The Zero-P Natural Plate is intended for anterior plate and screw fixation of the cervical spine. The plate and four screw system has been designed for use with structural allograft to provide stabilization as an adjunct to cervical fusion. Indications for use of this plate system include degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis or scoliosis), tumor, pseudarthosis or failed previous fusion. The plate is intended for one level in the cervical spine, from C2 to T1.

Device Description

The Zero-P Natural Plate is intended for anterior plate and screw fixation of the cervical spine. The Zero-P Natural Plate and four screw system has been designed to provide stabilization as an adjunct to cervical fusion. The Zero-P Natural Plate is secured to the spine through unicortical fixation with bone screws. The plate is positioned flush with the adjacent vertebral bodies. Four bone screws attach to the plate for fixation through the adjacent vertebral bodies; two screws are directed into the superior and inferior vertebrae through the endplates.

The Zero-P Natural Plate has been designed for use with a Musculoskeletal Transplant Foundation (MTF) allograft spacer. Size pairings of the Zero-P Natural Plate and the allograft spacer are identified in the labeling to ensure a proper fit and height relationship of the allograft spacer to the Zero-P Natural Plate.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Zero-P Natural Plate System," a spinal intervertebral body fixation orthosis. The submission seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving a specific performance level of an AI device through a clinical study. Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not directly applicable to this type of regulatory submission.

However, I can extract information related to the device's performance data as presented in the document, which focuses on mechanical and biomechanical testing demonstrating equivalence to predicate devices, rather than AI performance.

Here's the information that can be extracted from the provided text:

Acceptance Criteria and Device Performance:

The document describes performance data through mechanical and biomechanical testing, compared to predicate devices, to establish substantial equivalence. It does not provide specific numerical "acceptance criteria" and "reported device performance" in the format of AI metrics (e.g., sensitivity, specificity). Instead, it states that the mechanical and biomechanical properties were evaluated and found to be "consistent with those of the predicate devices," thereby establishing substantial equivalence.

Acceptance Criteria Category	Device Performance (How Equivalence was Established)
Mechanical Properties	Evaluated through static compression bending, static torsion, and dynamic compression bending in accordance with ASTM F1717-14. Performance: "consistent with those of the predicate devices."
Biomechanical Properties	Evaluated through a cyclic cadaveric range of motion study. Performance: Tested the "Zero-P Natural Plate and predicate plate" with results showing consistency.

Study Details (as applicable to a medical device, not an AI model):

Sample size used for the test set and the data provenance:
- Mechanical Testing: Not explicitly stated as a "sample size" in the context of an N-number for a test set. ASTM F1717-14 specifies methodologies for testing implants.
- Biomechanical Testing: "cyclic cadaveric range of motion study." The number of cadaveric specimens used is not specified.
- Data Provenance: Not specified, but likely laboratory testing data rather than patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical and biomechanical testing study for a medical implant, not an AI study requiring expert consensus for ground truth on clinical data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No human adjudication process is described for this type of testing.
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 or an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For mechanical testing, the "ground truth" would be the physical properties and failure modes under defined loads as measured by testing equipment, adhering to ASTM standards.
- For biomechanical testing, the "ground truth" would be the measured range of motion and stability characteristics in cadaveric models. This is not "expert consensus" or "pathology" in the AI/clinical sense.
The sample size for the training set:
- Not Applicable. This is not an AI model.
How the ground truth for the training set was established:
- Not Applicable. This is not an AI model.

Summary

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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, layered on top of each other to create a sense of depth and unity.

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

December 2, 2015

Synthes USA, LLC % Ms. Laura Bleyendaal Regulatory Affairs Associate DePuy Synthes 325 Paramount Drive Raynham, Massachusetts 02767

Re: K152239

Trade/Device Name: Zero-P Natural Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 6, 2015 Received: November 9, 2015

Dear Ms. Bleyendaal:

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

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Page 2 - Ms. Laura Bleyendaal

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.

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 yours,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) к152239

Device Name Zero-P Natural Plate System

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)

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510(k) Summary

A. Submitter Information

510(k) Sponsor:	Synthes USA, LLC1101 Synthes AvenueMonument, CO 80132
Contact Person:	Laura BleyendaalDePuy Synthes325 Paramount DriveRaynham, MA 02767
Telephone number:Fax number:Email:	(508) 828-3267(508) 828-3797LBleyend@its.jnj.com
Date Prepared	November 6, 2015
Device Name
Trade/Proprietary Name:	Zero-P Natural Plate System
Common/Usual Name:	Spinal intervertebral body fixation orthosis
Device Classificationand Regulation:	Class II per 21 CFR § 888.3060
Classification Product and Panel

D. Predicate Device Name

Code:

Primary Predicate Device: Optio-CTM Anterior Cervical Plate System (K141500) Additional Predicate Device: VECTRA-ONE™ Cervical Plate (K071667)

KWQ; Orthopedic

E. Device Description

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spine through unicortical fixation with bone screws. The plate is positioned flush with the adjacent vertebral bodies. Four bone screws attach to the plate for fixation through the adjacent vertebral bodies; two screws are directed into the superior and inferior vertebrae through the endplates.

F. Indications for Use

The Zero-P Natural Plate is intended for anterior plate and screw fixation of the cervical spine. The plate and four screw system has been designed for use with structural allograft to provide stabilization as an adjunct to cervical fusion. Indications for use of this plate system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion. The plate is intended for one level in the cervical spine, from C2 to T1.

G. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use

The technological characteristics including material, design and performance of the Zero-P Natural Plate are consistent with those of the predicate devices.

H. Materials

The Zero-P Natural Plate and screws are manufactured from titanium alloy conforming to ASTM F1295 which is anodized.

I. Performance Data

In order to characterize the Zero-P Natural Plate and establish its substantial equivalence, mechanical, as well as biomechanical testing was conducted in a comparative manner. The mechanical properties of the Zero-P Natural Plate were evaluated through the following tests in accordance with ASTM F1717-14 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model:

static compression bending,
static torsion and .
o dynamic compression bending.

The biomechanical properties of the Zero-P Natural Plate were evaluated through a cyclic cadaveric range of motion study in which the Zero-P Natural Plate and predicate plate were tested.

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J. Conclusion

The indications for use and intended use of the Zero-P Natural Plate are consistent with that of the predicate devices. The technological characteristics of the Zero-P Natural Plate in terms of design, materials and performance are consistent with those of the predicate devices. The Zero-P Natural Plate is substantially equivalent to the aforementioned predicate devices.

Regulation Number and Section

N/A