(84 days)
The MicroSTAAR ™ MSI Injector Foam Tip System is a device intended to fold and insert STAAR Surgical one and three piece Collamer® lenses for surgical placement in the human eye.
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This document is a 510(k) clearance letter from the FDA for the MicroSTAAR™ MSI Injector Foam Tip System, a device intended to fold and insert intraocular lenses.
The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
Therefore, I cannot fulfill your request for the detailed table and study information. The letter only confirms that the device is substantially equivalent to a legally marketed predicate device and can proceed to market, subject to general controls provisions. It does not include performance data, study design, or ground truth establishment relevant to the questions asked.
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.