The SILC® Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques:
. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
Spinal degenerative surgery, as an adjunct to spinal fusions. .

The SILC® Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.

Device Description

The SILC® Fixation System consists of bands and cords, clamps to mate with 4.5mm-6.5mm diameter rods, and associated manual surgical instruments. The bands and cords are manufactured from polyethylene terephthalate (PET). The bands have commercially pure titanium tips, as specified in ASTM F67, which are detached after insertion and are not intended to be implanted. The clamps are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F138, F1295, F1472, and F1537. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium molybdenum alloy implants.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SILC® Fixation System. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance data) that would typically be found in a comprehensive clinical or performance study report.

The document is an FDA clearance letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed account of a study designed to meet specific acceptance criteria in the way a clinical trial or algorithm validation study would.

Here's what can be extracted based on the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria (e.e.g, "sensitivity of X% with a lower bound of Y%") are NOT described. The performance is reported in a general statement about meeting performance standards.

Acceptance Criteria (Not Explicitly Stated in a Quantifiable Form)	Reported Device Performance
Mechanical Performance: The device should perform equivalently to the predicate device in terms of static and dynamic tension, static cord pull-through, and rod push-through. (Implicitly, the device should meet the requirements of ASTM F1798.)	"Mechanical testing (static and dynamic tension, static cord pullthrough, and rod push-through) was conducted in accordance with ASTM F1798. Performance data demonstrate substantial equivalence to the predicate device."
Biocompatibility: The device should not cause adverse reactions related to bacterial endotoxins.	"Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011." (Results are not given, but the implication is that it passed.)
Technological Characteristics: The additional implants should share the same fundamental characteristics as the predicate devices.	"SILC® Fixation System additional implants devices have the same technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes."

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

The document does not describe a "test set" in the context of an algorithm or clinical study. The performance evaluation mentioned is mechanical testing. Therefore, information about sample size, country of origin, or retrospective/prospective nature of a clinical "test set" is not provided.

For the mechanical testing, the specific number of samples for each test (static and dynamic tension, cord pull-through, rod push-through) is not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided as the submission is for a mechanical fixation system, not an AI/imaging device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided as there is no "test set" subject to expert review for ground truth establishment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable and not provided. MRMC studies are typically performed for AI-assisted image analysis or diagnostic devices. The SILC® Fixation System is a mechanical implant.

6. Standalone Performance Study (Algorithm Only)

This information is not applicable and not provided. The SILC® Fixation System is a mechanical implant, not an algorithm.

7. Type of Ground Truth Used

For the mechanical performance, the "ground truth" would be established by the physical performance measurements and compliance with the ASTM F1798 standard and the performance of the predicate device. For the bacterial endotoxin testing, the ground truth would be the results in accordance with ANSI/AAMI ST-72:2011 standard limits. No other types of ground truth (e.g., pathology, outcomes data, expert consensus) are mentioned or relevant to this device type in this context.

8. Sample Size for the Training Set

This information is not applicable and not provided. This is a mechanical implant, not an AI/machine learning model that requires a training set.

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

This information is not applicable and not provided for the reasons stated above.

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.

October 26, 2017

Globus Medical Inc. Ms. Lori Burns Director, Regulatory Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K172417

Trade/Device Name: SILC® Fixation System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: August 9, 2017 Received: August 10, 2017

Dear Ms. Burns:

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

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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,

Ronald P. Jean -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K172417

Device Name SILC® Fixation System

Indications for Use (Describe)

· Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;

· Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis;

· Spinal degenerative surgery, as an adjunct to spinal fusions.

The SILC® Fixation System may also be used in conjunction with other medical implants metals whenever "wiring" may help secure the attachment of other implants.

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: SILC® Fixation System Additional Implants

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
Primary Contact:	Lori BurnsDirector, Regulatory Affairs
Secondary Contact:	Kelly J. Baker, Ph.D.Senior Vice President, Regulatory and Clinical Affairs
Date Prepared:	August 9, 2017
Device Name:	SILC® Fixation System
Classification:	Per 21 CFR as follows:§888.3010 Bone Fixation CerclageProduct Code OWI RegulatoryClass II, Panel Code 87
Predicate(s):	Primary: SILC® Fixation System (K133482)Additional: Medtronic TRANSLACE™ SpinalTethering System (K163181)

Purpose:

The purpose of this submission is to request clearance for additional implants of the SILC® Fixation System.

Device Description:

Indications for Use:

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. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques:
. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
Spinal degenerative surgery, as an adjunct to spinal fusions. .

The SILC® Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.

Performance Data:

Mechanical testing (static and dynamic tension, static cord pullthrough, and rod push-through) was conducted in accordance with ASTM F1798. Performance data demonstrate substantial equivalence to the predicate device. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

Technological Characteristics:

SILC® Fixation System additional implants devices have the same technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes.

Basis of Substantial Equivalence:

SILC® Fixation System additional implants have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject implants 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.