(167 days)
The MR Q and the MR SUPINE are intended to perform:
- Posterior capsulotomy -
- Iridotomy -
The MR Q SLT in YAG mode is intended to perform:
- Posterior capsulotomy -
- -Iridotomy
The MR Q SLT in SLT mode is intended to perform:
- Selective laser trabeculoplasty
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria, study details, and specific performance metrics of the device.
The document is a 510(k) clearance letter from the FDA, which confirms that the device (Meridian AG's MR Q, MR Q SUPINE, MR Q SLT) is substantially equivalent to legally marketed predicate devices for its stated indications for use. It outlines regulatory requirements and general information but does not include the results of clinical studies, acceptance criteria, or detailed performance data for the device.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for test sets.
- Information on Multi-Reader Multi-Case (MRMC) studies or the effect size of AI assistance.
- Results from standalone algorithm performance studies.
- Details on the type of ground truth used.
- Sample sizes for training sets or how ground truth for training data was established.
The "Indications for Use" section (page 3) describes what the device is intended to do (e.g., Posterior capsulotomy, Iridotomy, Selective laser trabeculoplasty), but not the performance metrics or studies used to demonstrate those capabilities.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.