(56 days)
To perform microlamellar keratoplasty for the correction of myopia or hyperopia
Power unit, Turbine motor, Fixed keratome head, Keratome blade, Pneumatic fixation rings, Applanation lenses
This device is a surgical keratome, intended to perform microlamellar keratoplasty for the correction of myopia or hyperopia. The provided text is a summary comparing the submitted device with predicate devices. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on comparing the features and specifications of the submitted device with existing predicate devices to demonstrate substantial equivalence, rather than presenting performance data against defined acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
To be able to answer your questions, I would need a document that includes:
- Specific performance metrics (e.g., cut depth accuracy, cut quality, safety outcomes).
- Numerical acceptance criteria for these metrics.
- Details of a clinical or non-clinical study (e.g., preclinical testing, animal studies, human clinical trials) where the device's performance was evaluated against these criteria.
- Information regarding sample sizes, ground truth establishment, expert qualifications, and adjudication methods for such a study.
§ 886.4370 Keratome.
(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.