The KLS Martin LSS Plating System is to be used in conjunction with sternal closure wire for use in primary or secondary closure/repair of the sternum following sternotomy and is intended to reinforce the sternal halves and distribute wire tension.

Device Description

The KLS Martin LSS Plating System includes plates and screws that are intended to be used in conjunction with stainless steel suture wire for midline sternal closure. The LSS plates, where applied, are used to reinforce the sternal halves and mitigate the chance of sternal wire pulling through bone. The plates are manufactured from PEEK and offered in one size. The thickness of each plate ranges from 2.1 mm – 2.5 mm (minimum – maximum dimensions) and are fixated using 2.3mm titanium screws. Once the sternum is reapproximated, the midline is closed using circumferentially wrapped stainless steel suture wires. Emergent re-entry is accomplished by cutting the stainless steel suture wire.

AI/ML Overview

This document is a 510(k) premarket notification for the KLS Martin LSS Plating System, a medical device for sternal closure. The document states that clinical testing was not necessary to support substantial equivalence (page 4). Therefore, the information typically requested regarding acceptance criteria based on clinical studies, sample sizes, expert involvement, and ground truth establishment is not available in this filing.

However, the document does describe non-clinical mechanical testing performed to demonstrate that the device met performance standards. Since the request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria", I will extract the information related to the mechanical testing, which serves as the "study" in this case for demonstrating safety and effectiveness for substantial equivalence.

Here's a summary of the non-clinical testing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Maximum Force & Path to Reach Maximum Force	Three-point bending testing performed on LSS plate.
Behavior under Lateral, Longitudinal, and Transverse Shear	Tensile testing performed on the system using PUR foam sternum and metal sternum models.
Comparison of Wire Performance	Tensile tests performed on stainless steel wire alone for comparison against the LSS plate.
Locking Mechanism Comparison	Torsion testing performed to compare the locking mechanism of the LSS plate versus a titanium plate.
Screw Behavior under Load	Pressure testing performed to test the behavior of the screw under load in the LSS plate versus a titanium plate.
Performance under Continuous Oscillation (Simulating Respiration)	Continuous oscillation testing performed using parameters from cited literature to simulate loads applied to the implant during various modes of respiration.
Overall Performance for Substantial Equivalence	The mechanical testing demonstrated that the subject device construct had equivalent or better performance compared to the predicate devices and that any differences in technological characteristics do not raise new issues of safety or effectiveness.

Note: The document doesn't explicitly state numerical acceptance criteria values. The implied acceptance criterion for each test is to perform "equivalently or better" than the predicate devices or to demonstrate acceptable mechanical behavior for its intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: The document does not specify the exact number of samples (e.g., number of plates or screws) used for each mechanical test. It mentions "various apparatus set-ups" and "a series of tensile tests."
Data Provenance: Not applicable in the context of mechanical, non-clinical testing. This was laboratory testing, not human-subject data.

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

Not applicable. This was non-clinical mechanical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This was non-clinical mechanical testing.

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:

No. This was non-clinical mechanical testing of a physical device, not an AI-assisted diagnostic device.

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

No. This was non-clinical mechanical testing of a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Ground Truth: For mechanical testing, the "ground truth" is established by engineering principles, accepted testing standards, and comparison with the known performance of legally marketed predicate devices, as well as general expectations for structural integrity and durability.

8. The sample size for the training set:

Not applicable. This was non-clinical mechanical testing, not a machine learning study.

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

Not applicable. This was non-clinical mechanical testing, not a machine learning study.

Summary

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

April 6, 2016

KLS Martin L.P. Mr. Gary Moore Quality Management and Regulatory Affairs Manager 11201 Saint Johns Industrial Parkway South Jacksonville, Florida 32246

Re: K151983

Trade/Device Name: KLS Martin LSS Plating System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ, HRS Dated: March 4, 2016 Received: March 8, 2016

Dear Mr. Moore:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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/ResourcesforYou/Industry/default.htm. 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 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

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Indications for Use

510(k) Number (if known) K151983

Device Name KLS Martin LSS Plating System

Indications for Use (Describe)

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

2 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)

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kts martir

11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 - Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com

Section 5 510(k) Summary 21 CFR 807.92

Submitter:	KLS Martin L.P.11201 Saint Johns Industrial Pkwy SJacksonville, FL 32246
Contact Person:	Jennifer DamatoDirector of Quality MGT & Regulatory AffairsPhone: 800-625-1557Fax: 904-641-7378
Date Prepared:	April 5, 2016
Trade Name:	KLS Martin LSS Plating System
Common Name:	Bone fixation cerclage
Classification:	Class II; Panel Code: 8721 CFR 888.3010 – Cerclage, Fixation (JDQ)21 CFR 888.3030 – Plate, Fixation, Bone (HRS)
Predicate Devices:	Synthes Sternal ZipFix™ System (K110789)Ethicon Surgical Stainless Steel Suture (K931271)KLS Martin Sternal Plating System (K032413, K070169)
Reference Devices:	Patient Contoured Implant – PEEK (K072707, K151382)Recon Talon (K122860)
Device Description:	The KLS Martin LSS Plating System includes plates and screwsthat are intended to be used in conjunction with stainless steelsuture wire for midline sternal closure. The LSS plates, wherapplied, are used to reinforce the sternal halves and mitigate thechance of sternal wire pulling through bone. The plates aremanufactured from PEEK and offered in one size. The thickness ofeach plate ranges from 2.1 mm – 2.5 mm (minimum – maximumdimensions) and are fixated using 2.3mm titanium screws. Oncethe sternum is reapproximated, the midline is closed usingcircumferentially wrapped stainless steel suture wires. Emergentre-entry is accomplished by cutting the stainless steel suture wire.
Indications for Use:	The KLS Martin LSS Plating System is to be used in conjunctionwith sternal closure wire for use in primary or secondaryclosure/repair of the sternum following sternotomy and is intendedto reinforce the sternal halves and distribute wire tension.

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Image /page/4/Picture/0 description: The image shows the logo for KLS Martin L.P. The text "KLS" is in red, while "martin" is in gray. "L.P." is in black and is slightly smaller than the other text. The logo is simple and modern.

Non-Clinical Testing: Mechanical testing was performed on the KLS Martin LSS Plating System. Simulated-use testing was conducted in various apparatus set-ups based on worst-case constructs. Three-point bending testing was performed on the LSS plate to determine both the maximum force and the path to reach the maximum force. Tensile testing was performed on the system to simulate behavior under lateral, longitudinal, and transverse shear using a PUR foam sternum model as well as metal sternum model. An additional series of tensile tests were performed on the stainless steel wire alone for comparison against the LSS plate. Torsion testing was performed to compare the locking mechanism of the LSS plate versus a titanium plate. Pressure testing was performed to test the behavior of the screw under load in the LSS plate versus a titanium plate. To simulate the loads applied to the implant during various modes of respiration, continuous oscillation testing was performed using parameters from cited literature. The mechanical testing demonstrated that the subject device construct had equivalent or better performance compared to the predicate devices.

Clinical Testing: Clinical testing was not necessary to support substantial equivalence.

Substantial Equivalence Discussion

Similarities to Predicates: The KLS Martin LSS Plating System is similar to the predicate devices with respect to intended use, materials, principles of operation, and mechanical performance. The KLS Martin LSS Plating System has the same intended use for sternal closure as the predicate devices. The KLS Martin LSS Plating System has the same principles of operation as K110789 – Synthes Sternal ZipFix "System and K931271 – Ethicon, Inc. Ethi-Pack Surgical Stainless Steel Suture for cerclage closure of the sternum. The KLS Martin LSS Plating System demonstrated equivalent performance characteristics compared to K032413, K070169 -KLS Martin Sternal Plating System and K931271 - Ethicon, Inc. Ethi-Pack Surgical Stainless Steel Suture.

Differences to Predicates: The KLS Martin LSS Plating System differs from K032413, K070169 - KLS Martin Sternal Plating System in that the subject device is not intended for stabilization and fixation of fractures and utilizes cerclage fixation to achieve sternal closure. The KLS Martin LSS Plating System differs from K110789 - Synthes Sternal ZipFix™ in that the subject device does not require a tensioning instrument to secure the implants. Unlike the subject device, K110789 - Synthes Sternal ZipFix" and K931271 - Ethicon, Inc. Ethi-Pack Surgical Stainless Steel Suture do not require plates to re-distribute wire tension.

Reference Devices: The KLS Martin LSS Plating System includes implants manufactured from the same materials as the reference devices. The PEEK plates and titanium screws are identical in chemical composition, undergo identical manufacturing processes, and have the same permanent body contact duration as those cleared in K151382 - Patient Contoured Implant -PEEK and K122860 - Recon Talon, respectively. The screws used to fixate the PEEK plates are identical to those cleared in K122860.

Conclusion: The KLS Martin LSS Plating System has the same intended use and shares similar technological characteristics to the predicate devices. Non-clinical testing data demonstrates that any differences in technological characteristics do not raise new issues of safety or effectiveness. The information presented supports substantial equivalence of the KLS Martin LSS Plating System to the predicate devices.

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.