PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER) by PIONEER SURGICAL TECHNOLOGY

The Pioneer Vertebral Spacer is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Pioneer Vertebral Spacer is also indicated for treating fractures of the thoracic and lumbar spine. The Pioneer Vertebral Spacer is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with the Pioneer Quantum Pedicle Screw System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). Additionally, the Pioneer Vertebral Spacer implant is intended to be used with bone graft.

Device Description

The Pioneer Vertebral Spacer is a radiolucent vertebral body replacement device of various heights and footprints used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following partial replacement of a diseased vertebral body.

AI/ML Overview

The Pioneer Vertebral Spacer is a medical device and its predicate device is K043206.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Mechanical Performance: The device must demonstrate structural integrity and long-term stability suitable for supporting the spinal column after partial vertebrectomy.	"Mechanical and Chemical information were presented." The submission states the device's substantial equivalence is based on "similar materials, performance, and indications for use" compared to the predicate device.
Chemical Performance: The device materials must be biocompatible and conform to relevant standards.	"Mechanical and Chemical information were presented." The device uses "Radiolucent polymer and titanium alloy materials in conformance with ASTM Standard Specifications."
Material Conformance: Materials used must adhere to specified ASTM standards.	"Radiolucent polymer and titanium alloy materials in conformance with ASTM Standard Specifications."
Indication for Use Match: The device's intended use must be substantially equivalent to the predicate device.	The device's indications for use are detailed (thoracolumbar spine (T1-L5) for partial replacement of diseased vertebral bodies due to tumors or fractures, to restore height and biomechanical integrity). Substantial equivalence assertion is based on "similar materials, performance, and indications for use demonstrated."
Radiolucency: The device must be radiolucent.	"The Pioneer Vertebral Spacer is a radiolucent vertebral body replacement device."

2. Sample size used for the test set and the data provenance:

This 510(k) submission primarily relies on bench testing (mechanical and chemical information) and demonstrated substantial equivalence to a predicate device (K043206).
The document does not mention a "test set" in the context of clinical data, human subjects, or image-based evaluations. Therefore, there is no sample size for a test set and no data provenance in terms of country of origin or retrospective/prospective human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no mention of a test set involving expert review of clinical cases.

4. Adjudication method for the test set:

Not applicable. There is no mention of a test set involving adjudication.

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:

No MRMC study was done. This device is a passive vertebral spacer, not an AI-powered diagnostic or assistive tool.

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

No standalone algorithm performance study was done. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's performance is established through engineering principles, material science testing (mechanical and chemical data), and comparison to the characteristics and performance of a legally marketed predicate device. There is no biological or diagnostic ground truth (like pathology or outcomes data) directly mentioned as part of the submission for this type of device.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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Pioneer Spine 510(k) Premarket Notification Vertebral Spacer

: ・

Koriisi

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SPONSOR:	PIONEER SURGICAL TECHNOLOGY375 River Park CircleMarquette, MI 49855Contact: Jonathan M. Gilbert(906) 226-4812
DEVICE NAME:	Vertebral Spacer
	JUL 2 4 2006
CLASSIFICATION:	The classification of the Pioneer Vertebral Spacer is Class II, as per the Code of Federal Regulations, Title 21, Section 888.3060:Implant, fixation, spinal intervertebral body fixation orthosis devices. The product code is MQP. The Panel code is 87.
PREDICATE DEVICE:	K043206
DEVICE DESCRIPTION:	The Pioneer Vertebral Spacer is a radiolucent vertebral body replacement device of various heights and footprints used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following partial replacement of a diseased vertebral body.
INTENDED USE:	The Pioneer Vertebral Spacer is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Pioneer Vertebral Spacer is also indicated for treating fractures of the thoracic and lumbar spine. The Pioneer Vertebral Spacer is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with the Pioneer Quantum Pedicle Screw System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). Additionally, the Pioneer Vertebral Spacer implant is intended to be used with bone graft.
MATERIAL:	Radiolucent polymer and titanium alloy materials in conformance with ASTM Standard Specifications.
PERFORMANCE DATA:	Mechanical and Chemical information were presented.
BASIS OF SUBSTANTIAL EQUIVALENCE:	The Pioneer Vertebral Spacer implants are substantially equivalent to the components of a previously cleared Pioneer spinal system, with similar materials, performance, and indications for use demonstrated.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures connected by flowing lines, representing health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2006

Pioneer Surgical Technology c/o Mr. Jonathan M. Gilbert Director, Regulatory/Clinical Affairs 375 River Park Circle Marquette, Michigan 49855

Re: K061151

Trade/Device Name: Vertebral Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: June 8, 2006 Received: June 9, 2006

Dear Mr. Gilbert:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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); 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.

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Page 2 – Mr. Jonathan M. Gilbert

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Kalvare Buelup
for

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

K061151

PIONEER Vertebral Spacer

V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative.	Page 1 of __
and Neurological Devices
510(k) Number	K061151

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.