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.

Device Description

The Pioneer Posterior Cervico-Thoracic System consists of a variety of rods, hooks, polyaxial screws, favored 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 Pioneer Quantum® Spinal Rod 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

This 510(k) summary for the "Pioneer Posterior Cervico-Thoracic System" is a medical device submission seeking clearance for market, not a study report demonstrating acceptance criteria with performance data. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document.

The document primarily focuses on establishing substantial equivalence to previously approved predicate devices, a common pathway for 510(k) clearance, rather than presenting a detailed performance study against specific acceptance criteria.

Here's an analysis based on the provided text, highlighting what can and cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as quantifiable metrics for a performance study. The "acceptance criteria" for a 510(k) in this context is typically demonstrating substantial equivalence to predicate devices in terms of intended use, design, materials, and technological characteristics.
Reported Device Performance: The document states "Testing per recognized ASTM standards was presented." However, it does not provide the specific results or performance values from these tests, nor does it define what values would constitute "acceptance." The performance is implicitly considered acceptable if it allows for a determination of substantial equivalence.

Acceptance Criteria (Implied for 510(k) Equivalence)	Reported Device Performance (Summary Only)	Details from Document
Similar Intended Use	Similar to predicate devices	Yes, detailed in "Intended Use" section.
Similar Design	Similar to predicate devices	Yes, implied by discussion of components (rods, hooks, screws, etc.).
Similar Materials	Medical grade titanium alloy and cobalt chromium, following ASTM standards	Yes, specified in "Description" and "Material" sections.
Similar Technological Characteristics	Similar to predicate devices	Yes, implied by the substantial equivalence argument.
Meets recognized ASTM standards for performance	Testing per recognized ASTM standards was presented	Yes, stated under "Performance Data," but no specific results are provided.

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

Sample Size for Test Set: Not specified. The document refers to "Testing per recognized ASTM standards was presented," which implies mechanical or material testing, not human subject testing. The sample sizes for such engineering tests (e.g., fatigue, static strength) would be dictated by the specific ASTM standards followed, but these details are not provided.
Data Provenance: Not applicable in the context of human data. For materials and mechanical testing, the data would originate from laboratory tests conducted by the manufacturer or a third-party lab. No information on country of origin is provided. The tests are prospective in nature (conducted for the submission), not retrospective.

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

Not applicable. This information pertains to studies involving clinical data, image interpretation, or diagnostic device performance where expert consensus is used to establish ground truth. This 510(k) summary is for a spinal implant system and does not contain such a study.

4. Adjudication Method for the Test Set

Not applicable. See explanation for #3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. This type of study (MRMC) is relevant for diagnostic devices where human readers interpret outputs (e.g., images) and AI assists in that interpretation. The Pioneer Posterior Cervico-Thoracic System is a surgical implant; therefore, an MRMC study is not relevant to its clearance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. Not applicable, as this is a physical medical device (spinal implant), not a software algorithm.

7. The Type of Ground Truth Used

For the mechanical and material performance mentioned, the "ground truth" would be the engineering specifications and performance characteristics defined by the relevant ASTM standards. The device is tested against these standards to demonstrate compliance. There is no biological or diagnostic "ground truth" in this submission.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this 510(k) submission, as it does not involve machine learning or AI algorithms requiring data for training.

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

Not applicable. See explanation for #8.

In summary, the provided document is a 510(k) summary for a spinal implant, which establishes substantial equivalence based on physical and mechanical characteristics and intended use compared to legally marketed predicate devices. It references performance testing to recognized ASTM standards but does not provide specific performance data or detailed study designs that would align with the questions about acceptance criteria, clinical studies, or AI/ML evaluation.

Summary

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Pioneer Posterior Cervico-Thoracic System

510(k) Summary

FEB 1 9 2010

Sponsor:	Pioneer Surgical Technology375 River Park CircleMarquette, MI 49855(906) 226-4812Contact: Emily M. Downs
Device Name:	Pioneer Posterior Cervico-Thoracic System
Classification Name:	Spinal Interlaminal Fixation OrthosisPedicle Screw System
Classification Number:	Product Code/ Regulation Number:KWP/ 888.3050 - Spinal Interlaminal Fixation OrthosisMNI/ 888.3070(b)(1)- Pedicle Screw Spinal SystemMNH/ 888.3070(b)(1)- Pedicle Screw Spinal SystemPanel Code: 87
Description:	The Pioneer Posterior Cervico-Thoracic System consists of a variety ofrods, hooks, polyaxial screws, favored angle screws, locking caps, andconnecting components used to build a cervico-thoracic spinalconstruct.
	The Pioneer Posterior Cervico-Thoracic System components aremanufactured from medical grade titanium alloy and medical gradecobalt chromium. Medical grade titanium alloy and medical gradecobalt chromium may be used together.
	The Pioneer Posterior Cervico-Thoracic System can be attached toPioneer Quantum® Spinal Rod System using parallel connectors.
	The system also contains Class 1 manual surgical instruments and casesthat are considered exempt from premarket notification.
Intended Use:	The Pioneer Posterior Cervico-Thoracic System is indicated to promotefusion of the cervico- thoracic regions of the spine (C1-T3). Theintended indications are as follows:
	- Degenerative Disc Disease (as defined by neck or back pain ofdiscogenic origin with degeneration of the disc confirmed by historyand radiographic studies
	- Spondylolisthesis
Pioneer Surgical Technology		119	February 12, 2010

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K0922 95
Pioneer Posterior Cervico-Thoracic System
	- 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 notintended for use in the cervical spine.
	The hooks and rods are also intended to provide stabilization to promotefusion following reduction of fracture/ dislocation or trauma in thecervical/ upper thoracic (C1-T3) spine.
Material:	Materials used to manufacture the implants and instruments of thissystem follow ASTM Standard Specifications.
Performance Data:	Testing per recognized ASTM standards was presented.
Performance and SEDetermination:	The characteristics of the Pioneer Posterior Cervico-Thoracic Systemare similar to the following predicate devices:
	1. Atoll Cervico-Thoracic System (K070638), Theken Spine, SE date05/30/2007.
	2. Summit OCT Spinal System (K002733), DePuy AcroMed, Inc., SEdate 12/15/2000.
	3. VERTEXTM Reconstruction System (K003780), Medtronic SofamorDanek USA, Inc., SE date 09/28/2001.
	4. Spine Oasys System (K032394), Stryker, SE date 2/20/2004
	5. Cervifix/ Starlock System (K990965) Synthes (USA), SE date7/1/1999.
	Equivalence for Pioneer Posterior Cervico-Thoracic System is based onsimilarities of intended use, design, and physical characteristics whencompared to predicate devices. Therefore, Pioneer Surgical Technologybelieves that there is sufficient evidence to conclude that the PioneerPosterior Cervico-Thoracic System is substantially equivalent toexisting legally marketed devices.

2002

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February 12, 2010

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains the department's emblem, which is a stylized representation of a human figure.

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

FEB 1 9 2010

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

Re: K092295

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 12, 2010 Received: February 16, 2010

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

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Page 2 - Ms. Emily M. Downs

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/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 A. Millman

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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Pioneer Posterior Cervico-Thoracic System

3.0 Indications for Use Statement

K09 2295 510(k) Number (if knówn):

Pioneer Posterior Cervico-Thoracic System Device Name:

Indications:

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 (Per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(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
	Page 1 of 1

Pioneer Surgical Technology Premarket Notification	510(k) Number: K092295	Confidential July 27, 2009
----------------------------------------------------	------------------------	----------------------------

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.