The Sternal Closure System is intended for use in the stabilization of fractures of the sternum, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

Device Description

The Sternal Closure System is comprised of bone screw, bone plate and fastener components and instruments for implantation. The plates are offered in a fixed one-piece and a fastenable two-piece style. Bone screws are available in a single diameter having a range of lengths. The interconnecting components come in solid and cable versions and fasten the halves of the two-piece plate.

AI/ML Overview

Here's the information regarding the acceptance criteria and study for the Sternal Closure System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Mechanical Performance (Static and Dynamic Lateral Distraction)	The Sternal Closure System construct performance is substantially equivalent to the Ethicon Stainless Steel Suture Wire.
Mechanical Performance (Static Longitudinal Shear)	The Sternal Closure System construct performance is substantially equivalent to the Ethicon Stainless Steel Suture Wire.
Bone Screw Performance (ASTM F543)	The Sternal Closure System screw performance is substantially equivalent to the Biomet Microfixation Sternal Closure System screws.
General Technological Characteristics	The Sternal Closure System possesses the same technological characteristics as the predicate devices, including performance, implant grade materials, and basic design. Differences are supported with descriptive information and/or performance data.

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

Sample Size: The document does not explicitly state a numerical sample size for the "test set" in terms of number of devices tested. It refers to "worst case Sternal Closure System constructs" tested.
Data Provenance: Not specified in the provided text. The testing was conducted as part of the 510(k) submission, implying a laboratory setting rather than patient data.

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

This information is not applicable to this type of device (mechanical fixation system). The "ground truth" here is the physical performance of the device against established engineering standards and predicate device performance, not clinical interpretation by experts.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication method" concept is typically for clinical data or expert interpretation, not mechanical testing. The results of mechanical tests are objective measurements.

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 device is a mechanical surgical implant, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant.

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

Not applicable. This device is a mechanical surgical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:
- Mechanical Test Standards: Specifically, ASTM F543 for bone screws.
- Predicate Device Performance: Comparison to the performance of legally marketed predicate devices (Ethicon Stainless Steel Suture Wire and Biomet Microfixation Sternal Closure System screws). The implicit "ground truth" is that the new device should perform at least as well as these established devices.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not an AI algorithm that requires a "training set" of data.

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

Not applicable. As above, there is no "training set" for this type of device.

Summary

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

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

October 31, 2014

JACE Medical LLC Mr. Justin May Director of Engineering 536 East 200 North Warsaw, Indiana 46582

Re: K142484 Trade/Device Name: Sternal Closure System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC, JDQ Dated: August 29, 2014 Received: September 4, 2014

Dear Mr. May:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

Page 2 - Mr. Justin May

forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K142484

Device Name Sternal Closure System

Indications for Use (Describe)

The Sternal Closure System is intended for use in the stabilization of fractures of the sternum, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

Type of Use (Select one or both, as applicable)

× Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

510(k) Summary

Date:	29 August 2014
Sponsor:	JACE Medical, LLC536 East 200 NorthWarsaw, IN 46582 USA(574) 527-1663
Contact Person:	Justin May, Director of Engineering
Trade Name:	Sternal Closure System
Common Name:	Cable/rod, plate and screw system
Device Classification:	Class II
Regulation, Name:	888.3010, Bone fixation cerclage888.3030, Single/multiple component metallic bone fixationappliances and accessories888.3040, Smooth or threaded metallic bone fixation fastener
Device ProductCodes:	JDQ, HRS, HWC
Device Description:	The Sternal Closure System is comprised of bone screw, bone plateand fastener components and instruments for implantation. Theplates are offered in a fixed one-piece and a fastenable two-piecestyle. Bone screws are available in a single diameter having a rangeof lengths. The interconnecting components come in solid and cableversions and fasten the halves of the two-piece plate.
Intended Use:	The Sternal Closure System is intended for use in the stabilizationand fixation of fractures of the sternum, including sternal fixationfollowing sternotomy and sternal reconstructive surgical procedures.
Materials:	The Sternal Closure System implant components are manufacturedtitanium alloy as described by ASTM F136.
Predicate Devices:	Biomet Microfixation Sternal Closure System (Biomet Microfixation:K110574, K111908, K121302)Ethicon Stainless Steel Suture Wire (Ethicon Inc.: K931271,K946173)Sternal Talon (KLS Martin, LP: K051165, K070169)
Performance Data:	Mechanical testing of the worst case Sternal Closure Systemconstructs was performed in static and dynamic lateral distractionand static longitudinal shear. Sternal Closure System bone screwswere evaluated according to ASTM F543.The mechanical test results demonstrate that the Sternal ClosureSystem construct performance is substantially equivalent to theEthicon Stainless Steel Suture Wire and that the Sternal ClosureSystem screw performance is substantially equivalent to the BiometMicrofixation Sternal Closure System screws.
TechnologicalCharacteristics:	The Sternal Closure System possesses the same technologicalcharacteristics as the predicate devices. These include:• performance,• implant grade materials, and• basic design.Technological characteristics which are different have beensupported with descriptive information and/or performance data.Therefore the fundamental scientific technology of the SternalClosure System devices is the same as previously cleared devices.
Conclusion:	The Sternal Closure System possesses the same intended use andtechnological characteristics as the predicate devices. Therefore theSternal Closure System is substantially equivalent for its intendeduse.

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

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.