The Altus Spine Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine 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); trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudosarthrosis and/or failed previous fusions. The Altus Spine Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.

Device Description

The Altus Spine Cervical Plate System is intended for anterior fixation of the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with both self-tapping and self-drilling bone screws. The plates are available in a variety of lengths addressing multiple levels of fixation (one to four). The Altus Spine Cervical Plate System includes graft windows on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Fixed or variable bone screws are available in two diameters and a variety of lengths, with the options of either self-tapping or self-drilling threads.

AI/ML Overview

This FDA 510(k) K163061 submission for the Altus Spine Cervical Plate System focuses on mechanical performance testing rather than AI/software performance. Therefore, many of the requested categories related to AI model evaluation (like sample sizes for test sets, ground truth establishment for training sets, expert qualifications, adjudication methods, or MRMC studies) are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the testing was performed in accordance with ASTM F1717. This standard defines the acceptance criteria implicitly through its testing methodologies for static and dynamic mechanical properties. The "reported device performance" is essentially that the device met these criteria and demonstrated substantial equivalence.

Acceptance Criteria (Implicit from ASTM F1717)	Reported Device Performance
Static compression bending performance	Demonstrated substantial equivalence to predicate devices (met criteria).
Dynamic compression bending performance	Demonstrated substantial equivalence to predicate devices (met criteria).
Static torsion testing performance	Demonstrated substantial equivalence to predicate devices (met criteria).
Overall mechanical integrity and durability	Substantially equivalent to predicate devices, ensuring safe performance.

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

Sample Size for Test Set: Not explicitly stated. For mechanical testing, this typically refers to the number of devices or constructs tested per configuration (e.g., specific plate length, screw diameter). The ASTM F1717 standard would generally specify minimum sample sizes for such tests.
Data Provenance: This is a physical device, so "data provenance" in the sense of patient data doesn't apply. The tests are conducted in a laboratory setting on the physical device and its constructs.

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

Not applicable. For mechanical testing of a physical device, "ground truth" is established by the physical laws and engineering principles tested against the ASTM standard. There are no "experts" in the context of clinical interpretation or AI model training involved here.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for subjective interpretations, especially in clinical settings or when establishing ground truth for AI. This is a physical device tested against objective mechanical standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human readers' diagnostic performance, which is not applicable to an orthopedic implant.

6. Standalone (Algorithm only without human-in-the loop performance) Study

No, a standalone (algorithm only without human-in-the loop performance) study was not done. This is an orthopedic implant, not an algorithm, so this type of study is not relevant.

7. Type of Ground Truth Used

The "ground truth" for this medical device is established by the physical and mechanical properties of the materials and design, evaluated against established industry standards (ASTM F1717) for spinal implants. It's an objective measurement of mechanical performance, not expert consensus, pathology, or outcomes data in the clinical sense.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model, so there is no "training set."

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

Not applicable. As there is no training set for a physical device, the concept of establishing ground truth for it does not apply.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

February 6, 2017

Altus Partners, LLC Claudia Hill RA/OA Lead 1340 Enterprise Drive West Chester, Pennsylvania 19380

Re: K163061

Trade/Device Name: Altus Spine Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 10, 2017 Received: January 11, 2017

Dear Ms. Hill:

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,

Mark N. Melkerson -S

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) K163061

Device Name Altus Spine Cervical Plate System

Indications for Use (Describe)

The Altus Spine Cervical Plate System is interior interbody fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine 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); trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudosarthrosis and/or failed previous fusions. The Altus Spine Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.

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)

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

SUBMITTER:	Altus Partners1340 Enterprise DriveWest Chester, PA 19380Phone: 610-355-4156Fax: 610-300-3049
CONTACT PERSON:	Claudia Hill, MSME, RACRegulatory Affairs & Quality Assurancechill@altus-spine.com
DATE PREPARED:	October 3, 2016
COMMON NAME:	Anterior Cervical Plate System
PROPRIETARY NAME:	Altus Spine Cervical Plate System
PRIMARY PREDICATE DEVICE:	Cardo Medical Cervical Plate System from Cardo Medical Corporation(K091396)
ADDITIONAL PREDICATE DEVICES:	Accin Cervical Plate System by Accelerated Innovations, LLC(K073530); Vertebron SCP Cervical Plate System (K040003)
CLASSIFICATION NAME:	21 CFR §888.3060
PRODUCT CODES:	KWQ
DEVICE CLASS:	Class II
MATERIAL:	The material used is Titanium Alloy that conforms to ASTM F136

DEVICE DESCRIPTION:

INDICATIONS FOR USE:

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

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

The technological characteristics of the Altus Spine Cervical plate system is equivalent to the predicate device, except for the locking mechanism. The locking mechanism is provided to ensure that the bone screws remain in place.

SUMMARY OF NON-CLINICAL TESTS SUBMITTED:

Static and dynamic compression bending and static torsion testing in accordance with ASTM F1717 was performed and demonstrated that the Altus Spine Cervical Plate System is substantially equivalent to the predicate devices.

SUBSTANTIAL EQUIVALENCE CONCLUSION:

The Altus Spine Cervical Plate System is substantially equivalent to the predicate devices in terms of intended use, material used, and performance. The device has a similar design, dimensions and instrumentation to the predicate devices.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.