(173 days)
This Monarch® III C 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 (C Cartridge), hereafter referred to as the Monarch® III C Cartridge, is a modification to the previously cleared Alcon Monarch® II IOL Delivery System (C Cartridge) consisting of a disposable polypropylene cartridge and reusable titanium handpiece. The Monarch® III C Cartridge features nozzle tip sizing like the currently marketed Monarch® II C Cartridge and is intended to fold and deliver Alcon AcrySof® intraocular lenses into the posterior chamber of the eye. The width of the loading zone has been increased to ease loading of 6 mm lenses. The exterior body has been modified, similar to Monarch® III D cartridge to improve manufacturability. It is designed to work with the currently marketed Monarch® III handpiece, and has been qualified for use with Alcon's AcrySof® Intraocular Lens models.
The provided text describes a 510(k) premarket notification for a medical device, the Monarch® III IOL Delivery System (C Cartridge). It focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.
Therefore, much of the requested information cannot be extracted directly from this document.
Here's what can be inferred or stated based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the device "has been tested and found to deliver the AcrySof® Intraocular Lens in conformance with the requirements set forth in ISO 11979-3, ISO 10993, ISO 11135, and ISO 14971." However, the specific acceptance criteria (e.g., maximum force, minimum delivery success rate) from these ISO standards and the reported device performance against those criteria are not detailed in the summary.
Since specific criteria and numerical performance are not provided, a table cannot be constructed with this information.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "tested," but it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This was likely part of the detailed test reports submitted with the 510(k), but not included in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the testing described relates to the physical performance of an intraocular lens delivery system against industrial standards (ISO), not the interpretation of medical images or diagnostic outputs requiring expert ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as #3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not conducted and is not applicable. This device is a delivery system, not a diagnostic or interpretive tool that would involve human readers.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
This information is not applicable. The device is not an algorithm; it is a physical medical device. The "performance" described relates to its ability to deliver an IOL in conformance with ISO standards, which is inherently a standalone physical test.
7. Type of Ground Truth Used:
The "ground truth" for the device's performance is compliance with international ISO standards (ISO 11979-3, ISO 10993, ISO 11135, and ISO 14971) which dictate requirements for intraocular lenses and their delivery systems, biocompatibility, sterilization, and risk management.
8. Sample Size for the Training Set:
This information is not applicable as the device is a mechanical delivery system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as #8.
§ 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.