neon3™ is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical spine (C1 to C7) and the thoracic spine (T1 to T3): 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, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. neon3™ 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 of fusion.

Device Description

neon3™ is a modular, posterior system used for the surgical stabilization and fixation of the occipital, cervical and thoracic regions of the spine. The system components include longitudinal rods, screw and hook anchors, and interconnecting devices such as anchor- to-rod connectors, and rod-to-rod and screw-to-screw crosslinks.

AI/ML Overview

The document describes the neon3™ universal OCT spinal stabilization device, a modular posterior system for spinal stabilization and fixation.

However, the provided text does not contain details about acceptance criteria, device performance metrics, or a study comparing its performance against specific quantitative criteria for diagnostic accuracy or clinical outcomes as would be found in a study proving a device meets acceptance criteria.

Instead, the document details the device's 510(k) premarket notification for FDA clearance, focusing on substantial equivalence to predicate devices based on mechanical testing.

Here's an analysis based on the information available regarding the provided request:

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

The document does not provide a table of acceptance criteria as quantitative metrics (e.g., sensitivity, specificity, accuracy) for device performance in a clinical or diagnostic context.

The performance data section mentions:

"Mechanical testing of worst case neon3TM craniocervical constructs included static and dynamic compression bending and static torsion according to ASTM F1717 as well as static and dynamic compression bending and static and dynamic torsion per ASTM F2706."
"The mechanical test results demonstrate that neon3TM performance is substantially equivalent to the predicate devices."

This indicates that the "acceptance criteria" were likely related to meeting the performance specifications outlined in the ASTM standards (F1717 and F2706) for spinal implant mechanical properties, and demonstrating substantial equivalence to predicate devices (Synapse Occipital-Cervical-Thoracic (OCT) System, Halifax Interlaminar Clamp, neon3TM (K150650), and Ascent™ POCT System) in these mechanical properties. The specific numerical values or success/failure thresholds for these mechanical tests are not presented in this document.

2. Sample sized used for the test set and the data provenance

Not applicable. The "test set" in this context refers to mechanical testing of device constructs, not a clinical data set. The sample size for the mechanical testing is not specified beyond "worst case neon3TM craniocervical constructs". Data provenance is the manufacturing process and materials used for the constructs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a mechanical testing study, not a study requiring expert clinical assessment for ground truth.

4. Adjudication method for the test set

Not applicable. This is a mechanical testing study, not a study involving human reader adjudication.

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 a mechanical testing study for a spinal stabilization device, not an AI-assisted diagnostic or imaging device for which an MRMC study would be relevant.

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

Not applicable. This is a mechanical testing study for a spinal stabilization device.

7. The type of ground truth used

For the mechanical testing, the "ground truth" would be established by the physical and mechanical properties of the materials and constructs themselves, as measured by standardized testing procedures (ASTM F1717 and F2706). The comparison point is the performance of predicate devices, implying that their mechanical properties served as a benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI or machine learning study.

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

Not applicable. There is no training set mentioned.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized image of an eagle with three heads, representing the department's commitment to health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

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

December 22, 2016

ulrich GmbH & Co. KG % Mr. Hans Stover President and CEO ulrich medical USA, Inc. 18221 Edison Avenue Chesterfield, Missouri 63005

Re: K161032

Trade/Device Name: neon3TM universal OCT spinal stabilization Regulatory Class: Unclassified Product Code: NKG, KWP Dated: December 2, 2016 Received: December 5, 2016

Dear Mr. Stover:

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 devicerelated 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.

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

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.

VincentJ. Devlin -S

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

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known)

K161032

Device Name

neon3TM universal OCT spinal stabilization

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)

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)

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

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."

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

Section 8 – 510(k) Summary

Image /page/4/Picture/1 description: The image shows the logo for Ulrich medical USA. The word "Ulrich" is written in a bold, slanted font, with the "U" extending into a black square on the left side. Below the word "Ulrich" is the text "medical USA" in a smaller, non-bold font.

Date:	2 December 2016
Sponsor:	ulrich GmbH & Co. KG
	Buchbrunnenweg 12
	89081 Ulm
	Germany
	Phone: +49 (0) 731-9654-1304
	Fax: +49 (0) 731-9654-2802
Contact Person:	Hans Stover
	ulrich medical USA, Inc.
	18221 Edison Avenue
	Chesterfield, MO 63005
	(636) 519-0268 Office
	(636) 519-0271 Fax
Trade Name:	neon3™ universal OCT spinal stabilization
Common Name:	Posterior occipital-cervical-thoracic system,
	Cervical Pedicle Screw Spine Fixation
Device Classification:	Unclassified
	Orthopaedic and Rehabilitation Devices Panel
	Product Code: NKG, KWP
Submission Purpose:	To add occipital-cervical and cervicothoracic construct components to thecleared neon3™ system including rods, plates, screws, hooks, crosslinksand fasteners.
Device Description:	neon3™ is a modular, posterior system used for the surgical stabilization andfixation of the occipital, cervical and thoracic regions of the spine. Thesystem components include longitudinal rods, screw and hook anchors, andinterconnecting devices such as anchor- to-rod connectors, and rod-to-rodand screw-to-screw crosslinks.
Indications for Use:	neon3™ is intended to provide immobilization and stabilization of spinalsegments as an adjunct to fusion for the following acute and chronicinstabilities of the craniocervical junction, cervical spine (C1 to C7) and thethoracic spine (T1 to T3): 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.neon3™ is also intended to restore the integrity of the spinal column even inthe absence of fusion for a limited time period in patients with advancedstage tumors involving the cervical spine in whom life expectancy is of
Materials:	neon3TM components are manufactured from Grade 2 titanium (ASTM F67),Ti-6Al-4V titanium alloy (ASTM F136) or Cobalt Chrome (ASTM F1537)
Primary Predicate:	Synapse Occipital-Cervical-Thoracic (OCT) System (DePuy Synthes Spine,K142838)
Additional Predicates:	Halifax Interlaminar Clamp (Osteonics- K962314), neon3TM (K150650 –ulrich medical GmbH & Co. KG) and Ascent™ POCT System (BlackstoneMedical, K033480 and K073420)
Performance Data:	Mechanical testing of worst case neon3TM craniocervical constructs includedstatic and dynamic compression bending and static torsion according toASTM F1717 as well as static and dynamic compression bending and staticand dynamic torsion per ASTM F2706.The mechanical test results demonstrate that neon3TM performance issubstantially equivalent to the predicate devices.
TechnologicalCharacteristics:	neon3TM possesses technological characteristics similar to one or more ofthe predicate devices. These include:x intended use (as described above)x basic design (rod-based having screw and/or hook anchors),x material (titanium / titanium alloy),x sizes (dimensions are comparable to those offered by the predicatesystems) andMinor differences in technological characteristics were identified and shownto not raise new questions of safety and effectiveness. Therefore thefundamental scientific technology of neon3TM is the same as previouslycleared devices.
Conclusion:	neon3TM possesses the same intended use and technologicalcharacteristics as the predicate devices. Therefore neon3TM is substantiallyequivalent for its intended use.

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

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.