(53 days)
The AMO Ophthalmic Surgical System is a modular ophthalmic microsurgical system that facilitates both anterior segment (i.e., cataract) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The posterior segment surgery module is optional. The modular design allows the users to configure the system to meet their surgical requirements.
The AMO Ophthalmic Surgical System is a device designed for use in performing anterior segment ophthalmic surgery (cataract) and posterior segment ophthalmic surgery. The device is intended for use in performing phacoemulsification, phacofragmentation, diathermy, irrigation/aspiration, vitrectomy, extrusion and silicone oil injection and extraction.
The provided document describes the AMO Ophthalmic Surgical System, a device for anterior and posterior segment ophthalmic surgery. However, it does not include information about acceptance criteria, a study proving device performance against such criteria, sample sizes for test or training sets, ground truth establishment, or any details about AI/ML algorithms or their evaluation.
This 510(k) submission is for a traditional medical device (phacofragmentation system) and focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and compliance with general safety and performance standards. It does not involve AI/ML components or associated performance studies typical for AI-powered devices.
Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as these elements are not present in the provided text regarding the AMO Ophthalmic Surgical System.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.