The Signature Orthopaedics Pinehurst Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is in the immobilisation and stabilisation of the spine as an adjunct to fusions in patients with:
· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);

· Spondylolisthesis;
· Trauma (I.e fracture or dislocations);
Tumors:
· Deformity (defined as kyphosis, lordosis, or scoliosis);
· Pseudoarthrosis:
· Failed previous fusion;
· Spinal stenosis

Device Description

The Signature Orthopaedics' Pinehurst Anterior Cervical Plate System's components are manufactured from Ti6Al4V alloy per ISO 5832-3 and ASTM-F136.
The Pinehurst Anterior Cervical Plate Systemis temporary supplemental fixation device consisting of variety of shapes and sizes of plates and screws. The plates attach to the anterior cervical spine with a minimum four screw per plate. The plates are offered in one-level, two-level, three-level and four-level fusion configurations. The plates have an integrated locking mechanism that prevents screw-backout. The Pinehurst plates and screws are supplied sterile.

AI/ML Overview

The document describes the Pinehurst Anterior Cervical Plate System, a medical device, and its successful 510(k) premarket notification to the FDA. The submission demonstrates substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device are primarily based on non-clinical performance standards to ensure safety and mechanical integrity. The document details the types of tests performed. While specific numerical acceptance thresholds are not provided in this summary, the statement "Non-clinical testing and engineering evaluations were conducted to verify that the performance of Pinehurst Anterior Cervical Plate System is adequate for anticipated invivo use" confirms that the device met these implicit performance criteria.

Acceptance Criteria Category	Specific Test/Evaluation	Reported Device Performance
Mechanical System Integrity	Static and dynamic compression bending testing	Performance adequate for anticipated in vivo use (successful)
	Static torsion testing	Performance adequate for anticipated in vivo use (successful)
Screw Fixation Strength	Screw insertion testing	Performance adequate for anticipated in vivo use (successful)
	Screw pull-out testing	Performance adequate for anticipated in vivo use (successful)
	Screw torque to failure testing	Performance adequate for anticipated in vivo use (successful)
Biocompatibility	Material composition (Ti6Al4V alloy per ISO 5832-3 and ASTM-F136)	Same material as most predicates, slight difference from two predicates (Ti6Al4V ELI vs Ti6Al4V) which was deemed equivalent and not raising new safety/effectiveness questions.
Design Characteristics	Plate configurations (1, 2, 3, 4 levels)	Meets specified configurations
	Integrated locking mechanism	Present and prevents screw back-out
Dimensional Equivalence	Profile thickness	Within the profile thickness of predicates
	Size range	Within the size range of predicates
Functional Equivalence	Number of supplemental fixation points	Accommodates same number as predicates
	Contouring to vertebral body	Contoured to match vertebral body (like predicates)
	Implantation method (manual, hand-tightened screws)	Same as predicates

2. Sample Size Used for the Test Set and Data Provenance

The document states that "Non-clinical testing ... were carried out on the worst case sizes of the plates and screws." This indicates a focused testing approach on the configurations most likely to experience mechanical stress.

Test Set Sample Size: Not explicitly stated as a number of devices, but rather as "worst case sizes" for both plates and screws. This implies a representative selection from the product range.
Data Provenance: The testing was non-clinical, meaning it focused on laboratory and engineering evaluations. This type of data is typically generated in a controlled environment by the manufacturer or contracted testing facilities, not directly from human patients. The country of origin for the testing would likely be Australia, given the manufacturer's location. The data is prospective in the sense that the tests were conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

For non-clinical performance testing of a physical medical device like an anterior cervical plate system, the "ground truth" is established through adherence to recognized engineering standards and validated testing protocols.

Number of Experts: Not applicable in the same way as for diagnostic AI. The "experts" would be the engineers, test technicians, and quality assurance personnel responsible for conducting the tests and interpreting the results according to established biomechanical testing standards.
Qualifications of Experts: These individuals would typically hold engineering degrees (e.g., biomedical, mechanical) and possess expertise in medical device testing, biomechanics, and ISO/ASTM standards relevant to spinal implants.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1) are typically used for clinical studies involving human readers or expert consensus on clinical data (e.g., imaging interpretation). For non-clinical, objective performance testing, an adjudication method for test results is generally not applicable. Test failures/passes are determined by predefined engineering criteria and measurement systems. Quality control and review processes by qualified engineers would ensure the validity of the results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to assess the performance of diagnostic imaging devices or AI algorithms when interpreted by human readers, often comparing performance with and without AI assistance. This document describes the non-clinical performance testing of a physical implantable device, not a diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm or AI software. Therefore, this type of study is not relevant.

7. The Type of Ground Truth Used

For the non-clinical performance testing, the ground truth is based on:

Engineering Standards and Biomechanical Principles: The "ground truth" for the device's performance in static and dynamic loading, screw pull-out, etc., is derived from industry-accepted and regulatory-recognized biomechanical testing standards (e.g., ASTM F1717 for spinal implants). These standards define how the device should behave under specific conditions to meet safety and effectiveness requirements.
Material Specifications: Adherence to material standards (e.g., ISO 5832-3 and ASTM-F136 for Ti6Al4V alloy) constitutes a form of ground truth for material composition and properties.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires training data. The "training set" concept is relevant to machine learning algorithms, not for the physical attributes and mechanical performance testing of an implantable medical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 17, 2019

Signature Orthopaedics Pty Ltd. % Dr. Declan Brazil Managing Director 7 Sirius Road Lane Cove, New South Wales 2066 AUSTRALIA

Re: K181190

Trade/Device Name: Pinehurst Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: December 19, 2018 Received: December 26, 2018

Dear Dr. Brazil:

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. 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

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

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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

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

Indications for Use

510(k) Number (if known) K181190

Device Name

Pinehurst Anterior Cervical Plate System

Indications for Use (Describe)

· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);

· Spondylolisthesis;
· Trauma (I.e fracture or dislocations);
Tumors:
· Deformity (defined as kyphosis, lordosis, or scoliosis);
· Pseudoarthrosis:
· Failed previous fusion;
· Spinal stenosis

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

X | Prescription Use (Part 21 CFR 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}------------------------------------------------

2 510(K) SUMMARY

Manufacturer:	Signature Orthopaedics Pty Ltd7 Sirius RoadLane Cove, NSW 2066Australia
Device TradeName:	Pinehurst Anterior Cervical Plate System
Common Name:	Spinal Intervertebral Body Fixation Orthosis
Contact:	Dr. Declan BrazilManaging Director of Signature Orthopaedics
Prepared By:	Signature Orthopaedics Pty Ltd7 Sirius RoadLane Cove, NSW 2066AustraliaPhone: +61 (2) 9428 5181Fax: +61 (2) 8456 6065
Date Prepared:	April 30th, 2018
Classification:	Class II per 21 CFR 888.3060: Spinal Intervertebral Body FixationOrthosis (KWQ)
Predicate Devices:	Primary PredicateL&K Biomed LnK Anterior Cervical Plate System(K143279)Additional Predicate● Spinal Concepts SC-AccFix Thinline Anterior CervicalPlate System (K013979)● Orthofix CETRA Anterior Cervical Plate System(K162638)● Globus Medical PROVIDENCE Anterior Cervical PlateSystem (K070775)● DePuy Synthes CSLP System (K945700, K000536,K000742, K030866)● Signature Orthopaedics NOOSA Anterior Lumbar PlateSystem (K163625)

Device Description:

The Signature Orthopaedics' Pinehurst Anterior Cervical Plate System's components are manufactured from Ti6Al4V alloy per ISO 5832-3 and ASTM-F136.

The Pinehurst Anterior Cervical Plate Systemis temporary supplemental fixation device consisting of variety of shapes and sizes of plates and screws. The plates attach to the anterior cervical spine with a minimum four screw per plate. The plates are offered in

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

one-level, two-level, three-level and four-level fusion configurations. The plates have an integrated locking mechanism that prevents screw-backout. The Pinehurst plates and screws are supplied sterile.

Indications for Use:

The Signature Orthopaedics Pinehurst Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilisation and stabilisation of the spine as an adjunct to fusions in patients with:

Degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies);
. Spondylolisthesis;
Trauma (I.e fracture or dislocations); ●
. Tumors:
. Deformity (defined as kyphosis, lordosis, or scoliosis);
Pseudoarthrosis;
Failed previous fusion;
Spinal stenosis

Performance Testing:

Non-clinical testing and engineering evaluations were conducted to verify that the performance of Pinehurst Anterior Cervical Plate System is adequate for anticipated invivo use. The following non-clinical testings were carried out on the worst case sizes of the plates and screws:

. Static and dynamic compression bending testing
. Static torsion testing
Screw insertion testing ●
. Screw pull-out testing
. Screw torque to failure testing

Substantial Equivalence:

That Signature Orthopaedics' Pinehurst Anterior Cervical Plate System have the same intended use, indication for use, materials and similar design features as the Spinal Concepts SC-AccFix Thinline Anterior Cervical Plate System (K013979), L&K Biomed LnK Anterior Cervical Plate System (K143279), Orthofix CETRA Anterior Cervical Plate System (K162638), Globus Medical PROVIDENCE Anterior Cervical Plate System (K070775), Synthes CSLP System (K945700, K000536, K000742, K030866) and Signature Orthopaedic NOOSA Anterior Lumbar Plate System (K163625). Nonclinical testing results support the substantial equivalence claim.

Comparison of technological characteristics

Temporary immobilisation and stabilisation of spinal segments as supplemental fixation in spinal fusion procedure is the technological principle for both the subject device and the predicate devices. The subject and predicate devices are based on the following same technological elements:

. The indication for use of the subject device is the same as the predicate devices

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

. The intended surgery sites of the subject device is the same as intended surgery sites of the predicates
. The subject device is manufactured from the same material as the predicate devices
. The locking mechanism of the subject device is equivalent to the locking mechanism of LnK and CETRA plate systems
. The profile thickness of the subject device are within the profile thickness of the predicates
The size range of the subject devices fall within the size range of the predicates
. The subject device accommodate the same number of supplemental as the predicate devices
. Both subject device and predicates are contoured to match the vertebral body
. Both subject device and predicates are implanted manually and the screws are hand tightened

The following technological differences exist between the subject and predicate devices:

Some of the design features are different between the subject and predicate devices
. The material used on one of the predicates are slightly different than the subject device
The material used for two of the predicate devices are slightly different than the subject device (Ti6Al4V ELI vs Ti6Al4V)
. The screw locking mechanism on two of the predicates are different the subject device

Conclusions:

Technical comparison of the subject and predicate devices demonstrates equivalence in device design, intended use, indications for use and material. Non-clinical data raises no new safety or effectiveness questions of the Pinehurst Anterior Cervical Plate System.

Regulation Number and Section

N/A