The DePuy Synthes MatrixRIB Fixation System is indicated for use in skeletally mature patients with normal or osteoporotic bone for chest wall fixation, where:
DePuy Synthes MatrixRIB pre-contoured plates are indicated for the fixation, stabilization and reconstruction of:

Rib fractures, fusions, osteotomies, and/or resections, including spanning gaps and/or defects
Pectus Excavatum, Pectus Carinatum, and other chest wall deformities
DePuy Synthes MatrixRIB straight plates are indicated for the fixation, stabilization and reconstruction of:
Rib and sternum fractures, fusions, osteotomies, and/or resections, including spanning gaps and/or defects
Pectus Excavatum, Pectus Carinatum, and other chest wall deformities
DePuy Synthes MatrixRIB sternal plates, 2.8mm thickness, are indicated for fixation, stabilization and reconstruction of:
Sternum fractures, fusions, and/or osteotomies
Pectus Excavatum, Pectus Carinatum, and other chest wall deformities
The DePuy Synthes MatrixRIB intramedullary splints and the universal plate are indicated for the fixation and stabilization of ribs.

Device Description

The devices subject to this notification are proposed for addition to the MatrixRIB Fixation System.
The subject devices consist of self-drilling screws and screw guides designed to be used with the previously cleared MatrixRIB 1.5mm plates and the splints.
The MatrixRIB Self-Drilling Screws are available as
• locking screws, for permanent fixation,
• and non-locking screws, for temporary fixation only.
The subject screws are manufactured from Titanium Alloy (Ti-6Al-7Nb). They are provided in a range of lengths
• locking: 13 lengths from 8mm to 20mm, with 1mm increments;
• non-locking: 2 lengths from 10mm to 12 mm, with 2 mm increments).
The MatrixRIB Screw Guides are to be used with the subject self-drilling screws to facilitate their fixation on patient's ribs and sternum. The subject screw guides are manufactured from Stainless Steel and are provided in 2 designs,
• one for the 1.5mm MatrixRIB plates,
• and one for the MatrixRIB IM splints.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or study details for a device that involves performance metrics such as reader studies or algorithm performance. The document describes a 510(k) premarket notification for the "MatrixRIB Fixation System" which is a metallic bone fixation appliance. The acceptance criteria and performance data discussed are related to the mechanical properties of the screws within the system, not diagnostic or AI-driven performance.

Therefore, I cannot fulfill the request for information on acceptance criteria, a table of acceptance criteria and reported device performance, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, or how training set ground truth was established, as this information is not present in the provided document.

The document does mention:

Non-clinical performance data: "Non-clinical testing and analyses conducted as part of this submission include: Screw Pull-Out Testing per ASTM F543-17, Screw Failure Torque Testing per ASTM F543-17, Screw Cantilever Load Testing, Construct Dynamic Testing. The non-clinical performance data demonstrates that the mechanical performance of the proposed MatrixRIB Self-Drilling Screws met all acceptance criteria and is comparable to that of the predicates."
Clinical testing: "Clinical testing was not necessary for the determination of substantial equivalence."

This indicates that the "acceptance criteria" referred to in the document are mechanical and material-specific, not related to diagnostic accuracy or AI performance.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

DePuy Synthes Francoise Cettour-Delbart Senior RA Program Lead 1301 Goshen Parkway West Chester, Pennsylvania 19380 May 3, 2019

Re: K190409

Trade/Device Name: MatrixRIB Fixation 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 Dated: February 20, 2019 Received: February 21, 2019

Dear Francoise Cettour-Delbart:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about mediation-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,

For CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190409

Device Name MatrixRIB Fixation System

Indications for Use (Describe)

The DePuy Synthes MatrixRIB Fixation System is indicated for use in skeletally mature patients with normal or osteoporotic bone for chest wall fixation, where:

DePuy Synthes MatrixRIB pre-contoured plates are indicated for the fixation, stabilization and reconstruction of:

· Rib fractures, fusions, osteotomies, and/or resections, including spanning gaps and/or defects
· Pectus Excavatum, Pectus Carinatum, and other chest wall deformities

DePuy Synthes MatrixRIB straight plates are indicated for the fixation, stabilization and reconstruction of:

· Rib and sternum fractures, fusions, osteotomies, and/or resections, including spanning gaps and/or defects
· Pectus Excavatum, Pectus Carinatum, and other chest wall deformities

DePuy Synthes MatrixRIB sternal plates, 2.8mm thickness, are indicated for fixation, stabilization and reconstruction of: · Sternum fractures, fusions, and/or osteotomies

· Pectus Excavatum, Pectus Carinatum, and other chest wall deformities
The DePuy Synthes MatrixRIB intramedullary splints and the universal plate are indicated for the fixation and stabilization of ribs.

Contraindications

The MatrixRIB Fixation System is contraindicated for:

· The fixation of the sternum in acute cardiac patients, due to the potential delay if emergent re-entry is required
· Screw attachment or fixation to the clavicle or spine

· Use in patients with latent or active infection, with sepsis, or who are unwilling or incapable of following postoperative care instructions.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Sponsor:	DePuy Synthes1301 Goshen ParkwayWest Chester, PA 19380USA
	Primary Contact: Françoise Cettour-DelbartEmail: fcettour@its.jnj.com
	Phone: +41 61 965 6765
	Alternate Contact: Thomas Shea
	Email: tshea@its.jnj.comPhone: 610-719-5679
Date Prepared:	April 25, 2019
Subject Device Name:	MatrixRIB Fixation System
Commonor Usual Name:	Plate, Fixation, Bone;Screw, Fixation, Bone
Classification Name:	Single/multiple component metallic bone fixation appliances and accessories;Smooth or threaded metallic bone fixation fastener
Classification:	Class IIRegulation Number: 21 CFR 888.3030; 21 CFR 888.3040Product Code: HRS, HWC
Predicate Device:	Biomet Microfixation RibFix Blu Thoracic Fixation System(K162974)
Reference Device:	Synthes MatrixRIB Fixation System(K161590)
Subject DevicesDescription:	The devices subject to this notification are proposed for addition to the MatrixRIBFixation System.
	The subject devices consist of self-drilling screws and screw guides designed to beused with the previously cleared MatrixRIB 1.5mm plates and the splints.
	The MatrixRIB Self-Drilling Screws are available as• locking screws, for permanent fixation,• and non-locking screws, for temporary fixation only.The subject screws are manufactured from Titanium Alloy (Ti-6Al-7Nb). They areprovided in a range of lengths• locking: 13 lengths from 8mm to 20mm, with 1mm increments;• non-locking: 2 lengths from 10mm to 12 mm, with 2 mm increments).
	The MatrixRIB Screw Guides are to be used with the subject self-drilling screws tofacilitate their fixation on patient's ribs and sternum. The subject screw guidesare manufactured from Stainless Steel and are provided in 2 designs,• one for the 1.5mm MatrixRIB plates,• and one for the MatrixRIB IM splints.
Subject DevicesIndications for use:	The DePuy Synthes MatrixRIB Fixation System is indicated for use in skeletallymature patients with normal or osteoporotic bone for chest wall fixation, where:
	DePuy Synthes MatrixRIB pre-contoured plates are indicated for the fixation,stabilization and reconstruction of:• Rib fractures, fusions, osteotomies, and/or resections, including spanning
	gaps and/or defects• Pectus Excavatum, Pectus Carinatum, and other chest wall deformities
	DePuy Synthes MatrixRIB straight plates are indicated for the fixation, stabilizationand reconstruction of:
	• Rib and sternum fractures, fusions, osteotomies, and/or resections, includingspanning gaps and/or defects
	• Pectus Excavatum, Pectus Carinatum, and other chest wall deformities
	DePuy Synthes MatrixRIB sternal plates, 2.8mm thickness, are indicated for thefixation, stabilization and reconstruction of:
	• Sternum fractures, fusions, and/or osteotomies
	• Pectus Excavatum, Pectus Carinatum, and other chest wall deformities
	The DePuy Synthes MatrixRIB intramedullary splints and the universal plate areindicated for the fixation and stabilization of ribs.
	Contraindications
	The MatrixRIB Fixation System is contraindicated for:
	• The fixation of the sternum in acute cardiac patients, due to the potential delayif emergent re-entry is required
	• Screw attachment or fixation to the clavicle or spine
	• Use in patients with latent or active infection, with sepsis, or who are unwillingor incapable of following postoperative care instructions.
Comparison toPredicate Device:	The predicate device is part of the Biomet Microfixation System.
	Indications:
	The Biomet Microfixation System is indicated for use in the stabilization andfixation of fractures in the chest wall including sternal reconstructive surgicalprocedures, trauma, or planned osteotomies. The system may be used in normaland poor bone to promote union.
	Proposed MatrixRIB screws have a bone thread major diameter of 2.7 mm and the predicate RibFix Blu screws come in two bone thread major diameters, 2.4 mm and 2.7mm. Proposed MatrixRIB are offered in lengths from 8mm to 20mm, and the predicate RibFix Blu screws are offered in lengths from 7mm to 16mm.
	Technological Differences between the MatrixRIB Self-Drilling Screws and theBiomet Microfixation Self-Drilling Screws:The proposed MatrixRIB self-drilling screws are designed to be inserted with theaid of a Screw Guide to ensure proper alignment, while the predicate RibFix Bluself-drilling screws are inserted without the aid of a Screw Guide.The proposed MatrixRIB Fixation System offers a non-locking version of the self-drilling screw for temporary fixation of the rib plate to the bone; while thepredicate RibFix Blu system offers a temporary fixation screw to secure the ribplate to the boneThe proposed MatrixRIB self-drilling screws are manufactured from Ti-6Al-7Nbwhile the predicate RibFix Blu self-drilling screws are manufactured from Ti-6Al-4V.
Non-clinicalPerformance Data:	Non-clinical testing and analyses conducted as part of this submission include: Screw Pull-Out Testing per ASTM F543-17 Screw Failure Torque Testing per ASTM F543-17 Screw Cantilever Load Testing Construct Dynamic Testing. The non-clinical performance data demonstrates that the mechanical performance of the proposed MatrixRIB Self-Drilling Screws met all acceptance criteria and is comparable to that of the predicates.
Clinical	Clinical testing was not necessary for the determination of substantial

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Contraindications:

1. Spanning a midline sternotomy
1. Active infection
1. Foreign body sensitivity
1. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.

Technological similarities between the MatrixRIB Self-Drilling Screws and the Biomet Microfixation Self-Drilling Screws:

Same principles of operation between the proposed and predicate screws, i.e. metallic screws with a self-drilling tip designed to be inserted into a rib without pre-drilling a hole, and a thread profile on the head of the screw designed to lock to a fixation plate.

Similar sizes compared to the predicates:

Performance Data:

equivalence.

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The subject device has similar intended use compared to the predicate device. Substantial Equivalence: The non-clinical performance data included in this submission supports that any differences in technological characteristics from the predicate device do notraise any new questions of safety and effectiveness.

lt is concluded that the information provided in this submission supports substantial equivalence.

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.