PIONEER SPINAL PROCESS FUSION PLATE by PIONEER SURGICAL TECHNOLOGY, INC

The Pioneer BacFuse Device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Pioneer BacFuse Device is intended for use with bone graft material (i.e. allograft or autograft), not intended for stand-alone use.

Device Description

The Pioneer Spinous Process Fusion Plate is a plate with spacer system designed to provide posterior fixation by physically linking adjacent spinous processes. The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification. The Pioneer Spinous Process Fusion Plate is composed of Ti Alloy per ASTM F136.

AI/ML Overview

The Pioneer Spinous Process Fusion Plate is a medical device designed for posterior, non-pedicle supplemental fixation in the non-cervical spine (T1-S1). It aims to achieve supplemental fusion by linking adjacent spinous processes, intended for use with bone graft material.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Static Torsion	Equivalent or superior to predicate devices.
Static Tension	Equivalent or superior to predicate devices.
Static Compression	Equivalent or superior to predicate devices.
Static Locking Mechanism	Equivalent or superior to predicate devices.
Dynamic Flexion-Extension	Equivalent or superior to predicate devices.
Dynamic Locking Mechanism	Equivalent or superior to predicate devices.
Intended Use	Identical to predicate devices.
Material Composition	Identical to predicate devices (Ti Alloy per ASTM F136).
Design Characteristics	Identical to predicate systems.
Mechanism of Action	Identical to predicate systems.

2. Sample Size Used for the Test Set and Data Provenance

The document states that "representative worst case constructs" were used for each test mode. However, it does not specify the exact sample size for these tests.

The data provenance is not explicitly mentioned (e.g., country of origin). The testing described is in vitro performance testing rather than human clinical trial data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the study described is a series of mechanical performance tests, not a clinical study involving expert assessment of patient outcomes or imaging. The "ground truth" for these tests would be the established engineering standards and specifications for spinal implants.

4. Adjudication Method for the Test Set

This information is not applicable as it pertains to expert disagreement in clinical evaluations, not mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The presented data focuses on mechanical performance testing of the device itself, not on human reader performance with or without AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This information is not applicable as the device is a mechanical medical implant, not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for these performance tests is based on established engineering standards and specifications suitable for spinal interlaminal fixation devices, as demonstrated by comparison to predicate devices, which are already legally marketed and have met equivalent standards. These standards would dictate acceptable ranges for static and dynamic mechanical properties.

8. Sample Size for the Training Set

This information is not applicable as the device is a mechanical implant, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above.

Summary

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MAR 2 3 2011

510(k) SUMMARY

Pioneer Spinous Process Fusion Plate

Sponsor:	Manufacturer	Pioneer Surgical Technology375 River Park CircleMarquette, MI 49855
	Official Contact	Emily M. Downs
	Phone:	(906) 225-5602
	Fax:	(906) 226-4459
	Date prepared:	February 4, 2011
Device Name:	Pioneer BacFuse Spinous Process Fusion Plate
Product Code/Classification:	KWP/ 888.3050 – Spinal Interlaminal Fixation Orthosis
Predicate Device:Description:	Pioneer Spinous Process Fusion Plate (K101525, SE date 10/22/2010)The Pioneer Spinous Process Fusion Plate is a plate with spacer system designed toprovide posterior fixation by physically linking adjacent spinous processes.
	The system also contains Class 1 manual surgical instruments and cases that areconsidered exempt from premarket notification.
Intended Use:	The Pioneer BacFuse Device is a posterior, non-pedicle supplemental fixationdevice, intended for use at a single level in the non-cervical spine (T1-S1). It isintended for plate fixation/attachment to spinous processes for the purpose ofachieving supplemental fusion in the following conditions: degenerative discdisease (defined as back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies); spondylolisthesis; trauma (i.e.,fracture or dislocation); and/or tumor. The Pioneer BacFuse Device is intended foruse with bone graft material (i.e. allograft or autograft), not intended for stand-alone use.
Material:	The Pioneer Spinous Process Fusion Plate is composed of Ti Alloy per ASTM F136.	The predicate device is composed of the same material.
PerformanceData:	Static torsion, static tension, static compression, static locking mechanism, dynamicflexion-extension, and dynamic locking mechanism testing was performed on therepresentative worst case construct for each test mode. Results found the subjectdevice to perform equivalent or superior to predicate devices.

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The indications for use of the Pioneer Spinous Process Fusion Plate are the same as Comparison to the predicate device. Implant material, design characteristics, and mechanism of Predicate action for the Pioneer Spinous Process Fusion plate are identical to that of Devices: predicate systems.

SE Determination: Equivalence for Pioneer Spinous Process Fusion System is based on similarities of intended use, design, and physical characteristics when compared to predicate devices. Therefore, Pioneer Surgical Technology believes that there is sufficient evidence to conclude that the Pioneer Spinous Process Fusion Plate System is substantially equivalent to existing legally marketed devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Pioneer Surgical Technology, Inc. % Ms. Emily M. Downs Regulatory Affairs Manager 375 River Park Circle Marquette, Michigan 49855

MAR 2 3 2011

Re: K110367

Trade/Device Name: Pioneer Spinous Process Fusion Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: March 10, 2011 Received: March 11, 2011

Dear Ms. Downs:

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

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Page 2 - Ms. Emily M. Downs

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ycm1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Aty B. R. for

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

Enclosure

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Indications for Use Statement

K11 0367 510(k) Number (if known):

Device Name:

Pioneer Spinous Process Fusion Plate

Indications:

Prescription Use _ V

Over-the-Counter Use

(Per 21 CFR 801.109)

(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 Surgical, Orthopedic, and Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.