The SJM™ Rigid Saddle ring is indicated for use to correct annular dilation, increase leaflet coaptation, and prevent further dilatation of the mitral valve annulus caused by diseased states such as degenerative disease, rheumatic disease, Ischemia or vascular disease. The combination of prosthetic ring with valvuloplasty may be used in all acquired or congenital mitral insufficiencies with dilation and deformation of the fibrous mitral annulus.

For mitral insufficiencies with no subvalvular lesions and normal valvular movements, r of that ring implant alone may be sufficient. However, annuloplasty ring implant along with mitral valvuloplasty repair must be considered for insufficiencies with a prolapsed while mark relongation or rupture of the chordae tendineae and for insufficiencies with valve ado to blongation ements due to fusion of the commissures or chordae tendineae, or chordal hypertrophy.

Device Description

The SJM™ Rigid Saddle Ring assembly consists of a rigid core machined from titanium covered with a double velour polyester fabric with a sewing cuff created for suturability. The ring is mounted on a holder and placed in a dual barrier package system. The package system is then steam sterilized. The SJM™ Rigid Saddle Ring is available in sizes 24mm-34mm (even sizes). Sizing is based on the inter-commissural distance as indicated by the commissure markers placed on the ring.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "SJM™ Rigid Saddle Ring" (Model RSAR). This submission aims to demonstrate substantial equivalence to a predicate device, not to establish new performance criteria through a study with acceptance criteria in the same way one might for a novel device or AI software. Therefore, much of the requested information regarding acceptance criteria, extensive studies, expert ground truth, and training sets for an AI device is not directly applicable.

However, I can extract and present the information available from the document in a structured way that aligns with your request where possible, and clearly state when information is not provided or applicable.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify "acceptance criteria" in a quantitative sense as might be typical for a new device's performance study (e.g., minimum sensitivity/specificity). Instead, the submission relies on demonstrating substantial equivalence to a predicate device based on characteristics and non-clinical testing. The "reported device performance" is the conclusion that it is "safe and effective for the intended use" and "substantially equivalent" to predicate devices.

Characteristic Tested (Non-Clinical)	Acceptance/Equivalency Standard	Reported Device Performance
Product Labeling	Substantially Equivalent	Substantially Equivalent
Intended Use	Substantially Equivalent	Substantially Equivalent
Physical Characteristics	Substantially Equivalent	Substantially Equivalent
Anatomical Sites	Identical	Identical
Target Population	Substantially Equivalent	Substantially Equivalent
Performance Testing	Substantially Equivalent	Substantially Equivalent
Safety Characteristics	Substantially Equivalent	Substantially Equivalent
Ring Tensile Strength	Not explicitly stated	Conducted
Ring Compressive Strength	Not explicitly stated	Conducted
Suture Pullout Test	Not explicitly stated	Conducted
Needle Penetration Test	Not explicitly stated	Conducted
Computational Structural Analysis	Not explicitly stated	Conducted
Holder Evaluation	Not explicitly stated	Conducted
Assembled Ring/Holder Evaluation	Not explicitly stated	Conducted
MR Safety	Not explicitly stated	Conducted
Package Shelf Life Evaluation	Not explicitly stated	Conducted
Manufacturing Process Validation	Not explicitly stated	Conducted
Biocompatibility Evaluation	Not explicitly stated	Conducted
Chemical and Morphological Evaluation	Not explicitly stated	Conducted
Sterilization Validation	Not explicitly stated	Conducted
Bioburden	Not explicitly stated	Conducted
Pyrogenicity	Not explicitly stated	Conducted

2. Sample size used for the test set and the data provenance

This information is not provided in the document. The submission details "non-clinical tests" but does not specify the sample sizes for these tests or the origin of any data (as it's not a study on patient data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as this is a submission for a medical device (an annuloplasty ring), not an AI device requiring expert-established ground truth from medical imaging or patient data. The "ground truth" for a mechanical device would be laboratory measurements against relevant standards or engineering specifications.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3.

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

This information is not applicable as this is a medical device, not an AI or imaging diagnostic device that would involve human readers.

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

This information is not applicable as this is a medical device, not an algorithm.

7. The type of ground truth used

For the non-clinical tests conducted, the "ground truth" would be established by engineering specifications, material science standards, and accepted physiological/biocompatibility benchmarks. The document lists tests like "Ring Tensile Strength," "Biocompatibility Evaluation," and "Sterilization Validation," implying that these were assessed against a set of predetermined criteria based on these standards.

8. The sample size for the training set

This information is not applicable as this is a medical device, not an AI device trained on data.

9. How the ground truth for the training set was established

This information is not applicable as this is a medical device, not an AI device.

Summary

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

K042734

ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ(ن مﺎ ﺗ113	.Vﺔ ﻓﻴﻬﺎ	જુC	Care4
t

510(K) SUMMARY

(as required by 21 CFR 807.92)

Submitters Information A.

Submitter's Name and Address:	St. Jude Medical, Inc.Cardiac Surgery DivisionOne Lillehei PlazaSt. Paul, MN 55117
Contact Name	William McKelvey, RACRegulatory Affairs SpecialistSt. Jude Medical, Inc.Bus: (651) 415-7029Fax: (651) 766-3049Email: wmckelvey@sjm.com
Submission Prepared	September 30, 2004

B. Device Information

Proprietary Name:	SJM™ Rigid Saddle ringmodel RSAR-(size)
-------------------	---------------------------------------------

Common or Usual Name:

Classification:

Predicate Device:

K032250-Edwards Lifesciences GeoForm™ annuloplasty ring model 4200 (Carpentier-McCarthy-Adams |MR-ETlogix annuloplasty ring model 4100)

Rigid Annuloplasty ring,

Class II per 21 CFR 870.3800,

Mitral Repair Ring

Annuloplasty rings

Device Description:

SJM® IAR annuloplasty ring - 510(k) Summary

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

Intended Use:

The SJM™ Rigid Saddle Ring is indicated for use to correct annular dilation, increase leaflet coaptation, and prevent further dilatation of the mitral valve annulus caused by liseased states such as degenerative disease, rheumatic disease, ischemia or vascular disease. The combination of prosthetic ring with valvuloplasty may be used in all acquired or congenital mitral insufficiencies with dilation and deformation of the fibrous mitral annulus.

Comparison of Required Technological Characteristics C.

SJM considers the SJM™ Rigid Saddle Ring to be substantially equivalent in technological characteristics (e.g. design and materials) and intended use to the predicate devices. The table below is a comparison of the equivalency characteristics between the SJM™ Rigid Saddle Ring and the predicate device.

Characteristic	Equivalency
a. Product Labeling	Substantially Equivalent
b. Intended Use	Substantially Equivalent
c. Physical Characteristics	Substantially Equivalent
d. Anatomical Sites	Identical
e. Target Population	Substantially Equivalent
f. Performance Testing	Substantially Equivalent
g. Safety Characteristics	Substantially Equivalent

Summary of Non-Clinical Tests D.

The following performance testing was conducted;

Ring Tensile Strength .
Ring compressive Strength .
Suture Pullout Test .
Needle Penetration Test .

SJM® IAR annuloplasty ring ~ 510(k) Summary

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

Computational Structural Analysis
Holder Evaluation .
Assembled Ring/Holder Evaluation .
MR Safety .
Package Shelf Life Evaluation .
Manufacturing Process validation .
Biocompatibility Evaluation .
Chemical and Morphological Evaluation .
Sterilization Validation .
Bioburden .
Pyrogenicity .

Conclusion

SJM has demonstrated that the SJM™ Rigid Saddle Ring is safe and effective for the intended use. The SJM™ Rigid Saddle Ring is, with respect to intended use and technological characteristics, substantially equivalent to the predicate device.

SJM® IAR annuloplasty ring - 510(k) Summary

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

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

St. Jude Medical, Inc. c/o Mr. William McKelvey Regulatory Affairs Specialist Cardiac Surgery Division One Lillehei Plaza St. Paul, MN 55117

K042734 Re:

SJMTM Rigid Saddle Ring Model RSAR-(size) Regulation Number: 21 CFR 870.3800 Regulation Name: Rigid Annuloplasty Ring Regulatory Class: Class II (two) Product Code: KRH Dated: September 30, 2004 Received: October 1, 2004

Dear Mr. McKelvey:

We have reviewed your Section 510(k) premarket notification of intent to market the device in diedi we nave reviewed your becaon 910(t) promotion is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in intersuate for tose stated in the clebosity to regally manation to the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Ford, Frys commerce prior to May 20, 1976, are encordance with the provisions of the Federal Food, Drug, devices that have been recuired in accession in accessor and of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvial controls provisions of the Act. The You may, uteretore, market me device, books of the months for annual registration, listing of general controls provisions of the rest 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 If your device is classified (500 a00 v) ols. Existing major regulations affecting your device can may be subject to such additional controliations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{4}------------------------------------------------

Page 2 - Mr. William McKelvey

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 or any I vith 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 OFF Part 877) its extens (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. product radiall of own 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 promation hotel in "Tresults 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 (2017) 97 + 1055 - 1055 Part 807.97) you may obtain. 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Duma R. Lechner

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

Enclosure

{5}------------------------------------------------

U.S. Food and Drug Administration - Center for Devices and Radiological Health

Page 1 of 1 -

510(k) Number (if known): K042734

SJM™ Rigid Saddle Ring _______________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use

The SJM™ Rigid Saddle ring is indicated for use to correct annular dilation, increase The Ouw - Right Cadele Heather dilatation of the mitral valve annulus caused by diseased states such as degenerative disease, rheumatic disease, Ischemia or vascular disease. The combination of prosthetic ring with valvuloplasty may be used in all discuse. "The ochibitation insufficiencies with dilation and deformation of the fibrous mitral annulus.

For mitral insufficiencies with no subvalvular lesions and normal valvular movements, r of thirds including may be sufficient. However, annuloplasty ring implant prostred img million valvuloplasty repair must be considered for insufficiencies with a along with intral value of elongation or rupture of the chordae tendineae and for insufficiencies with limitation of valvular movements due to fusion of the commisures or chordae tendineae, or chordal hypertrophy.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dwane D. Schurch

(Division Sign-Off) (Division Orgin Sign Scular Devices

510(k) Number_K642734

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.”