(166 days)
The VICTUS Femtosecond Laser Platform is indicated for use for:
· the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
• for anterior capsulotomy during cataract surgery.
· the creation of cuts / incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring cuts / incisions in the cornea.
· laser-assisted lens fragmentation of nuclear cataracts during cataract surgery, not for fragmentation of posterior subcapsular (PSC) and cortical cataracts
The VICTUS Femtosecond Laser is a precision ophthalmic surgical laser indicated for use in patients undergoing ophthalmic surgery in the anterior segment of the eye. The VICTUS Femtosecond Laser system produces scanned patterns designed to create flaps, produce corneal incisions, arcuate incisions, capsulotomy cuts, and crystalline lens fragmentation patterns for use in cataract surgery. The patient is treated while supine on a patient bed that the physician can position electromechanically via simple controls. The physician controls the VICTUS laser system itself through a touchscreen display and other user controls. Laser emission and of PI suction vacuum are actuated by the physician using separate footswitch pedals.
The mode of operation for the VICTUS Platform is using Yb:KYW Femtosecond laser to produce Laser-Induced Optical Breakdown (LIOB) of the corneal tissue. Scanned patterns of laser pulses from the VICTUS are delivered through a sterile, disposable Patient Interface (PI). The PI consists of two components: (i) a contacting lens, and (ii) a suction clip. Together, the suction clip and contacting lens connect to make a single assembly during a VICTUS procedure. The surface of the contacting lens that contacts the eye is spherically curved to match the curvature of the human eye. The suction clip assembly gently immobilizes the eye with respect to the VICTUS laser beam and optical visualization systems. The PI contacting lens and suction clip together allow for proper optical coupling of the laser and optical paths into the patient's eye and create a precise opto-mechanical reference surface for depth control of the scanning laser beam.
The provided text focuses on the 510(k) premarket notification for the VICTUS Femtosecond Laser Platform, specifically regarding modifications to its Patient Interface. It primarily discusses the technological comparison and non-clinical performance data to establish substantial equivalence to a previously cleared device. Therefore, the information regarding in-depth acceptance criteria and a standard study that proves the device meets those criteria (especially in the context of AI/ML performance) is not available in the provided document.
However, based on the non-clinical performance data section, we can infer some aspects related to acceptance criteria and the study performed, even though it's not presented in a typical AI/ML study format.
Here's an attempt to structure the answer based on the available information, noting where specific details are absent:
Acceptance Criteria and Study for VICTUS Femtosecond Laser Platform (Modified Patient Interface)
This submission describes changes to the Patient Interface (PI) of the VICTUS Femtosecond Laser Platform. The study's primary goal was to demonstrate that these modifications do not negatively impact the device's performance compared to the previously cleared version, thus establishing substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from study goals) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet ISO 10993-1 requirements for patient-contacting material. | Test results satisfied the acceptance criteria as defined by the associated ISO standards. (Implies the modified PI is biocompatible). |
| Endotoxin Content | Limulus Amebocyte Lysate (LAL) Endotoxin testing: Endotoxin levels |
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.