The Sulzer Carbomedics AnnuloFlex™ Annuloplasty System is indicated as a reinforcement for repair of the human cardiac mitral and tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

Device Description

The AnnuloFlex™ Annuloplasty System consists of an annuloplasty ring mounted on a holder assembly for implantation in the mitral or tricuspid position. A complete set of instrumentation is available separately to properly size the annulus and implant the annuloplasty ring.

AI/ML Overview

This report describes the acceptance criteria and the study that proves the device meets those criteria for the AnnuloFlex™ Annuloplasty System. However, it's important to note that the provided documents are from a 510(k) premarket notification and primarily focus on demonstrating substantial equivalence to predicate devices, rather than a rigorous study with acceptance criteria and statistical performance metrics typically seen in AI/ML device submissions.

Here's an analysis based on the provided text, structured to answer your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Biocompatibility	Non-toxic, non-hemolytic, non-pyrogenic	Biocompatibility testing supports that materials are non-toxic, non-hemolytic, and non-pyrogenic.
Mechanical Performance	Suture retention strength comparable to vascular prostheses.	Suture retention testing demonstrated the sewing ring fabric is comparable to fabrics used in vascular prostheses.
Substantial Equivalence	Identical materials, manufacturing process, and function to predicate devices.	The AnnuloFlex™ Annuloplasty Ring is "substantially equivalent to the predicate devices for repair of the mitral or tricuspid valve." This equivalence is based on: - Identical materials, manufacturing, and function to the Sulzer Carbomedics® AnnuloFlex™ Annuloplasty Ring (a previous version). - Identical function to the Medtronic Duran Flexible Ring (complete ring). - Identical function to the Baxter Cosgrove-Edwards Ring (partial ring).

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

This document does not describe a "test set" in the context of evaluating an AI/ML device. The testing mentioned refers to:

Biocompatibility testing on device materials.
Mechanical testing (e.g., suture retention) on the device components.
Comparison of the device's design, materials, and function to existing predicate devices already on the market.

Therefore, there is no mention of a sample size for a test set or data provenance related to clinical data for performance evaluation in the way an AI/ML device would be assessed.

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

Not applicable. This submission is for a medical device (annuloplasty ring), not an AI/ML diagnostic or therapeutic device that would require expert-established ground truth for a test set. The "ground truth" for this device's performance is established through physical, mechanical, and biocompatibility testing, and comparison to established predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" in the context of a clinical performance evaluation that would necessitate an adjudication method among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a 510(k) submission for a physical medical device, not a software or AI/ML device. An MRMC study is not relevant to this type of device.

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

Not applicable. This is a physical medical device; there is no "algorithm" or standalone performance to evaluate in this context.

7. The Type of Ground Truth Used

The "ground truth" for this device can be interpreted as:

Biocompatibility Standards: The established scientific understanding and regulatory requirements for materials to be non-toxic, non-hemolytic, and non-pyrogenic when in contact with human tissue.
Mechanical Engineering Principles and Standards: The expected performance characteristics of a medical implant in terms of material strength, durability, and suture retention.
Clinical Efficacy of Predicate Devices: The proven safety and effectiveness of the legally marketed predicate annuloplasty rings for their intended use. The new device's "ground truth" for clinical utility is essentially its demonstrated similarity to these established devices.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device and does not involve AI/ML or a "training set."

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

Not applicable, as there is no training set for this device.

Summary

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

5185

DEC 1 7 2002

Summary of Safety and Effectiveness per SMDA 1990 and 21 CFR 807.92 AnnuloFlex™ Annuloplasty System

Submitter:	Sulzer Carbomedics, Inc.1300 East Anderson LaneAustin, Texas 78752U.S.A.	Contact:	Teffany HankinsonRegulatory Affairs SpecialistTelephone: (512) 435-3202Facsimile: (512) 435-3350
Date of Summary: September 19, 2002		Classification Name: Annuloplasty Ring
Common Name: Annuloplasty Ring		Proprietary Name: AnnuloFlex™ Annuloplasty System

Description of Device: The AnnuloFlex™ Annuloplasty System consists of an annuloplasty ring mounted on a holder assembly for implantation in the mitral or tricuspid position. A complete set of instrumentation is available separately to properly size the annulus and implant the annuloplasty ring.

Statement of Intended Use: The Sulzer Carbomedics Annuloplasty System is indicated as a reinforcement for repair of the human cardiac mitral and tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

Technological Comparison: The AnnuloFlex™ Annuloplasty Ring is a flexible annuloplasty ring that can be implanted either as a partial or complete ring, according to the surgeon's preference and/or patient condition. For purposes of this submission, the AnnuloFlex " Annuloplasty Ring was compared to the following predicate devices:

Sulzer Carbomedics® AnnuloFlex™ Annuloplasty Ring: flexible complete or partial ring with � identical materials, identical manufacturing process, and identical function
Medtronic Duran Flexible Ring: flexible complete ring with identical function �
� Baxter Cosgrove-Edwards Ring: flexible partial ring with identical function

Testing: Results of biocompatibility testing supports that the materials used in the manufacture of the AnnuloFlex" are non-toxic, non-hemolytic, and non-pyrogenic. Mechanical testing for the AnnuloFlex™ annuloplasty ring includes suture retention testing and demonstrated that the sewing ring, fabric is comparable to fabrics used in vascular prostheses. Testing demonstrated that the AnnuloFlex Annuloplasty Ring is substantially equivalent to the predicate devices for repair of the mittal or tricuspid valve.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2002

Sulzer Carbomedics Inc. c/o Ms. Teffany Hankinson 1300 East Anderson Lane Austin, TX 78752-1793

Re: K023185

AnnuloFlex™ Annuloplasty System Regulation Number: 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (two) Product Code: 74 KRH Dated: September 19, 2002 Received: September 24, 2002

Dear Ms. Hankinson:

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 10 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 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

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

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. 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 Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

C. Tiller

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

INDICATIONS FOR USE STATEMENT

510(K) Number:	K
Device Name:	AnnuloFlex™ Annuloplasty System

Indications for Use: The Sulzer Carbomedics AnnuloFlex™ Annuloplasty System is indicated
as a reinforcement for repair of the human cardiac mitral and tricuspid
valves damaged by acquired or congenital disease, or as a replacement
for a previously implanted annuloplasty ring. The annuloplasty ring
should be used only in cases where visual inspection confirms that the

valve is repairable and does not require replacement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

C.K.Tir

sion Sign-Off) Division of Cardiovascular Devices

510(k) Number K003185

Regulation Number and Section

§ 870.3800 Annuloplasty ring.

(a)
Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”