The Pioneer Sternal Cable Plate System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures.

Device Description

The Pioneer Sternal Cable Plate System contains various configurations of plates, some with integrated cables and crimps, and. 2.7mm and 3.0mm diameter self-drilling screws (lengths 8-20mm) to allow for multiple sternal repair and reconstruction options. The Pioneer Sternal Cable Plate System implants are manufactured from medical grade ASTM F67 Grade IV commercially pure titanium and ASTM F136 Titanium alloy.

AI/ML Overview

The provided document describes the Pioneer Sternal Cable Plate System, a medical device for stabilizing and fixing anterior chest wall fractures. However, it does not contain information about acceptance criteria, device performance metrics, or a study that specifically "proves" these criteria are met in the way a diagnostic AI device would be evaluated.

This document is a 510(k) summary for a mechanical medical device (implants for bone fixation). The performance data cited is for mechanical equivalence testing, not for a diagnostic algorithm.

Therefore, many of the requested categories (sample size, data provenance, experts for ground truth, adjudication, MRMC, standalone algorithm, ground truth type, training set size, and ground truth for training set) are not applicable to the information provided in this regulatory submission for the Pioneer Sternal Cable Plate System.

Here's a breakdown of what is available based on the request:

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

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance: Equivalent to predicate devices.	Screw-Plate Interface Tests: Conducted to demonstrate performance. (Details not provided on specific metrics or acceptance thresholds in this summary document, but implied to be equivalent to predicates.)
	Static and Dynamic Tensile Tests: Conducted to demonstrate performance. (Details not provided on specific metrics or acceptance thresholds in this summary document, but implied to be equivalent to predicates.)
Dimensional Compatibility: Equivalent to predicate devices.	Dimensional Comparisons: Performed to support substantial equivalence. (Details not provided on specific comparisons or acceptance thresholds in this summary document, but implied to be within acceptable ranges for equivalence.)
Material Compatibility: Use of medical-grade materials.	Implants are manufactured from medical grade ASTM F67 Grade IV commercially pure titanium and ASTM F136 Titanium alloy, which are standard materials for medical implants, supporting material compatibility and safety.
Intended Use: Similar to predicate devices.	The intended use for stabilization and fixation of fractures of the anterior chest wall (including sternotomy and reconstructive procedures) is stated to be similar to legally marketed predicate devices, forming the basis for substantial equivalence for clinical application.

Explanation for the nature of equivalence claimed: This 510(k) summary focuses on demonstrating "substantial equivalence" of the Pioneer Sternal Cable Plate System to existing legally marketed predicate devices. For mechanical devices like bone plates and screws, this typically involves showing that the new device has similar designs, materials, and equivalent mechanical performance to predicate devices under specified test conditions. The goal is to ensure the device performs safely and effectively without raising new safety or effectiveness concerns compared to already approved devices. The specific acceptance criteria (e.g., maximum deflection under load, fatigue life) would have been part of the full 510(k) submission, but are generalized here as "performs in a manner substantially equivalent to that of predicate systems."

The Study that Proves the Device Meets Acceptance Criteria:

The document states: "Performance Data: Screw-Plate Interface Tests, Static and Dynamic Tensile Tests, and dimensional comparisons were provided to support that the Pioneer Sternal Cable Plate System performs in a manner substantially equivalent to that of predicate systems. No new issues of safety or effectiveness were raised."

This refers to a series of benchtop mechanical performance tests and dimensional analyses comparing the Pioneer Sternal Cable Plate System to its predicate devices. The study is this set of mechanical and dimensional comparisons.

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 this summary. For mechanical tests, the "sample size" would refer to the number of test specimens (e.g., plates, screws, cable assemblies) subjected to each specific mechanical test (tensile, fatigue, etc.). These are not human or patient samples.
Data provenance: Benchtop testing (laboratory-generated data). Not applicable for country of origin or retrospective/prospective in the sense of clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. For mechanical device testing, "ground truth" is established by engineering specifications, material standards (e.g., ASTM), and comparison to predicate device performance, not by expert medical review of images or clinical outcomes.

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

Not Applicable. Adjudication methods are relevant for subjective interpretations (like image diagnosis) where multiple readers might disagree. Mechanical tests yield objective quantitative data.

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 is a mechanical device, not a diagnostic algorithm or an AI-assisted tool. No MRMC study was performed.

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

Not Applicable. This is a mechanical device, not an algorithm.

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

Engineering Specifications and Standardized Test Methods: The "ground truth" for mechanical performance would be defined by established ASTM or ISO standards for testing orthopedic implants, and the performance characteristics of the predicate devices. For material composition, it's compliance with ASTM medical grade titanium standards.

8. The sample size for the training set

Not Applicable. This is a mechanical device, not an algorithm that requires a training set.

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

Not Applicable. No training set was used.

Summary

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K122293

5.0 510(k) Summary

Sponsor:	Pioneer Surgical Technology, Inc.375 River Park CircleMarquette, MI 49855(906) 225-5861 ·Contact: Sarah McIntyrePrepared: July 30, 2012
Device Name:	Pioneer Sternal Cable Plate System
Classification:	Class II; Panel Code: 87§888.3010 Cerclage, Fixation, Metallic (JDQ)§888.3030 Plate, Fixation, Bone, Non-Spinal, Metallic (HRS)§888.3040 Screw, Fixation, Bone, Non-Spinal, Metallic (HWC)
Predicate Devices:	Ethicon Stainless Steel Suture Wire (K946173)Pioneer Songer Cable System (K935481)Lorenz Sternal Closure System with Modular Screw (Biomet SternaLock)(K011076)Biomet SternaLock Blu Microfixation Sternal Closure System (K110574)Synthes Modular Sternal Cable / Sternal Reconstruction System (K031508/K033816)
Description:	The Pioneer Sternal Cable Plate System contains various configurations ofplates, some with integrated cables and crimps, and. 2.7mm and 3.0mmdiameter self-drilling screws (lengths 8-20mm) to allow for multiple sternalrepair and reconstruction options.The Pioneer Sternal Cable Plate System implants are manufactured frommedical grade ASTM F67 Grade IV commercially pure titanium and ASTMF136 Titanium alloy.
Indications for Use:	The Pioneer Sternal Cable Plate System is intended for use in thestabilization and fixation of fractures of the anterior chest wall includingSternal fixation following Sternotomy and Sternal reconstructive surgicalprocedures.
Performance Data:	Screw-Plate Interface Tests, Static and Dynamic Tensile Tests, anddimensional comparisons were provided to support that the Pioneer SternalCable Plate System performs in a manner substantially equivalent to that ofpredicate systems. No new issues of safety or effectiveness were raised.
Performance andSE Determination:	Equivalence for the Pioneer Sternal Cable Plate System is based onsimilarities of intended use, performance, design, materials, and physicalcharacteristics when compared to predicate devices. Therefore, PioneerSurgical Technology believes that there is sufficient evidence to concludethat the Pioneer Sternal Cable Plate System is substantially equivalent toexisting legally marketed devices.

OCT 1 2 2012

: 上一篇:

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

OCT 12 2012

Pioneer Surgical Technology, Inc. % Ms. Sarah McIntyre Regulatory Affairs Associate 375 River Park Circle Marquette, Michigan 49855

Re: K122293

Trade/Device Name: Pioneer Sternal Cable Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: Class II

Product Code: HRS, JDQ, HWC Dated: July 30, 2012 Received: July 31, 2012

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.

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Page 2 - Ms. McIntyre

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.

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.

Radiological Health

Mark N. Melkerson

Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and

Enclosure

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4.0 Indications for Use Statement

K122292 510(k) Number (if known):

Device Name: Pioneer Sternal Cable Plate System

Indications: The Pioneer Sternal Cable Plate System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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)

Ash

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

k 122297 510(k) Number _

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.