(54 days)
The CLAREON MONARCH IV IOL Delivery System is for implantation of qualified Alcon foldable IOLs. No unqualified lenses should be used with the CLAREON MONARCH IV IOL Delivery System.
The CLAREON MONARCH IV IOL Delivery System consists of two parts. An autoclavable, reusable, titanium handpiece and a sterile, single-use cartridge are used for implanting foldable intraocular lenses into the eye following removal of the natural crystalline lens.
The system provides a controlled means to reliably place Alcon qualified intraocular lenses (IOLs) into the capsular bag when a qualified combination of handpiece, cartridge, Alcon foldable IOL, and ophthalmic viscosurgical device (OVD) is used.
The cartridge is loaded by inserting the IOL into the opening in the back of cartridge after OVD is applied to the inner lumen of the cartridge. The loaded cartridge is installed into the handpiece and the IOL is delivered through the cartridge nozzle.
The provided text describes a 510(k) summary for the CLAREON MONARCH IV IOL Delivery System. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for an AI/software device would.
The information given relates to a hardware medical device (an intraocular lens delivery system), not an AI-powered diagnostic or predictive tool. Therefore, many of the requested categories (like "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "training set size," or "ground truth for training set") are not applicable to this type of device and are not present in the provided text.
However, I can extract the relevant information regarding performance testing and acceptance criteria as described for this hardware device.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the standards and characteristics tested to demonstrate substantial equivalence to the predicate device. The performance is reported as meeting these standards and demonstrating equivalence.
| Performance Characteristic / Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| IOL Delivery Performance | Compatibility and reliable delivery with qualified Monarch cartridges, Clareon IOLs, and OVDs per ISO 11979-3-12. | Demonstrates compatibility and delivery performance in accordance with ISO 11979-3-12. |
| Biocompatibility | Meets biocompatibility requirements for patient-contact aspects per ISO 10993-18-20 and ISO 10993-5-09. | Meets biocompatibility requirements in accordance with intended use and specified ISO standards. |
| Reprocessing & Sterilization | Meets reprocessing and sterilization over claimed use life per ISO 17664-17, ISO 17665-1-06, and ISO 14937-09. | Achieves reprocessing and sterilization performance in accordance with specified ISO standards. |
| Human Factors & Usability | Demonstrates safe and effective use by intended users per IEC 62366-1-20 and FDA guidance. | Meets human factors and usability requirements for safe and effective use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test mentioned (e.g., how many IOLs were delivered, how many sterilization cycles were performed for specific tests). It only lists the types of tests conducted. "Data provenance" as in country of origin or retrospective/prospective is not specified, as these are typically bench and lab tests for a physical device, not an imaging or diagnostic study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided. The testing described involves engineering, material, and biological compatibility assessments against established standards, not expert consensus on interpretations.
4. Adjudication Method for the Test Set
This is not applicable and not provided as it's not a study involving human interpretation of data for ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers' performance with and without AI assistance is compared. The described device is a physical delivery system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. This is a hardware device; thus, the concept of "standalone algorithm performance" is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on established international standards (ISO, IEC) and FDA guidance documents for medical device performance, biocompatibility, reprocessing, and human factors. For example:
- IOL Delivery Performance: Compliance with ISO 11979-3-12.
- Biocompatibility: Conformance to ISO 10993-18-20 and ISO 10993-5-09.
- Reprocessing and Sterilization: Adherence to ISO 17664-17, ISO 17665-1-06, and ISO 14937-09.
- Human Factors: Conformance to IEC 62366-1-20 and FDA guidance.
8. The Sample Size for the Training Set
No training set is applicable or mentioned. This is a physical device, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.