The Collamer 3 Piece IOL Injector, is an intraocular lens guide used to ford and into the capsular bag or ciliary sulcus following cataract extraction.

Device Description

The Collamer 3 Piece Injector is made of titanium alloy designed for inserting intraocular lenses into the human eye following cataract extraction. The Collamer 3 Piece Injector materials and mechanical behavior are similar to those used with the predicate device.

AI/ML Overview

The provided document is a 510(k) summary for the STAAR Surgical Collamer 3 Piece Injector, and it describes a medical device (injector), not an AI/ML powered device, therefore most of the requested information (like acceptance criteria for an AI model, sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this document.

However, I can extract the information relevant to the device's performance based on the provided text, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's the relevant information:

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

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical performance equivalent to predicate device	The Collamer 3 Piece Injector was found to perform equivalently to the predicate device, the MS1-P Elastic Lens Injector, with respect to mechanical performance.
Mechanical behavior equivalent to predicate device	The Collamer 3 Piece Injector was found to perform equivalently to the predicate device, the MS1-P Elastic Lens Injector, with respect to mechanical behavior.
Designed and tested in accordance with applicable safety standards	The Collamer 3 Piece Injector has been designed and tested in accordance with applicable safety standards.

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing an AI/ML algorithm's performance on a dataset. The testing described is non-clinical mechanical performance testing of a physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm is not relevant here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an AI algorithm.

7. The type of ground truth used: Not applicable. The "ground truth" in this context would be the objective measurements and observations of the physical device's mechanical performance and behavior, compared to a predicate device and safety standards.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary of the Study:

The study described is a non-clinical test to demonstrate the substantial equivalence of the Collamer 3 Piece Injector to its predicate device, the MS1-P Elastic Lens Injector (K861085). The study focused on validating the mechanical performance and mechanical behavior of the new injector.

The device meets the (implicit) acceptance criteria because the non-clinical tests showed that it performs equivalently to the predicate device in terms of mechanical performance and behavior, and it was designed and tested in accordance with applicable safety standards. The FDA's clearance letter (K032412) confirms that the device is substantially equivalent, allowing it to be marketed.

Summary

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K032 4/2

Section 15

Summary of Safety and Effectiveness

The 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 datesummary prepared:
a.	Submitter: STAAR Surgical Company1911 Walker AvenueMonrovia, CA 91016(626) 303-7902

b. Contact Person:	Helene Lamielle
c. Date Summary Prepared	May 14, 2004

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

a.	Trade/Proprietary Name:	Collamer 3 Piece Injector
b.	Classification Name:	Intraocular Lens Guide

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

a.	Company:	STAAR Surgical Company
b.	Device:	MS1-P Elastic Lens Injector
c.	510(K):	K861085
d.	Date Cleared:	5/28/1986

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1. 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):
  The Collamer 3 Piece Injector is made of titanium alloy designed for inserting intraocular lenses into the human eye following cataract extraction. The Collamer 3 Piece Injector materials and mechanical behavior are similar to those used with the predicate device.

5. Statement of intended use:

The Collamer 3 Piece Injector is an intraocular lens guide used to fold and insert STAAR Surgical's 3 Piece Collamer intraocular lenses for surgical placement in the human eye. " ------------------------------------------------------------------------------------------------------------------------------------------------

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

CHARACTERISTICS	Collamer 3 Piece Injector	MS1-P ElasticLens Injector
Intended Use	For Surgical placement of an intraocularlens in the human eye	Same
Material	Titanium, 6-Aluminum, 4-Venadium, andPEEK (polyetheretherketone)	Titanium
Sterilization	Provided non-sterile, may be steamsterilized	Provided non-sterile;may be steam sterilized
Mode of Operation	Intraocular lenses are folded and placedinside a lens cartridge made frompolypropylene. The lens is then pusheddown via a plunger and plunger rod andexpelled from the lens cartridge into thehuman eye.	Same
Single Use or Re-useable	Re-usable	Same

Comparative Technological Characteristics

7. Brief summary of non-clinical tests and results:

The Collamer 3 Piece Injector has been designed and tested in accordance with applicable safety standards. In addition, the Collamer 3 Piece Injector was found to perform equivalently to the predicate device, the MS1-P Elastic Lens Injector with respect to mechanical performance and mechanical behavior.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2004

STAAR Surgical Company c/o Helene Lamielle, M.D. 1911 Walker Ave. Monrovia, CA 91016

Re: K032412

Trade/Device Name: Collamer 3 Piece Injector Regulation Number: 21 CFR 886.4300 Regulation Name: Ophthalmic lens guide Regulatory Class: Class I Product Code: KYB Dated: May 14, 2004 Received: May 17, 2004

Dear Dr. Lamielle:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrosal of togally to togens the Medical Device Amendments, or to commerce prof to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices may have been recuire approval of a premarket approval application (PMA). and Cosmetic Ace (71ct) that as novice, subject to the general controls provisions of the Act. The r ou may, dicterore, market the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (600 a00 70) als. Existing major regulations affecting your device can may be subject to sater additions, Title 21, Parts 800 to 898. In addition, FDA may or found in the Overning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dri 3 ibsualled by our device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any I cacrates and regulations and limited to: registration and listing (21 Comply with an the Act 31equirements, 01); good manufacturing practice requirements as set CTK in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality !!)Stems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – K032412

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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html

Sincercly yours,

Akeiji Korentthal

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

Enclosure

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Page 3 - K032412

Indications for Use

510(k) Number (if known):_K032412

Device Name: STAAR Surgical Collamer 3 Piece Injector

Indications For Use:

The Collamer 3 Piece IOL Injector, is an intraocular lens guide The Collamer 3 I a man Surgical 3 Piece Collamer used to ford and into the capsular bag or ciliary sulcus following cataract extraction.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Copc@rrenee-of CDRH, Office of Device Evaluation (ODE)

- Division of Ophthalmic Ear.Nose and Throat Devises
510(k) Number_KO32412	Page 1 of

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.