The Spineology Fortress™ Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (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, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/ or failed previous fusion.

Device Description

The Spineology Fortress Pedicular Fixation System consists of screws (titanium alloy), curved and straight rods (cobalt chrome), adjustable ConneX Cross Connector (titanium alloy), and fixed ConneX Rod Connector (titanium alloy) devices to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Fortress System screws are available with or without a hydroxyapatite coating. 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 screws can be placed in the pedicles in a variety of trajectories ranging from the standard anatomic transpedicular path projected medially toward the ventral vertebral body, to a caudocephalad path sagittally and a laterally directed path in the transverse plane.

Spineology Connex Cross Connector devices are transversely-placed implants that are intended to connect the rod on one side of the spinal construct to the rod on the other side. These devices are manufactured from titanium alloy and are adjustable to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. ConneX Cross Connector devices are intended to be used with Spineology's Fortress™, Threshold V2™, and Palisade™ Pedicular Fixation Systems which are 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.

Spineology Connex Rod Connector devices are implants that are intended to connect two rods in a spinal construct. These devices are manufactured from titanium alloy and the components allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Connex Rod Connector devices are intended to be used with Spineology's Fortress™, Threshold™, Threshold V2™, and Palisade™ Pedicular Fixation Systems which are 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.

AI/ML Overview

The provided document is a 510(k) clearance letter for a medical device called the "Fortress™ Pedicular Fixation System." This type of document is for device clearance, not a study proving the device meets acceptance criteria.

The 510(k) process in the US FDA framework establishes "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical studies to prove effectiveness or safety from scratch, especially for Class II devices like this one.

Therefore, many of the requested details about acceptance criteria, efficacy studies, sample sizes, ground truth, and expert involvement are not applicable to this document or the 510(k) clearance process described. This document focuses on demonstrating that new components added to an existing system are "substantially equivalent" to already-cleared devices, primarily through non-clinical (mechanical) testing.

Here's how to address your questions based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document does not explicitly state "acceptance criteria" in terms of specific performance thresholds for clinical outcomes. Instead, the "acceptance criteria" for the 510(k) clearance are implicitly demonstrating substantial equivalence to predicate devices through mechanical testing. The core "acceptance" is that the device behaves mechanically similarly to other cleared spinal fixation systems.
Reported Device Performance: The document doesn't provide specific numerical performance results from the mechanical tests (e.g., specific bending strength values). It only lists the tests performed and states that the devices "have been shown to be substantially equivalent."

Since specific numerical acceptance criteria and performance data are not detailed in this regulatory document, a table cannot be constructed with these specifics. The document simply confirms that mechanical testing (ASTM F1717, ASTM F1798, ASTM F2193, and Bacterial Endotoxin Testing) was conducted according to FDA guidance and applicable standards, and the conclusion was that the devices are "substantially equivalent."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified for the mechanical tests. Mechanical testing typically uses a certain number of representative samples for each test condition, but the exact count is not given in this summary document.
Data Provenance: The testing appears to be non-clinical (mechanical and endotoxin) rather than human subject data. Therefore, "country of origin of the data" and "retrospective or prospective" are not applicable. The tests were conducted according to US FDA Guidance and ASTM standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The "test set" here refers to mechanical testing of physical device components, not diagnostic or clinical data requiring expert interpretation or "ground truth" establishment in a biological sense. The "ground truth" for mechanical testing is derived from engineering principles and standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or expert review panels for clinical data, not for mechanical laboratory testing of device components.

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 question is not applicable. This document is about a spinal fixation system (physical implant for surgery), not an AI/imaging diagnostic device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable. This document is about a spinal fixation system (physical implant), not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical testing comprises the established mechanical properties and safety profiles (e.g., sterilization/biocompatibility) required for spinal implant components, as defined by FDA guidance and
ASTM standards (e.g., F1717, F1798, F2193, ANSI/AAMI ST-72). There isn't "expert consensus" or "pathology" in the typical sense for this type of device clearance.

8. The sample size for the training set

This question is not applicable. This is not a machine learning or AI device, so there is no "training set."

9. How the ground truth for the training set was established

This question is not applicable. As there is no training set for this type of device, there is no ground truth to establish for one.

Summary

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

Public Health Service

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

Spineology Inc. Ms. Jacqueline A. Hauge Regulatory Affairs Manager 7800 3rd Street North. Suite 600 Saint Paul, Minnesota 55128

April 14, 2017

Re: K170268

Trade/Device Name: Fortress™ Pedicular Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: January 26, 2017 Received: January 27, 2017

Dear Ms. Hauge:

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-

Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

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.

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,

Image /page/1/Picture/9 description: The image shows the name "Mark N. Melkerson -S" in a clear, sans-serif font. The text is horizontally aligned and appears to be part of a document or label. The letters are uniformly sized and spaced, contributing to the legibility of the name.

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K170268

Device Name Fortress™ Pedicular Fixation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON SEPARATE PAGE IF NEEDED

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

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

Image /page/3/Picture/11 description: The image shows the word "Spineology" in a bold, sans-serif font. There is a horizontal line underneath the word. To the right of the word is a graphic of a cluster of dots, with one larger dot in the center and several smaller dots surrounding it. The dots are arranged in a circular pattern.

Date Prepared:	April 11, 2017
Submitter:	Spineology Inc.7800 3rd Street NorthSuite 600Saint Paul, MN 55128Establishment Registration Number: 2135156
Contact Person:	Jacqueline A. HaugeRegulatory Affairs ManagerPhone: 651.256.8534Fax: 651.256.8505Email: jhauge@spineology.com

Device Name and Classification

Trade Name:	Fortress™ Pedicular Fixation System
Common Name:	Thoracolumbosacral Pedicle Screw System
Classification Name:	Orthosis, Spinal Pedicle Fixation
Product Codes:	NKB
Regulatory Class:	Class II
Regulation Number:	21 CFR 888.3070
Panel:	Orthopedic

Predicate Devices

Primary:	K152148	Fortress™ Pedicular Fixation System (Spineology Inc.)
Additional:	K140010	Fortress™ Pedicular Fixation System (Spineology Inc.)
	K123352	S4™ Spinal System (Aesculap Implant Systems, Inc.)
	K162494	CD Horizon™ Spinal System (Medtronic Sofamor Danek)
	K152968	Arsenal™ Spinal Fixation System (Alphatec Spine, Inc.)
	K120838	Synthes Matrix™ System (Synthes Spine)

I. Purpose

The purpose of this submission is to obtain FDA clearance for the addition of Spineology's ConneX™ Cross Connector, ConneX™ Rod Connector, and 4.75mm cobalt chrome Straight Rod devices to its Fortress Pedicular Fixation System.

II. FDA Clearance History

Device Name	510(k) #	Purpose of 510(k)
Fortress™ Pedicular Fixation System	K140010	Initial FDA Clearance
	K152148	Addition of Hydroxyapatite (HA) coated pedicle screws

{4}------------------------------------------------

Device Description III.

A. Fortress™ System

B. ConneX™ Cross Connectors

C. ConneX™ Rod Connectors

IV. Indications for Use

The Spineology Fortress™ Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (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.

V. Comparison to Predicate

When compared to the predicate devices, the Connex Cross Connector, ConneX Rod Connector, and Straight Rod devices have the same:

Intended Use ●
Indications for Use
Fundamental Scientific Technology ●
Principle of Operation
Materials of Construction

{5}------------------------------------------------

VI. Non-Clinical Testing

A. ConneX™ Cross Connectors and ConneX™ Rod Connectors

The following mechanical testing was conducted on representative worst case ConneX Cross Connector and Connex Rod Connector devices in accordance with FDA Guidance: Spinal System 510(k)s (2004) and applicable American Society for Testing and Materials (ASTM) standards:

ASTM F1717

ASTM F1798 • Flexural Grip • ASTM F2193 • Static Cantilever Bending

Static Compression Bending • Dynamic Compression Bending
Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

B. Straight Rods

The following mechanical testing was conducted on representative Straight Rod devices in accordance with FDA Guidance: Spinal System 510(k)s (2004) and applicable American Society for Testing and Materials (ASTM) standards:

ASTM F1717-15

· Static Compression Bending
Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

VII. Conclusion

Based on the indications for use, technological characteristics, and comparison to the predicate devices, the ConneX Cross Connector, Connex Rod Connector, and Straight Rod devices have been shown to be substantially equivalent to the legally marketed 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.