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510(k) Data Aggregation
(307 days)
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.
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 < 40 mmHg. The device is meant to be used at home. worn overnight while the patient sleeps.
The Physicians App is an integral component to the FSYX™ Ocular Pressure Adjusting Pump System that allows the physician to program the FSYX™ Ocular Pressure Adjusting Pump with specific patient treatment parameters and to review patient wear information. Instructions on how to use the Physicians App preloaded onto a preconfigured laptop is available. Once programmed the FSYX™ Ocular Pressure Adjusting Pump can be activated by the patient at home via the touch-screen interface. Treatment programming is only possible via the Physicians App. The FSYX™ Ocular Pressure Adjusting Pump touch-screen interface only allows for patients to 1) start the treatment; 2) view treatment settings; and/or 3) pause and resume the treatment or completely stop the treatment after pausing.
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 < 0.001). |
| Secondary Endpoint: Proportion of eyes in the mITT population with Week-52 sleep lab IOP (measured supine during NP application) reduction of 20% or greater compared to baseline IOP 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," 63.4% (59/93) of study eyes achieved ≥ 20% reduction in IOP compared to 3.2% (3/93) of control eyes. This difference was statistically significant (p < 0.001). | |
| Clinical Performance - Safety | Adverse events, including all ocular and periorbital events, worsening of visual field, and assessment of ocular tissue damage are acceptable. | Ocular AEs: 39 reports in 25 study eyes (26.9%). Most frequent: lid edema (11.8%), dry eye (5.4%), conjunctival hyperemia (4.3%), eye pain (3.2%). 24 ocular AEs in 19 study eyes were device-related. Periorbital AEs: 20 reports in 17 study eyes (18.3%). Most frequent: periorbital edema (12.9%), periorbital contact dermatitis (4.3%). All study-eye periorbital AEs were device-related and resolved. Visual Field (VF) MD: Worsening >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 <40 Db at 1 meter distance during treatment with no leakage through the goggle seals. | Verification and Validation testing confirmed the Ocular Pressure Adjusting Pump met performance criteria. Pressure Release Valve Cycle Test verified regulated release pressure and >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 <40 Db at 1 meter. |
| Biocompatibility | Patient-contacting components must be demonstrated to be biocompatible. | Performed in accordance with ISO 10993-1, -5, -10. All tests were performed in accordance with GLP. Evaluation found acceptable. |
| Software/Cybersecurity | Software verification, validation, and hazard analysis performed. Validation for programmable treatment parameters. Documentation includes programmable treatment limits and mitigation measures for failures. Device is cyber-secured. | Documentation classified as "Enhanced Documentation." Provided software description, architecture, design specifications, risk assessments, V&V testing. Met recommendations in FDA guidance documents. Hazard analysis characterized software and cybersecurity risks; V&V testing addressed these with satisfactory results. Cybersecurity documentation included threat modeling, security architecture, hazard analysis, mitigation controls, vulnerability/penetration testing, post-market plan. Evaluation found acceptable. |
| Electrical, Thermal, Mechanical Safety & EMC | Performance testing must demonstrate EMC and electrical, thermal, and mechanical safety in the intended use environment. | Electrical Safety and EMC testing performed per IEC 60601-1, IEC 60601-1-11, IEC 62133, IEC 60601-1-2. Testing supported electrical safety, pump life, EMC, battery capacity/transport/safety, and RFID immunity. Evaluation found acceptable. |
| Human Factors | Testing must demonstrate that intended users can correctly use the device, based solely on labeling. | Formative usability study (13 glaucoma/ocular hypertension patients, US) evaluated ease of use, unanticipated use errors, patient satisfaction. Summative label comprehension and usability study (20 participants: 11 patients, 9 caregivers) involved training, post-training delay, and testing (written exam, device demonstration). Supercritical task: maintaining a seal. Risks lowered to acceptable level. Results demonstrated use-safety and effectiveness of the user interface. |
| Labeling | Labeling must include: - Warnings regarding negative pressure and treatment duration limitations. - A summary of clinical performance testing, study population, results, and adverse events. | Labeling is sufficient per 21 CFR 801.109. Separate instructions for patients (with Quick Start Guide and Goggle Fitting Guide) and healthcare professionals (with Physicians Application Quick Start Guide). Includes warnings about treatment duration (6-8 hours) and NP levels (≥ -17 mmHg). Includes a summary of the clinical study procedures, patient population, and results. |
2. Sample Size Used for the Test Set and Data Provenance
The primary clinical study, named the "Artemis" study, served as the test set for the device's efficacy and safety.
- Sample Size: The modified intent-to-treat (mITT) population consisted of 93 participants.
- Data Provenance: The study was a prospective, longitudinal study conducted at 11 sites in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided text does not specify the number of experts or their qualifications for establishing the ground truth for the test set. The clinical study involved IOP measurements using Goldmann applanation tonometry (GAT) and pneumotonometry, which are standard clinical procedures performed by trained medical professionals (opthalmologists, optometrists, etc.). However, there's no mention of a separate "expert consensus" process for establishing ground truth beyond these clinical measurements. The investigators at the 11 sites would have been qualified medical professionals.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the test set data. The clinical study collected quantitative measurements (IOP) and adverse event reports. Adverse events were reported and classified, but the process for resolving discrepancies or reaching expert consensus on specific cases within the study data is not detailed as a separate adjudication step.
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
There was no MRMC comparative effectiveness study done. This device is a physical pump system that directly applies negative pressure to the eye, not an AI-assisted diagnostic or interpretative tool that would involve human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" is not applicable here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a standalone performance of the device itself, as it is not an AI algorithm.
- Yes, a standalone performance study was done. The "Artemis" study evaluated the device's ability to reduce IOP when applied directly to the eye, with physicians programming initial settings and making adjustments based on clinical data and patient comfort. There isn't a "human-in-the-loop" aspect in the sense of a continuous real-time interaction for every measurement; the device operates independently to apply the programmed negative pressure for a set duration. The primary and secondary endpoints directly assessed the device's performance in achieving IOP reduction.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the efficacy endpoints was based on direct physiological measurements (Intraocular Pressure reduction) obtained through validated clinical methods (pneumotonometry and Goldmann applanation tonometry). For safety, the ground truth was based on reported adverse events as determined by clinical observation and patient reports, and objective measures like BCDVA, slit-lamp, ophthalmoscopy, VF, and OCT imaging.
8. The Sample Size for the Training Set
The provided text does not explicitly mention a separate "training set" for the device in the context of an algorithm or AI. The "Artemis" study served as the pivotal clinical study, analogous to a validation or test set for demonstrating efficacy and safety. Device development and initial performance testing (non-clinical) would have involved internal testing and iterative design, but this is not typically referred to as a "training set" in the way an AI model would have one.
9. How the Ground Truth for the Training Set Was Established
As there's no explicitly defined "training set" for an algorithm in the provided information, the concept of establishing ground truth for it is not applicable. The device's "training" in a functional sense would have occurred during its engineering design, development, and numerous non-clinical performance tests (e.g., pressure control, seal integrity, noise levels, software V&V), where its intended performance specifications served as the targets for achieving "truth."
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