The AdvantageRib System consists of bridges (with locking posts) and locking caps for the thoracoscopic fixation and stabilization of ribs. These implants are manufactured from commercially pure titanium and titanium alloys (Ti-6Al-7N per ASTM F1295 and Ti-6Al-4V per ASTM F136 or ASTM F1472). The system is comprised of the following implants:

Titanium alloy AdvantageRib Bridge with threaded locking posts
Commercially pure locking caps
When fully assembled, the bridge is placed on the underside of the rib, the threaded locking posts extends through pre-drilled holes in the rib, and the locking caps are fixed to the locking post on the anterior side of the rib. The combined threaded locking post/locking cap provides for fixation of the bridge.

AI/ML Overview

The provided FDA 510(k) summary for the AdvantageRib System does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML-driven medical device.

The document discusses a medical device for bone fixation (rib fractures) and its equivalence to a predicate device. It focuses on mechanical testing, material specifications, and sterilization validation for a physical implant, not a software algorithm.

Therefore, I cannot extract the following information from the provided text:

Table of acceptance criteria and reported device performance related to an AI/ML algorithm.
Sample size and data provenance for a test set (as no AI/ML test set is mentioned).
Number and qualifications of experts for ground truth (as no AI/ML ground truth is mentioned).
Adjudication method (as no AI/ML ground truth is mentioned).
MRMC comparative effectiveness study or effect size of human improvement with AI (as no AI is discussed).
Standalone algorithm performance (as no algorithm is discussed).
Type of ground truth used (as no AI/ML ground truth is mentioned).
Sample size for the training set (as no AI/ML training set is mentioned).
How ground truth for the training set was established (as no AI/ML training set is mentioned).

The document describes the non-clinical testing performed for the AdvantageRib System as follows:

Non-Clinical Testing Information Provided:

Category	Description
Study Purpose	To demonstrate that the AdvantageRib System, which is identical in geometry and manufacturing process to the predicate device, with specified material and dimensional changes, is as safe and effective as the identified predicate. This was done by ensuring the introduced changes did not create a new "worst case" scenario concerning mechanical performance and by validating the sterilization process.
Acceptance Criteria (Implicit from context)	Mechanical Performance: The device (bridge, locking post, locking cap construct) must demonstrate equivalent or superior dynamic and static performance compared to the predicate device. The changes in material or dimensions must not introduce a new worst-case scenario. (Specific numerical acceptance values are not provided in this summary, but would be detailed in the full test reports).Sterilization: The sterilization process must achieve a Sterility Assurance Level (SAL) of $10^{-6}$. (This is a standard acceptance criterion for sterilization validation).
Reported Device Performance	Mechanical Performance: "Dynamic and static testing was performed on the bridge, locking post, locking cap construct demonstrating that neither the material or dimensional changes introduced a new worst case." (Specific quantitative results not provided in summary).Sterilization: "Sterilization validation was performed on the subject device per ISO 14937:2009... to establish SAL of $10^{-6}$." (This confirms the acceptance criterion was met).

Additional Context from the Document:

Device Name: AdvantageRib System
Intended Use: Fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
Predicate Device: MatrixRIB Endo Thorascopic Rib Plating System (K141241)
Modifications vs. Predicate: Includes option for different titanium alloys, optional washer, increased lengths of locking posts and locking caps with an internal X-drive feature (vs. external hex), and ability for all implants to be steam sterilized (vs. predicate's gamma radiation for some components).
Conclusion: "The conclusions drawn from the nonclinical testing demonstrates that the device is as safe and as effective as the identified predicate."

In summary, the provided document is a 510(k) summary for a physical medical implant device, not an AI/ML diagnostic or therapeutic algorithm. Therefore, the specific details requested regarding AI/ML performance, ground truth, and study design are not present. The acceptance criteria and performance discussed relate to the mechanical and sterilization properties of the physical implant.

Summary

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February 14, 2019

Image /page/0/Picture/1 description: The image contains 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.

SIG Medical Corporation % Lauren Smith Project Engineer JALEX Medical, LLC. 30311 Clemens Road, Suite #5D Westlake, Ohio 44145

Re: K183317

Trade/Device Name: AdvantageRib 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: January 14, 2019 Received: January 15, 2019

Dear Lauren Smith:

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 mav, 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 avare 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 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.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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.

Shumaya Ali -S

for 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)

K183317

Device Name AdvantageRib System

Indications for Use (Describe)

The AdvantageRib System is intended for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

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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Image /page/3/Picture/0 description: The image shows the logo for SIGMEDICAL. The logo consists of a stylized ribcage on the left, followed by the text "SIG" in black and "MEDICAL" in a light blue color. The ribcage graphic is a simplified representation of the human ribcage, with the sternum and ribs clearly visible.

510(k) Summary

Submitted For:	SIG Medical Corp.238 E. Chocolate Ave. Suite 2Hershey, PA 17033
Date:	02/14/2019
Contact Person:	Lauren Smith, Project Engineer, JALEX Medical
Contact Telephone:	(440) 541-0060
Contact Fax:	(440) 933-7839
Contact Address:	30311 Clemens Rd. Suite 5D, Westlake, OH 44145
Device Trade Name:	AdvantageRib System
Common Names:	Plate, Fixation, Bone and Screw, Fixation, Bone
Regulation Names:	Single/multiple component metallic bone fixation appliances andaccessories and Smooth or threaded metallic bone fixation fastener
Regulation Numbers:	21 CFR 888.3030, 21 CFR 888.3040
Regulatory Class:	Class II
Product Codes:	HRS, HWC
Reviewing Panel:	Orthopedic
Primary Predicate Device:	MatrixRIB Endo Thorascopic Rib Plating System (K141241)

Device Description:

Titanium alloy AdvantageRib Bridge with threaded locking posts ●
. Commercially pure locking caps

When fully assembled, the bridge is placed on the underside of the rib, the threaded locking posts extends through pre-drilled holes in the rib, and the locking caps are fixed to the locking post on the anterior side of the rib. The combined threaded locking post/locking cap provides for fixation of the bridge.

Indications for Use:

The AdvantageRib System is intended for the fixation, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

Substantial Equivalence:

The AdvantageRib System has the same intended use, indications for use, principles of operation, and technological characteristics of the predicate. The modifications are not being made as a corrective action for any quality or compliance issues with the predicate version. Modifications summarized in the following table do not raise new questions of safety or effectiveness. Therefore, the AdvantageRib System is substantially equivalent to the predicate.

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Image /page/4/Picture/0 description: The image contains the logo for SIGMEDICAL. The logo features a stylized image of a ribcage on the left. To the right of the ribcage is the text "SIGMEDICAL" in a sans-serif font, with "SIG" in black and "MEDICAL" in a light blue color.

Item	ModifiedAdvantageRib System	MatrixRIB EndoThorascopic Rib PlatingSystem	Comparison
Product Code	HRS, HWC	HRS, HWC	Same
ClassificationName	Plate, fixation, bone andScrew, fixation, bone	Plate, fixation, bone andScrew, fixation, bone	Same
Class	II	II	Same
Indicationsfor Use	The AdvantageRibSystem is intended forthe fixation,stabilization, and fusionof rib fractures andosteotomies of normaland osteoporotic bone.	The Synthes Matrix RibFixation System isindicated for the fixationand stabilization of ribfractures, fusions andosteotomies of normal andosteoporotic bone.	Same
Materials	Bridge (plate) andlocking posts: Ti-6Al-7N per ASTM F1295,Ti-6Al-4V per ASTMF136, Ti-6Al-4V perASTM F1472Locking cap andwasher: CommerciallyPure Titanium Grade 4per ASTM F67	Plate and locking posts:Ti-6Al-7N per ASTMF1295Locking cap:Commercially PureTitanium Grade 4 perASTM F67	The modifiedAdvantageRib Systemincludes the option ofmanufacturing thebridges (plates) andlocking posts from Ti-6Al-4V per ASTMF136 or Ti-6Al-4V perASTM F1472.
DesignFeatures	Optional washerIncreased lengths oflocking posts andlocking caps withinternal X-drive feature.	No washer includedLocking caps withexternal hex drive feature.	Optional washerdistributes the load oftightening the lockingposts in poor bonequality.Increased length oflocking posts allowsfor increased threadengagement. Lockingcap modified drivefeature minimizes softtissue obstruction.
Sterilization	Steam Sterilization (Allimplants andinstruments)	Gamma radiation (platesand locking posts), Steamsterilization (locking capsand instruments)	All implants can besteam sterilized andprovided non-sterile.

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Image /page/5/Picture/0 description: The image contains the logo for SIGMEDICAL. To the left of the company name is a grey image of a ribcage. The company name is in all caps, with SIG in black and MEDICAL in a light blue color.

Non-Clinical Testing:

The AdvantageRib System is identical in geometry and manufacturing process to the predicate device. Dynamic and static testing was performed on the bridge, locking post, locking cap construct demonstrating that neither the material or dimensional changes introduced a new worst case. Sterilization validation was performed on the subject device per ISO 14937:2009 Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices to establish SAL of 10-6.

Conclusion:

The conclusions drawn from the nonclinical testing demonstrates that the device is as safe and as effective as the identified predicate.

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.