(84 days)
Ophthalmic surgical system for cataract and vitro retinal surgery.
Anterior and Posterior Segment Ophthalmic Surgeries
The Storz PREMIERE II is a modular ophthalmic microsurgical system which is designed to be configured by Storz for use in anterior segment surgery only, posterior segment surgery only, or both. The modular design allows user configuration of the system. The PREMIERE II system is divided into the following functional sections: 1. Computer Unit. This unit will sit upon the PREMIERE II Ophthalmic Unit and is composed of an embedded PC and a display console. 2. Ophthalmic Unit. This unit is comprised of a base unit, a power supply module. and up to five selected ophthalmic modules. The base unit is the primary housing for the system ophthalmic instrumentation, and is designed to facilitate front loading and unloading of up to six modules. The power supply module is the power source for the remaining five modules occupving the base unit. The ophthalmic modules are functional units, each of which contain the necessary components to interface the module with the Ophthalmic Base Unit or Ophthalmic Expansion Unit. The ophthalmic modules which will be available at product introduction are: a. Air/Fluid Exchange and Scissors/Forceps module. b. Bipolar Coagulation module. c. Illumination module. d. Irrigation, Scroll Aspiration, and Vitrectorny module. e. Irrigation, Venturi aspiration, and Vitrectorny module. f. Phacoemulsification and Phacofragmentation module. g. Phaco module. h. Frag module. 3. Peripherals. The following peripheral devices will be available at product introduction: Instrument Cart with automated IV pole, Ophthalmic Expansion Unit for additional modules. Remote Control Unit, and Foot Control.
This is a 510(k) summary for a medical device called the "Storz PREMIERE II Microsurgical System," and it does not contain information about studies proving the device meets acceptance criteria in the manner you've described for AI/ML device evaluations.
The document is a submission to the FDA for substantial equivalence, a regulatory pathway for devices that are "as safe and effective as" a legally marketed predicate device. This process primarily relies on comparing the new device's technological characteristics and intended use to those of existing, legally marketed devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, or AI/MRMC study results because this document is describing a traditional hardware medical device and not an AI/ML device that would undergo such evaluation.
The tables in the document compare the Storz PREMIERE II system to predicate devices based on general information (like intended use, presence of real-time display, modular design, power requirements, operating temperature, and humidity) rather than performance metrics from a clinical study against specific acceptance criteria.
§ 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.