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.

Device Description

The Constellation® Vision System is a combined anterior and posterior procedure ophthalmic system that is modular in design and serves as an enhanced version of the Alcon Vision System. The Constellation® Vision System is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, and illumination as well as irrigation, lens emulsification and fragmentation, cautery and diathermy. The system was developed with a dual purpose: to make it simple to operate, and to allow the surgeon control and flexibility.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Alcon Constellation® Vision System:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided 510(k) summary, there are no specific quantitative acceptance criteria or reported device performance metrics listed in the document for clinical or diagnostic efficacy. The submission focuses on substantial equivalence to predicate devices and adherence to standards.

Acceptance Criteria	Reported Device Performance
None explicitly stated in terms of performance metrics for efficacy (e.g., accuracy, sensitivity, specificity).	The device conforms to the same standards as the original K063583 clearance. Regression testing for Electromagnetic Compatibility (EMC) was performed to verify changes to the touchscreen PCBA.

The document primarily states:

"Technological characteristics affecting clinical performance are similar to that of other ophthalmic devices."
"Test data and documents were submitted that demonstrated that the functional requirements had been met and that the system specifications have been met prior to commercial product release."

This implies that the acceptance criteria are related to the successful completion of functional tests, compliance with electrical safety and EMC standards, and similarity to predicate device performance, rather than specific numerical efficacy targets.

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

The document does not describe a test set in the context of clinical or diagnostic performance evaluation. The testing mentioned is for:

"regression testing for the Electromagnetic Compatibility (EMC) standard"
"functional requirements" and "system specifications"

Therefore, sample size and data provenance (country of origin, retrospective/prospective) are not applicable or mentioned in the context of clinical efficacy for this 510(k) submission.

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

This information is not applicable as there is no mention of a human-read test set or a clinical study for diagnostic or clinical performance that would require establishing ground truth by experts. The submission relies on technical testing and substantial equivalence.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a clinical test set requiring expert adjudication.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an ophthalmic microsurgical system, not an AI-powered diagnostic or assistive tool for human readers that would necessitate such a study.

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

This is not applicable as the Constellation® Vision System is a surgical device, not a standalone algorithm. Its "performance" is primarily defined by its functionality, safety, and operational characteristics in a surgical context, rather than a diagnostic output.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the type of technical and functional testing described, the "ground truth" would be established by engineering specifications, regulatory standards compliance, and predefined functional outputs expected from the system. It would not be based on clinical outcomes data or expert medical consensus in the way a diagnostic device's ground truth is established.

8. The Sample Size for the Training Set

This information is not applicable. The device is a surgical system, not a machine learning or AI algorithm that requires a training set of data.

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

This information is not applicable as there is no training set for this type of device.

Summary

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Alcon
RESEARCH, LTD.
ALCON RESEARCH, LTD.

510 (2):

K101285

ALCON RESEARCH, LTD.

15800 ALTON PARKWAY

IRVINE, CA 92816

510(K) SUMMARY

This summary is in accordance with 21 CFR 807.92(c). The submitter of the 510(k) is:

Martin A. Kaufman Director, Regulatory Affairs Alcon Research Ltd. 15800Alton Parkway Irvine, CA 92618, USA Phone: (949) 753-6250 Fax: (949) 753-6237

NOV 1 3 2010

Date Prepared: November 05, 2010

Device Subject to this 510(k):

Trade Name:	Constellation® Vision System
Common Name:	Vitreous Aspiration & Cutting Instrument/PhacofragmentationSystemVitreous Aspiration & Cutting Instrument (21 CFR 886.4150)Phacofragmentation System (21 CFR 886.4670)
Classification Name:	Class II

Predicate Devices

510(k) Number	Device
K063583	Alcon Vision System
K091777	Alcon UltraChopper
K093305	Enhanced UltraVit Probe
K062604	Next Generation Laser

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Device Description

Indications for Use

The Constellation® Vision System is indicated for the following:

Comparison of the Constellation Vision System to the previously cleared Alcon Vision System (K063583)

The following technical feature was added since clearance of K063583:

3D Phaco/Fragmentation control modality this control modality expanded the user . interface to include a screen that allows the operator to apply the same 3D control algorithm to phaco and fragmentation modes as is available in the vitrectomy modes. This capability is the equivalent feature as currently available on the Alcon Accurus® system. This was a software interface change only and included no new hardware.
In addition to the expanded feature set described above, the following product has been cleared since K063583:
K093305 Enhanced UltraVit Probe .
This version of the Constellation® Vision System has provisions to incorporate the functionality of these added accessory items. All other technical features remain equivalent between the

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previously cleared (K063583) version and this current version of the Constellation® Vision System.

Modifications were made to this current version of the Constellation® Vision System to correct anomalies in the hardware and software. These corrections did not introduce new functional capabilities.

Brief Summary of Nonclinical Tests and Results

The Constellation® Vision System conforms to the same standards as were listed in the original K063583 clearance. For this current version of the Constellation® Vision System, regression testing for the Electromagnetic Compatibility (EMC) standard was performed to verify changes made to the touchscreen PCBA.

No other testing was necessary to satisfy compliance to the remaining standards listed in the original Alcon Vision System 510(k), K063583.

Consumables

The Constellation® Vision System consumable products are provided sterile and intended for single use only. These products will be EtO or gamma sterilized and the process will be validated per the standards: EN ISO 11135-1:2007: Sterilization of health care products — Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices or EN ISO 11137-1:2006: Sterilization of Health care Products -Radiation - Part 1: requirements for development, validation, and routine control of a sterilization process for medical devices. Reusable handpieces are not provided sterile. Validated reprocessing instructions for cleaning, sterilization and re-use will be provided in the Directions for Use of the product.

Conclusion

Technological characteristics affecting clinical performance are similar to that of other ophthalmic devices. The Constellation® Vision System has been developed and is manufactured in compliance with FDA and ISO quality system requirements. Test data and documents were submitted that demonstrated that the functional requirements had been met and that the system specifications have been met prior to commercial product release.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

Alcon Research, Ltd. c/o Mr. Martin Kaufman Director, Regulatory Affairs 15800 Alton Parkway Irvine, CA 92618

Re: K101285

Trade/Device Name: Constellation Vision System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: II Product Code: HOC Dated: October 1, 2010 Received: October 4, 2010

NOV 1 3 20.0

Dear Mr. Kaufman:

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

signature

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

NOV 1 3 2010

K101285 510(k) Number (if known): _ Device Name: Constellation® Vision System

Indications for Use:

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 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, Neurological and Ear, Nose and Throat Devices

K101285 510(k) Number.

Regulation Number and Section

§ 886.4670 Phacofragmentation system.

(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.