(147 days)
The intended use of the xPORT 304 (miCOR) System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.
Not Found
The provided document, a 510(k) premarket notification letter from the FDA regarding the xPORT 304 (miCOR) System Lens Fragmentation System, does not contain any information about acceptance criteria or a study proving the device meets specific acceptance criteria.
The document details the FDA's clearance of the device for marketing, confirms its substantial equivalence to predicate devices, and outlines regulatory requirements. It also includes the device's indications for use: "fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting."
Without information directly related to performance studies, acceptance criteria, or their validation, I cannot provide the requested details regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC study details or effect size.
- Standalone performance details.
- Type of ground truth used.
- Training set sample size.
- Ground truth establishment method for the training set.
The document is purely a regulatory clearance notice, not a clinical study report or a technical performance specification.
§ 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.