K Number
K981571
Manufacturer
Date Cleared
1998-07-09

(66 days)

Product Code
Regulation Number
886.4300
Panel
OP
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The intended use of this device is to fold and deliver Alcon ACRYSOF® intraocular lenses into the eye for replacement of the human crystalline lens

Device Description

The MONARCH IOL Delivery System consists of two parts: an autoclavable, reusable titanium handbiece 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.

AI/ML Overview

This document is a 510(k) premarket notification for the Alcon MONARCH IOL Delivery System, submitted in 1998. It describes a medical device and its intended use, rather than a study on an AI/Machine Learning device. Therefore, much of the requested information regarding acceptance criteria, study design for AI evaluation, ground truth, and expert involvement is not applicable.

However, I can extract the available information and explain why other sections are not present in this type of submission.

Applicable Information:

1. A table of acceptance criteria and the reported device performance

Acceptance CriteriaReported Device Performance
Maintain overall diameter of the IOLThe performance test demonstrated that the MONARCH IOL Delivery System can be used to deliver ACRYSOF IOLs without affecting the overall diameter.
Maintain haptic angle of the IOLThe performance test demonstrated that the MONARCH IOL Delivery System can be used to deliver ACRYSOF IOLs without affecting the haptic angle.
Maintain power of the IOLThe performance test demonstrated that the MONARCH IOL Delivery System can be used to deliver ACRYSOF IOLs without affecting the power.
Maintain resolution of the IOLThe performance test demonstrated that the MONARCH IOL Delivery System can be used to deliver ACRYSOF IOLs without affecting the resolution.
Maintain cosmetic attributes of the IOLThe performance test demonstrated that the MONARCH IOL Delivery System can be used to deliver ACRYSOF IOLs without affecting the cosmetic attributes.
Smooth delivery of the IOLThe test lenses were delivered smoothly.
Complete unfolding of the IOL in a controlled fashionThe test lenses unfolded completely in a controlled fashion.

Reasoning for Other Missing Information (Specific to AI/ML devices):

The provided document is a 510(k) submission for a physical medical device (an intraocular lens delivery system), not an AI/Machine Learning diagnostic or assistive tool. Therefore, the concepts of "test set," "training set," "ground truth established by experts," "MRMC studies," "standalone performance," and "data provenance" in the context of AI evaluation are not relevant to this document.

The "performance data" mentioned in the document refers to physical testing of the device's ability to handle and deliver an IOL without damage, not the performance of an algorithm.

Summary of Device and its "Study" (from the document's perspective):

  • Device Name: MONARCH IOL Delivery System
  • Intended Use: To fold and deliver Alcon ACRYSOF® intraocular lenses into the eye for replacement of the human crystalline lens.
  • "Study" (Performance Test): The document refers to a "performance test" that demonstrated the device's ability to deliver ACRYSOF IOLs without causing damage or affecting their critical characteristics. This is a functional and integrity test of the physical device.
  • Ground Truth: For this type of physical device, the "ground truth" is the established specifications and integrity of the IOLs themselves. The device is expected to deliver them without altering these pre-established qualities.
  • Sample Size for Test Set: Not explicitly stated, but implied to be a sufficient number of ACRYSOF IOLs to conduct the performance test.
  • Data Provenance: Not applicable in the context of AI/ML. The "data" here refers to the outcomes of physical testing.
  • Number/Qualifications of Experts: Not applicable in the context of AI/ML. The evaluation would have been conducted by engineers and quality control personnel.
  • Adjudication Method: Not applicable.
  • MRMC Comparative Effectiveness Study: Not applicable (this is not an AI assistive device).
  • Standalone Performance: Not applicable (this is a physical delivery system, not an algorithm).
  • Type of Ground Truth: Physical integrity and functional performance of the IOLs post-delivery.
  • Sample Size for Training Set: Not applicable (no "training" in the ML sense).
  • How Ground Truth for 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.