The Posterior Cable Screw System is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures as an adjunct to a rigid posterior fixation system cleared/approved for trauma and spondylolisthesis. The system is indicated for the following:
· Defect of the pars interarticularis
· Spondylolisthesis
The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between T1 and the sacrum. Cables may be used for interspinous wiring. The grommet may be used with the cable. The system is not intended to be used in conjunction with a stainless steel implant.

Device Description

The Posterior Cable Screw System consists of screws, cables, and grommets utilized for the correction of pars defects. A construct consists of two cable screws with locking set screws and a cable connecting the two screws. The screws are inserted into the pedicles and the cable is passed around the spinous process between the two screws. The grommet surrounds the cable at the location of the spinous process. The cable is tensioned and the set screws are tightened and fully locked per the surgical technique. The implants are manufactured from medical grade titanium alloy per ASTM F136 and cobalt chromium alloy per ASTM F90. The implants are provided sterile. The Posterior Cable Screw System utilizes Class I manual instruments to facilitate implantation of the device components.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA regarding the "Frontier Medical Devices Posterior Cable Screw System." It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically seen for AI/software-as-a-medical-device (SaMD) clearances.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a physical medical implant. Therefore, most of the requested information (sample sizes, expert adjudication, MRMC studies, standalone performance for an algorithm, ground truth methods for AI, training set sizes) is not applicable or present in this given text.

However, I can extract the relevant information from the provided text regarding the device's performance in the context of substantial equivalence.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a physical medical device seeking substantial equivalence, "acceptance criteria" and "reported device performance" are evaluated in the context of mechanical and material properties similar to predicate devices, rather than diagnostic accuracy or algorithmic performance.

Criterion Type	Acceptance Criteria (Implied)	Reported Device Performance
Functional/Mechanical Performance	Perform in a manner substantially equivalent to predicate systems under dynamic testing conditions (implies meeting or exceeding the mechanical strength and durability standards of the predicate).	"Dynamic tests were provided to support that the Posterior Cable Screw System performs in a manner substantially equivalent to that of predicate systems. No new issues of safety or effectiveness were raised." "Any differences [in technological characteristics compared to predicates] were not considered significant based on mechanical bench testing."
Material Composition	Utilize medical-grade materials commonly used in similar devices, comparable to predicate devices.	"The implants are manufactured from medical grade titanium alloy per ASTM F136 and cobalt chromium alloy per ASTM F90." (This aligns with industry standards for spinal implants and is implicitly compared to predicate materials).
Safety and Effectiveness	Not raise any new types of safety or efficacy issues compared to legally marketed predicate devices.	"No new issues of safety or effectiveness were raised" by the dynamic tests. "The minor differences in technological characteristics that do exist do not raise any new types of safety or efficacy issues." "There are no significant differences between the subject system and the predicates which would adversely affect the use of the product."
Intended Use	Align with the intended use of predicate devices for specific spinal conditions and anatomical locations.	The "Indications for Use" section explicitly states: "The Posterior Cable Screw System is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures as an adjunct to a rigid posterior fixation system cleared/approved for trauma and spondylolisthesis. The system is indicated for the following: · Defect of the pars interarticularis · Spondylolisthesis" (This is directly comparable to the predicate's use).

Note: The FDA's 510(k) clearance process for devices like this typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than establishing completely new performance metrics. The "acceptance criteria" are therefore framed in terms of equivalence.

The following questions are not applicable to this document as it pertains to a physical medical device (spinal implant system) and not an AI/software device. The document describes pre-clinical performance data (dynamic tests) for mechanical properties, not an algorithm's diagnostic performance.

Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to mechanical bench testing, not a dataset of patient cases.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering specifications and test results, not expert consensus on medical images/data.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For this device, the "ground truth" for proving substantial equivalence lies in established engineering standards (ASTM F136, ASTM F90) for materials and mechanical testing methodologies accepted by the FDA for spinal implants.
The sample size for the training set: Not applicable. There is no "training set" for physical device manufacturing in this context.
How the ground truth for the training set was established: Not applicable.

Summary

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

Frontier Medical Devices, Incorporated Ms. Bethany D. Byman Director of Regulatory Affairs 512 Fourth Street Gwinn, Michigan 49841

August 20, 2015

Re: K151346

Trade/Device Name: Frontier Medical Devices Posterior Cable Screw System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: May 15, 2015 Received: May 20, 2015

Dear Ms. Byman:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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Page 2 - Ms. Bethany D. Byman

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" (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 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) K151346

Device Name

Frontier Medical Devices Posterior Cable Screw System

Indications for Use (Describe)

· Defect of the pars interarticularis

· Spondylolisthesis

The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between 71 and the sacrum. Cables may be used for interspinous wiring. The grommet may be used with the cable. The system is not intended to be used in conjunction with a stainless steel implant.

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 Pursuant to 21 CFR 807.92

Sponsor:	Frontier Medical Devices, Inc.512 Fourth StreetGwinn, MI 49841 USA
	Contact: Bethany BymanPh: 906-232-1200Fx: 906-232-1222
	Prepared: July 17, 2015
Name:	Posterior Cable Screw System
Trade name:	Frontier Medical Devices Posterior Cable Screw System
Common name:	Pedicle Screw and Spinal Cable System
Classifications:	§888.3010 Cerclage, Fixation, Metallic
Product Codes:	JDQ
Panel/ Branch:	Orthopaedic and Rehabilitation Devices Panel; Panel Code 87
Primary Predicate:	Pioneer Posterior Cable Screw System (K022908)
ReferencePredicates:	ParsFix (K003351)Stainless Steel Wire (pre-1976)
Description:	The Posterior Cable Screw System consists of screws, cables, andgrommets utilized for the correction of pars defects. A construct consistsof two cable screws with locking set screws and a cable connecting thetwo screws. The screws are inserted into the pedicles and the cable ispassed around the spinous process between the two screws. The grommetsurrounds the cable at the location of the spinous process. The cable istensioned and the set screws are tightened and fully locked per the surgicaltechnique. The implants are manufactured from medical grade titaniumalloy per ASTM F136 and cobalt chromium alloy per ASTM F90. Theimplants are provided sterile. The Posterior Cable Screw System utilizesClass I manual instruments to facilitate implantation of the devicecomponents.

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Intended Use:	The Posterior Cable Screw System is intended to reduce pars defect andto stabilize the spinal operative site during fusion procedures as an adjunctto a rigid posterior fixation system cleared/approved for trauma andspondylolisthesis. The system is indicated for the following:Defect of the pars interarticularis Spondylolisthesis The Posterior Cable Screw System is indicated for pedicle screwattachment for these indications between T1 and the sacrum. Cables maybe used for interspinous wiring. The grommet may be used with the cable.The system is not intended to be used in conjunction with a stainless steelimplant.
Pre-ClinicalPerformance Data:	Dynamic tests were provided to support that the Posterior Cable ScrewSystem performs in a manner substantially equivalent to that of predicatesystems. No new issues of safety or effectiveness were raised.
TechnologicalCharacteristics:	The Posterior Cable Screw System and predicate devices are similar interms of indications for use, material composition, technologicalcharacteristics, design characteristics, and mechanical strength. Theminor differences in technological characteristics that do exist do not raiseany new types of safety or efficacy issues.
SubstantialEquivalence:	This submission supports the position that the subject Posterior CableScrew System is substantially equivalent to previously cleared systems.There are no significant differences between the subject system and thepredicates which would adversely affect the use of the product. Anydifferences were not considered significant based on mechanical benchtesting.

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.