The CONSTELLATION® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification, removal of cataracts, and intraocular lens injection) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. The AutoSert® IOL Injector Handpiece is intended to deliver qualified ACRYSOF® intraocular lenses into the eye following cataract removal.

The AutoSert® IOL Injector Handpiece achieves the functionality of intraocular lenses. The AutoSert® is indicated for use with ACRYSOF lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySoft® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Flex-Tip Laser Probes
· Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
o Proliferative and nonproliferative retinopathy (including diabetic);
o Choroidal neovascularization secondary to age-related macular degeneration;
o Retinal tears and detachments;
o Macular edema;
o Retinopathy of prematurity;
o Choroidal neovascularization;
o Leaking microaneurysms.
Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma.
· Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma.
· And other laser treatments including:
o Internal sclerostomy;
o Lattice degeneration;
o Central and Branch Retinal Vein Occlusion;
o Suturelysis;
o Vascular and pigmented skin lesions.

UltraVit Probes
· Vitreous aspiration & cutting.
Membrane cutting & aspiration.
· Lens removal.

Endoilluminator Probes
· Endoillumination
Valved Entry Systems
Scleral incision
· Canulae for posterior segment instrument access
· Venting (of valved cannulae)

Infusion Cannulas
Posterior segment infusion (liquid or gas)

Device Description

The CONSTELLATION® Vision System is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, aspiration, and illumination as well as irrigation, lens emulsification and fragmentation, cautery, diathermy, and IOL Insertion.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CONSTELLATION® Vision System, focusing on its substantial equivalence to predicate devices and adherence to various safety and performance standards. However, it does not include the detailed breakdown of acceptance criteria, device performance, or specific study information (like sample sizes, ground truth establishment, or expert qualifications) that you've requested.

The document primarily outlines:

Indications for Use: The system is for anterior (phacoemulsification, cataract removal, IOL injection) and posterior (vitreoretinal) ophthalmic surgery. Specific probes and systems within CONSTELLATION® (e.g., Flex-Tip Laser Probes, UltraVit Probes, AutoSert® IOL Injector Handpiece) have their own detailed indications.
Predicate Devices: Several previously cleared Alcon devices (e.g., K101285 CONSTELLATION® Vision System, K121555 CENTURION® Vision System) are listed as predicates.
Nonclinical Tests and Results: The device's compliance with numerous international and industry standards for sterilization, risk management, electrical safety, electromagnetic compatibility, usability, and biocompatibility is stated.

Therefore, based solely on the provided text, I cannot complete your requested table and study details. The document focuses on regulatory compliance through adherence to standards and substantial equivalence, rather than presenting a performance study with specific acceptance criteria and outcome metrics for the device itself.

The information requested, such as specific performance metrics (e.g., sensitivity, specificity for a diagnostic device), sample sizes for test sets, details about ground truth, expert qualifications, or MRMC study results, are typical for AI/ML device submissions, but this document predates broad AI/ML medical device regulation and describes a surgical hardware system with accessories.

Here's a summary of what could be extracted and what is missing, based on the input:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as performance metrics. The closest are adherence to various safety, sterilization, and biocompatibility standards (e.g., EN ISO 11135-1 for sterilization, UL 60601-1 for electrical safety, ISO 10993-1 for biocompatibility). These are pass/fail criteria for compliance.
Reported Device Performance: Not provided in terms of quantitative clinical performance (e.g., success rates, complication rates, or diagnostic accuracy). The document states "Safety tests... have demonstrated its compliance with applicable requirements of the following standards" and "Non-clinical testing... has demonstrated that the functional requirements have been met and that the modified device is equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document refers to non-clinical testing for compliance with standards, not a specific clinical test set with human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. No "ground truth" in the diagnostic sense is established in this document, as it's not a diagnostic AI/ML device study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. No human adjudication of a test set is described.

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/ML device. No MRMC study is mentioned.

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

No. This is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable/Not provided. "Ground truth" as a diagnostic reference standard is not relevant to the compliance testing described for this surgical system. The "truth" in this context is whether the device meets engineering specifications and safety standards.

8. The sample size for the training set

Not applicable/Not provided. 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/Not provided. This is not an AI/ML device.

In conclusion: The provided document is a 510(k) summary for a surgical system, detailing its intended use and compliance with general medical device standards. It does not contain the specific study design, performance metrics, or "ground truth" information typically associated with the evaluation of AI/ML diagnostic or assistive devices, which is what your questions suggest.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines representing hair or fabric. The profiles are stacked slightly offset from each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.

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

August 22, 2014

Alcon Research Ltd. Mr. Robert Lundberg Vice President Regulatory Affairs, VGR 20511 Lake Forest Drive Lake Forest, CA 92630

Re: K141065

Trade/Device Name: CONSTELLATION® Vision System Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous Aspiration & Cutting Instrument Regulatory Class: Class II Product Code: HQE Dated: July 23, 2014 Received: July 24, 2014

Dear Mr. Lundberg:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education 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,

Eric A. Mann -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

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Traditional 510(k) Premarket Submission

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name

CONSTELLATION® Vision System

Indications for Use (Describe)

Flex-Tip Laser Probes

· Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including:

o Proliferative and nonproliferative retinopathy (including diabetic);

o Choroidal neovascularization secondary to age-related macular degeneration;
o Retinal tears and detachments;
o Macular edema;
o Retinopathy of prematurity;
o Choroidal neovascularization;
o Leaking microaneurysms.
Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma.
· Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma.
· And other laser treatments including:
o Internal sclerostomy;
o Lattice degeneration;
o Central and Branch Retinal Vein Occlusion;
o Suturelysis;
o Vascular and pigmented skin lesions.

UltraVit Probes

· Vitreous aspiration & cutting.
Membrane cutting & aspiration.
· Lens removal.

Endoilluminator Probes

· Endoillumination
Valved Entry Systems
Scleral incision
· Canulae for posterior segment instrument access
· Venting (of valved cannulae)

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Traditional 510(k) Premarket Submission Constellation(R) Vision System
Infusion Cannulas

Posterior segment infusion (liquid or gas)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
---------------------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Eric A. Mann - S

2014.08.22 14:24:42 -04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(K) SUMMARY 5

The 510(k) Summary is provided here.

This summary is in accordance with 21 CFR 807.92(c).

The submitter of the 510(k) is:

Robert Lundberg VP, Regulatory Affairs - VGR Alcon Research Ltd. 20511 Lake Forest Drive Lake Forest, CA 92630, USA Phone: (949) 505-7817 Fax: (949) 505-6237

Date Prepared: April 23, 2014

Device Subject to this 510(k):

Trade Name:	CONSTELLATION® Vision System
Common Name:	Vitreous Aspiration & CuttingInstrument/Phacofragmentation System
Classification Name:	Class IIVitreous Aspiration & Cutting Instrument(21 CFR 886.4150)Phacofragmentation System(21 CFR 886.4670)

5.1 Predicate Devices:

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

510(k) Number	Date Cleared	Device
K101285	11/12/2010	CONSTELLATION® Vision System
K063583	05/09/2008
K121555	12/21/2012	CENTURION® Vision System
K120912	06/15/2012	INFINITI® Vision System

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510(k) Number	Date Cleared	Device
K112425	11/21/2011
K082845	02/12/2009
K021566	07/02/2002
K091777	10/20/2009	Alcon UltraChopper

5.2 Device Description:

5.3 Indications for Use:

The CONSTELLATION® Vision System is indicated for the following:

The CONSTELLATION® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. The AutoSert® IOL Injector Handpiece is intended to deliver qualified ACRYSOF® intraocular lenses into the eye following cataract removal.

The AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert is indicated for use with ACRYSOF® lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved ACRYSOF® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

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Flex-Tip Laser Probes	Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including: Proliferative and nonproliferative retinopathy (including diabetic); Choroidal neovascularization secondary to age-related macular degeneration; Retinal tears and detachments; Macular edema; Retinopathy of prematurity; Choroidal neovascularization; Leaking microaneurysms. Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma. Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma. And other laser treatments including: Internal sclerostomy; Lattice degeneration; Central and Branch Retinal Vein Occlusion; Suturelysis; Vascular and pigmented skin lesions.
UltraVit Probes	Vitreous aspiration & cutting. Membrane cutting & aspiration. Lens removal.
Endoilluminator Probes	Endoillumination
Valved Entry Systems	Scleral incision Canulae for posterior segment instrument access Venting (of valved cannulae)
Infusion Cannulas	Posterior segment infusion (liquid or gas)

5.4 Brief Summary of Nonclinical Test and Results:

Safety tests of the CONSTELLATION® Vision System have demonstrated its compliance with applicable requirements of the following standards:

Standard #	Title
EN ISO 11135-1:2007	Sterilization of health care products - Ethylene oxide - Part 1:Requirements for development, validation and routine controlof a sterilization process for medical devices

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Standard #	Title
AAMI/ANSI/ ISO orEN ISO 11137-1:2006/(R)2010	Sterilization of health care products - Radiation - Part 1:Requirements for development, validation and routine controlof a sterilization process for medical devices
AAMI/ANSI/ ISO orEN ISO 11137-2:2012	Sterilization of health care products - Radiation - Part 2:Establishing the sterilization dose
EN ISO 14971: 2012	Medical devices - Application of risk management to medicaldevices
UL 60601-1: 2003	Medical Electrical Equipment, Part 1 - General Requirementsfor Safety
EN 60601-1:2006/AC: 2010	Medical electrical equipment -- Part 1: General requirementsfor basic safety and essential performance
EN 60601-1-2:2007/AC: 2010	Medical electrical equipment -- Part 1-2: General requirementsfor basic safety and essential performance - Collateralstandard: Electromagnetic compatibility - Requirements andtests
IEC-60601-1-4 - Part1-4: 2000	General Requirements for Safety - Collateral Standard:Programmable Electric Medical Systems
IEC 60601-1-6: 2010	Medical electrical equipment -- Part 1-6: General requirementsfor basic safety and essential performance - Collateralstandard: Usability
EN 60601-2-2: 2009	Medical electrical equipment -- Part 2-2: Particularrequirements for the basic safety and essential performance ofhigh frequency surgical equipment and high frequency surgicalaccessories
EN 80601-2-58: 2009	Medical electrical equipment -- Part 2-58: Particularrequirements for the basic safety and essential performance oflens removal devices and vitrectomy devices for ophthalmicsurgery

Biocompatibility evaluations of materials coming in contact with the patient fluid path have been performed to the following standards:

Standard #	Title
ISO 10993-1: 2009	Biological Evaluation of Medical Devices -- Part 1: Evaluationand Testing within a Risk management Process
ISO 10993-5: 2009	Biological Evaluation of medical devices -- Part 5: Tests for InVitro cytotoxicity
ISO 10993-7: 2010	Biological Evaluation of Medical Devices -- Part 7: EthyleneOxide Sterilization Residuals
ISO 10993-10: 2006	Biological Evaluation of Medical Devices -- Part 10: Tests forIrritation and Delayed-Type Hypersensitivity
ISO 10993-11: 2006	Biological Evaluation of Medical Devices -- Part 11: Tests forSystemic Toxicity

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Standard #	Title
ISO 10993-12: 2009	Biological Evaluation of Medical Devices --Part 12: SamplePreparation and Reference Materials

CONSTELLATION® accessories that are provided sterile and intended for single use only are EtO or Gamma sterilized. The sterilization process has been validated per ISO 11135-1: 2007: Medical Devices – Validation and Routine Control of Ethylene Oxide Sterilization or per ISO 11137-1: 2006, Sterilization of health care products - Radiation - Part1: Requirements for the development, validation and routine control of a sterilization process for medical devices. Reusable handpieces are provided non-sterile. Validated reprocessing instructions for cleaning, sterilization, and re-use of the handpieces are provided in the Directions for Use of the product.

Technological characteristics affecting clinical performance are similar to those of the predicate devices previously listed. The current CONSTELLATION® Vision System as well as the predicate systems have been developed and manufactured in compliance with 21 CFR 820 and ISO 14971: 2012. Non-clinical testing noted above has demonstrated that the functional requirements have been met and that the modified device is equivalent to the predicate devices.

Regulation Number and Section

§ 886.4150 Vitreous aspiration and cutting instrument.

(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.