control of pressure for each goggle within ±1 mmHg.
Exposure to pressure of -40 mmHg shall not exceed 10 seconds.
Logging patient usage and compliance data gathered over a period of six months of daily 8-hour usage.
Noise level of 100,000 cycles.
Over Pressure Valve Flow Test verified system maintains pressure at or above -40mmHg if relief valve activated.
Goggle Verification (Mechanical Integrity Testing): Seal integrity, tubing joint strength, nose bridge joint strength, lens bonding integrity all met requirements.
Goggle Kink Resistance testing showed inner vacuum line occludes before sensor line, preventing over-pressurization.
Design Verification testing on the identical MPD Gen2 system confirmed:
Independent pressure control within ±1 mmHg.
Max exposure to -40 mmHg not exceeding 10 seconds.
Logging of patient usage and compliance data over 6 months of daily 8-hour use.
Noise level

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