The Spineology Fortress™ Pedicle Screw System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative discase (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

Device Description

The Spineology Fortress™ Pedicle Screw System consists of screws (titanium) and rods (cobalt chrome) to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The 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 and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The devices are provided sterile or non-sterile. The associated instruments are provided non-sterile.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what would typically be found in a medical device submission for performance:

The provided text describes a 510(k) submission for the Spineology Fortress™ Pedicle Screw System, a Class III medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a predicate device, which often involves mechanical testing rather than studies involving human participants or AI performance.

Therefore, many of the requested categories related to AI performance, human readers, ground truth for training data, and clinical study details are not applicable (N/A) to this specific submission.

Acceptance Criteria and Device Performance

The acceptance criteria for the Spineology Fortress™ Pedicle Screw System are established by demonstrating that its mechanical performance is equivalent or superior to the predicate devices when evaluated against recognized ASTM standards. These standards define the expected performance thresholds for pedicle screw systems.

Acceptance Criteria (Standard)	Reported Device Performance (Summary from Text)
ISO 1798-97(2008) Flexural Grip	"Mechanical testing was performed as follows: flexural grip, torsional grip, and axial grip tests according to F1798-97(2008)"The text states these tests were performed, implying the device met the requirements of the standard for substantial equivalence. Specific quantitative results are not provided in the summary, but in the full submission, these would demonstrate meeting or exceeding predicate device performance.
ISO 1798-97(2008) Torsional Grip	"Mechanical testing was performed as follows: flexural grip, torsional grip, and axial grip tests according to F1798-97(2008)"As above.
ISO 1798-97(2008) Axial Grip	"Mechanical testing was performed as follows: flexural grip, torsional grip, and axial grip tests according to F1798-97(2008)"As above.
ASTM F543-13 Axial Pullout	"axial pullout and torque to failure per ASTM F543-13"The text states these tests were performed, implying the device met the requirements of the standard for substantial equivalence. Specific quantitative results are not provided in the summary.
ASTM F543-13 Torque to Failure	"axial pullout and torque to failure per ASTM F543-13"As above.
ASTM F1717-13 Static Torsion	"static torsion and static and dynamic compression bending according to ASTM F1717-13"The text states these tests were performed, implying the device met the requirements of the standard for substantial equivalence. Specific quantitative results are not provided in the summary.
ASTM F1717-13 Static Compression Bending	"static torsion and static and dynamic compression bending according to ASTM F1717-13"As above.
ASTM F1717-13 Dynamic Compression Bending	"static torsion and static and dynamic compression bending according to ASTM F1717-13"As above.
Substantial Equivalence	"The device is shown to be substantially equivalent to the intended use, materials, configuration, and performance characteristics of the predicate products." and "The information submitted in this premarket notification supports a determination that the devices subject to this submission are substantially equivalent in technological characteristics and intended use to the predicate devices."Overall conclusion based on all testing.

Study Details (Mechanical Testing)

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary document. For mechanical testing, sample sizes are typically defined by the relevant ASTM standards to ensure statistical validity (e.g., n=6 for certain tests).
- Data Provenance: The testing was "performed" by the applicant, Spineology Inc., likely in a laboratory setting. This is not clinical data (e.g., country of origin for clinical data, retrospective/prospective). It refers to in-vitro mechanical testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Mechanical testing against ASTM standards does not involve "ground truth" derived from expert consensus in the same way clinical or AI studies do. The "ground truth" here is the defined performance requirement within the standard.
Adjudication method for the test set:
- N/A. See point 2. The outcome is determined by adherence to the pass/fail criteria of the ASTM standards.
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:
- No. This is a 510(k) for a physical implant (pedicle screw system), not an AI/software device. Therefore, no MRMC study, human readers, or AI assistance is involved.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical implant.
The type of ground truth used:
- For this type of mechanical testing, the "ground truth" is adherence to the specified performance characteristics and thresholds defined within the referenced ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards (e.g., acceptable flexural strength, pullout force, fatigue life). The comparison is made against predicate devices, demonstrating the new device performs at least as well.
The sample size for the training set:
- N/A. This is mechanical testing of a medical device, not an AI algorithm. There is no concept of a "training set" in this context.
How the ground truth for the training set was established:
- N/A. See point 7.

Summary

{0}------------------------------------------------

APR 2 3 2014

510(k) Summary

Applicant:	Spineology Inc.7800 3rd Street N., Suite 600Saint Paul, MN 55128Phone: 651-256-8500Fax: 651-256-8505
Contact Person:	Karen Roche
Date Prepared:	April 21, 2014
Trade Name:	Spineology Fortress™ Pedicle Screw System
Product Classificationand Code:	Class III per 21 CFR 888.3070. Product Codes MNI. MNH, and NKB
Predicate Device(s):	KBB EOS Pedicle Screw System (K082509) and CD Horizon SpinalFixation System from Medtronic Sofamor Danek (most recent clearance isK132471)
Device Description:	The Spineology Fortress™ Pedicle Screw System consists of screws (titanium)and rods (cobalt chrome) to allow the surgeon to build an implant system to fitthe patient's anatomical and physiological requirements. The system is intendedto provide immobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion in the treatment of acute and chronicinstabilities or deformities of the thoracic, lumbar, and sacral spine. The devicesare provided sterile or non-sterile. The associated instruments are provided non-sterile.
Intended Use:	The Spineology Fortress™ Pedicle Screw System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for thefollowing indications: degenerative disc disease (defined as back pain ofdiscogenic origin with degeneration of the disc confirmed by history andradiographic studies) spondylolisthesis; trauma (i.e., fracture or dislocation);spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor;pseudoarthrosis; and/or failed previous fusion.
Purpose of this 510(k):	New product.
Summary ofTechnologicalCharacteristics:	The device is shown to be substantially equivalent to the intended use, materials,configuration, and performance characteristics of the predicate products.
Testing	Mechanical testing was performed as follows: flexural grip, torsional grip, andaxial grip tests according to F1798-97(2008), axial pullout and torque to failureper ASTM F543-13, static torsion and static and dynamic compression bendingaccording to ASTM F1717-13.
Conclusion:	The information submitted in this premarket notification supports adetermination that the devices subject to this submission are substantiallyequivalent in technological characteristics and intended use to the predicatedevices.

{1}------------------------------------------------

Image /page/1/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 seal is a stylized symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.

Public Health Service

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

April 23, 2014

Spineology Incorporated Ms. Karen Roche Vice President, Operations & Technology 7800 Third Street North. Suite 600 Saint Paul, Minnesota 55128

Re: K140010

Trade/Device Name: Fortress™ Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: March 25, 2014 Received: March 26, 2014

Dear Ms. Roche:

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

{2}------------------------------------------------

Page 2 - Ms. Karen Roche

forth in the quality systems (QS) regulation (2) 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

{3}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510{k} Number (if known) K140010

Device Name

Fortress Pedicle Screw system

Indications for Use (Describe)

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

2 Proscription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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)

James P. Bertram -S 2014.04.23 08:47:44 -04'00'

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."

. ..

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

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.