The Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lenses identifying the Crystalsert delivery system in their approved labeling.

Device Description

The Crystalsert Delivery System is a sterile, single-use device used to fold and insert an intraocular lens through surgical procedure into a human eye. The system provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the capsular bag.

AI/ML Overview

The provided document describes the Bausch & Lomb Crystalsert Delivery System, a device for inserting intraocular lenses. However, it does not contain a study to prove the device meets acceptance criteria in the context of an AI/ML algorithm or a typical clinical trial with acceptance criteria for performance metrics like sensitivity, specificity, or accuracy.

Instead, this 510(k) submission focuses on demonstrating substantial equivalence to a predicate device through comparative analysis and functional testing against an international standard.

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I will address the parts that are relevant to this type of device submission.

Here's the breakdown of what can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria or reported performance in the typical format of a study for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, safety and effectiveness are established through demonstrating equivalence to a predicate device and conformance to an international standard.

Acceptance Criteria (Implicit)	Reported Device Performance
Equivalence to Predicate Device (K082944)	"The Crystalsert Delivery System has been demonstrated to be equivalent to the predicate device for its intended use."
Functional Testing per ISO 11979-3, section 5	"The Crystalsert Delivery System has successfully undergone functional testing and was found to deliver IOLs in conformance with the requirements set forth in ISO 11979-3, section 5."
Materials	Body, drawer, plunger: polypropylene; Spring: stainless steel (matches predicate)
Single Use?	Single use (matches predicate)
Sterile?	Sterile (matches predicate)
How sterilized?	Ethylene oxide (matches predicate)
Sterility Assurance Level	10^-6 (matches predicate)
Shelf life	12 months (matches predicate)
Indications for Use	Intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lenses identifying the Crystalsert delivery system in their approved labeling (expanded from predicate but still functionally equivalent).

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

Not applicable for this type of device submission. This is a medical device for IOL insertion, not an AI/ML algorithm evaluated on a data set. The "test set" would be the functional testing of the device itself (e.g., number of units tested during engineering verification), which is not explicitly stated but implied by the "successful functional testing" claim. Data provenance like country of origin or retrospective/prospective is not relevant here.

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. The "ground truth" for this device would be its ability to correctly fold and insert an IOL, which is assessed via engineering and performance testing against a standard. Experts would be engineers and quality control personnel.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1) are for human interpretation of data for AI/ML algorithm training/testing. This device relies on objective functional testing against a standard.

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-assisted diagnostic or prognostic device for human readers.

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

Not applicable. This device is a manual tool, not an algorithm.

7. The type of ground truth used

For this device, the "ground truth" is established by conformance to an international standard (ISO 11979-3, section 5) and successful functional performance specifications for its intended use (folding and inserting an IOL without damage). This is validated through engineering and performance testing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary

{0}------------------------------------------------

BAUSCH+LOMB

Pg. 1 of 2

30 Enterprise, Suite 450
www.bausch.com

K123736

510(k) Summary
Submitter:	Bausch & Lomb, Inc.30 Enterprise, Suite 450Aliso Viejo, CA 92656	K123736
Contact Person:	Jason SmithGlobal Regulatory Affairs ManagerPhone: 949-521-7804Fax: 949-521-7760Email: jason.smith@bausch.com	MAY 1 6 2013
Date Prepared:	December 4, 2012
Trade name:	Crystalsert Delivery System
ClassificationName:	Intraocular lens guide (21 CFR 886.4300)
PredicateDevices:	K082944 Crystalsert Crystalens Delivery System
DeviceDescription:	The Crystalsert Delivery System is a sterile, single-usedevice used to fold and insert an intraocular lens throughsurgical procedure into a human eye. The systemprovides a tubular pathway through an incision over theiris, allowing delivery of an IOL into the capsular bag.
Indications forUse:	The Crystalsert Delivery System is intended to be used tofold and deliver the Crystalens accommodatingintraocular lens and other intraocular lenses identifyingthe Crystalsert Delivery System in their approved labeling.
ComparativeAnalysis:	The Crystalsert Delivery System has been demonstratedto be equivalent to the predicate device for its intendeduse.
Functional/SafetyTesting:	The Crystalsert Delivery System has successfullyundergone functional testing and was found to deliverIOLs in conformance with the requirements set forth inISO 11979-3, section 5.
Conclusion:	The Crystalsert Delivery System is substantiallyequivalent to the predicate device.

{1}------------------------------------------------

BAUSCH+LOMB

Pg. 2 of 2

30 Enterprise, Suite 450
Aliso Viejo, CA 92656 800.393.6642 www.bausch.com

Characteristic	Predicate K082944Crystalsert Crystalens DeliverySystem	Crystalens Delivery System(Proposed Device)
Indications for use	The Crystalsert Crystalens deliverysystem is intended to fold and deliverthe Crystalens (AT-52SE, AT-50SE,HD520 and HD500) accommodatingintraocular lens into the capsular bag.	The Crystalsert delivery system isintended to be used to fold and deliverthe Crystalens accommodatingintraocular lens and other intraocularlenses identifying the Crystalsertdelivery system in their approvedlabeling.
Contraindications	None	None
Materials	Body, drawer, plunger: polypropyleneSpring: stainless steel	Body, drawer, plunger: polypropyleneSpring: stainless steel
Single use?	Single use	Single use
Sterile?	Sterile	Sterile
How sterilized	Ethylene oxide	Ethylene oxide
Sterility assurancelevel	10-6	10-6
Shelf life	12 months	12 months

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of an eagle with three wing-like shapes extending from its body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

May 16, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Bausch & Lomb Inc. % Mr. Jason Smith Global Regulatory Affairs Manager 30 Enterprise, Suite 450 Aliso Viejo, CA 92656

Re: K123736

Trade/Device Name: Crystalsert Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I (reserved) Product Code: MSS Dated: April 4, 2013 Received: April 5, 2013

Dear Mr. Smith:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

{3}------------------------------------------------

Page 2 - Mr. Jason Smith

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

. Kesia Y. Alexander -S

for Malvina B. Eydelman, M.D.

Director

Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

BAUSCHELO

30 Enterprise, Suite 450 Aliso Viejo, CA 92656 800.393.6642 www.bausch.com

Indications for Use Statement

510(k) Number (if known):

Device Name: Crystalsert Delivery System

Indications for Use:

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

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)

Image /page/4/Picture/11 description: The image shows the name "Tieuvi-H-Nguyen" at the top. Below the name, the date and time "2013:05:07 19:01:48" are displayed. The timezone offset "-04'00'" is located below the date and time. The text appears to be extracted from a document or a photograph.

(Division Sign-Off)

Division of Ophthalmic and Ear, Nose

and Throat Devices

510(k) Number K123736

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.