The Liberty Anterior Cervical Plate System is interior screw fixation of the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

degenerative disc disease (as defined by neck pain of discogenic origin with the degeneration of the disc confirmed by patient history and radiographic studies),
spondylolisthesis.
trauma (i.e. fractures or dislocations),
tumors.
deformity (i.e. kyphosis, lordosis or scoliosis),
pseudarthrosis.
failed previous fusion,
spinal stenosis

Device Description

The Liberty Anterior Cervical Plate is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-drilling and self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (10 mm – 100 mm), addressing multiple levels of fixation (one to five). The plate incorporates graft visualization holes on the longitudinal center line for intraoperative visualization. Bone screws are available in two diameters (4.0 mm, and 4.5 mm) and a variety of lengths (10 mm - 18 mm).

AI/ML Overview

This document describes the premarket notification (510(k)) for the Liberty Anterior Cervical Plate System. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria based on clinical performance with an AI component.

Therefore, we cannot extract information about acceptance criteria, device performance from a clinical study, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, ground truth establishment, or training set details as these are not relevant to this type of medical device submission.

The provided document describes a Class II medical device (Spinal Intervertebral Body Fixation Orthosis), for which the FDA typically requires non-clinical performance testing to demonstrate substantial equivalence to legally marketed predicate devices, rather than extensive clinical efficacy studies with human-in-the-loop or AI components.

Here's what can be extracted based on the document:

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

Acceptance Criteria: No specific numerical acceptance criteria are stated in terms of clinical performance (e.g., accuracy, sensitivity, specificity). The acceptance criteria were based on demonstrating substantial equivalence to predicate devices through non-clinical mechanical testing.
Reported Device Performance: The document states: "The results of these tests [Static and dynamic compression (per ASTM F1717), Static torsion (per ASTM F1717)] indication that the Liberty Anterior Cervical Plate is substantially equivalent to the predicate devices."
- No specific numerical performance values (e.g., load capacity, fatigue cycles) are provided in this summary document, only that the device met the standards to demonstrate equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This is a mechanical device lacking an AI component, so there is no "test set" in the context of clinical data. The "tests" refer to laboratory mechanical testing of physical implants.
Sample Size for Mechanical Testing: Not specified in the provided summary. Mechanical testing typically involves a set number of physical prototypes or production units.
Data Provenance: Not applicable. The data comes from in-vitro mechanical testing, not clinical data.

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 as this is a mechanical device subject to non-clinical testing, not a diagnostic AI device requiring expert ground truth for clinical performance.

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 device does not involve human readers, AI assistance, or diagnostic interpretation.

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

Not applicable. This is not an algorithm.

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

For mechanical testing, the "ground truth" is defined by established engineering standards (ASTM F1717) and the performance of predicate devices. There is no clinical "ground truth" in this context.

8. The sample size for the training set:

Not applicable. This device does not use an AI algorithm that requires training data.

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

Not applicable.

Summary of Device and Performance Demonstrated:

Device Type: Liberty Anterior Cervical Plate System (a mechanical implant for spinal fixation).
Regulatory Class: Class II (Spinal Intervertebral Body Fixation Orthosis).
Basis for Clearance: Substantial equivalence to predicate devices.
Testing Performed: Non-clinical mechanical testing:
- Static and dynamic compression (per ASTM F1717)
- Static torsion (per ASTM F1717)
Conclusion: The device was found to be substantially equivalent to predicates, meaning it demonstrated comparable safety and effectiveness based on the non-clinical mechanical tests.

Summary

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

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized emblem. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text. The logos are positioned side by side, indicating a connection between the two organizations.

Valorus Spine % Mr. Nick Cordaro CEO Watershed Idea Foundry 533 2nd Street Encinitas, California 92024 October 23, 2017

Re: K172585

Trade/Device Name: Liberty Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: August 24, 2017 Received: August 28, 2017

Dear Mr. Cordaro:

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-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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

{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 (DICE) 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 (DICE) 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) K172585

Device Name Liberty Anterior Cervical Plate System

Indications for Use (Describe)

degenerative disc disease (as defined by neck pain of discogenic origin with the degeneration of the disc confirmed by patient history and radiographic studies),
spondylolisthesis.
trauma (i.e. fractures or dislocations),
tumors.
deformity (i.e. kyphosis, lordosis or scoliosis),
pseudarthrosis.
failed previous fusion,
spinal stenosis

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

DATE PREPARED

August 24, 2017

MANUFACTURER AND 510(k) OWNER

Valorus Spine 696 San Ramon Valley Blvd., Suite 411, Danville CA 94526, USA Telephone: (858) 245-9798 Fax: (925) 718-5615 Official Contact: Leah Fero, VP Engineering

REPRESENTATIVE/CONSULTANT

Nicholas M. Cordaro Watershed Ideas Foundry Telephone: Email: NickCordaro@watershedideas.com

PROPRIETARY NAME OF SUBJECT DEVICE

Liberty Anterior Cervical Plate

COMMON NAME

Anterior Cervical Plate

DEVICE CLASSIFICATION

Spinal intervertebral body fixation orthosis (21 CFR 888.3060, Product Code KWQ, Class II)

Orthopedic Panel

INDICATIONS FOR USE

The Liberty Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion 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. fractures or dislocations),
tumors,
deformity (defined as kyphosis, lordosis, or scoliosis),

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

pseudarthrosis,
failed previous fusion,
spinal stenosis

DEVICE DESCRIPTION

PREDICATE DEVICE IDENTIFICATION

The Liberty Anterior Cervical Plate is substantially equivalent to the following predicates:

510(k)Number	Predicate Device Name / Manufacturer	PrimaryPredicate
K151553	Anterior Cervical Plate System / Osteomed Implantes, LTDA	✓
K031276	ACLP System / Synthes Spine
K022965	Blackstone™ “Classic” Anterior Cervical Plate / Blackstone Medical, Inc.

SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the Liberty Anterior Cervical Plate. The following tests were performed to demonstrate safety based on current industry standards:

. Static and dynamic compression (per ASTM F1717)
. Static torsion (per ASTM F1717)

The results of these tests indication that the Liberty Anterior Cervical Plate is substantially equivalent to the predicate devices.

EQUIVALENCE TO PREDICATE DEVICES

Valorus believes that the Liberty Anterior Cervical Plate is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has a similar design and dimensions, and uses similar or identical materials as the devices cleared in K151553, K031276, and K022965. The subject device has the same intended use and similar technological characteristics to the devices cleared in K151553 and K022965. The device has similar instrumentation to the device cleared in K151553, and K031276.

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

CONCLUSION

The Liberty Anterior Cervical Plate is considered substantially equivalent to the predicate devices based on the testing performed, the identical indications for use, and similar technological characteristics. Based on the testing performed, including static and dynamic compression as well as static torsion (per ASTM F1717), it can be concluded that that the subject device is as safe and as effective compared to the predicate devices.

Regulation Number and Section

N/A