The Contour 3D™ Annuloplasty Ring, Model 690R, consists of a titanium core encapsulated with silicone and covered with polyester fabric. The titanium core enables radiographic visualization of the device. The Contour 3D™ Ring is for single-use only. It is available in six sizes for the tricuspid position: 26, 28, 30, 32, 34, and 36 mm. The device size is identified by the inside diameter of the ring at its widest point. The ring is marked at three (3) points by colored sutures. The three (3) markers correspond to the commissures of the tricuspid valve. The ring is packaged with a single annuloplasty ring assembled on a disposable holder.

AI/ML Overview

The provided document describes the Medtronic Contour 3D™ Annuloplasty Ring, Model 690R. This document is a 510(k) Summary for a medical device and therefore focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with strict acceptance criteria and a detailed analysis of device performance against those criteria as would be found in a clinical trial for a novel AI device.

Therefore, many of the requested elements are not applicable or cannot be extracted from this type of regulatory submission. The device is a physical annuloplasty ring, not an AI/software device, so terms like "AI assistance," "training set," "test set," "multi reader multi case (MRMC)," and "effect size" are not relevant in this context.

Here's an analysis based on the information provided, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for an already existing device type (annuloplasty ring) being compared to a predicate device, the "acceptance criteria" are primarily related to general performance, safety, and equivalence to the predicate. Specific quantitative "reported device performance" metrics, as would be found for an AI model's accuracy, sensitivity, or specificity, are not provided. The performance data section broadly states that the device was subjected to verification and validation studies and that the results demonstrate the Contour 3D™ Ring is safe and effective.

Acceptance Criterion (Implicit from 510(k))	Reported Device Performance (Summary)
Biocompatibility: Device materials are safe for human implantation.	Testing confirmed biocompatibility in accordance with EN ISO 10993-1:2003.
Structural Integrity (Computational): The ring can withstand expected physiological forces.	Computational structural analysis was conducted.
Tensile Strength: The ring can endure pulling forces without breaking.	Testing confirmed tensile strength.
Suture Pull-out Strength: The ability of sutures to remain attached to the ring.	Testing confirmed suture pull-out performance.
Fatigue Resistance: The ring can withstand repeated stress cycles over time.	Testing confirmed fatigue resistance.
MRI Compatibility: Safe for use in MRI environments.	MRI compatibility testing was performed.
Radiopacity: Observable via X-ray for placement and monitoring.	Radiopacity testing was performed.
Sterilization Efficacy: The sterilization process renders the device sterile.	Sterilization validation was performed in accordance with EN ISO 17665-1:2006 and EN 556-1:2001.
Bioburden Control: Level of microorganisms on the unsterilized device.	Bioburden testing was performed.
Pyrogenicity: Absence of fever-inducing substances.	Pyrogen testing was performed.
Shelf Life Stability: Device maintains integrity and sterility over its shelf life.	Shelf life validation was performed.
Substantial Equivalence: Features and performance are comparable to the predicate device.	Review determined the device is substantially equivalent to the MC³ Tricuspid Annuloplasty System (K020864).

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

Sample Size: Not explicitly stated in terms of patient numbers or specific units tested for each criterion. The testing would have involved a sufficient number of annuloplasty rings or simulated environments to statistically validate each performance characteristic.
Data Provenance: The studies were conducted internally by Medtronic. The document does not specify country of origin for any physical test components or if any of the "bio-related" tests involved animal or human cadaveric data. All tests are considered retrospective laboratory or bench tests for device verification and validation.

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

Not applicable. For a physical medical device's verification and validation testing (e.g., tensile strength, fatigue), "experts" are typically engineers, material scientists, and quality assurance specialists. Their qualifications are inherent in their roles in designing and conducting such tests, following established regulatory standards (e.g., ISO, FDA guidance). There's no concept of "ground truth" derived from expert consensus in the way it applies to diagnostic image interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are common in clinical trials or studies where human interpretation of data (e.g., images for AI model validation) requires consensus. For physical device performance testing, results are typically objective measurements, not subjective interpretations requiring 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

Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool. No human readers or AI assistance are involved in the performance testing described.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For each performance test, the "ground truth" is the objective physical measurement or outcome. For example:

Tensile Strength: The force at which the device breaks.
Biocompatibility: Standardized assays measuring cellular response or toxicity.
Sterility: Absence of microbial growth after incubation.
These are determined by established scientific methods and industry standards, not by expert consensus on clinical findings or pathological diagnosis in the context of patients.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model. There is no "training set."

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

Not applicable. As there's no training set, there's no ground truth for it.

Summary

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. K101212

AUG - 7 2010

5. 510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CRF 807.92.

SUBMITTER INFORMATION I.

Company Name:	Medtronic CardioVascular - Structural Heart(Medtronic)
Company Address:	8200 Coral Sea Street N.E.Mounds View, MN 55112
Company Phone:Company Facsimile:	763-514-9840763-367-8147
Contact Person:	Becky HannackSenior Regulatory Affairs Specialist
Date Summary Prepared:	April 29, 2010

II. DEVICE IDENTIFICATION

Trade/Proprietary Name:	Contour 3D™ Annuloplasty Ring, Model 690R
21 CFR Reference:	870.3800
21 CFR Common Name:	Ring, Annuloplasty
Classification:	Class II
Panel:	CV (74) KRH

III. IDENTIFICATION OF PREDICATE DEVICE

Trade/Proprietary Name:	MC 3 Tricuspid Annuloplasty System
510(k) Number:	K020864
510(k) Clearance Date:	April 17, 2002

IV. DEVICE DESCRIPTION

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The Contour 3D™ Ring is for single-use only. It is available in six sizes for the tricuspid position: 26, 28, 30, 32, 34, and 36 mm. The device size is identified by the inside diameter of the ring at its widest point. The ring is marked at three (3) points by colored sutures. The three (3) markers correspond to the commissures of the tricuspid valve. The ring is packaged with a single annuloplasty ring assembled on a disposable holder.

V. DESCRIPTION OF INTENDED USE

The Contour 3DTM Annuloplasty Ring is indicated for the reconstruction and/or remodeling of pathological tricuspid valves.

VI. SUBSTANTIAL EQUIVALENCE

The Contour 3D™ Annuloplasty Ring is substantially equivalent to the predicate device, the MC3 Tricuspid Annuloplasty System. Both devices are indicated for and intended to be used with tricuspid annuloplasty procedures for reconstructive treatment of valvular insufficiency. The two devices have the same technological characteristics as they are both rigid remodeling rings designed for use in the tricuspid valve. They both consist of a titanium core encapsulated with silicone and covered with polyester fabric. Both rings are provided sterile, mounted on a holder, and come in varying sizes. Substantial equivalence has also been determined by comparing results of tensile strength and suture pull-out performance testing of the two devices.

VII. PERFORMANCE DATA

The Contour 3D™ Annuloplasty Ring was subjected to verification and validation studies. This testing was conducted in accordance with the FDA Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and Staff issued January 31, 2001. The results of the testing demonstrate the Contour 3D™ Ring is safe and effective for its use in the reconstruction and/or remodeling of pathological tricuspid valves.

Testing included: biocompatibility, computational structural analysis, tensile strength, suture pull out, fatigue, MRI, radiopacity, sterilization validation, bioburden, pyrogen, and shelf life validation.

The following page contains a table of the standards applicable to this device.

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Standard Number	Standard Title
EN ISO 13485:2003	Medical devices - Quality management systems - requirements forregulatory purposes
EN ISO 14971:2007	Application of risk management to medical devices
EN ISO 10993-1:2003	Biological evaluation of medical devices - Part 1: Evaluation and testing
EN ISO 11607-1:2006	Packaging for terminally sterilized medical devices Part 1: Requirementsfor materials, sterile barrier systems and packaging systems
EN ISO 11607-2:2006	Packaging for terminally sterilized medical devices Part 2: Validationrequirements for forming, sealing and assembly processes
EN ISO 17665-1:2006	Sterilization of health care products Moist heat Part 1: Requirements forthe development, validation and routine control of a sterilization processfor medical devices
EN 556-1:2001	Sterilization of Medical Devices - Requirements for medical devices to bedesignated "sterile" - Part 1: Requirements for terminally sterilizedmedical devices
EN 980:2008	Graphical symbols for use in the labeling of medical devices
EN 1041:1998	Information supplied by the manufacturer with medical devices

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

AUG - 7 2010

Medtronic Inc c/o Ms. Becky Hannack Senior Regulatory Affairs Specialist 8200 Coral Sea Street NE MoundsView, MN 55112

Re: K101212

Medtronic Contour 3D Annuloplasty Ring Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (two) Product Code: KRH Dated: July 29, 2010 Received: July 30, 2010

Dear Ms. Hannack:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beeermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to tegans the Medical Device Amendments, or to commerce print to rize, 2011-12-11 in accordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, manot at the Act include requirements for annual registration, listing of general controls of the Frective, labeling, and prohibitions against misbranding and devices, good manufacturing praction, lace information related to contract liability adulteration. Trease note: ODFET active 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 If your device is classified (see above) institions affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. ' In addition, FDA may found in the Oode of Peacharts concerning your device in the Federal Register.

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Page 2 - Ms. Becky Hannack

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 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.html fast 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,

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

Enclosure

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Indications for Use

K10/2/2

AUG - 7 2010

510(k) Number (if known): |<|○|乙|乙

Medtronic Contour™ 3D Annuloplasty Ring Device Name:

Indications For Use:

The Contour 3D™ Ring is indicated for the reconstruction The Contour SB Ring ID LD .
and/or remodeling of pathological tricuspid valves.

Over-The-Counter Use X AND/OR Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(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 Cardiovascular Devices
510(k) Number K10 1212
Page 1 of 1

medtronic confidential

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.”