(118 days)
The Aero Z Cartridge IOL Delivery System is indicated to fold and insert Aaren Scientific IOLs that have the use of this inserter in their approved labeling.
The Aero Z Cartridge IOL Delivery System is a two-part device comprised of a reusable handpiece and single use disposable cartridge. The single use disposable cartridge is , fabricated from polypropylene with a glyceryl monostearate (GMS) agent incorporated for lubricity. It is intended for single use only and is provided sterile. The reusable handpiece is titanium, is supplied non-sterile and is designed to accommodate the cartridge and lens for delivery of the lens into the eye. The reusable handpiece is supplied in both a push-and-turn and screw type configuration.
Here's an analysis of the provided text regarding the AERO™ Z Cartridge IOL Delivery System, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Biocompatibility | Non-cytotoxic | Device was found to be non-cytotoxic. |
| Non-sensitizing | Device was found to be non-sensitizing. | |
| Non-irritating | Device was found to be non-irritating. | |
| Functional Performance | Ability to deliver IOL Models EC-3 and EC-3 PAL without significant impact on optical or mechanical performance | Demonstrated that the system can deliver IOL Models EC-3 and EC-3 PAL without significantly impacting the optical or mechanical performance of the lens. |
| Ability to deliver IOL Models EC-3 and EC-3 PAL without significant impact on dimensions | Demonstrated that the system can deliver IOL Models EC-3 and EC-3 PAL without significantly impacting the dimensions of the lens. | |
| Ability to deliver IOL Models EC-3 and EC-3 PAL without significant impact on cosmetic appearance | Demonstrated that the system can deliver IOL Models EC-3 and EC-3 PAL without significantly impacting the cosmetic appearance of the lens. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state a specific sample size used for the test set associated with the performance studies (e.g., how many IOLs were tested for optical/mechanical impact).
The data provenance is retrospective in the sense that the testing was conducted on samples of the device and IOLs. There is no mention of prospective clinical trials. The country of origin for the data is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The provided text does not mention the use of experts to establish ground truth for the test set in the context of the reported non-clinical tests. The tests performed (biocompatibility and functional performance for IOL delivery) are typically objective laboratory measurements against defined standards (e.g., ISO 10993-1, ISO 11979-3) rather than interpretations requiring expert consensus.
4. Adjudication Method for the Test Set
As the evaluation primarily relies on objective laboratory tests against ISO standards, an adjudication method (like 2+1 or 3+1) for expert consensus is not applicable and not mentioned in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical delivery system, not an AI-assisted diagnostic tool that would involve human readers interpreting cases. Therefore, there's no mention of an effect size for human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This question is applicable to AI algorithms. The Aero Z Cartridge IOL Delivery System is a medical device for physically delivering intraocular lenses, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop does not apply.
7. The Type of Ground Truth Used
The ground truth used for the device's performance evaluation is based on objective measurements against established international standards.
- Biocompatibility: Conformance to ISO 10993-1:2009 for non-cytotoxicity, non-sensitization, and non-irritation.
- Functional Performance: Conformance to ISO 11979-3 for demonstrating delivery of IOLs (Models EC-3 and EC-3 PAL) without significant impact on their optical performance, mechanical performance, dimensions, or cosmetic appearance.
8. The Sample Size for the Training Set
The provided information does not refer to a "training set" in the context of an algorithm or AI. This device is a mechanical delivery system, and its development and testing do not involve machine learning training sets.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of this device, this question is 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.