The Pioneer SlimFuse Anterior Cervical Plating System is intended for anterior cervical fixation as an adjunct to cervical fusion 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 SlimFuse Anterior Cervical Plating System consists of an assortment of plates and screws. The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

AI/ML Overview

Below is an analysis of the provided FDA 510(k) summary for the Pioneer SlimFuse Anterior Cervical Plating System.

Acceptance Criteria and Device Performance

This 510(k) submission is for a spinal intervertebral body fixation orthosis, which is a mechanical device. The acceptance criteria and performance data for such devices typically focus on mechanical properties and material conformance rather than diagnostic accuracy as would be found in AI/ML medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Mechanical Performance	Testing per recognized ASTM standards (e.g., for strength, fatigue, static/dynamic limits)	"Testing per recognized ASTM standards was presented." (Specific ASTM standards and numerical results are not detailed in this summary, but would have been provided in the full submission).
Material Conformance	Conformance to ASTM Standard Specifications for Ti 6A1 4V ELI (e.g., chemical composition, mechanical properties)	"Materials (Ti 6A1 4V ELI) used to manufacture the implants and instruments of this system are in conformance with ASTM Standard Specifications."
Substantial Equivalence	Comparison of device performance data, materials, indications, and design/function to legally marketed predicate devices.	"Comparisons of device performance data, materials, indications and design/function to predicate devices were provided in making a determination of substantial equivalence."

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

This information is not applicable in the context of this 510(k) summary. This device is a mechanical implant, not an AI/ML diagnostic or prognostic tool that processes data from a test set of patient cases. The "test set" here refers to the actual physical components of the device undergoing mechanical testing. The provenance of these test samples would typically be the manufacturing batch from Pioneer Surgical Technology.

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

This information is not applicable. The "ground truth" for a mechanical device is established through physical and material testing against established engineering standards (ASTM standards in this case), not through expert consensus on clinical cases or diagnoses. The "experts" involved would be engineers and material scientists interpreting the test results, rather than medical experts establishing a diagnostic ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human readers or expert panels, usually for diagnostic accuracy studies. For mechanical device testing, the results are typically objectively measured against pre-defined engineering specifications.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic tools to assess the impact of AI assistance on human reader performance. As this is a mechanical implant, such a study design is not appropriate.

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

No, a standalone performance study as described is not applicable. This concept applies to AI algorithms that can perform a task (e.g., detect a disease) independently. The Pioneer SlimFuse system is a physical surgical implant, not an algorithm. Its "performance" is its mechanical integrity and biocompatibility.

7. The Type of Ground Truth Used

For this mechanical device, the ground truth or reference standard is:

Established ASTM (American Society for Testing and Materials) Standards: These provide the objective benchmarks for material composition (e.g., Ti 6A1 4V ELI) and mechanical performance (e.g., strength, fatigue life, static/dynamic limits).
Predicate Device Data: The performance data of legally marketed predicate devices serves as a common reference point for demonstrating substantial equivalence. The "Acceptance Criteria" for substantial equivalence is that the device performs as well as or better than the predicate device for its intended use, or that any differences do not raise new questions of safety or effectiveness.

8. The Sample Size for the Training Set

This information is not applicable. The concept of "training set" refers to data used to train an AI/ML model. For a mechanical device, there is no AI/ML model to train. The development and design of the device would be based on engineering principles and existing knowledge, not a "training set" of data in the AI sense.

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

This information is not applicable for the same reasons mentioned in point 8.

Summary

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K072703

Pioneer SlimFuse Anterior Cervical Plating System

3.0 510(k) Summary

Sponsor:	Pioneer Surgical Technology375 River Park CircleMarquette, MI 49855(906) 226-4812Contact: Jonathan M. Gilbert	JAN 10 2008
Device Name:	Pioneer SlimFuse Anterior Cervical Plating System
Classification Name:	Spinal Intervertebral Body Fixation Orthosis, Class II.
Classification Number:	Regulation Number: 888.3060Product Code: KWQPanel Code: 87
Predicate Devices:	K040366 K053053 K042544
Description:	The Pioneer SlimFuse Anterior Cervical Plating Systemconsists of an assortment of plates and screws. Thesystem also contains Class 1 manual surgical instrumentsand cases that are considered exempt from premarketnotification.
Intended Use:	The Pioneer SlimFuse Anterior Cervical Plating Systemintended for anterior cervical fixation for the followingindications: degenerative disc disease (DDD) (defined asneck pain of discogenic origin with degeneration of thedisc 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, andfailed previous fusion.
Material:	Materials (Ti 6A1 4V ELI) used to manufacture theimplants and instruments of this system are inconformance with ASTM Standard Specifications.
Performance Data:	Testing per recognized ASTM standards was presented.
Performance and SEDetermination:	Comparisons of device performance data, materials,indications and design/function to predicate devices wereprovided in making a determination of substantialequivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three overlapping wing segments, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

JAN 10 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pioneer Surgical Technology % Mr. Jonathan M. Gilbert 375 River Park Circle Marquette, MI 49855

Re: K072703

Trade/Device Name: Pioneer SlimFuse Anterior Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: December 14, 2007 Received: December 17, 2007

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 yours,

Mark M. Milliman

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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2.0 Indications for Use Statement

K072703 510(k) Number (if known):

Device Name:

Pioneer SlimFuse Anterior Cervical Plating System

Indications:

Prescription Use (Per 21 CFR 801.109)

Over-the

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)

Barbave Pouellm
(Division Sign Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K02703

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.