The Spineology Threshold™ V2 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 Threshold Pedicular Fixation System consists of solid standard and reduction screws (titanium alloy), curved and straight rods (titanium alloy), and adjustable ConneX Cross Connector 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. Threshold solid standard and reductions 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 solid standard and reduction 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.

AI/ML Overview

This document describes the Spineology Threshold™ V2 Pedicular Fixation System, a medical device, and its clearance through a 510(k) premarket notification. The information provided is primarily focused on demonstrating substantial equivalence to previously marketed predicate devices, rather than a standalone clinical study with detailed acceptance criteria and performance metrics for a diagnostic or AI-driven device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, ground truth for training set) are not applicable to this type of regulatory submission and device. This is a spinal fixation system, not a device that relies on interpretation, diagnostic accuracy, or AI.

However, I can extract the relevant information regarding acceptance criteria derived from non-clinical testing and the studies that demonstrate compliance.

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

For a spinal fixation system, "acceptance criteria" and "reported device performance" are typically defined by compliance with established mechanical testing standards and comparison to predicate device performance. The document explicitly states:

"New mechanical testing was not required to establish the performance of Threshold V2 pedicle screws, pre-bent rods, and set screws. These devices were previously cleared under a separate 510(k) and have not been modified since their initial clearance." This implies that their previous performance met the relevant standards.
"New mechanical testing was not required to support the performance of Threshold V2 reduction screws. These screws are identical to previously cleared Threshold V2 pedicle screws with the exception of the integrated removable (non-implanted) extension towers on the tulip of the device." Again, reliance on previous clearance and identical mechanical properties.
For Straight Rods and ConneX™ Cross Connectors and ConneX™ Rod Connectors, specific ASTM tests were conducted. The "acceptance criteria" for these would be to meet or exceed the performance of the predicate devices and the requirements outlined in the referenced ASTM standards and FDA Guidance. While specific numerical performance values are not provided in this summary, the conclusion of the submission is that the device "has been shown to be substantially equivalent to the legally marketed predicate devices," implying successful performance in these tests.

Therefore, the table would look like this, with the understanding that "reported performance" is demonstrated by substantial equivalence and meeting standard requirements rather than specific numerical data points explicitly stated here:

Acceptance Criteria (Implied)	Reported Device Performance (Demonstrated by)
Maintain performance of previously cleared pedicle screws, pre-bent rods, and set screws.	No new mechanical testing required, as these components were previously cleared and unmodified. Their performance is considered equivalent to the predicate devices and compliant with applicable standards from their original clearance.
Maintain performance of previously cleared pedicle screws for reduction screws.	No new mechanical testing required, as reduction screws are identical to previously cleared V2 pedicle screws (excluding non-implanted extension towers). Performance is considered equivalent.
Meet mechanical requirements for Straight Rods as per FDA Guidance: Spinal System 510(k)s (2004) and ASTM F1717-15.	Static Compression Bending testing was conducted on representative Straight Rod devices in accordance with ASTM F1717-15 and FDA Guidance. The conclusion of the submission states substantial equivalence, indicating successful performance in these tests.
Meet mechanical requirements for ConneX™ Cross Connectors and ConneX™ Rod Connectors as per FDA Guidance: Spinal System 510(k)s (2004), ASTM F1717, ASTM F1798, and ASTM F2193.	Flexural Grip (ASTM F1798), Static Cantilever Bending (ASTM F2193), Static Compression Bending (ASTM F1717), and Dynamic Compression Bending (ASTM F1717) testing was conducted on representative worst-case devices in accordance with the specified standards and FDA Guidance. The conclusion of the submission states substantial equivalence, indicating successful performance in these tests.
Compliance with bacterial endotoxin limits.	Bacterial endotoxin testing (BET) was conducted for all Threshold V2 devices in accordance with ANSI/AAMI ST-72:2011. The successful conclusion of the submission implies compliance.

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 for Test Set: Not applicable in the context of clinical studies for diagnostic accuracy. For mechanical testing, representative "worst-case" devices were tested, a standard practice for non-clinical verification. Specific numerical sample sizes for each test are not provided in this summary but would be detailed in the full test reports.
Data Provenance: Not applicable for a clinical study. The mechanical testing data would originate from the manufacturer's testing facilities or a certified lab. The document does not specify the country of origin for the testing itself, but Spineology Inc. is located in Saint Paul, MN, USA.
Retrospective or Prospective: Not applicable, as this is non-clinical mechanical testing, not a clinical study.

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 device is a pedicular fixation system (an implant for spine surgery), not a diagnostic device requiring expert interpretation or ground truth establishment for a test set.

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

Not applicable.

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 diagnostic or interpretation device.

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

Not applicable.

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

Not applicable for clinical ground truth. For mechanical testing, the "ground truth" is compliance with established engineering standards (ASTM and FDA Guidance) and performance comparable to predicate devices.

8. The sample size for the training set

Not applicable. This device does not have a "training set" in the context of machine learning or AI.

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

Not applicable.

Summary

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

April 14, 2017

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

Re: K170255

Trade/Device Name: Threshold™ V2 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 of medical device

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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,

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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Indications for Use

510(k) Number (if known) K170255

Device Name Threshold™ V2 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)

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510(k) Summary

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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: ihauge@spineology.com

Device Name and Classification

Trade Name:	Threshold™ V2 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:	K161694	Threshold™ Pedicular Fixation Systems (Spineology Inc.)
Additional:	K143403	Threshold™ Pedicular Fixation System (Spineology Inc.)
	K160980	Threshold™ and Palisade™ Pedicular Fixation Systems (Spineology Inc.)
	K123352	S4™ Spinal System (Aesculap Implant Systems, Inc.)
	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 of Spineology's Threshold™ V2 Pedicular Fixation System.

II. Regulatory History

No prior submissions have been provided to FDA for the Threshold V2 Pedicular Fixation System.

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III. Device Description

Threshold™ V2 System A.

B. ConneX™ Cross Connectors

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.

C. ConneX™ Rod Connectors

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.

IV. Indications for Use

The Spineology Threshold™ V2 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.

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V. Comparison to Predicate

When compared to the predicate devices, the Threshold V2 Pedicular Fixation System has the same:

Intended Use ●
. Indications for Use
. Fundamental Scientific Technology

VI. Non-Clinical Testing

Bacterial endotoxin testing (BET) for all Threshold V2 devices was conducted in accordance with ANSI/AAMI ST-72:2011.

A. Pedicle Screws, Pre-Bent Rods, and Set Screws

New mechanical testing was not required to establish the performance of Threshold V2 pedicle screws, pre-bent rods, and set screws. These devices were previously cleared under a separate 510(k) and have not been modified since their initial clearance.

B. Reduction Screws

New mechanical testing was not required to support the performance of Threshold V2 reduction screws. These screws are identical to previously cleared Threshold V2 pedicle screws with the exception of the integrated removable (non-implanted) extension towers on the tulip of the device.

C. 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

D. 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

VII. Conclusion

Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Threshold V2 Pedicular Fixation System has been shown to be substantially equivalent to the legally marketed predicate devices.

Principle of Operation
. Materials of Construction

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.