The intended use of this device is to fold the Alcon ACRYSOF® intraocular lens prior to its insertion into the eye. The AcryPak Folder is used as the folding forceps. A pair of implantation forceps is used to remove the folded lens from the AcryPak® Folder for lens implantation.

Device Description

The AcryPak® Folder is a sterile, single-use IOL folder that allows the user to load and fold ACRYSOF® lenses in 6-12, 3-9, or 4-10 orientation. This lens folder is easy to use and does not require user cleaning and resterilization. The AcryPak® Folder is supplied separately from the IOL.

AI/ML Overview

This device is a medical device, not an AI/ML device. Therefore, the requested information regarding AI/ML study parameters (sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, etc.) is not applicable.

Here's the available information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Even folding of ACRYSOF® lenses	The AcryPak® Folded all the lenses evenly in all three folding orientations.
Lenses maintain acceptable quality post-folding	All the test lenses possessed acceptable focal length, resolution, haptic angle, overall length, and cosmetic quality after testing.
Ease of use	The AcryPak® Folder is easy to use.
Reliability of performance	Performs reliably.
Effectiveness in folding IOLs	Effective in folding ACRYSOF® IOLs without compromising the quality of the lens.
Sterile and single-use	Supplied sterile and eliminates the need for user cleaning and resterilization.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated. The text mentions "low, medium and high diopter ACRYSOF® lenses" were used, implying a subset of these lens types.
Data Provenance: Not specified, but given it's a device manufactured by Alcon Laboratories, Inc. in Fort Worth, TX, it's likely testing was conducted internally or within the US. The data is retrospective in the sense that the testing was completed prior to the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this is a physical device performance test, not an AI/ML ground truth establishment. The performance was likely assessed against established manufacturing specifications for the lenses.

4. Adjudication method for the test set:

Not applicable as this is a physical device performance test, not an AI/ML adjudication. Performance was likely assessed against technical specifications.

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:

Not applicable. This is a physical device, not an AI system that interacts with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This refers to the performance of the device itself in its intended function. The "Summary of the Performance Data" directly addresses the standalone performance of the AcryPak® Folder. It successfully folded all tested lenses evenly and maintained their quality.

7. The type of ground truth used:

Technical specifications/Quality standards for IOLs: The "ground truth" for the device's performance was the ability to fold the lenses evenly and for the lenses to maintain acceptable physical and optical properties (focal length, resolution, haptic angle, overall length, cosmetic quality) after being folded by the AcryPak® Folder.

8. The sample size for the training set:

Not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable as this is not an AI/ML device.

Summary

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K965185

Alcon Laboratories, Inc.
K965185 AcryPak® Folder

HAR 3 | 1997

510(K) SUMMARY

Submitted by:

Martin A. Kaufman Manager, Regulatory Affairs, Surgical Devices Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76132 (817) 551-8388 (Phone) (817) 551-4630 (Fax)

Trade Name: Common Name Classification Name

11 - 11 - 11 -

AcryPak® Folder IOL Len Folder Intraocular Lens Guide, 21 CFR 886.4300

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K965185

Alcon Laboratories, Inc. K965185 AcryPak® Folder

1. Predicate Device

The legally marketed device(s) to which we are claiming equivalence to is:

K913626, Softrans The Injector, (STAAR Surgical Company) 1.
K903574, ChiroFlex® Lens Microsert®, (Chiron Ophthalmics Inc.) 2.

2. Device Description

3. Intended Use of the Device

4. Summary of the Technological Characteristics of the Device

The folding of the ACRYSOF® lens is typically done using conventional metal forceps which requires great dexterity of the user to fold the lens evenly. In addition, folding metal forceps require time to properly clean and re-sterilize for each use.

The AcryPak® Folder is a sterile, single use folder molded from polypropylene. The folder allows the user to load the ACRYSOF® lens for 6-12, 3-9, or 4-10 folding. Use of the AcryPak® Folder will not affect the incision size, which is determined by the lens and the implantation forceps.

The lens folding function of the AcryPak® Folder is equivalent to that of the cartridges of lens injectors used for other types of lenses. However, AcryPak® Folders provide the capability of multi-axis lens folding which cartridges do not provide.

5. Summary of the Performance Data

The performance of the AcryPak® Folder was tested using low, medium and high diopter ACRYSOF® lenses. The test results demonstrated that the AcryPak® Folded all the lenses evenly in all three folding orientations. All the test lenses possessed acceptable focal length, resolution, haptic angle, overall length and cosmetic quality after testing.

6. Conclusions

The AcryPak® Folder is easy to use, performs reliably, and is effective in folding ACRYSOF® IOLs without compromising the quality of the lens. It is supplied sterile and eliminates the need for user cleaning and resterilization.

Regulation Number and Section

§ 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.