The Pioneer Aspect Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Description

The Pioneer Aspect Anterior Cervical Plate System consists of an assortment of plates and screws. The screws are used to secure the plates to the vertebral bodies of the cervical spine through an anterior approach. The system consists of static plates in lengths that range from 10-105mm and include one, two, three, four, and five level designs. The plates have an integrated screw retention mechanism. The system includes fixed/variable self-tapping and self-drilling screws in 04.0 or 04.5mm, ranging from 10-20mm in length.

AI/ML Overview

The provided text is a 510(k) summary for the Pioneer Aspect Anterior Cervical Plate System. This document focuses on demonstrating substantial equivalence to existing predicate devices through mechanical performance testing, rather than establishing efficacy or safety through clinical trials with specific acceptance criteria in the manner often seen for diagnostic AI/ML devices. As such, many of the requested categories are not applicable to this type of submission.

Here's a breakdown of the available information in relation to your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Mechanical Strength (General)	"Performance testing showed that the mechanical strength of the subject system is equivalent to or better than predicate devices and is therefore sufficient for the intended use."
ASTM F1717 (Dynamic and Static Compression Bending)	Completed. (Implicitly met standards, as the device was cleared)
Torsion Static Testing	Completed. (Implicitly met standards, as the device was cleared)
ASTM F543 (Screw Pull-Out Testing)	Completed. (Implicitly met standards, as the device was cleared)
Internal Protocols (Screw Pull-Through and Retention)	Completed. (Implicitly met standards, as the device was cleared)
Design Equivalence	"Available screw lengths, screw diameters, plate prominence and width, and plate types (one, two, three, four and five-level; static) fall within the range of predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in terms of number of devices or tests. The document mentions "non-clinical mechanical tests" and "testing per internal protocols."
Data Provenance: The tests are non-clinical mechanical tests, not human data. Therefore, country of origin or retrospective/prospective is not applicable. The tests were performed by the manufacturer, Pioneer Surgical Technology, Inc.

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

This is not applicable. The "ground truth" for mechanical testing is established by industry standards like ASTM and internal engineering specifications, not by human expert consensus on clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a non-clinical mechanical test report.

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

Not applicable. This device is a surgical implant, not an AI/ML diagnostic or assistive tool.

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

Not applicable. This device is a surgical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" or reference for the performance evaluation was established by:
- ASTM (American Society for Testing and Materials) standards: Specifically ASTM F1717 for dynamic and static compression bending, and ASTM F543 for screw pull-out.
- Internal protocols: For assessing screw pull-through and retention characteristics.
- Performance of predicate devices: The "equivalent to or better than predicate devices" is the comparative benchmark for the mechanical strength.

8. The sample size for the training set

Not applicable. This is a medical device for surgical implantation, not an AI/ML system requiring a training set.

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

Not applicable, as there is no training set for this type of device.

Summary of the Study (Mechanical Performance Testing):

The study primarily consisted of non-clinical mechanical tests to demonstrate that the Pioneer Aspect Anterior Cervical Plate System's mechanical performance is equivalent or superior to its legally marketed predicate devices.

Tests performed included:
- ASTM F1717 dynamic and static compression bending.
- Torsion static testing.
- ASTM F543 screw pull-out testing.
- Internal protocols for screw pull-through and retention characteristics.
Conclusion: The performance testing indicated that the mechanical strength of the subject system is equivalent to or better than predicate devices and is sufficient for its intended use. This demonstrated substantial equivalence, leading to the device's clearance.

Summary

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510(k) SUMMARY (as required by 21 CFR 807.92(c))

Sponsor: Manufacturer: Pioneer Surgical Technology, Inc. 375 River Park Circle Marquette, MI 49855 Official Contact: Sarah McIntyre, Regulatory Affairs Associate II Phone: (906) 225-5861 Fax: (906) 226-4459 Date prepared: May 20, 2013 Name: Trade/Device Name: Pioneer Aspect Anterior Cervical Plate System Common Name: Anterior Cervical Plate System Classification: Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Product Code: KWO Regulatory Class: Class II Description: The Pioneer Aspect Anterior Cervical Plate System consists of an assortment of plates and screws. The screws are used to secure the plates to the vertebral bodies of the cervical spine through an anterior approach. The system consists of static plates in lengths that range from 10-105mm and include one, two, three, four, and five level designs. The plates have an integrated screw retention mechanism. The system includes fixed/variable self-tapping and self-drilling screws in 04.0 or 04.5mm, ranging from 10-20mm in length. The purpose of this submission is to communicate the next generation Aspect Anterior Cervical Plate System to the Agency. Intended Use: The Pioneer Aspect Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. The plates and screws are manufactured from ASTM F 136 titanium alloy. The screw Material: retention mechanism ("retaining clip") of the plate is manufactured from ASTM F2063 Nitinol. Performance For a determination of substantial equivalence, non-clinical mechanical tests including ASTM Data: F1717 dynamic and static compression bending and torsion static testing were completed. In addition, ASTM F543 screw pull-out testing and testing per internal protocols to assess screw pull through and retention characteristics were performed. Performance testing showed that the mechanical strength of the subject system is equivalent to or better than predicate devices

K 130427 Pioneer Aspect Anterior Cervical Plate System

Page 1 of 2

and is therefore sufficient for the intended use.

JUN 5 2013

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Comparison toPredicate Devices	The Sponsor is claiming substantial equivalence to the following legally marketed predicatedevices:
	K111528 Pioneer Aspect Anterior Cervical Plate System (24-series, SE 8/24/11)K 100708 Pioneer Anterior Cervical Plate System (SE 6/4/10)K083663 Pioneer PACP (SE 2/25/09)K971883 Synthes Spine Small Stature Anterior Cervical Plate System (SE 10/16/97)�K 103491/K052552 DePuy Spine, Inc. SKYLINE Anterior Cervical Plate System(SE 2/14/11)
	The subject Pioneer Aspect Anterior Cervical Plate System (27-series) has indications for useidentical to those of the predicate Pioneer Anterior Cervical Plate Systems and employs thesame principles of operation. Identical materials are used in predicate systems. A vailablescrew lengths, screw diameters, plate prominence and width, and plate types (one, two, three,four and five-level; static) fall within the range of predicate devices. The differences betweenthe subject and predicate device do not affect the substantial equivalence of the device, asdemonstrated by a full battery of performance testing.
Performance andSE .Determination:	Based on the supporting documentation within this premarket notification, the subject systemdemonstrates substantial equivalence to the listed predicate devices and is expected to be assafe, as effective, and perform as well as or better than the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

June 5, 2013

Pioneer Surgical Technology, Incorporated % Ms. Sarah MoIntyre Regulatory Affairs Associate II 375 River Park Circle Marquette, Michigan, 49855

Re: K130427

Trade/Device Name: Pioneer Aspect Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 5, 2013 Received: March 7, 2013

Dear Ms. McIntyre:

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. Sarah McIntyre

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/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.

For

Sincerely yours,

rin Keith

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K130427

Device Name: Pioneer Aspect Anterior Cervical Plate System

Indications:

V 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)

Anton-E-Dmitriev, PhD-Division of Orthopedic Devices

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.