(167 days)
The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.
The Sight Sciences OMNI Surgical System (with modified indication) is a handheld, manually operated device used by ophthalmologists to access, microcatheterize, and viscodilate Schlemm's canal ("canaloplasty") and to re-access Schlemm's canal and cut trabecular meshwork tissue ("trabeculotomy"). The OMNI Surgical System is provided sterile and disposed after single-patient use. The device is fabricated from biocompatible materials standard to the medical device industry. Each OMNI Surgical System device dispenses fluid on the principle of exchanging volumes much like a syringe and is designed to function with commercially available cohesive viscoelastic fluids (also known as ophthalmic viscosurgical device, or "OVD").
The OMNI Surgical System device includes a stainless-steel cannula, polymeric microcatheter, removable priming lock, internal reservoir and plunger tube, a Luer fitting for direct connection with an OVD cartridge to prime the internal reservoir, and two advancement wheels. A single advancement wheel is located on each side of the handle. This allows the OMNI Surgical System device to be used in either eye (OD or OS) and in either hand of the surgeon (left or right), by turning the device 180 degrees along its vertical axis. These wheels are used to advance and retract the microcatheter.
The stainless-steel cannula has a curved shape with a beveled tip for entry through the trabecular meshwork into Schlemm's canal. To perform the combined and sequential canaloplasty/trabeculotomy procedures, the canaloplasty is performed first, followed by trabeculotomy as explained in further detail below.
Performing Canaloplasty First: the microcatheter is advanced into Schlemm's canal up to 180 degrees (one hemisphere) by rotating the advancement wheel forward until the wheel stops (about 20mm). When the device is being used to deliver viscoelastic fluid, retraction of the microcatheter causes the plunger tube to advance into the viscoelastic fluid reservoir thereby automatically dispensing viscoelastic fluid along the length of Schlemm's canal and collector channels. The microcatheter can be advanced/retracted up to 20 mm per cycle by manually rotating the advancement wheel. The microcatheter can be fully advanced/retracted multiple times, however, viscoelastic fluid can only be dispensed during the first two advancement/retraction cycles in order to dispense viscoelastic fluid along each hemisphere of Schlemm's canal. Thus, the OMNI Surgical System device is designed to be used twice within Schlemm's canal to deliver a controlled volume of viscoelastic fluid along the first 180 degrees of the canal, followed by a second delivery of viscoelastic fluid along the other 180 degrees. The OMNI Surgical System delivers a total viscoelastic fluid volume of 11 microliters throughout Schlemm's canal (approximately 5.5 microliters for each of the first two advancement/retraction cycles).
Performing Trabeculotomy Second: the beveled tip of the curved stainless-steel cannula is repositioned into the same Schlemm's canal location after finishing canaloplasty. The polymeric microcatheter is re-advanced into Schlemm's canal up to 180 degrees (one hemisphere) by rotating the advancement wheel forward until the wheel stops (about 20 mm). With the microcatheter resting in the canal, the cannula is removed from the corneal incision and out of the eye causing the microcatheter to cut through the trabecular meshwork. This process can be repeated in the second Schlemm's hemisphere.
The provided text describes the OMNI® Surgical System and its substantial equivalence to a predicate device, focusing on bench testing and clinical evidence rather than explicitly defining acceptance criteria and subsequent studies in the typical AI/ML context. This document is a 510(k) summary for a medical device (infusion pump), not an AI/ML device. Therefore, the questions related to AI/ML device performance (like experts for ground truth, adjudication methods, MRMC studies, standalone performance, training sets) are not directly applicable or answerable from the provided text.
However, I can extract information related to the device's performance based on the clinical study.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a non-AI/ML medical device, there aren't explicit acceptance criteria in the way one would define them for an AI/ML algorithm (e.g., target specificity, sensitivity, etc.). Instead, the device's performance is demonstrated through its ability to reduce intraocular pressure (IOP) and its safety profile, which are compared against a historical control and expected outcomes. The key performance indicators evaluated were IOP reduction and medication reduction.
| Performance Metric | Acceptance Criteria (Implicit from Study Design/Objectives) | Reported Device Performance (ROMEO Study) |
|---|---|---|
| Effectiveness: IOP Reduction | Clinically significant IOP reduction in adult patients with primary open-angle glaucoma, sustained up to 12 months. (Compared against Lewis 2007 literature control). | +Cataract Group (Baseline IOP ≥ 16 mmHg, n=45): |
- Baseline Mean IOP: 19.5 ± 3.8 mmHg
- 12 Month Mean IOP: 15.2 ± 3.0 mmHg
Standalone Group (Baseline IOP ≥ 16 mmHg, n=38): - Baseline Mean IOP: 20.0 ± 3.6 mmHg
- 12 Month Mean IOP: 15.3 ± 2.7 mmHg
Responders (≥ 20% IOP reduction at 12 months, no medication increase, no secondary surgery): - Standalone (Pre-op IOP > 18 mmHg): 58.3% (14/24)
- Standalone (Lewis criteria, Baseline IOP ≥ 16 mmHg): 45.7% (16/35)
- +Cataract (BL > 18 mmHg): 62.5% (15/24)
- +Cataract (Lewis criteria, Baseline IOP ≥ 16 mmHg): 43.5% (20/46) |
| Effectiveness: Medication Reduction | Reduction in the number of ocular hypotensive medications or at least no increase. | All Patients (n=129): - Baseline Mean Medications: 1.8 ± 1.3
- 12 Month Mean Medications: 1.1 ± 1.2 |
| Safety and Adverse Events | Adverse events should be infrequent, mild, non-serious, transient, and consistent with those expected in the target population. No serious device-related adverse events. | Adverse events were generally infrequent, mild, non-serious, transient, and resolved with or without treatment. No serious adverse events or serious device-related adverse events reported.
Most common (12-month visit): Posterior capsular opacity (14.7%), Mild anterior chamber inflammation (10.9%), Cystoid macular edema (5.4%), Corneal edema (4.7%), IOP increase ≥ 10 mmHg above baseline >30 days postoperative (4.7%), Hyphema > 1 mm (3.9%). |
| Secondary Surgical Interventions | Acceptable rate of re-intervention. | 7.0% (9/129 eyes) required secondary surgical intervention to reduce IOP. - +Cataract: 4.9% (4/81)
- Standalone: 10.4% (5/48) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size:
- Clinical Study (ROMEO): 129 patients with a single qualifying eye.
- +Cataract group: 81 procedures
- Standalone group: 48 procedures
- Bench Testing (Cadaver Eyes): 4 cadaver eyes, using 8 OMNI Surgical System devices.
- Clinical Study (ROMEO): 129 patients with a single qualifying eye.
- Data Provenance:
- Clinical Study (ROMEO): Retrospective, observational, multi-center, single-arm, consecutive case series study conducted at 11 sites throughout the U.S.
- Bench Testing: Human cadaver eyes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This is not applicable as the device is a surgical instrument, not an AI/ML diagnostic or prognostic device requiring expert-established ground truth on a test set. The clinical performance data involves measuring physiological parameters (IOP) and observing real-world outcomes over time. The "ground truth" here is the clinical efficacy and safety observed in patients. The document mentions the study was performed by an ophthalmologist and a physician assistant during cadaver eye testing.
4. Adjudication Method for the Test Set
Not applicable for this type of medical device study. Data collected in the ROMEO study would have followed standard clinical trial data collection and monitoring practices, but not specific adjudication for ground truth in the AI/ML sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a manually operated surgical instrument.
7. The Type of Ground Truth Used
- Clinical Study (ROMEO): The "ground truth" for effectiveness was direct physiological measurement (intraocular pressure, number of medications) and observed clinical outcomes (adverse events, need for secondary surgery) in live human patients. The study compared its findings to a reference literature control (Lewis RA, von Wolff K, Tetz M, Kearney JR, Shingleton B, Samuelson TW. Canaloplasty: circumferential viscodilation and tensioning of Schlemm's canal using a flexible microcatheter for the treatment of open-angle glaucoma in adults: interim clinical study analysis. J Cataract Refract Surg. 2007 Jul;33(7):1217-26.)
- Bench Testing (Cadaver Eyes): The ground truth was the validated ability of an ophthalmologist to perform the intended surgical steps (access, microcatheterize, viscodilate, cut trabecular meshwork) using the device in cadaveric tissue as per the Instructions For Use.
8. The Sample Size for the Training Set
Not applicable. This is a non-AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a non-AI/ML device.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).