(88 days)
To perform microlamellar keratoo asty for the correction of myopia or hyperopia
Power urit Turbine motor Adjustable keratome head Keratome blade Pneumatic fixation rings Applanation lenses Plate check ng gauge
I understand you're looking for a detailed breakdown of acceptance criteria and study information for a medical device. However, the provided text snippets (K960395) are primarily descriptive comparisons of device features (intended use, system composition, turbine motor, keratome, etc.) between a submitted device and two predicated devices.
This information does not contain any details about:
- Acceptance Criteria: There are no stated performance metrics, thresholds, or targets.
- Study Design or Results: There's no mention of any clinical trials, pre-clinical studies, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
It seems this document is a summary for demonstrating substantial equivalence based on device features and intended use, rather than a performance study report.
Therefore, I cannot fulfill your request for the tables and study details based on the provided text.
To answer your request, I would need a document that describes:
- Specific numerical or qualitative performance targets the device must meet.
- Details of a study conducted to evaluate the device's performance against those targets. This would include information on the study's methodology, data collection, analysis, and results.
§ 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.