The KLS Martin Thoracic Plating System is indication and fixation of fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies.

Device Description

The KLS Martin Thoracic Plating System includes metallic plates and screws that provide rigid fixation to fractures, planned osteotomies, and can be used for reconstructive procedures in the thoracic anatomy. The implants are available non-sterile or sterile in multiple shapes and sizes. Plates are manufactured from CP Titanium (ASTM F67:2013) and range in thickness from 1.0 - 3.0mm. Screws are manufactured from Ti-6Al-4V (ASTM F136:2013) and range in diameter from 2.3 - 3.2mm with lengths from 7 - 17mm. The system also includes the necessary instruments to facilitate placement of the implants.

AI/ML Overview

This document is a 510(k) Premarket Notification for the KLS Martin Thoracic Plating System, dated April 6, 2016. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a study against those criteria in the way one might for a novel AI device or a new diagnostic method.

Therefore, many of the requested categories are not applicable to this type of submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Rationale: This document describes a KLS Martin Thoracic Plating System, which is a metallic bone fixation appliance. The acceptance criteria here relate to the mechanical properties of the device and its substantial equivalence to existing predicate devices, rather than diagnostic performance metrics (e.g., sensitivity, specificity) typically associated with AI or imaging studies. Therefore, specific acceptance criteria as percentages for diagnostic accuracy are not present.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Material Composition	Plates manufactured from CP Titanium (ASTM F67:2013); Screws manufactured from Ti-6Al-4V (ASTM F136:2013).	The subject device uses the same materials (CP Titanium and Ti-6A1-4V) as the predicate devices. This indicates compliance with the material standards and similarity to predicates.
Mechanical Strength	Static and dynamic 4-point bending tests in accordance with ASTM F382; Strength properties of subject plates compared against predicate plates.	"Results met or exceeded the defined test conditions and demonstrate that the performance of the subject plates is substantially equivalent to the predicate devices." (No specific numerical values are provided, only a comparative statement of meeting/exceeding expectations relative to predicates).
Manufacturing Process	Same manufacturing process as predicate devices (e.g., KLS Martin Recon Talon - K122860, KLS-Martin Sternal Plating System - K032413 / K070169).	The subject device "undergoes identical manufacturing and sterilization processes as the KLS Martin Recon Talon - K122860 and the KLS-Martin Sternal Plating System - K032413 / K070169."
Sterilization Process	Same sterilization process as predicate devices.	The subject device "undergoes identical manufacturing and sterilization processes as the KLS Martin Recon Talon - K122860 and the KLS-Martin Sternal Plating System - K032413 / K070169." (Note: The subject device also offers implants in sterile packaging, whereas some predicates may not have explicitly stated sterile packaging as a distinguishing factor in this summary, but the process is stated as identical).
Intended Use	Stabilization and fixation of fractures in the chest wall, sternal reconstructive surgical procedures, trauma, or planned osteotomies.	The subject device has the "same intended use" as the predicate devices.
Principles of Operation	Rigid fixation of bone.	The subject device has "same principles of operation" as the predicate devices.
Technological Features	Similar technological features to predicates (e.g., metallic plates and screws, locking plate and screw characteristics).	The subject device has "similar technological features compared to the predicate devices." Differences (e.g., sterile packaging, additional plate shapes for thoracic anatomy, expanded indications for lateral/posterior chest wall fixation) were evaluated and determined "not to raise different questions of safety and effectiveness."

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

Sample Size for Test Set: Not explicitly stated. The document refers to "Static and dynamic 4-point bending tests" of the plates, but doesn't quantify the number of plates tested. This generally involves a small number of samples to assess mechanical properties according to ASTM standards.
Data Provenance: Not applicable in the context of this device. The testing is laboratory-based mechanical testing, not clinical data provenance (e.g., country of origin for clinical cases).

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

Not applicable. This device undergoes mechanical testing against specified material and performance standards (ASTM) and comparison to predicate devices, not evaluation against a "ground truth" established by clinical experts in the same way an AI diagnostic tool would.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as this is not a diagnostic or clinical study requiring expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is a medical device for surgical implantation, not an AI or diagnostic tool that involves human readers interpreting results.

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

Mechanical Standards and Predicate Device Performance: The "ground truth" for this device's performance is established by existing ASTM standards for material composition (ASTM F67, ASTM F136) and mechanical testing (ASTM F382) and by the established performance and safety profiles of the cited predicate devices. The device's performance is compared against these benchmarks to establish substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning device, so there is no "training set."

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

Not applicable. As there is no training set for an algorithm, this question is not relevant.

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: K153482

Trade/Device Name: KLS Martin Thoracic Plating 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 Dated: March 3, 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)

K153482

Device Name

KLS Martin Thoracic Plating System

Indications for Use (Describe)

The KLS Martin Thoracic Plating System is indication and fixation of fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies.

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)

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FOR FDA USE ONLY

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Image /page/3/Picture/0 description: The image shows the logo for KLS Martin L.P. The words "KLS" are in red, "martin" is in gray, and "L.P." is in black. The logo is simple and modern, and it is likely used to represent the company in a variety of contexts.

1201 Saint Johns Industrial Pkwy S . Jacksonville, FL 32246 hone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 w.klsmartinnorthamerica.com

Section 5 510(k) Summary 21 CFR 807.92

Submitter:	KLS Martin LP11201 Saint Johns Industrial Pkwy S.Jacksonville, FL 32246
Contact Person:	Jennifer DamatoDirector of Quality MGT & Regulatory AffairsPhone: 800-625-1557Fax: 904-641-7378
Date Prepared:	April 4, 2016
Trade Name:	KLS Martin Thoracic Plating System
Common Name:	Plate, Fixation, Bone
Classification:	Single/multiple component metallic bone fixation appliancesand accessoriesClass II, 21 CFR 888.3030, Product Code HRS
Predicates:	Biomet Microfixation Thoracic Fixation System (K142823)KLS-Martin Sternal Plating System (K032413 / K070169)KLS Martin Recon Talon (K122860)

Device Description:

Indications for Use:

The KLS Martin Thoracic Fixation System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies.

Contraindications: 1. Active Infection. 2. Not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical or lumbar spine. 3. Patient conditions including: blood supply limitations, insufficient quantity of bone or latent infections. 4. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions. 5. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation.

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Image /page/4/Picture/0 description: The image shows the logo for KLS Martin L.P. The logo is composed of three parts: "KLS" in red, "martin" in gray, and "L.P." in black. The letters are bold and sans-serif.

Substantial Equivalence Discussion:

Similarities to Predicate Devices

The subject and predicate devices include metallic plates and screws intended to provide rigid fixation of bone in the thoracic anatomy. All implant systems are manufactured from CP Titanium and Ti-6A1-4V and are implanted using the same method of fixation. The subject device incorporates locking plate and screw characteristics similar to the KLS Martin Recon Talon - K122860, and undergoes identical manufacturing and sterilization processes as the KLS Martin Recon Talon - K122860 and the KLS-Martin Sternal Plating System - K032413 / K070169.

Differences to Predicate Devices

The subject device offers implants in sterile packaging and additional plate shapes from the primary predicate. Biomet Microfixation Thoracic Fixation System - K142823. The subject device differs from the KLS Martin Recon Talon - K122860 and KLS-Martin Sternal Plating - K032413 / K070169 with expanded indications for use in lateral and posterior chest wall fixation and includes additional plate shapes for rib fractures.

Non-Clinical Performance Data:

Static and dynamic 4-point bending tests were performed in accordance with ASTM F382. The strength properties of the subject plates were compared against the predicate plates. Results met or exceeded the defined test conditions and demonstrate that the performance of the subject plates is substantially equivalent to the predicate devices.

Clinical Performance Data:

Clinical testing was not necessary for the determination of substantial equivalence.

Conclusion:

The KLS Martin Thoracic Plating System has the same intended use, same principles of operation, and similar technological features compared to the predicate devices. Any differences in technological features between the subject and predicate devices do not raise different questions of safety and effectiveness. The non-clinical performance data presented supports substantial equivalence of the KLS Martin Thoracic Plating System to the predicate devices.

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.