(110 days)
The intended use of this device is to fold and deliver Alcon ACRYSOF® intraccular lenses into the eye for replacement of the human crystalline lens.
The MONARCH™ IOL Delivery System consists of two parts: an autoclavable, reusable titanium handpiece and a sterile, single-use cartridge. It is a device used for folding and delivering ACRYSOF intraocular lenses into the eye for replacement of the human crystalline lens. The system provides a controlled means to reliably place the ACRYSOF® intraocular lens into the capsular bag.
This document is a 510(k) summary for the MONARCH™ IOL Delivery System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not provide the level of detail requested in the prompt regarding acceptance criteria and performance study specifics that would typically be found for a modern AI/ML medical device submission.
Here's a breakdown based on the provided text, highlighting what's missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in a tabular format with numerical targets. The document mentions the device should deliver IOLs "without affecting the overall length, haptic angle, power, resolution, or cosmetic attributes of the lenses." It also states lenses "unfolded completely within 30 seconds." These are qualitative and quantitative performance aspects, but not presented as formal acceptance criteria with limits.
- Reported Device Performance:
- "The performance test demonstrated that the MONARCH™ IOL Delivery System can be used to deliver ACRYSOF® IOLs without affecting the overall length, haptic angle, power, resolution, or cosmetic attributes of the lenses."
- "The test lenses were delivered smoothly and unfolded completely within 30 seconds in a controlled fashion."
Missing Information: Specific numerical values for "overall length, haptic angle, power, resolution, or cosmetic attributes" and what constitutes "without affecting" (e.g., tolerance limits).
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only refers to "the test lenses."
- Data Provenance: Not specified. It does not mention country of origin or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. This device is a mechanical delivery system, not an AI/ML diagnostic or prognostic tool that relies on expert interpretation for ground truth. The "performance test" would likely involve laboratory measurements rather than human expert assessment of a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a mechanical device, not an AI system. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a mechanical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device would be based on physical measurements and observations of the delivered IOLs (e.g., integrity, dimensions) and the delivery process itself (e.g., smoothness, unfolding time). It is not based on expert consensus, pathology, or outcomes data in the context of an AI/ML system.
8. The sample size for the training set
- Not applicable. This document describes a mechanical device. There is no concept of a "training set" in the context of AI/ML algorithm development for this type of product. The "test lenses" mentioned are for performance evaluation, not training.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary: The provided 510(k) summary is for a traditional medical device (an IOL delivery system). The prompt's questions are largely geared towards the evaluation and validation of Artificial Intelligence/Machine Learning (AI/ML) powered medical devices. Therefore, most of the specific details requested regarding ground truth, expert adjudication, training/test sets, and comparative effectiveness (MRMC) studies are not applicable to this document. The "performance data" provided relates to the physical and functional characteristics of the mechanical device.
§ 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.