The Centurion POCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 - T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Centurion POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.

Device Description

The Centurion POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of Titanium alloy or Cobalt Chrome alloy that allow the surgeon to build a spinal implant construct. The Centurion POCT System consists of an assortment of rods, set screws, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws, and cables (Titanium).

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the Centurion POCT System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving the device meets specific acceptance criteria through a clinical or algorithmic performance study.

The submission is for additional components (new rods) to an already cleared system (K180025). The manufacturer explicitly states:

"The subject devices being added to the previously cleared Centurion POCT System (K180025) specify the same rod diameter, material, surface finish, and intended use as the previously cleared devices and therefore are substantially equivalent in design and performance. There are no significant differences between the new subject devices and the predicate devices that would introduce a new worse case for performance testing. Therefore, no additional performance testing is required."

This means they are not presenting a study with acceptance criteria and performance data for a new device's efficacy or accuracy. Instead, they are arguing that because the new components are so similar to already approved ones, they don't need new performance studies.

Therefore, for your specific requests, I cannot extract the information because the provided document does not contain an acceptance criteria table or details of a study proving device performance against such criteria. There is no mention of AI/ML, human readers, or expert consensus analysis related to performance.

Here's why each point cannot be addressed from the given text:

A table of acceptance criteria and the reported device performance: Not present. The document focuses on mechanical equivalence to predicate devices, not performance criteria for a clinical outcome or diagnostic accuracy.
Sample sized used for the test set and the data provenance: Not applicable. No test set or data provenance mentioned for performance evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a performance study.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML or diagnostic device requiring such a study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is a physical orthopedic implant system, not a software algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable. No training set for an algorithm.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for device modifications based on substantial equivalence, not a study report demonstrating clinical or algorithmic performance against predefined acceptance criteria.

Summary

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June 15, 2020

Image /page/0/Picture/1 description: The image shows 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.

Orthofix Inc. Jacki Koch Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056

Re: K201481

Trade/Device Name: Centurion POCT System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG, KWP Dated: June 3, 2020 Received: June 4, 2020

Dear Jacki Koch:

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

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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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, MBE Acting 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) K201481

Device Name Centurion POCT System

Indications for Use (Describe)

The Centurion POCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 - T3): traumatic spinal fraumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Centurion POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.

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

Centurion POCT System

510(k) Owner InformationName:Address:	Orthofix Inc.3451 Plano ParkwayLewisville, TX 75056
Telephone Number:Fax Number:Email:	214-937-2100214-937-3322jackikoch@orthofix.com
Registration Number:	2183449
Contact Person:	Jacki Koch, Senior Regulatory Affairs Specialist
Date Prepared:	June 3, 2020
Name of DeviceTrade Name / ProprietaryName:	Centurion POCT System
Common Name:	Posterior, Cervical Pedicle Screw Spine FixationSpinal Interlaminal Fixation OrthosisPosterior Cervical System Instrumentation
Product Code:	NKG, KWP
Classification Name:	Posterior Cervical Screw System (21 CFR 888.3075)
Regulatory Classification:	II
Review Panel:	Orthopedic Device Panel
Primary Predicate Devices:	K180025 - Centurion POCT System - Orthofix Spine, Incorporated
Additional Predicate Device:	K153631 - Zimmer Virage OCT Spinal Fixation System - Zimmer

Reason for 510(k) Submission:

Due to the advancements in surgical techniques and surgeons requests, Orthofix is submitting this Special 510(k) premarket notification for the addition of the below listed devices to the previously cleared devices:

1. Addition of new 3.5mm/5.5mm Transition Rods
1. Addition of new 3.5mm Occipital Rods
1. Addition of new 3.5mm Straight Rods
1. Addition of new 3.5mm Lordosed Rods

In addition, each subject device listed above will feature a longitudinal line along the length of all rods to provide better identification of induced curvature.

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The subject additions to the previously cleared Centurion POCT System (K180025) do not alter the indications for use, contraindications, warnings or precautions.

Device Description

Intended Use / Indications for Use

The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.

Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices

The technological characteristics of the new subject devices are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics. The new implants feature a longitudinal anodized line along their length. The new offerings include the addition of pre-cut straight rods, pre-cut lordosed rods, and a new transition rod size. There are no significant differences between the new subject devices and the predicate devices which would adverselv affect the use of the product.

PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence

The subject devices being added to the previously cleared Centurion POCT System (K180025) specify the same rod diameter, material, surface finish, and intended use as the previously cleared devices and therefore are substantially equivalent in design and performance. There are no significant differences between the new subject devices and the predicate devices that would introduce a new worse case for performance testing. Therefore, no additional performance testing is required.

Conclusion

The technological characteristics of the subject devices being added to the Centurion POCT System have the same intended use, same indications for use, same materials, substantially equivalent design, same materials and the same principles of operation as the predicate Centurion POCT System (K180025) and Zimmer Virage OCT Spinal Fixation System (K153631). There are no significant differences between the subject devices and the previously cleared predicate device, which would adversely affect the use of the product.

Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.