(161 days)
The MONARCH® III IOL Delivery System is used for implantation of ALCON® qualified ACRYSOF® intraocular lenses into the eye following cataract removal.
The Monarch© III IOL Delivery System is a modification to the previously cleared Alcon Monarch(r) II IOL Delivery System (K003768) consisting of a disposable cartridge and reusable handpiece. The Monarch II cartridges are designated as A, B, and C, and feature various nozzle tip sizes that correspond to the various AcrySof® IOL models. As with the cleared cartridges, the Monarch© III IOL Delivery System presented in this submission utilizes a one-piece disposable cartridge (designated as D) with progressive folding in combination with a reusable handpiece (H4). This new cartridge possesses the same basic inner lumen design and lens guiding mechanisms as the existing Monarch*) II A, B, and C cartridges, but differs in nozzle tip sizing.
The document provided is a 510(k) summary for the Alcon Monarch® III IOL Delivery System. It is a premarket notification to the FDA to demonstrate substantial equivalence to previously marketed devices. The summary outlines the device description, indications for use, and a brief summary of nonclinical tests. However, it does not contain detailed acceptance criteria, specific study results proving device performance against those criteria, or the other specific information requested in your prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training set details).
This document is a regulatory submission, not a detailed scientific study report. It states that Alcon will conform to requirements but doesn't provide the test results or the specific acceptance criteria themselves.
Therefore, I cannot provide the requested table and detailed study information based on this document.
Here's an explanation of why the requested information is absent:
- Acceptance Criteria & Reported Performance: The document states that the device "will conform in all respects with the requirements set forth in the FDA Intraocular Lens Guidance Document (Draft released 10/14/1999) Section C. Mechanical Testing, 5. Folding and Injection Testing prior to marketing the product." This is a statement of intent to conform to guidance, not a set of specific, quantified acceptance criteria or a report of the device's performance against them.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): This type of detailed information would typically be found in a comprehensive test report or clinical study report, which is usually part of the full 510(k) submission but not typically included in the public 510(k) summary. For a device like an IOL delivery system, the "ground truth" often relates to mechanical integrity, successful delivery without damage to the IOL or ocular structures, and consistent performance, rather than expert consensus on images.
- Training Set Information: This device is a mechanical delivery system, not an AI or image-based diagnostic tool. Therefore, concepts like "training set," "ground truth for the training set," "experts," and "MRMC studies" are generally not applicable in the context of this type of medical device submission.
In summary, the provided text confirms:
- Device Name: Monarch® III IOL Delivery System (D Cartridge and H4 Handpiece)
- Indication for Use: Implantation of ALCON® qualified ACRYSOF® intraocular lenses into the eye following cataract removal.
- Regulatory Clearance: K063155, cleared March 27, 2007.
- Nonclinical Test Summary: "Alcon has provided a Statement of Conformance... that the Monarch® III IOL Delivery System... will conform in all respects with the requirements set forth in the FDA Intraocular Lens Guidance Document (Draft released 10/14/1999) Section C. Mechanical Testing, 5. Folding and Injection Testing prior to marketing the product."
No further details regarding specific acceptance criteria, study methodologies, statistical results, or expert involvement are present in this 510(k) summary.
§ 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.