The Saxxony™ Posterior Cervical Thoracic System is intended to immobilize and stabilize cervical (C1 to C7) and thoracic (T1 to T3) spinal segments as an adjunct to fusion for the following acute and chronic instabilities: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Saxxony™ Posterior Cervical Thoracic System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Saxxony™ Posterior Cervical Thoracic System rods may be connected to cervicothoracic or thoracolumbar stabilization systems ranging in diameter from 3.5mm to 6.5mm, using corresponding rod to rod connectors and/or transition rods.

Device Description

SaxxonyTM Posterior Cervical Thoracic System consists of longitudinal members, anchors, interconnecting devices and fasteners in a variety of sizes to accommodate differing anatomic requirements. The implants are sold non-sterile.

AI/ML Overview

Here's an analysis of the provided text regarding the Saxxony™ Posterior Cervical Thoracic System, focusing on the absence of information typically found in studies related to AI/ML device performance:

The provided document is a 510(k) summary for a medical device, specifically a surgical implant system, not an AI/ML diagnostic or assistive device. As such, it does not contain the information requested in your prompt regarding acceptance criteria, study details, ground truth, or expert involvement for an AI study. The performance data presented is for mechanical testing of the physical implant, demonstrating its structural integrity and equivalence to predicate devices.

Therefore, for the information you requested about AI/ML device performance, the answer is that none of the requested information is present in this document because it is not an AI/ML device.

Here's a breakdown of why each point is not applicable:

A table of acceptance criteria and the reported device performance: This document does have performance data, but it's for mechanical tests (static and dynamic compression bending, static torsion) according to ASTM F1717, showing the physical device's load-bearing capabilities. It does not relate to accuracy, sensitivity, specificity, or other metrics common for AI/ML performance.

Table of Mechanical Performance (from document):

Acceptance Criteria	Reported Device Performance
Static and dynamic compression bending and torsion	Demonstrated performance substantially equivalent to predicate devices according to ASTM F1717. (Specific numerical criteria and results are not detailed in this summary.)

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The "test set" here refers to physical implant constructs for mechanical stress tests, not data for an AI algorithm.
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. Ground truth for mechanical testing is based on engineering standards and physical measurements, not expert consensus on medical images or diagnoses.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There's no human adjudication in evaluating mechanical properties against engineering 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: 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 in the context of AI. For the mechanical testing, the "ground truth" would be established engineering principles and ASTM standards for material strength and fatigue.
The sample size for the training set: Not applicable. This is not an AI device.
How the ground truth for the training set was established: Not applicable. This is not an AI device.

In summary, the provided document describes a medical hardware device (a spinal implant system) and its mechanical performance testing for substantial equivalence to other legally marketed predicate devices. It does not involve any Artificial Intelligence or Machine Learning components, and therefore, the questions pertaining to AI device performance are not addressed.

Summary

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November 13, 2018

Nexxt Spine, LLC % Karen E. Warden, Ph.D. President BackRoads Consulting Inc. P.O. Box 566 Chesterland, Ohio 44026

Re: K182508

Trade/Device Name: Saxxony™ Posterior Cervical Thoracic System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: September 10, 2018 Received: September 12, 2018

Dear Dr. Warden:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Ronald P. Jean -S

for 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: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K182508

Device Name

SaxxonyTM Posterior Cervical Thoracic System

Indications for Use (Describe)

In order to achieve additional levels of fixation, the Saxxony™ Posterior Cervical Thoracic System rods may be connected to cervicothoracic or thoracolumbar stabilization systems ranging in diameter from 3.5mm, using corresponding rod to rod connectors and/or transition rods.

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

Date:	10 September 2018
Sponsor:	Nexxt Spine, LLC14425 Bergen Blvd, Suite BNoblesville, IN 46060Office: 317.436.7801Fax: 317.245.2518
Contact Person:	Andy Elsbury, President
510(k) Contact:	Karen E. Warden, PhDBackRoads Consulting Inc.PO Box 566Chesterland, OH 44026Office: 440.729.8457
Proposed Trade Name:	SaxxonyTM Posterior Cervical Thoracic System
Common Name:	Posterior cervical-thoracic system
Device Classification	Unclassified, Pre-amendment Device
Classification Name;Regulation; DeviceProduct Code:	Orthosis, Cervical Pedicle Screw Spine Fixation; Unclassified, Pre-amendment; NKGAppliance, Fixation, Spinal Interlaminal: 888.3050; KWP
Device Description:	SaxxonyTM Posterior Cervical Thoracic System consists of longitudinalmembers, anchors, interconnecting devices and fasteners in a variety ofsizes to accommodate differing anatomic requirements. The implants aresold non-sterile.
Intended Use:	The SaxxonyTM Posterior Cervical Thoracic System is intended toimmobilize and stabilize cervical (C1 to C7) and thoracic (T1 to T3) spinalsegments as an adjunct to fusion for the treatment of the following acuteand chronic instabilities: traumatic spinal fractures and/or traumaticdislocations; instability or deformity; failed previous fusions (e.g.pseudarthrosis); tumors involving the cervical/thoracic spine; anddegenerative disease, including intractable radiculopathy and/ormyelopathy, neck and/or arm pain of discogenic origin as confirmed byradiographic studies, and degenerative disease of the facets with instability.The SaxxonyTM Posterior Cervical Thoracic System is also intended torestore the integrity of the spinal column even in the absence of fusion for alimited time period in patients with advanced stage tumors involving thecervical spine in whom life expectancy is of insufficient duration to permitachievement of fusion.In order to achieve additional levels of fixation, the SaxxonyTM PosteriorCervical Thoracic System rods may be connected to cervicothoracic orthoracolumbar stabilization systems ranging in diameter from 3.5mm to6.5mm, using corresponding rod to rod connectors and/or transition rods.
Materials:	The SaxxonyTM Posterior Cervical Thoracic System is manufactured fromTi-6Al-4V ELI titanium alloy (ASTM F136) or cobalt chrome (ASTM F1537).
Primary Predicate	ELLIPSE® and PROTEX® CT Occipito-Cervico-Thoracic Spinal Systems(Globus Medical, Incorporated, K150552)
Additional Predicates:	Atoll Cervico-Thoracic System (Theken Spine – K070638), CerviFixStarLock System (Synthes USA – K994187), Synthes (USA) AnteriorCervical Vertebrae Plate System (Synthes (USA) – K945700), SynapseOCT System (Synthes USA Products LLC ) – K142838)
Performance Data:	Mechanical testing of worst case Saxxony™ Posterior Cervical ThoracicSystem constructs included static and dynamic compression bending andstatic torsion according to ASTM F1717.
	The mechanical test results demonstrate that Saxxony™ Posterior CervicalThoracic System performance is substantially equivalent to the predicatedevices.
TechnologicalCharacteristics:	The Saxxony™ Posterior Cervical Thoracic System possesses similartechnological characteristics as the predicate devices. These include:• performance (as described above),• basic design (rod, screw, hook and connectors configuration),• material (titanium and cobalt chrome alloys), and• sizes (dimensions are comparable to those offered by the predicatesystems).
	Therefore the fundamental scientific technology of the Saxxony™ PosteriorCervical Thoracic System is the same as previously cleared devices.
Conclusion:	The Saxxony™ Posterior Cervical Thoracic System possesses the sameintended use and technological characteristics as the predicate devices.Therefore the Saxxony™ Posterior Cervical Thoracic System issubstantially equivalent for its intended use.

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Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.