The Tri-Ad 2.0 Adams tricuspid band is indicated for the reconstruction or remodeling of pathological tricuspid valves. The band provides support and restricts expansion of the tricuspid annulus.

Device Description

The Tri-Ad 2.0 Adams, Model 900SFC, consists of an MP35N polished and formed wire stiffener fitted with 2 end caps. The band is covered with a braided polyester fabric. The stiffener runs from the posteroseptal commissure to the anterior segment distal to the anteroposterior commissure. The stiffener helps remodel and stabilize the enlarged portion of the tricuspid annulus. The band has 3 radial green markers to locate the following 3 areas of the band:

The end of the stiffener section at the posteroseptal commissure.
The anteroposterior commissure. ●
The end of the stiffener section in the anterior segment of the band. ●
A green demarcation suture runs around the middle of the band in the stiffener region. The band size refers to the dimension of the band where the implantation sutures are placed, except in the stiffener region. The internal stiffener, and the radiopaque core in both fully flexible ends of the band, provide radiographic visualization along the entire circumference of the band is available in the following sizes: 26 mm, 28 mm, 32 mm, 34 mm, and 36 mm.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "Tri-Ad™ 2.0 Adams Tricuspid Band." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with acceptance criteria in the way one might see for novel technologies or AI algorithms.

Therefore, the document does not contain the acceptance criteria or a study proving it meets those criteria in the traditional sense of a clinical trial or performance validation for an AI device. Instead, the submission describes the device, compares it to a predicate device, and lists the types of verification testing performed to demonstrate fundamental safety and performance.

Here's an analysis based on the information provided, explaining why certain sections cannot be filled:

A table of acceptance criteria and the reported device performance

This information is not present in the document. The 510(k) summary focuses on demonstrating substantial equivalence through design characteristics and verification testing, rather than setting specific performance criteria (e.g., sensitivity, specificity, accuracy) that an AI device would typically have, or reporting specific clinical outcomes against quantitative targets.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not applicable/not present in the document. The "tests" mentioned (Visual Inspection, Biocompatibility, Sterilization, Design Validation / Human Factors Engineering) are engineering and technical verification tests, not clinical performance studies that would involve test sets of patient data.
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)

This information is not applicable/not present. Ground truth, in the context of clinical performance, is not discussed as there were no clinical performance studies involving interpretation of data by experts. The "ground truth" for the device's characteristics would be established through engineering specifications and material testing standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable/not present. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth for a diagnostic or AI-assisted task. This document details a medical device, not an AI diagnostic tool.
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

This information is not applicable/not present. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance. The Tri-Ad™ 2.0 Adams Tricuspid Band is an annuloplasty ring, a physical implantable device, and not an AI-powered diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not present. This refers to the performance of an AI algorithm in isolation. The described device is a physical medical implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/not present in the context of clinical performance. For the engineering tests mentioned (Biocompatibility, Sterilization, etc.), the "ground truth" would be established by validated test methods and established standards confirming material properties, sterility, etc.
The sample size for the training set

This information is not applicable/not present. "Training set" refers to data used to train an AI model.
How the ground truth for the training set was established

This information is not applicable/not present. This refers to the process for annotating data for AI model training.

Summary of Device Acceptance/Equivalency:

The document focuses on demonstrating substantial equivalence to a predicate device (Tri-Ad™ Semi-Flexible Tricuspid Annuloplasty Ring, K093903). The "acceptance criteria" are implied by the regulatory framework for 510(k) submissions: the device must be as safe and effective as a legally marketed predicate device.

The study that "proves" the device meets these (implied) criteria consists of:

Comparison to Predicate Device: The document highlights that the Tri-Ad 2.0 Adams tricuspid band is "identical" to the predicate in Intended Use, Principles of Operation, Sterilization, Shelf Life, Packaging, and Size Range. Minor modifications are noted in product labeling but are deemed substantially equivalent.
Verification Testing: A list of performed studies is provided:
- Visual Inspection
- Biocompatibility
- Sterilization
- Design Validation / Human Factors Engineering

The conclusion states that "Based upon the testing performed, the modifications to the Tri-Ad 2.0 Adams do not affect the intended use of the devices or alter the fundamental scientific technology of the devices. No change has been made to the implantable band. Therefore, Tri-Ad 2.0 Adams is substantially equivalent to the currently marketed predicate device."

In essence, the "acceptance criteria" here are regulatory (substantial equivalence), and the "study" is a combination of direct comparison to a predicate and basic engineering verification tests demonstrating that the device itself, and the minor modifications, do not introduce new questions of safety or effectiveness.

Summary

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1.0 510(k) Summary

1.1 Applicant Information

Date Prepared: April 27, 2018

Applicant: Medtronic Medtronic Heart Valves Division 1851 East Deere Ave Santa Ana, CA 92705
Contact Person: Tracy Gray Regulatory Affairs Medtronic Phone: (949) 399-1678 Email: tracy.l.gray@medtronic.com

Alternate Contact

Zach Larsen Regulatory Affairs Specialist Medtronic Phone: (949) 382-1034 Email: zach.s.larsen@medtronic.com

1.2 Device Name and Classification

Trade Name:	Tri-Ad™ 2.0 Adams tricuspid band
Common Name:	Tri-Ad 2.0 Adams
Classification Name:	Annuloplasty Ring
Predicate Device:	Tri-Ad™ Semi-Flexible Tricuspid Annuloplasty Ring (K093903)
Regulation Number:	21 CFR 870.3800
Product Classification:	Class II
Product Code:	KRH
Classification Panel:	Cardiovascular Devices Panel
Special Controls:	Yes

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1.3 Address of Manufacturing Facilities

Design Site: Manufacturing Site: Medtronic Heart Valves Division Medtronic Mexico S. de R.L. de CV 1851 E Deere Ave Av. Paseo Cucapah 10510 El Lago Tijuana, Baja California Mexico C.P. 22210 Establishment Registration Number: 2025587 Establishment Registration Number: 9617601

1.4 Device Description

The end of the stiffener section at the posteroseptal commissure.
The anteroposterior commissure. ●
The end of the stiffener section in the anterior segment of the band. ●

A green demarcation suture runs around the middle of the band in the stiffener region. The band size refers to the dimension of the band where the implantation sutures are placed, except in the stiffener region. The internal stiffener, and the radiopaque core in both fully flexible ends of the band, provide radiographic visualization along the entire circumference of the band is available in the following sizes: 26 mm, 28 mm, 32 mm, 34 mm, and 36 mm.

1.5 Indications for use

The Tri-Ad 2.0 Adams tricuspid band is indicated for the reconstruction or remodeling of pathological tricuspid valves. The band provides support and restricts expansion of the tricuspid annulus.

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1.6 Comparison to Predicate Devices

The Tri-Ad 2.0 Adams tricuspid band is identical to the Tri-Ad Semi-Flexible Tricuspid Annuloplasty Ring in the following characteristics: Intended Use, Principles of Operation, Sterilization, Shelf Life, Packaging and Size Range. The Tri-Ad 2.0 Adams tricuspid band is substantially equivalent to the Tri-Ad Semi-Flexible Tricuspid Annuloplasty Ring according to the comparison table below.

Characteristic	Tri-Ad 2.0 Adamstricuspid band(Subject)	Tri-Ad Semi-FlexibleTricuspid Annuloplasty Ring(Predicate)	Equivalency
Indications for Use	The Tri-Ad 2.0 Adamstricuspid band is indicatedfor the reconstruction orremodeling of pathologicaltricuspid valves. The bandprovides support andrestricts expansion of thetricuspid annulus.	The Tri-Ad Semi-FlexibleTricuspid Annuloplasty Ring isindicated for use in patientsundergoing surgery for diseasedor damaged tricuspid valves. TheTri-Ad Semi-Flexible TricuspidAnnuloplasty Ring providessupport for and restrictsexpansion of the tricuspidannulus.	SubstantiallyEquivalent
Product Labeling	Minor modificationsincluding:• Update to productname• Addition of newhandle		SubstantiallyEquivalent

Summary of Performance Data 1.7

Verification testing was used to verify the performance characteristics of the Tri-Ad™ 2.0 Adams tricuspid band. The following studies were performed:

Visual Inspection ●
Biocompatibility ●
Sterilization ●
Design Validation / Human Factors Engineering

1.8 Conclusion

Based upon the testing performed, the modifications to the Tri-Ad 2.0 Adams do not affect the intended use of the devices or alter the fundamental scientific technology of the devices. No change has been made to the implantable band. Therefore, Tri-Ad 2.0 Adams is substantially equivalent to the currently marketed predicate device.

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Image /page/3/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration."

May 29, 2018

Medtronic Ms. Tracy Gray Regulatory Affairs 1851 East Deere Ave Santa Ana, California 92705

Re: K181132

Trade/Device Name: Tri-AdTM 2.0 Adams Tricuspid Band Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II Product Code: KRH Dated: April 27, 2018 Received: April 30, 2018

Dear Ms. Gray:

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

Enclosure

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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.”