The Pioneer Posterior Cervico-Thoracic System is indicated to promote fusion of the cervico- thoracic regions of the spine (C1-T3). The intended indications are as follows:

Degenerative Disc Disease (as defined by neck or back pain of discogenic origin ー with degeneration of the disc confirmed by history and radiographic studies)
Spondylolisthesis -
-Spinal Stenosis
Fracture/ Dislocation -
-Deformities or Curvature
-Tumors
-Pseudoarthrosis
-Revision of previous cervical and upper thoracic spine surgery

The use of the screws is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.

Device Description

The Pioneer Posterior Cervico-Thoracic System consists of a variety of rods, hooks, polyaxial screws, high-angle screws, locking caps, and connecting components used to build a cervico-thoracic spinal construct.

The Pioneer Posterior Cervico-Thoracic System components are manufactured from medical grade titanium alloy and medical grade cobalt chromium. Medical grade titanium alloy and medical grade cobalt chromium may be used together.

The Pioneer Posterior Cervico-Thoracic System can be attached to FDA approved pedicle screw systems (e.g. Quantum® Spinal Fixation System or Streamline TL Spinal System) using parallel connectors.

The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called the Pioneer Posterior Cervico-Thoracic System. This type of submission is for establishing substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria related to a diagnostic output or outcome.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the way one might expect for a diagnostic or AI-driven device (e.g., sensitivity, specificity, AUC) does not directly apply to this 510(k) submission.

Instead, the "acceptance criteria" here revolve around demonstrating substantial equivalence to a predicate device. The "study" proving this involves mechanical testing and comparison of intended use, materials, and design.

Here's how to frame the information based on the provided document:

Acceptance Criteria and Evidence for Substantial Equivalence (for a 510(k) Submission)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Pioneer Posterior Cervico-Thoracic System Performance
Intended Use	Must be similar to the predicate device.	"Equivalency of this device is based on similarities in intended use... to other currently marketed posterior cervico-thoracic systems."
Materials	Must be similar to or equivalent to the predicate device.	Manufactured from medical grade titanium alloy and medical grade cobalt chromium, which "may be used together." Implied to be similar/equivalent to predicate.
Design	Must be similar to the predicate device.	"Equivalency of this device is based on similarities in... design to other currently marketed posterior cervico-thoracic systems." Consists of rods, hooks, polyaxial screws, high-angle screws, locking caps, and connecting components.
Mechanical Properties	Must demonstrate comparable mechanical properties to the predicate device.	"Mechanical testing demonstrated comparable mechanical properties to the predicate device."
Safety and Effectiveness	Implied to be similar to legally marketed predicate device, relying on the established safety and effectiveness of the predicate.	Not explicitly stated as "performance results," but the conclusion of substantial equivalence implies acceptable safety and effectiveness based on predicate.

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

Test Set Description: This refers to the mechanical test samples.
Sample Size: Not explicitly stated in the document. The document mentions "Testing per recognized ASTM standards was presented (ASTM F 1717 Static and Fatigue, Compression and Torsional testing, ASTM F543 Screw Insertion and Screw Pullout testing)." ASTM standards usually specify sample sizes for such tests, but the specific number of units tested is not provided in this summary.
Data Provenance: The provenance is from internal testing conducted by the manufacturer, Pioneer Surgical Technology. The document does not specify country of origin for the data beyond that. This is a pre-clinical (bench-top) study, not a clinical study involving patients.

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

Not Applicable. For a mechanical performance test establishing substantial equivalence for an orthopedic implant, "experts" in the sense of clinicians establishing ground truth (e.g., radiologist for imaging) are not used. The "ground truth" is typically defined by the test standard (e.g., ASTM F1717 specifies how fatigue testing should be conducted and what constitutes failure).

4. Adjudication Method for the Test Set

Not Applicable. As this is mechanical testing to established standards, there is no adjudication process involving human interpretation of results in the way there would be for a clinical diagnostic study. The tests are designed to produce quantifiable, objective results against specified criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists interpreting images, assisted by AI). This 510(k) submission is for an orthopedic implant, where the primary evidence presented for substantial equivalence is mechanical testing and design/material comparison.

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

Not Applicable. This device is a surgical implant, not an algorithm or diagnostic tool. The performance evaluated is the physical mechanical integrity of the implant components.

7. The Type of Ground Truth Used

For mechanical properties, the "ground truth" is defined by the recognized ASTM standards (ASTM F 1717 and ASTM F543) which dictate the testing methodology and acceptance criteria for mechanical performance (e.g., static and fatigue strength, screw insertion and pullout forces). The objective measurements obtained during these tests are compared against the expected performance based on the predicate device.
For intended use, materials, and design, the "ground truth" is the characteristics of the predicate device.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of an orthopedic implant's 510(k) submission. This refers to data used to train AI models, which is irrelevant here.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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MAR 1 2 2012

PIONEER
SURGICAL

510(k) Summary Pioneer Posterior Cervico-Thoracic System

ADMINISTRATIVE INFORMATION Contact:

Pioneer Surgical Technology 375 River Park Circle Marquette, MI 49855 Telephone: -------------------------------------------------------------------------------+1(906) 225-5602 +1(906) 226-4459 Fax: Emily M. Downs emilydowns@pioneersurgical.com February 10, 2012

Date Prepared:

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations:

Product Code: Classification Panel: Reviewing Branch:

Streamline Cervico-Thoracic (CT) System Posterior Cervico-Thoracic System Spinal interlaminal fixation orthosis 21 CFR 888.3050, Class II Pedicle Screw Spinal System, 21 CFR 888.3070(b)(1), Class II KWP. MNI. MNH Orthopaedic and Rehabilitation Devices Orthopedic Spine Devices Branch

INTENDED USE

The Pioneer Posterior Cervico-Thoracic System is indicated to promote fusion of the cervico- thoracic regions of the spine (C1-T3). The intended indications are as follows:

Degenerative Disc Disease (as defined by neck or back pain of discogenic origin ー with degeneration of the disc confirmed by history and radiographic studies)
Spondylolisthesis -
-Spinal Stenosis
Fracture/ Dislocation -
-Deformities or Curvature
-Tumors
-Pseudoarthrosis
-Revision of previous cervical and upper thoracic spine surgery

The use of the screws is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.

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DEVICE DESCRIPTION

The Pioneer Posterior Cervico-Thoracic System can be attached to FDA approved pedicle screw systems (e.g. Quantum® Spinal Fixation System or Streamline TL Spinal System) using parallel connectors.

The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

PREDICATE DEVICES

Posterior Cervico-Thoracic System (K092295), Pioneer Surgical Technology, Inc.

COMPARISON TO MARKETED DEVICE

Equivalency of this device is based on similarities in intended use. materials and design to other currently marketed posterior cervico-thoracic systems. Mechanical testing demonstrated comparable mechanical properties to the predicate device.

PERFORMANCE TESTING

Testing per recognized ASTM standards was presented (ASTM F 1717 Static and Fatigue, Compression and Torsional testing, ASTM F543 Screw Insertion and Screw Pullout testing).

CONCLUSION

Based on information presented in this submission, we conclude that the Pioneer Posterior Cervico-Thoracic System is substantially equivalent to predicate device.

02/10/2012

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

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

MAR 1 2 2012

Re: K112757

Trade/Device Name: Pioneer Posterior Cervico-Thoracic System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI, MNH Dated: February 10, 2012 Received: February 13, 2012

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 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.

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Page 2 - Ms. Emily M. Downs

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/ucm115809.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/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 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,

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

KII 2757 510(k) Number (if known):

Device Name:

Pioneer Posterior Cervico-Thoracic System

Indications for use:

The Pioneer Posterior Cervico-Thoracic System is indicated to promote fusion of the cervico- thoracic regions of the spine (C1-T3). The intended indications are as follows:

Degenerative Disc Disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
Spondylolisthesis -
Spinal Stenosis -
Fracture/ Dislocation -
-Deformities or Curvature
Tumors -
Pseudoarthrosis -
Revision of previous cervical and upper thoracic spine surgery .

The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.

Prescription Use √ OR

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

K 112757 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.