(175 days)
The Whittingham UltraClean Phaco Handpiece is indicated for surgical removal of cataract tissues or other unwanted eye tissue.
The Whittingham UltraClean Phaco Handpiece is a phacoemulsification handpiece, for use with standard, disposable phaccemulsification needles, a 39 to 55 KHz Piezoelectric driver module, and the associated ophthalmic surgical system control units. A handpiece such as this is used in ophthalmic surgery to break up (emulsify) and remove unwanted or degenerative tissues, such as cataract tissue.
The provided document is a 510(k) summary for the Whittingham UltraClean™ Phaco Handpiece. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, the document does not contain the requested information regarding acceptance criteria, a study proving device performance against those criteria, sample sizes, ground truth establishment, or expert involvement.
The document primarily states:
- Intended Use: The Whittingham UltraClean Phaco Handpiece is intended for use as a component of a phacoemulsification surgical system, in the surgical removal of unwanted or degenerative tissues, such as cataract tissue.
- Comparison to Predicate Device: The device shares general technological characteristics with the predicate device (Allergan Model 5000 Ophthalmic Surgical System). Both are components of a surgical phacofragmentation system, are self-cooling, autoclavable, incorporate a piezoelectric motor, and accept a standard phaco needle.
- Design Improvements: The new device includes changes that allow for easier cleaning, rotation of connectors, and improved irrigation fluid delivery to prevent cavitation bubbles. These changes are "expected to enhance the safety and effectiveness of the device."
Without a dedicated performance study described in the document, it's impossible to populate the requested table and answer the specific questions about study methodology, sample sizes, and ground truth.
§ 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.