(28 days)
The COMPACT INTUITIV™ System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract.
The COMPACT INTUITIV™ System is a modular ophthalmic microsurgical system that is intended for use in anterior segment (cataract) surgery. The device is used to emulsify and extract a cataractous lens. The COMPACT INTUITIV™ is a mid-tier peristaltic system with a graphic-user that has updated technology and hardware to meet current electrical and material safety standards. The currently cleared COMPACT INTUITIV™ consists of the System Console, the Wireless Remote Control, the Open-Toe Foot Pedal, and the Single-Use Fluidics Pack, Model OPO80.
The closed-toe foot pedal is equivalent to the currently cleared open-toe foot pedal for use with the COMPACT INTUITIV" system. The closed-toe foot pedal provides similar functionality as the opentoe foot pedal. Both open-toe and closed-toe foot pedals contain three-programmable switches, and the closed-toe device incorporates a programmable treadle. Both open and closed toe foot pedals provide tactile feedback to the user. The switches and treadle on the foot pedal can be programmed to access features on the COMPACT INTUITIV™ System Console based on the surgeon's preference.
The provided text does not describe acceptance criteria for an AI/ML device in the traditional sense, nor does it detail a study proving such a device meets acceptance criteria. Instead, it is a 510(k) summary for a medical device (a phacofragmentation system and its foot pedal) that does not incorporate AI/ML.
The document explicitly states: "No animal or clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology when compared to the predicate device." This clearly indicates that the device being reviewed is not an AI/ML device requiring complex performance studies.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to the product described in the input document.
The "Performance Data" section (Page 3) discusses:
- Design verification and validation testing, including electromagnetic compatibility testing: This ensures the physical device (foot pedal) works as intended and is compatible with the system.
- Software validation: This was performed on a proposed software version with minor changes to accommodate the new foot pedal, ensuring the software functions correctly with the new component.
- Acceptance criteria for these engineering and software tests were met. Without further details, these acceptance criteria are likely related to electrical safety, functional performance (e.g., foot pedal response time, correct input recognition), and electromagnetic compatibility limits.
The document concludes that the new closed-toe foot pedal is substantially equivalent to the predicate open-toe foot pedal based on these non-clinical bench tests and software validation.
§ 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.