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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.

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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.

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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.

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