The SpineFrontier® PedFuse® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).

In addition, the SpineFrontier® PedFuse® Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.

When used in a percutaneous approach with MIS instrumentation, the SpineFrontier® PedFuse® Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (Pseudarthrosis) and severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.

Device Description

The SpineFrontier® PedFuse® Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system consists of longitudinal rods, polyaxial screws, and cross connector. Hydroxyapatite (HA)-coated titanium alloy screws and Cobalt Chrome (CoCr) alloy rods are added to the System in this submission.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the SpineFrontier® PedFuse® Pedicle Screw System. This specific submission focuses on modifications to an already cleared device, adding hydroxyapatite (HA)-coated titanium alloy screws and Cobalt Chrome (CoCr) alloy rods.

Therefore, the performance data presented is for the mechanical substantial equivalence of these new materials and components to previously cleared versions and predicate devices, rather than a usability or clinical effectiveness study of the entire system as an AI device or a novel medical device establishing its own set of acceptance criteria.

The document does not describe the use of AI in this device, nor does it detail a study involving human readers, test sets, ground truth establishment, or training sets in the context of AI performance. The study mentioned is purely mechanical testing of the physical components.

However, I can extract information related to the mechanical performance testing conducted to demonstrate substantial equivalence, framed in the context of acceptance criteria if we interpret "acceptance criteria" as meeting the performance standards of the predicate devices.

Description of Acceptance Criteria and Study for SpineFrontier® PedFuse® Pedicle Screw System (Mechanical Performance)

This 510(k) submission (K133153) describes an update to the SpineFrontier® PedFuse® Pedicle Screw System, specifically adding Hydroxyapatite (HA)-coated titanium alloy screws and Cobalt Chrome (CoCr) alloy rods. The study presented is a mechanical performance testing summary to demonstrate that these modifications maintain adequate and substantially equivalent mechanical strength compared to previously cleared versions and predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like pedicle screw systems, "acceptance criteria" for mechanical testing typically involve meeting or exceeding the performance established by recognized ASTM standards or demonstrating equivalence to predicate devices under those standards. The document states the purpose of the testing is to "demonstrate that the modifications... provide adequate and substantially equivalent mechanical strength for their intended use." While explicit numerical acceptance criteria are not provided in this summary, the implicit acceptance criterion is that the modified device's performance is comparable to or better than previously cleared devices and predicate devices when tested under specified ASTM standards.

Acceptance Criterion (Implicit)	Reported Device Performance
Mechanical Strength (Static Axial Compression Bending): Must meet or exceed performance of previously cleared PedFuse® system and predicate devices (e.g., Medtronic TSRH® Spinal System, Pioneer Quantum Spinal System, Globus Transition™ Stabilization System) as per ASTM F1717-13.	The submission states that "The PedFuse Pedicle Screw System was tested in the following modes: Static Axial Compression Bending (ASTM F1717-13)" and concludes that "The overall technology characteristics and mechanical performance data lead to the conclusion that the PedFuse® System is substantially equivalent to the predicate devices." (Specific numerical results are not provided in this summary.)
Mechanical Strength (Static Torsion): Must meet or exceed performance of previously cleared PedFuse® system and predicate devices as per ASTM F1717-13.	"Static Torsion (ASTM F1717-13)" was performed. Conclusion: "substantially equivalent to the predicate devices." (Specific numerical results are not provided in this summary.)
Mechanical Strength (Cyclic Axial Compression Bending): Must meet or exceed performance of previously cleared PedFuse® system and predicate devices as per ASTM F1717-13.	"Cyclic Axial Compression Bending (ASTM F1717-13)" was performed. Conclusion: "substantially equivalent to the predicate devices." (Specific numerical results are not provided in this summary.)
Custom Instrument Testing: Must demonstrate adequate performance.	"Custom Instrument Testing" was performed. Conclusion: "substantially equivalent to the predicate devices." (Specific numerical results are not provided in this summary.)

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

Sample Size: The document does not specify the exact sample size (number of devices or test repetitions) used for each mechanical test. Mechanical testing, especially for medical devices, typically involves multiple samples to ensure statistical validity, but the specific number is not disclosed in this summary.
Data Provenance: The testing was conducted by SpineFrontier, Inc. in support of their 510(k) submission. This is internal testing performed by the manufacturer, likely in the USA where the company is based. It is a prospective generation of data specifically for this submission.

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

This information is not applicable as the described study is mechanical performance testing of physical components, not a study involving human interpretation of data where "ground truth" would be established by experts.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is mechanical performance testing and does not involve human readers or adjudication processes.

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

This information is not applicable. This submission concerns mechanical properties of spinal implants, not an AI device or a study involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This submission concerns mechanical properties of spinal implants, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established mechanical performance benchmarks set by:

ASTM standards (specifically ASTM F1717-13).
The known performance of the previously cleared SpineFrontier® PedFuse® Pedicle Screw System (K123164, K092420).
The known performance of predicate devices (Medtronic TSRH® Spinal System K091797, Pioneer Quantum Spinal System K101790, Globus Transition™ Stabilization System K073439).

The aim of the study was to demonstrate that the modified device's mechanical properties met or were equivalent to these established benchmarks.

8. The Sample Size for the Training Set

This information is not applicable as the described study is mechanical performance testing and does not involve a training set for an algorithm.

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

This information is not applicable as the described study is mechanical performance testing and does not involve a training set for an algorithm.

Summary

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MAY 1 4 2014

5.510(K) SUMMARY

Submitter's Name:	SpineFrontier, Inc.
Submitter's Address:	500 Cummings Center, Suite 3500Beverly, MA 01915, U.S.A.
Submitter's Telephone:	978.232.3990 x116
Contact Person:	Paul L. SpeidelRegulatory Affairs ManagerTel: 978.279.9272Fax: 978.232.3991
Prepared by:	Meredith L. May, MSEmpirical Testing Corp.719.337.7579
Date Summary wasPrepared:	April 16th, 2014
Trade or Proprietary Name:	SpineFrontier® PedFuse® Pedicle Screw System
Common or Usual Name:	Orthosis, Spondylolisthesis Spinal FixationOrthosis, Spinal Pedicle Fixation
Classification:	Class II per 21 CFR §888.3070
Product Code:	MNH, MNI
Classification Panel:	Orthopedic and Rehabilitation Devices Panel
Predicate Devices:	SpineFrontier® PedFuse® Pedicle Screw System(K123164, K092420)Medtronic TSRH® Spinal System (K091797)Pioneer Quantum Spinal System (K101790)Globus Transition™ Stabilization System (K073439)

Description of the Device

CHANGE FROM PREVIOUSLY CLEARED SYSTEM

The purpose of this submission is to make additions to the components of the SpineFrontier® PedFuse® Pedicle Screw System cleared in K123164 and K092420. Hydroxyapatite (HA)-

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coated titanium alloy screws and Cobalt Chrome (CoCr) alloy rods are added to the System in this submission.

INDICATIONS FOR USE

The indications for use for the SpineFrontier® PedFuse® Pedicle Screw System have not changed relative to the previously cleared SpineFrontier® PedFuse® Pedicle Screw System (K123164. K092420). The indications for use of the SpineFrontier® PedFuse® Pedicle Screw System are similar to that of the predicates Medtronic TSRH® Spinal System (K091797), Pioneer Quantum Spinal System (K101790), and Globus Transition™ Stabilization System (K073439).

TECHNICAL CHARACTERISTICS

The subject screw components are fabricated from medical grade titanium alloy (ASTM F136) with hydroxyapatite coating and the subject rod components are fabricated from cobalt chrome alloy (35N LT or ASTM F1537). Titanium alloys, hydroxyapatite coatings, and cobalt chrome alloys have a successful history of use in the spinal implant industry and use of these materials in these devices does not introduce any previously unaccepted patient risks. The Medtronic TSRH® Spinal System (K091797) and the Pioneer Quantum Spinal System (K101790) include screws that are manufactured from titanium alloy with hydroxyapatite coating. The Medtronic TSRH®

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Spinal System (K091797) includes components made from medical grade cobalt-chromiummolybdenum alloy, and Pioneer Quantum Spinal System (K101790) includes rods that are manufactured from Cobalt Chrome. The Globus Transition™ Stabilization System includes titanium alloy screws that are hydroxyapatite (HA) coated (ASTM F1185).

PERFORMANCE TESTING SUMMARY

In support of this Special 510(k) Device Modification Premarket Notification, Spine Frontier has conducted mechanical testing to demonstrate that the modifications to the PedFuse® Pedicle Screw System provide adequate and substantially equivalent mechanical strength for their intended use. The PedFuse Pedicle Screw System was tested in the following modes:

. Static Axial Compression Bending (ASTM F1717-13)
. Static Torsion (ASTM F1717-13)
Cyclic Axial Compression Bending (ASTM F1717-13) .
Custom Instrument Testing .

CONCLUSION

The subject modified PedFuse® Pedicle Screw System is very similar to previously cleared PedFuse® Pedicle Screw System. The subject Pedicle Screw System has similar intended uses, indications, technological characteristics and principles of operation as the predicate devices. The modifications raise no new types of safety or effectiveness questions. The overall technology characteristics and mechanical performance data lead to the conclusion that the PedFuse® System is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

May 14, 2014

SpineFrontier, Incorporated Mr. Paul L. Speidel Regulatory Affairs Manager 500 Cummings Center, Suite 3500 Beverly, Massachusetts 01915

Re: K133153

Trade/Device Name: SpineFrontier® PedFuse® Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: April 17, 2014 Received: April 18, 2014

Dear Mr. Speidel:

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

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Page 2 - Mr. Paul L. Speidel

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" (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.

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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4. INDICATIONS FOR USE STATEMENT

Device Name: SpineFrontier® PedFuse® Pedicle Screw System

The SpineFrontier® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).

In addition, the SpineFrontier® Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.

Prescription Use X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)		(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

James P. Bertram -S 2014.05.14 14:48:31 -04'00'

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133153

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.