The Mastel 1 Folder™ Implantation System is intended to fold and assist in inserting the SENSAR™, model AR40e intraocular lens, ONLY into the capsular bag.

Device Description

The Mastel 1 Folder is an ophthalmic surgical device designed for use in inserting a foldable intraocular lens into the eye. The materials, basic scientific concepts, physical properties and intended use of the Mastel 1 Folder are similar to those of the predicate devices.

The Mastel 1 Folder Implantation System is comprised of a medical-grade titanium handpiece, a material commonly used in reusable surgical devices. The handpiece rod is designed to accept a single-use cartridge. The handpiece is reusable and is designed to withstand conventional in-office steam autoclaving. The handpiece is provided to the customer in a plastic case in a non-sterile state.

AI/ML Overview

Acceptance Criteria and Study for Mastel 1 Folder™ Implantation System

1. Table of Acceptance Criteria and Reported Device Performance

This document summarizes the safety and effectiveness for a device that is a mechanical inserter; therefore, the "acceptance criteria" are related to maintaining the physical integrity and optical properties of the intraocular lenses (IOLs) during the insertion process. The reported device performance indicates successful delivery of IOLs without degradation of their critical parameters.

Acceptance Criteria (Implied)	Reported Device Performance
Maintenance of IOL diopter	The results revealed that all Mastel 1 Folders provided acceptable results when delivering 130 intraocular lenses, ranging from 6.0 D to 23.0 D.
Maintenance of IOL astigmatism	The results revealed that all Mastel 1 Folders provided acceptable results when delivering 130 intraocular lenses, ranging from 6.0 D to 23.0 D.
Maintenance of IOL resolution	The results revealed that all Mastel 1 Folders provided acceptable results when delivering 130 intraocular lenses, ranging from 6.0 D to 23.0 D.
Maintenance of IOL visual acuity characteristics	The results revealed that all Mastel 1 Folders provided acceptable results when delivering 130 intraocular lenses, ranging from 6.0 D to 23.0 D.
Maintenance of IOL overall diameter	The results revealed that all Mastel 1 Folders provided acceptable results when delivering 130 intraocular lenses, ranging from 6.0 D to 23.0 D.
Maintenance of IOL loop angles	The results revealed that all Mastel 1 Folders provided acceptable results when delivering 130 intraocular lenses, ranging from 6.0 D to 23.0 D.
Maintenance of IOL sagitta	The results revealed that all Mastel 1 Folders provided acceptable results when delivering 130 intraocular lenses, ranging from 6.0 D to 23.0 D.
No damage to the IOL during insertion	The results revealed that all Mastel 1 Folders provided acceptable results when delivering 130 intraocular lenses, ranging from 6.0 D to 23.0 D. (Implied by "acceptable results" across multiple IOL parameters, indicating no critical damage or functional impairment occurred.)
Effective delivery of the IOL into the capsular bag (intended use)	"Mastel 1 Folders provided acceptable results when delivering 130 intraocular lenses" within the context of an "Implantation System" intended for insertion into the capsular bag. (Implied by successful delivery and maintenance of IOL properties.)

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

Sample Size for Test Set: 130 intraocular lenses (IOLs), ranging from 6.0 D to 23.0 D.
Data Provenance: The study was an in vitro performance test. The country of origin of the data is not specified, but the submission is to the U.S. FDA, suggesting the testing was conducted to U.S. standards, likely in the U.S. or by a U.S. entity. The data is prospective in the sense that it was specifically generated for the submission to demonstrate device performance.

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

Not applicable. The study was an in vitro performance test of a mechanical device's ability to handle and deliver intraocular lenses without damaging them or altering their critical physical and optical characteristics. The "ground truth" was established by objective measurements of the IOLs post-delivery against their known specifications/tolerances. No human expert interpretation of images or clinical outcomes was involved in establishing this in vitro performance ground truth.

4. Adjudication method for the test set

Not applicable. As described above, the "ground truth" was derived from direct physical and optical measurements of the IOLs. There was no need for expert adjudication because the assessment was objective and quantitative, comparing measured parameters against acceptable ranges.

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 device is a mechanical intraocular lens implantation system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

Yes, a standalone in vitro performance test was conducted. The device (Mastel 1 Folder Insertion System) was used to deliver 130 intraocular lenses, and the IOLs were subsequently evaluated for various physical and optical parameters. This test assesses the device's performance directly and independently of any human-in-the-loop clinical use evaluation.

7. The type of ground truth used

The ground truth used was based on objective physical and optical measurements of the intraocular lenses (IOLs) after being processed by the device. These measurements (diopter, astigmatism, resolution, visual acuity characteristics, overall diameter, loop angles, and sagitta) were compared against acceptable standards or specifications for IOLs, ensuring the device did not negatively impact their functional integrity.

8. The sample size for the training set

Not applicable. This device is a mechanical tool, not an artificial intelligence or machine learning system. Therefore, there is no "training set" in the context of algorithm development.

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

Not applicable. As this is a mechanical device and not an AI/ML system, no training set or its associated ground truth establishment methods are relevant.

Summary

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DEC 2 6 2002

SECTION 11

SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

1. Submitter's name, address, telephone number, contact person, and date summary prepared;

a. Applicant: Mastel Precision, Inc. 2843 Samco Road, Suite A Rapid City, SD 57702 (605) 341-4595
Maureen Weiner b. Contact Person: Regulatory Consultant to Mastel Precision, Inc. 53 Barcelona Irvine, CA 92614 (949) 757-0755

Maureen Weiner

c. Date Summary Prepared: December 17, 2002

2. Name of device, including trade name and classification name:

Trade/Proprietary Name: Mastel 1 Folder™ Implantation System a.
b. Classification Name: Intraocular Lens Guide

3. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

Company:	Allergan, Inc.
Device:	AMO PhacoFlex II Insertion System
510(k):	K961242
Date Cleared:	June 17, 1996

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Company:	Alcon Research, Ltd.
Device:	Monarch II IOL Delivery System
510(k):	K001157
Date Cleared:	June 27, 2000

4. A description of the device that is the subject of the 510(k), including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):

న. Statement of intended use:

The Mastel 1 Folder™ Insertion System is intended to fold and assist in inserting the SENSAR™, model AR40e intraocular lens, ONLY into the capsular bag.

5. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device.

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CHARACTERISTICS
	Mastel PrecisionMastel 1 Folder	AllerganAMO PhacoFlex II	AlconMonarch II IOL
	Implantation System	Insertion System	Delivery System
Indication for use	To fold and assist in insertingthe SENSAR, model AR40eintraocular lens, ONLY into thecapsular bag	To fold and assist in insertingthe AMO PhacoFlex II (SLM-2/UV) family of intraocularlenses, specifically the SI-30NB and SI-40NB, into theeye	To fold and deliver AlconACRYSOF intraocular lensesinto the eye for replacement ofthe human crystalline lens
Operating Principle	The handpiece delivers theloaded IOL into the eye	IOL is loaded into the cartridgeand the IOL is pushed throughthe cartridge and delivered intothe eye	The handpiece accepts thecartridge (loaded with the IOL)and delivers the IOL by using aplunger to express the lens intothe eye
Patient Contact Portion ofDevice	No patient contact	Cartridge contacts eye,cartridge material ispolypropylene	Cartridge contacts eye,cartridge material ispolypropylene
Handpiece Material	Titanium	Titanium	Titanium
Reusable/Disposable	Reusable	Reusable	Reusable
Handpiece Sterility	Provided non-sterile	Provided non-sterile	Provided non-sterile

Comparison of Devices for Substantial Equivalence

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7. Brief summary of nonclinical tests and results:

In vitro performance testing was conducted on the Mastel 1 Folder Insertion System. The intraocular lenses (IOLs) were delivered using the Mastel 1 Folder handpiece and then evaluated for diopter, astigmatism, resolution, visual acuity, overall diameter, loop angles, and sagitta. The results revealed that all Mastel 1 Folders provided acceptable results when delivering 130 intraocular lenses, ranging from 6.0 D to 23.0 D.

Based on the performance testing, Mastel Precision concludes that this system is a safe and effective device for folding and assisting in inserting the SENSAR™, model AR40e intraocular lens into the eye.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mastel Precision Inc. c/o Maureen Weiner Regulatory Affairs Consultant 53 Barcelona Irvine, CA 92614

Re: K022723

Trade/Device Name: Mastel 1 Folder™ Implantation System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I Product Code: KYB Dated: December 17, 2002 Received: December 18, 2002

Dear Ms. Weiner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Maureen Weiner

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrlv/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Mastel Precision. Inc. Mastel 1 Folder™

· K022723 Confidential

Page 1 of 1

510(k) Number (if known): K022723

Device Name: Mastel 1 Folder™ Implantation System

Indications for Use:

The Mastel 1 Folder™ Implantation System is intended to fold and assist in inserting the SENSAR™, model AR40e intraocular lens, ONLY into the capsular bag.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number	K022723
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Prescription Use		OR	Over-The-Counter Use
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

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.