The Sovereign™ Cataract Extraction System is a phacofragmentation system for use with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract. The Sovereign™ Cataract Extraction System is designed to provide the surgical capabilities desired by the Anterior Segment/Cataract Surgeon for use in the cataract extraction.

Device Description

The Sovereign™ Cataract Extraction System is a phaccemulsification system which is used by ophthalmic surgeons during cataract surgery. Accessories, which are connected to the consoles, aid the surgeon in breaking up and removing the cataract from the patient's eye. The Sovereign™ Cataract Extraction System is a modification of a previous device and is substantially equivalent to the predicate devices listed above.

AI/ML Overview

The provided Premarket Notification 510(k) Summary for the Sovereign™ Cataract Extraction System describes non-clinical performance testing rather than a clinical study with acceptance criteria in the format typically associated with AI/ML device evaluations. This submission precedes the widespread use of such technologies in medical devices.

Therefore, the information you requested about acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for AI/ML devices is not applicable or extractable from this document.

However, I can extract the information relevant to the performance testing that was conducted as described in the document.

Acceptance Criteria and Device Performance (Based on "Brief summary of nonclinical tests and results"):

Acceptance Criterion (Implicit)	Reported Device Performance
Phacoemulsification performance comparable to predicate device	Performance in an in vivo model system was comparable to the predicate with respect to phacoemulsification.
Irrigation performance comparable to predicate device	Performance in an in vivo model system was comparable to the predicate with respect to irrigation.
Diathermy performance comparable to predicate device	Performance in an in vivo model system was comparable to the predicate with respect to diathermy.
Vitrectomy performance comparable to predicate device	Performance in an in vivo model system was comparable to the predicate with respect to vitrectomy.
Fluidics performance comparable to predicate device	Performance in an in vivo model system was comparable to the predicate with respect to fluidics.
Reusable tubing sets (OPO55) durability	Reusable tubing sets (OPO55) qualified through cleaning, sterilization, and durability studies for up to 20 uses when reprocessed in accordance with the Directions for Use provided.
Overall function and intended use	The overall function and intended use of the modified device are substantially equivalent to the predicate devices. The results of these tests indicate that Sovereign™ Cataract Extraction System performs equivalent to the predicate devices.

Additional Information (Not Applicable/Not Provided in the Document for AI/ML specific criteria):

Sample size used for the test set and the data provenance: Not applicable. The document mentions "in vivo model system" but does not specify sample sizes or data provenance in the context of clinical test sets. This was likely bench and animal testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML models (e.g., expert consensus on images or pathology) is not relevant to this type of device and testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is a surgical system, not an AI diagnostic or assistance tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical system that requires a human operator (ophthalmic surgeon).
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is the performance of the predicate devices against which the Sovereign™ system's performance was compared in non-clinical settings (e.g., "in vivo model system"). The document implies that the established functionality and performance characteristics of the predicate devices served as the standard for comparison.
The sample size for the training set: Not applicable. This device does not use an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The study referenced in the 510(k) summary is a "performance testing" of the Sovereign™ Cataract Extraction System. This testing was non-clinical and involved comparisons to predicate devices (other AMO® cataract extraction devices). The primary purpose was to demonstrate "substantial equivalence" to previously cleared devices rather than to meet specific statistical performance metrics against a clinical ground truth as would be required for an AI/ML diagnostic system. The testing covered functional aspects like phacoemulsification, irrigation, diathermy, vitrectomy, and fluidics in an "in vivo model system," as well as durability studies for reusable components.

Summary

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Premarket Notification [510(k)] Summary 0.

K981116

This summary document is being submitted in accordance with section 807.92(c).

The submitter of the 510(k) is:

Marcia S. Yaross, Ph.D. Director, Worldwide Regulatory Affairs and Medical Compliance Allergan, Inc. 2525 Dupont Ave. Irvine, CA 92713-9534 714-246-2362 phone 714 246-2205 fax

Date Summary Prepared: March 26, 1998

Device Subject to this 510(k):

Trade Name:	Sovereign TM Cataract Extraction System
Common Name:	Phacofragmentation or Phacoemulsification System
Classification Name:	Phacofragmentation System (886.4670)

Comparison with Predicate Devices:

The device which is the subject of this 510(k), Sovereign™ Cataract Extraction System, is substantially equivalent to the other AMO® cataract extraction devices which were authorized for marketing via 510(k) K971186 (AMO®Diplomax® System-modified), K946054 (AMO®Diplomax® System), and K924235 (AMO®Prestige® system). The handpiece component of the Sovereign™ system is equivalent to ultrasonic handpieces authorized for marketing under 510(k) K951462 (AMO@ProFicient® Handpiece), and K844373 (AMO®Series III® Handpiece). The manufacturer of the predicate devices is Allergan.

The significant changes to the predicate devices are:

The name is changed to the Sovereign™ Cataract Extraction System. 1.
There is structural redesign, both internally and to the user interface. 2.
There are changes in the system control architecture. 3.
A new pressure measurement system, similar to that of the AMO®Prestige®, is 4. employed.
1. There is new host software and redesigned printed circuit boards.
A new biocompatible material is used in the OPO55 reusable tubing sets. 6.
A new graphical user interface (LCD display) is introduced. 7.
The phaco handpiece has been redesigned. 8.

* ALLERGAN*

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Sovereign TM Cataract Extraction System 510(k) Premarket Notification

Page 36 1481116

Device Description:

Indications for Use:

The intended use of the device is to emulsify and remove cataracts.

Brief summary of nonclinical tests and results:

Performance testing was conducted on the Sovereign™ Cataract Extraction System. Performance in an in vivo model system was comparable to the predicate with respect to phaccemulsification, irrigation, diathermy, vitrectorny and fluidics. The reusable tubing sets (OPO55) were qualified through cleaning, sterilization and durability studies for up to 20 uses when reprocessed in accordance with the Directions for Use provided.

The results of these tests indicate that Sovereign™ Cataract Extraction System performs equivalent to the predicate devices. The overall function and intended use of the modified device are substantially equivalent to the predicate devices. Therefore, the Sovereign™ Cataract Extraction System is substantially equivalent to the predicate devices in commercial distribution.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The eagle is a common symbol of the United States, and its presence on the seal signifies the department's role in protecting the health and well-being of the nation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 19 1998

Marcia S. Yaross, Ph.D. Director, Worldwide Regulatory Affairs and Medical Compliance Allergan, Inc. 2525 Dupont Ave. Irvine, CA 92713-9534

Re: K981116 Trade Name: Sovereign ™ Cataract Extraction System Regulatory Class: I Product Code: 86 KYG Dated: March 26, 1998 Received: March 27, 1998

Dear Ms. Yaross:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Ms. Marcia S. Yaross, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Roirl Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K981116 ORIGINAL

Indications for Use

510(k) Number (if known): _Unknown at this time

Device Name: Sovereign™ Cataract Extraction System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

Denis L. McCarthy

Division Sign-Off Division of Ophthalmic Devices 510(k) Number

ALLERILAN - SERICIEI CON - BENTIAL

Regulation Number and Section

§ 886.4360 Ocular surgery irrigation device.

(a)
Identification. An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.