(28 days)
The OMNI® PLUS Surgical System is an ophthalmic surgical tool for the delivery of controlled amounts of viscoelastic fluid into the anterior segment and the cutting of trabecular meshwork when a trabeculotomy is indicated.
The OMNI PLUS Surgical System is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small, controlled amounts of viscoelastic fluid into the anterior segment of the eye during ophthalmic surgery and cut trabecular meshwork tissue during trabeculotomy procedures. The OMNI PLUS device is provided sterile and disposed after singlepatient use. The device is fabricated from biocompatible materials standard to the medical device industry. The OMNI PLUS Surgical System dispenses fluid on the principle of exchanging volumes much like a syringe and are designed to function with commercially available cohesive viscoelastic fluids (also known as an ophthalmic viscosurgical device, or "OVD") that are commercially available from companies such as Johnson & Johnson, Bausch & Lomb, and Alcon.
The OMNI PLUS 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 PLUS 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 microcatheter can be advanced/retracted up to 20 mm per cycle by manually rotating either 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. When the OMNI PLUS device is being used to deliver viscoelastic fluid, retraction of the microcatheter causes a plunger tube to advance into the viscoelastic fluid reservoir thereby automatically dispensing viscoelastic fluid as the microcatheter is being retracted back into the stainless-steel cannula.
When the OMNI PLUS Surgical System is used to perform a trabeculotomy procedure, the beveled tip of the curved stainless-steel cannula is used to enter Schlemm's canal through the trabecular meshwork. The polymeric microcatheter is 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 OMNI PLUS Surgical System is an additional model based on the current OMNI Surgical System design; OMNI PLUS is designed to dispense a nominal volume of 21 microliters of viscoelastic fluid.
The provided text describes a 510(k) premarket notification for the OMNI® PLUS Surgical System, classifying it as an Infusion Pump. This document focuses on demonstrating substantial equivalence to a predicate device (OMNI® Surgical System, K173332) through non-clinical bench testing. It does not contain information about studies involving AI, human readers, or clinical ground truth.
Here's the information gleaned from the text as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance statistics in a traditional format. Instead, it describes various performance evaluations that were performed to demonstrate that the OMNI PLUS Surgical System "meets the defined specifications and functioned as intended." The key performance differences from the predicate device are related to the volume of viscoelastic fluid dispensed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Viscoelastic Fluid Dispensed Volume | $21 \pm 3$ µL (10.5 µL on first microcatheter retraction cycle and 10.5 µL on the second cycle) |
| Mechanical integrity, sterile barrier, physical requirements, product inspections, specification verifications after conditioning (sterilization, environmental, transit, aging) | "The results establish that the OMNI PLUS Surgical System functioned as intended and complies with the applicable requirements." |
| Sterility | "The tested units were found to be sterile after processing with the sub-lethal dose, confirming that the product may be labeled 'Sterile' per ANSI/AAMI/ISO 11137-2:2013." (Demonstrated for adoption into the predicate device's sterilization process). |
| Shelf Life (Functional performance & packaging integrity) | "The OMNI PLUS Surgical System is currently validated for total shelf life of 13 months." "The device packaging is labeled with an expiration date of 12 months, providing a one-month safety factor." |
| Biocompatibility | "Test results demonstrated that the device materials have an acceptable biocompatibility profile and met the requirements of the ISO standard (ISO 10993-1:2009/(R)2013)." |
| Bacterial Endotoxin Level | "Test results demonstrated that the samples do not have an unacceptable level of bacterial endotoxin and met the endotoxin limit requirement of ≤0.2 EU/device." |
| Risk Management | "All the identified hazards were mitigated to an acceptable level of risk. The potential benefits to patients outweigh the low residual risk of the design changes..." |
2. Sample Size Used for the Test Set and the Data Provenance
The document refers to "test samples" and "representative device samples" for various bench tests. However, it does not explicitly state the specific sample sizes used for each performance test (e.g., how many units were tested for viscoelastic fluid dispensing, or how many units for sterility verification).
The data provenance is from non-clinical bench testing conducted by the manufacturer, Sight Sciences, Inc., and approved contract laboratories. The document indicates these are verification studies for a new device, not data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document describes non-clinical bench testing for a medical device. There is no "ground truth" established by medical experts in the context of clinical data or image interpretation. The "ground truth" for these tests would be the design specifications and applicable standards, verified through objective measurements.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving expert review or adjudication of clinical cases.
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
No such study was conducted or mentioned in this document. The OMNI PLUS Surgical System is a manually operated ophthalmic surgical tool, not an AI-powered diagnostic or interpretive device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. The device is a surgical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical bench tests is based on design specifications, pre-defined performance requirements, and established industry standards (e.g., ISO 11137-2 for sterility, ISO 10993-1 for biocompatibility, USP for bacterial endotoxin).
8. The Sample Size for the Training Set
Not applicable. This document describes bench testing for a physical medical device, not the development or training of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm.
§ 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).