(476 days)
This MONARCH® III P Cartridge IOL insertion device is indicated to fold/hold and insert Alcon IOLs that have the use of this inserter in their approved labeling.
The Monarch® III IOL Delivery System (P Cartridge), hereafter referred to as the Monarch® III P Cartridge, is a modification to the previously cleared Alcon Monarch® III IOL Delivery System (D Cartridge) consisting of a disposable polypropylene cartridge and reusable titanium handpiece. The Monarch® III P Cartridge features nozzle tip sizing like the currently marketed Monarch® III D Cartridge and is intended to fold and deliver Alcon AcrySof® intraocular lenses into the anterior chamber of the eye. It is designed to work with the currently marketed Monarch® III handpiece.
The provided document describes the predicate device and the new device (Monarch® III IOL Delivery System (P Cartridge)) and concludes with an assessment of substantial equivalence. The document does not contain the acceptance criteria and performance data in the format requested. It states: "The Monarch® III P Cartridge, in conjunction with the currently marketed Monarch® III handpiece, has been tested and found to deliver Alcon IOL in conformance with the requirements set forth in ISO 11979-3, section 5." However, the specific acceptance criteria from ISO 11979-3, section 5, and the detailed results of the testing (actual performance metrics) are not provided in the document.
Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from the text. I also cannot fulfill the requests for sample size, data provenance, number or qualifications of experts, adjudication method, MRMC study details, standalone performance, training set details, or ground truth establishment, as this information is not present in the provided 510(k) summary.
The document primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and conformity to a standard (ISO 11979-3, section 5) rather than a detailed report of clinical study results against specific criteria.
§ 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.