Spineology Pedicular Fixation Systems are 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); turnor; pseudoarthrosis; and/ or failed previous fusion.

Device Description

Spineology Fortress™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems consist of screws (titanium alloy), curved and straight rods (see table below for diameters and material), and ConneX™ Connector (see table below for configurations and materials) devices to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. All screws are available with or without a hydroxyapatite coating. These systems 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. 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 titanium alloy implants that are intended to connect the rod on one side of a 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. Connextor devices are intended to provide immobilization 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 titanium alloy 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 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 Spineology Power Adapter is an instrument accessory intended to facilitate the preparation and placement of pedicle screws using powered instrumentation as an optional alternative to the existing manual technique. The Power Adapter is intended for exclusive use with Spineology Fortress, Threshold, Threshold V2, and Palisade System surgical instruments. The Power Adapter serves as a mechanical interface between the power driver and surgical instruments. When the Power Adapter is attached, the power driver provides appropriate power to rotate the surgical instrument for preparation and placement of pedicle screws.

AI/ML Overview

The provided text describes modifications to existing pedicular fixation systems and a new power adapter for surgical instrumentation, rather than a standalone AI device with specific acceptance criteria and a study to prove its performance in the typical sense of AI/ML evaluation (e.g., sensitivity, specificity, AUC, etc.).

Therefore, the requested information elements related to AI/ML device evaluation metrics, expert ground truth development, MRMC studies, or training sets are not applicable or derivable from this submission, as the submission pertains to a conventional medical device and not an AI/ML-driven diagnostic or prognostic tool.

However, I can extract the non-clinical testing performed to establish substantial equivalence for the modifications and the new Power Adapter, which functionally serve as "acceptance criteria" and the "study" demonstrating they meet those criteria within the context of a 510(k) submission for a non-AI device.

1. Table of Acceptance Criteria and Reported Device Performance

Component/Modification	Acceptance Criteria (Test Performed)	Reported Device Performance
4.75mm and 5.5mm Rods	Confirmatory ASTM F1798 Grip Testing	Deemed acceptable (implied as no issues reported)
	Drawing verification	Deemed acceptable (implied as no issues reported)
	Sterilization adoption	Deemed acceptable (implied as no issues reported)
	Risk Assessment	Deemed acceptable (implied as no issues reported)
	Confirmatory ASTM F1717 (dynamic compression bending)	Deemed acceptable (implied as no issues reported)
	Packaging adoption	Deemed acceptable (implied as no issues reported)
	Shelf Life adoption	Deemed acceptable (implied as no issues reported)
4.5mm Pedicle and Reduction Screws	Review, risk assessment, and comparison to cleared equivalent devices (primary design characteristics, materials, manufacturing processes, existing mechanical performance testing, product experience)	Substantially equivalent to predicate devices, no new risks identified
7.5mm Pedicle and Reduction Screws (Additional Lengths)	Review, risk assessment, and comparison to cleared equivalent devices (primary design characteristics, materials, manufacturing processes, existing mechanical performance testing, product experience)	Substantially equivalent to predicate devices, no new risks identified
Power Adapter	Strength assessment testing of instrumentation and implantable devices under simulated clinical use conditions	Deemed acceptable (implied as no issues reported)
	Screw loading and screw insertion during normal use without loss of function	Deemed acceptable (implied as no issues reported)
	Compatibility with existing surgical instruments	Deemed acceptable (implied as no issues reported)
	Evaluation of quality and accuracy of screw placement in simulated use environment	Deemed acceptable (implied as no issues reported)

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

Sample Size: Not explicitly stated in terms of number of devices tested for each test. The tests are described by type (e.g., ASTM F1798, ASTM F1717, simulated clinical use for the Power Adapter). For screw modifications, "a thorough review, risk assessment, and comparison" was performed.
Data Provenance: Not specified. Standard mechanical and performance tests (e.g., ASTM standards) are typically conducted in a laboratory setting. The "simulated use environment" for the Power Adapter implies lab-based testing rather than clinical data. No country of origin for data is mentioned. The studies appear to be laboratory-based and prospective in the sense that they were conducted for this specific submission, but not prospective clinical trials.

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)

Not applicable. This is a conventional medical device submission, not an AI/ML device relying on expert-annotated "ground truth" for performance evaluation. The "ground truth" is typically defined by engineering specifications, material properties, and adherence to performance standards.

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

Not applicable. This is not an AI/ML device requiring human adjudication of results from a diagnostic or prognostic algorithm.

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

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is a physical medical device and an instrument accessory, not an algorithm.

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

For the rods: Engineering specifications, material properties, and established mechanical testing standards (ASTM F1798, ASTM F1717).
For the pedicle screws: Comparison to the primary design characteristics, materials, manufacturing processes, existing mechanical performance testing, and product experience of already cleared equivalent devices.
For the Power Adapter: Functional performance in simulated use conditions, adherence to mechanical and functional specifications (e.g., screw loading, screw insertion, compatibility).

8. The sample size for the training set

Not applicable. There is no AI/ML component, and therefore no "training set."

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

Not applicable. Since there is no training set, there is no ground truth established for it.

Summary

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

Image /page/0/Picture/1 description: The image shows the text "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or informational context.

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

August 21, 2017

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

Re: K172107

Trade/Device Name: Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: July 19, 2017 Received: July 20, 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

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

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 (OS) 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 (DICE) 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 (DICE) 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. Katherine D. Kavlock -5 for

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) K172107

Device Name

Threshold™ V2 Pedicular Fixation System, Threshold™ Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System

Indications for Use (Describe)

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

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

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}------------------------------------------------

510(k) Summary

Spineology
Date Prepared:	August 16, 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 Names:	Threshold™ V2 Pedicular Fixation System,Threshold™ Pedicular Fixation System,Fortress™ Pedicular Fixation System,Palisade™ 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:	K170255 Threshold™ V2 Pedicular Fixation System (Spineology Inc.)
Additional:	K170251 Threshold™ Pedicular Fixation System (Spineology Inc.)K170268 Fortress ™ Pedicular Fixation System (Spineology Inc.)K171438 Palisade™ Pedicular Fixation System (Spineology Inc.)K120838 Synthes Matrix™ System (Synthes Spine)

Description of Device Modifications A.

The purpose of this submission is to obtain FDA clearance for the following modifications to Spineology's Fortress, Threshold, Threshold V2, and Palisade Pedicular Fixation Systems:

Addition to System	Fortress	Threshold	ThresholdV2	Palisade
4.75mm cobalt chrome rods (25mm to 400mm)		×	×
5.5mm titanium rods (600mm)		×	×
4.5mm pedicle screws and reduction screws (25 - 50mm lengths)			×
7.5mm pedicle screws and reduction screws (70 - 100mm lengths)			×
Power Adapter	×	×	×	×

This 510(k) also supports a labeling update to include reference to the added implantable devices and the option for pedicle screw preparation and placement using powered instrumentation.

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

B. Device Description

Pedicular Fixation Systems

ConneX™ Cross Connector

ConneX™ Rod Connector

Component	Fortress	Threshold	ThresholdV2	Palisade
5.5mm Curved Rod (titanium alloy)		X	X
5.5mm Straight Rod (titanium alloy)		X	X
4.75mm Curved Rod (cobalt chrome)	X	X	X	X
4.75mm Straight Rod (cobalt chrome)	X	X	X	X
ConneX Cross Connectors (titanium alloy)	X	X	X	X
ConneX Rod Connector, Off-set (titanium alloy)	X	X	X	X
ConneX Rod Connector, Axial (titanium alloy)		X	X
ConneX Rod Connector, Parallel (titanium alloy)		X	X

Power Adapter

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

C. Indications for Use

Spineology Pedicular Fixation Systems are 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.

D. Comparison to Predicate

When compared to the predicate device, the subject implantable devices and Power Adapter instrument accessory have the same:

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

E. Non-Clinical Testing

4.75mm and 5.5mm Rods

Assessments, verifications, and product adoptions included:

Confirmatory ASTM F1798 Grip Testing • Drawing verification
· Sterilization adoption . Risk Assessment
Confirmatory ASTM F1717 (dynamic compression bending)

4.5mm Pedicle and Reduction Screws

A thorough review, risk assessment, and comparison of these devices to equivalent devices currently cleared by FDA for use in other Spineology Pedicle Screw Systems confirmed that the 4.5mm Threshold V2 pedicle and reduction screws for their intended use are substantially equivalent to the predicate devices, and do not introduce any known new risks based the equivalence of their primary design characteristics, materials, manufacturing processes, existing mechanical performance testing, and product experience as compared to the predicate device.

7.5mm Pedicle and Reduction Screws (Additional Lengths)

A thorough review, risk assessment, and comparison of these devices to equivalent devices currently cleared by FDA for use it its other Pedicle Screw Systems confirmed that the 7.5mm Threshold V2 pedicle and reduction screws for their intended use are substantially equivalent to the predicate devices, and do not introduce any known new risks based the equivalence of their primary design characteristics, materials, manufacturing processes, existing mechanical performance testing, and product experience as compared to the predicate device.

Power Adapter

The following non-clinical testing was conducted for the Power Adapter device:

Strength assessment testing of instrumentation and implantable devices under simulated ● clinical use conditions
Screw loading and screw insertion during normal use without loss of function
Compatibility with existing surgical instruments
Evaluation of quality and accuracy of screw placement in simulated use environment

F. Conclusion

Based on the indications for use, technological characteristics, and comparison to the predicate devices, Spineology has demonstrated that the subject device components are substantially equivalent to the legally marketed predicate devices for their intended use.

Packaging adoption
Shelf Life adoption

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.