(90 days)
The Mentor® Phacoemulsification SIStem Remote Control is intended to be used by operating room personnel to control the main functions of the Mentor Phacoemulsification SIStem from a distance.
The Mentor® Phacoemulsification SIStem Remote Control is an accessory to the Mentor Phacoemulsification SIStem. It is a combination wireless and hard-wired hand-held device that allows the operator to control certain aspects of the Mentor Phacoemulsification SIStem's operation from a distance. When using the remote in a wireless mode, signals are transmitted to the console via IR (infrared) signals. When using the remote in the hard-wired mode, signals are transmitted to the console directly through the wire. The remote can be powered either by battery (when used in the wireless mode) or from the SIStem console itself (when the hard-wired mode is used).
The provided text is a 510(k) summary for the Mentor Phacoemulsification SIStem Remote Control. This document is a premarket notification to the FDA, demonstrating substantial equivalence to already marketed devices, rather than a study proving performance against defined acceptance criteria.
The information primarily discusses the device's description, intended use, and a comparison to predicate devices to establish substantial equivalence. It does not contain details about acceptance criteria, clinical studies, or performance metrics in the way a typical study report would.
Therefore, I cannot extract the requested information as it is not present in the provided text. Specifically:
- Acceptance Criteria Table: Not present. The document focuses on feature comparison, not performance metrics or acceptance criteria.
- Sample Size and Data Provenance: Not applicable as no clinical study or test set is described.
- Number of Experts and Qualifications: Not applicable as no ground truth establishment is described.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable. This document does not describe a clinical study.
- Standalone Performance: Not applicable.
- Type of Ground Truth: Not applicable.
- Training Set Sample Size: Not applicable. This is a device submission, not an AI/algorithm study.
- Ground Truth for Training Set: Not applicable.
The document's purpose is to demonstrate that the Mentor Phacoemulsification SIStem Remote Control is sufficiently similar to existing legally marketed remote controls for phacoemulsification systems (specifically Alcon Series 2000 Legacy and Chiron Vision Catalyst) to be allowed to market. The "performance" aspect discussed is limited to the functionality of the remote control (e.g., controlling IV pole height, memory access, mode changes, performance parameter adjustments) rather than a quantitative measure of its efficacy or safety against set 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.