(139 days)
The OptiMedica® Catalys® Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
OptiMedica's Catalys® Precision Laser System ("Catalys®System") is a Class II ophthalmic surgical laser system as defined by regulation number 21 CFR 886.4390. The Catalys® System is indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect phacofragmentation, thus facilitating efficient lens removal. The System also creates single-plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. The System employs femtosecond ("FS") laser technology with integrated Optical Coherence Tomography ("OCT"). all of which are controlled and monitored by dedicated electronics. The System utilizes a common optical path for the OCT and femtosecond treatment laser (including the three-dimensional scanner and Liquid Optics™ [patient] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. In addition to the laser classifications per 21 CFR 1040.10 and 1040.11, the Catalys® Precision Laser System complies with the requirements for Class I lasers per ANSI Z136.1-2007 as well as to ISO 15004-2:2007.
The provided text describes a 510(k) premarket notification for the Catalys® Precision Laser System. This device is an ophthalmic laser system intended for use in cataract surgery. However, the document does not contain information regarding an AI/ML-based device or a study involving human readers and AI assistance for diagnostic image interpretation. Therefore, I cannot provide details on acceptance criteria and a study that proves an AI/ML device meets these criteria based on the provided text.
The "study" described in the document pertains to the performance and safety of the laser system itself for surgical procedures, not an AI/ML diagnostic aid. It refers to:
- Bench testing: Demonstrated the system's ability to deliver corneal incision patterns with accuracy and precision (±75um relative to intended cut dimensions).
- Animal testing: Demonstrated corneal safety by comparing laser-created incisions to standard manual surgical incisions histologically.
- Cadaver eye testing: Qualitatively demonstrated the laser's ability to effectively cut various tissue types using bracketed laser parameters.
To directly answer your request based only on the provided text, I must state that the information requested about acceptance criteria and a study to prove an AI/ML device meets those criteria is not present.
If you have a different document that describes an AI/ML device and its validation, please provide it.
§ 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.