The One Series™ Ultra cartridge is used to fold and assist in the insertion of a TECNIS® 1-Piece soft acrylic intraocular lens (IOL) into the eye following cataract extraction. The cartridge, Model 1VIPR30 is a single-use component composed of polypropylene which is injection molded and coated with a lubricious coating. The cartridge is provided sterile. The IOL is loaded into the proximal portion of the cartridge using forceps. The cartridge is then placed in a reusable titanium handpiece, which advances the IOL through the tube section of the cartridge and delivers it into the eye.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device called the "ONE SERIES™ Ultra Cartridges" (later renamed ONE SERIESTM Ultra Cartridges). This document primarily serves as an FDA clearance letter and a 510(k) summary, establishing substantial equivalence to predicate devices rather than detailing a specific clinical study with granular acceptance criteria and performance metrics.

Therefore, much of the requested information regarding acceptance criteria, specific study design, sample sizes, expert qualifications, and ground truth establishment, as typically found in detailed study reports, is not present in these documents. The document focuses on demonstrating equivalence through bench testing and biocompatibility.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or specific performance metrics in a tabular format as would be found in a detailed study report. It broadly states that the device was found equivalent to predicate devices based on "material and performance characteristics."

Acceptance Criteria (Inferred/General)	Reported Device Performance (General)
Material equivalence to predicate devices	Found equivalent
Sterilization method equivalence	Found equivalent
Intended use equivalence	Found equivalent
Mode of operation equivalence	Found equivalent
Performance: Folding of IOL	Verified to be equivalent to predicate devices
Performance: Delivery of IOL	Verified to be equivalent to predicate devices
Performance: Retention of IOL	Verified to be equivalent to predicate devices
Performance: Cosmetic properties of IOL	Verified to be equivalent to predicate devices (implying no negative impact on cosmetic properties)
Performance: Dimensional properties of IOL	Verified to be equivalent to predicate devices (implying no negative impact on dimensional properties)
Performance: Optical properties of IOL	Verified to be equivalent to predicate devices (implying no negative impact on optical properties)
Biocompatibility	Conducted and verified

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document mentions "Bench testing and biocompatibility testing," but does not provide details on the number of cartridges or IOLs tested.
Data Provenance: Not specified. It's likely the testing was conducted in a laboratory setting by the manufacturer (Advanced Medical Optics, Inc.) in the USA, as indicated by their address. The testing is non-clinical.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable for this type of submission. The performance testing described (folding, delivery, retention, cosmetic, dimensional, optical properties) would likely be assessed against engineering specifications and predicate device performance, not by expert human interpretation in the way an AI diagnostic device would be.

4. Adjudication Method for the Test Set

Not applicable as the testing involves objective measurements against specifications rather than expert consensus on subjective interpretations.

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 not an AI-assisted diagnostic device, but rather a physical medical device (intraocular lens cartridge). Therefore, MRMC studies and AI-related effectiveness metrics are not relevant or present in this document.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No. This device is an intraocular lens cartridge, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance would be engineering specifications, material standards, and benchmark performance of the predicate devices. For example, successful folding and delivery without damage to the IOL would be objectively verifiable against defined criteria. Biocompatibility would be assessed against established standards for medical devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense. The "training" for such a device involves product development, engineering, and manufacturing processes to meet design specifications, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 20, 2021

Advanced Medical Optics, Inc. Ms. Kim Regis Manager, Regulatory Affairs Projects 1700 East St. Andrew Pl. Santa Ana, California 92705

Re: K081545

Trade/Device Name: ONE SERIESTM Ultra Cartridges Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I, reserved Product Code: MSS

Dear Ms. Kim Regis:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 2, 2008. Specifically, FDA is updating this SE Letter to include the correct product code as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Bennett Walker, Ph.D., OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-5094, bennett.walker(@fda.hhs.gov .

Sincerely,

Bennett N. Digitally signed by
Bennett N. Bennett N. Walker -S Date: 2021.09.20 Walker -S 09:14:14 -04'00'

Bennett Walker, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

OCT 02 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Advanced Medical Optics, Inc. c/o Ms. Kim Regis Manager, Regulatory Affairs Projects 1700 E. St. Andrew Place Santa Ana, CA 92705

Re: K081545 Trade Name: ONE SERIES™ ULTRA Cartridges Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: I Product Code: KYB Dated: September 25, 2008 Received: September 26, 2008

Dear Ms. Regis:

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. Iisting 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. Kim Regis

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Malvina B. Eggleston, M.D.

Malvina B. Eydelman M.I 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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CDRH INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name(s): Indications for Use: One Series™ Ultra cartridge

K081545

Used to fold and assist in inserting TECNIS® 1-Piece intraocular lenses into the eye.

Prescription Use	X (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number	K081545

Page 1 of 1

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K081545

Image /page/4/Picture/1 description: The image shows the logo for Advanced Medical Optics (AMO). The logo features a stylized "AMO" in bold, sans-serif font, with a curved line above the letters. Below the letters, the words "ADVANCED MEDICAL OPTICS" are printed in a smaller, sans-serif font.

OCT 02 2008

5.0 510(k) SUMMARY

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).

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

a. Applicant:	Advanced Medical Optics, Inc.1700 E. St. Andrew PlaceSanta Ana, CA 92705
b. Contact Person:	Kim RegisManager, Regulatory Affairs Projects1700 E. St. Andrew PlaceSanta Ana, CA 92705Ph: 714.247.8564Fax: 714.247.8677

c. Date Summary Prepared: May 30, 2008

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

a. Trade/Proprietary Name:	One Series™ Ultra cartridge
b. Classification Name:	Intraocular Lens Guide
c. Device Classification:	Class I per 21 CFR 886.4300
d. Product Code:	KYB

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

Company:	Advanced Medical Optics, Inc. (AMO®)
Device:	AMO® PhacoSert™ cartridge
510(k):	K961242
Date Cleared:	June 17, 1996
Company:	IntraLuminal Therapeutics, Inc.
Device:	Safe-Cross® Deflecting Catheter
510(k):	K031692
Date Cleared:	August 22, 2003

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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 One Series™ Ultra cartridge is used to fold and assist in the insertion of a TECNIS® 1-Piece soft acrylic intraocular lens (IOL) into the eye following cataract extraction. The cartridge, Model 1VIPR30 is a single-use component composed of polypropylene which is injection molded and coated with a lubricious coating. The cartridge is provided sterile. The IOL is loaded into the proximal portion of the cartridge using forceps. The cartridge is then placed in a reusable titanium handpiece, which advances the IOL through the tube section of the cartridge and delivers it into the eye.

5. Statement of intended use:

The One Series™ Ultra cartridge is used to fold and assist in the insertion of a TECNIS® 1-Piece soft acrylic intraocular lens (IOL) into the eye.

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

The technological characteristics of the One Series™ Ultra cartridge were compared to those of the predicate devices and were found to be equivalent with respect to materials, method of sterilization, intended use, and/or mode of operation.

7. Brief summary of nonclinical tests and results:

Bench testing and biocompatibility testing were conducted which verified that the material and performance characteristics (folding, delivery, and retention of IOL cosmetic, dimensional, and optical properties) associated with the One Series™ Ultra cartridge were equivalent to that of the predicate devices.

8. Conclusions:

AMO has demonstrated through its evaluation of the One Series™ Ultra cartridge that the device is equivalent to the predicate devices with respect to intended use. technological characteristics, and safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

OCT 02 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Advanced Medical Optics, Inc. c/o Ms. Kim Regis Manager, Regulatory Affairs Projects 1700 E. St. Andrew Place Santa Ana, CA 92705

Dear Ms. Regis:

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Page 2 - Ms. Kim Regis

Sincerely yours,

Malvina B. Eggleston, M.D.

Malvina B. Eydelman M.I 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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CDRH INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name(s): Indications for Use: One Series™ Ultra cartridge

K081545

Used to fold and assist in inserting TECNIS® 1-Piece intraocular lenses into the eye.

Prescription Use	X (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number	K081545

Page 1 of 1

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.