The CENTERPIECE™ Plate Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The CENTERPIECE™ Plate Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

Device Description

The CENTERPIECE™ Plate Fixation System consists of a variety of sizes of plates and screws. The CENTERPIECE™ Plate Fixation System screws are made of from medical grade titanium or titanium alloy. Screws will be provided sterile and non-sterile and are reusable.

AI/ML Overview

This FDA 510(k) K212428 submission is for a medical device, the CENTERPIECE™ Plate Fixation System, and not a software or AI/ML device. Therefore, the questions regarding acceptance criteria, study details, and ground truth establishment for AI/ML performance are not applicable in this context.

The document describes the device, its intended use, and its substantial equivalence to a predicate device based on performance testing of its mechanical properties and MRI safety, not on AI/ML diagnostic or predictive performance.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of numerical acceptance criteria for each test and reported performance values. Instead, it summarizes the types of performance testing conducted to demonstrate functionality and compatibility, and ultimately, substantial equivalence to the predicate device. The conclusion states that the implants "have shown through comparison and testing to be substantially equivalent to the identified predicate devices." This implies that the performance met the unstated acceptance criteria for demonstrating equivalence.

Test	Description	Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Static Compression	Compare the static compression properties of the CENTERPIECE™ subject and predicate screw-plate constructs. Compressive load applied in the posterior to anterior direction to simulate in vivo loading conditions.	Performance comparable to the predicate device.	Achieved comparable static compression performance to the predicate device.
MRI Safety Evaluation	Evaluate the MRI safety of the CENTERPIECE™ Plate Fixation System.	Demonstrates acceptable MRI safety for clinical use.	Demonstrated acceptable MRI safety.
Pull Out Strength Evaluation	Engineering rationale to address pullout strength testing of the CENTERPIECE™ Plate Fixation System.	Achieves adequate pullout strength for its intended application.	Achieved adequate pullout strength.

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study involving a test dataset of images or other clinical data. The "test set" refers to physical samples of the device undergoing mechanical and safety testing. The specific number of devices tested is not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of device performance, would be established by engineering standards, material properties, and regulatory requirements, not by expert consensus on clinical data.

4. Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical data, which is not relevant here.

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 is not an AI/ML product.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This device is not an AI/ML algorithm.

7. The type of ground truth used: For mechanical tests (Static Compression, Pull Out Strength), the "ground truth" would be established by engineering specifications, material science principles, and relevant ISO/ASTM standards for spinal fixation devices. For MRI Safety, the ground truth is based on established guidelines and testing protocols for medical device compatibility within MRI environments.

8. The sample size for the training set: Not applicable. This is not an AI/ML product.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML product.

Summary

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December 13, 2021

Image /page/0/Picture/1 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.

Medtronic Sofamor Danek Diamond Wallace Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K212428

Trade/Device Name: CENTERPIECE™ Plate Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: NQW Dated: November 8, 2021 Received: November 10, 2021

Dear Diamond Wallace:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K212428

Device Name CENTERPIECE™ Plate Fixation 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

November 5th, 2021

I. Company: Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, TN 38132 Telephone Number: (901) 396-3133
- Contact: Diamond Wallace Regulatory Affairs Specialist Telephone number: (901) 396-3133 Email: diamond.m.wallace@medtronic.com

II. Proprietary Trade Name: CENTERPIECE™ Plate Fixation System

Common Name: Appliance, Fixation, Interlaminal Classification Name: 21 CFR 888.3050 - Spinal interlaminal fixation orthosis

Classification: Class II

Product Code: NQW

III. Predicate Devices:

Primary Predicate: CENTERPIECE™ Plate Fixation System (K050082, S.E. 06/06/2005)

The predicate devices have not been subject to a design-related recall.

IV. Device Description:

V. Indications for Use:

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The CENTERPIECE™ Plate Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The CENTERPIECE TM Plate Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

VI. Comparison of the Technological Characteristics with the Predicate Device:

CENTERPIECE™ Plate Fixation System has the same fundamental scientific technology; indications for use, intended use, design, material levels of attachment as the predicate device. The predicate and subject devices are intended to restore spine stability and improve fusion.

Performance Data: VII.

Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. The following table summarizes the performance testing completed:

Test	Description
StaticCompression	The purpose of this testing was to compare the static compressionproperties of the CENTERPIECE™ subject and predicate screw-plate constructs. A compressive load was applied to the constructin the posterior to anterior direction to simulate in vivo loadingconditions.
MRI SafetyEvaluation	The purpose of this testing was to evaluate the MRI safety of theCENTERPIECE™ Plate Fixation System.
Pull Out StrengthEvaluation	The purpose of this engineering rationale was to address pulloutstrength testing of the CENTERPIECE™ Plate Fixation System.

VIII. Conclusions

The CENTERPIECE™ Plate Fixation System implants have shown through comparison and testing to be substantially equivalent to the identified predicate devices.

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.