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® 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 (L3 to S1).

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 screw assemblies, and cross connectors.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "PedFuse® Pedicle Screw System," specifically for the addition of a sliding washer component. It is a regulatory submission for substantial equivalence to previously cleared predicate devices.

It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria in the manner typically associated with studies demonstrating AI or diagnostic device performance metrics (e.g., sensitivity, specificity, accuracy against a ground truth). This document primarily focuses on demonstrating that the new component (sliding washer) does not change the fundamental safety and effectiveness of the existing device and remains substantially equivalent to already cleared devices.

Therefore, most of the requested information cannot be extracted from this document as it pertains to a different type of regulatory submission and device.

However, I can extract information related to the device itself and its regulatory context:

Device Name: PedFuse® Pedicle Screw System
Manufacturer: SpineFrontier®
Regulation Number: 21 CFR 888.3070
Regulation Name: Pedicle screw spinal system
Regulatory Class: Class II
Product Code: MNH, MNI
Indications for Use: 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 acute instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis). It is also 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 (L3 to S1).
Change from Previous System: Addition of a sliding washer.
Material: Medical grade titanium alloy (ASTM F136).
Predicate Devices: K133153, K123164, K092420 (SpineFrontier Pedfuse® Pedicle Screw System) and K071420 (Chameleon® FacetFuse® MIS Screw System as a reference).

Regarding your specific questions, based on the provided text, I can state the following:

Table of acceptance criteria and the reported device performance: Not applicable. This document is not about performance metrics like sensitivity or accuracy. It's about substantial equivalence for a hardware component.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document does not detail a test set for performance evaluation in the context of diagnostic or AI devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment is not relevant for this type of hardware component submission.
Adjudication method: Not applicable.
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: Not applicable. This is not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device component, not a study evaluating performance against specific acceptance criteria for a diagnostic or AI-driven device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.

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

February 12, 2015

SpineFrontier. Incorporated % Mr. Kenneth C. Maxwell II Empirical Consulting, LLC 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K143377

Trade/Device Name: 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: January 15, 2015 Received: January 16, 2015

Dear Mr. Maxwell:

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 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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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K143377

Device Name

PedFuse® Pedicle Screw System

Indications for Use (Describe)

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

[ Over-The-Counter Use (21 CFR 801 Subpart C) > Prescription Use (Part 21 CFR 801 Subpart D)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration

Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Submitter's Name:	SpineFrontier®
Submitter's Address:	500 Cummings Center, Suite 3500Beverly, MA 01915
Submitter's Telephone:	978.232.3990 x252
Company Contact Person:	Manthan Damani, MSRASenior Regulatory Affairs Associate
Official Contact Person:	Kenneth C Maxwell IIEmpirical Consulting LLC719.291.6874
Date Summary was Prepared:	2-Feb-15
Trade or Proprietary Name:	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:	87 Orthopedic Panel

5.510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

CHANGE FROM PREVIOUSLY CLEARED SYSTEM

The purpose of this submission is to add a component to the SpineFrontier® PedFuse® Pedicle Screw System cleared in K133153, K123164, and K092420. A sliding washer is being added to the system in this submission.

INDICATIONS FOR USE

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 (L3 to S1).

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The indications for use for the SpineFrontier® PedFuse® Pedicle Screw System have not changed relative to the previously cleared SpineFrontier® PedFuse® Pedicle Screw System (K133153, K123164, K092420).

TECHNICAL CHARACTERISTICS

The subject sliding washer is fabricated from medical grade titanium alloy (ASTM F136). Titanium 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.

510k Number	Trade or Proprietary or ModelName	Manufacturer	PredicateType
K133153, K123164,K092420	Pedfuse® Pedicle Screw System	SpineFrontier	Primary
K071420	Chameleon® FacetFuse® MIS ScrewSystem	SpineFrontier	Reference

Table 5-1 Predicate Devices

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 previously cleared. The modifications raise no new types of safety or effectiveness questions. The overall technology characteristics lead to the conclusion that the Pedfuse® Pedicle Screw System is substantially equivalent to the predicate devices.

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.