This system is not indicated for use in the spine. The Cannulated Screw System by Pioneer will be offered both sterile and non-sterile and is a single use device.

Device Description

The Cannulated Screw System by Pioneer consists of cannulated screws of varying diameters, lengths and thread configurations to accommodate variations in surgical technique and severity level of fracture. The system includes correspondingly sized washers, the use of which is optional. The cannulated screws are self-cutting and self-tapping in appropriate bone stock, which maximizes OR efficiency. The threads are reverse batting, facilitating of engle use and will be offered both sterile and nonsterile.

AI/ML Overview

The provided document is a 510(k) summary for the Pioneer Surgical Technology Cannulated Screw System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than performing clinical studies to establish novel performance criteria or the effectiveness of an AI algorithm.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable to this document.

The document describes the device, its intended use, and states that substantial equivalence is claimed based on existing predicate devices (Zimmer MAGNA-Fx, Zimmer Mini MAGNA-Fx, and Synthes Cannulated Screw System). The performance evaluation relies on demonstrating equivalence in material and adherence to established ASTM standards relevant to bone screws, rather than a clinical study or AI performance evaluation.

Summary of relevant information from the document:

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

Acceptance Criteria (ASTM Standards for comparison to predicate)	Reported Device Performance (Claimed)
F 1691: Standard Test Method for Determining the Axial Pull-Out Strength of Medical Bone Screws	Logically derived as at least equivalent based on screw material equivalence to predicate devices.
F 117: Standard Test Method for Driving Torque of Medical Bone Screws	Logically derived as at least equivalent based on screw material equivalence to predicate devices.
F 1622: Standard Test Method for Measuring the Torsional Properties in Metallic Bone Screws	Logically derived as at least equivalent based on screw material equivalence to predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The performance evaluation is based on in-vitro testing against ASTM standards for medical devices, not a test set derived from patient 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. Ground truth for a clinical or AI study is not relevant here. The "ground truth" in this context would be the adherence to validated ASTM standards and material equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for clinical or AI studies involving human interpretation, not for mechanical device testing.

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 not an AI device, and 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 not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the device's safety and effectiveness determination in this 510(k): The ground truth utilized is the established performance characteristics of legally marketed predicate devices (Zimmer MAGNA-Fx, Zimmer Mini MAGNA-Fx, and Synthes Cannulated Screw System) as demonstrated through compliance with recognized ASTM standards (F 1691, F 117, F 1622) for metallic bone screws.

8. The sample size for the training set:
Not applicable. This is not an AI device, and thus no training set was used.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI device.

Summary

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K003496

10F2

510(K) SUMMARY

Pioneer Surgical Technology 510(K) Notification Summary: Cannulated Screw System by Pioneer

ADMINISTRATIVE INFORMATION

Manufacturer IdentificationAnd Sponsor	Pioneer Surgical Technology375 River Park CircleMarquette, Michigan 49855-1781Telephone: (906) 226-9909Facsimile: (906) 226-9932
Official Contact	Amy H. Mommaerts, ManagerRegulatory Affairs

Date Prepared ................................................................................................................................................................

DEVICE IDENTIFICATION

Proprietary Name	Cannulated Screw System by Pioneer
Common Name:	Cannulated Screw
Classification Name	Screw, Fixation, Bone
And Reference	Screw, Fixation, Bone
Regulation Number	888.3040
Classification Number	87HWC

Proprietary Name	Cannulated Screw System by Pioneer
Common Name: Screw	Washer
Classification Name
And Reference: Screw	Washer, Bolt, Nut, Orthopaedic
Regulation Number	888.3030
Classification Number	87HTN

Devices on Which Substantial Equivalence is Claimed

The Cannulated Screw System by Pioneer is predicated on the ZIMMER MAGNA-Fx; the ZIMMER Mini MAGNA-Fx; and the Synthes Cannulated Screw System.

Device Description

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K003496
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tapping in appropriate bone stock, which maximizes OR efficiency. The threads are tapping in approphato bone otew removal and decreasing the chance of breakage. reverse batting, faoilitating of engle use and will be offered both sterile and nonsterile.

Intended Use

The Cannulated Screw System by Pioneer will be indicated for use in long and small bone fracture fixation, which may include the following:

Fractures of the tarsals and metatarsals; 1.
Metatarsal and phalangeal osteotomies; 2.
Fractures of the carpals and metacarpals; 3.
Carpal and metacarpal arthrodesis; ধ:
Small fragments of the hand and wrist; 5.
Ligament fixation; 6.
Sacroillac ioint disruptions; 7.
Fractures of the distal femur and proximal tibia; 8.
Intracapsular fractures of the hip; 9.
1. Ankle arthrodesis;
1. Pelvis and acetabulum fractures; and
1. Areas where accurate screw placement is vital.

This system is not indicated for use in the spine. The Cannulated Screw System by Pioneer will be offered both sterile and non-sterile and is a single use device.

Technological Characteristic Compared to Predicate Device

The Cannulated Screw system by Pioneer was designed referencing the following ASTM standards, similar to the predicate Zimmer Magna-FX, Mini Magna-FX and AO Hi Standardo, Similar to the production for Metallic Medical Bone Screws; and 2) F 116, Standard Specification for Medical Screwdriver Bits

Performance

r oreemianes
Based on the screw material equivalence in the proposed system an at least equivalent comparison has been logically derived from the information available.

Performance Data

The Cannulated Screw System by Pioneer is predicated on the use Zimmer Magna-FX and Synthes Cannulated screws. The Cannulated Screw system by Pioneer will be evaluated and compared to the predicate devices with the following ASTM Test standards: 1) F 1691, Standard Test Method for Determining the Axial Pull-Out Strength of Medical Bone Screws; 2) F 117, Standard Test Method for Driving Torque of Medical Bone Screws; and 3) F 1622, Standard Test Method for Measuring the Torsional Properties in Metallic Bone Screws.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three stylized human profiles facing to the right.

Public Health Service

FEB = 8 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Amy H. Mommaerts Manager, Regulatory Affairs Pioneer Surgical Technology 375 River Park Circle Marquette, Michigan 49855

Re: K003496 Trade Name: Cannulated Screw System Regulatory Class: II Product Codes: HTN and HWC Dated: November 10, 2000 Received: November 13 2000

Dear Ms. Mommaerts:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your Sccubit 910(x) notifically equivalent (for the indications for use above and we have determined the correct in interstate commerce prior to May 28, 1976, the stated in the elieboute) to device Amendments, or to devices that have been reclassified in enactment date of the Medical Dovieo Frinentialized, brug, and Cosmetic Act (Act). The program accordance with the provisions of the reacted control provisions of the Act. The general therefore, market the device, subject to answal registration, listing of devices, control provisions of the fiel merilibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III 11 your device is classified (see acc re) and additional controls. Existing major regulations (Pleniance Apployal), it may of success to sates from the Code of Federal Regulations, Title 21, Parts 800 to 895. allecting your devroe can or remination assumes compliance with the current Good A substantially cquiralent covernent, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspections, the Food and Drug Hammesult in regulatory action. In addition, FDA may publish Comply with the GMI Tegatator may readeral Register. Please note: this response to your premarket notification submission does not affect any obligation you might It spollse to your promation houseaus of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to ocgin maxantial equivalence of your device to a legally marketed nontication. The I Driving sification for your device and thus, permits your device to proceed to the market.

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Page 2 - Ms. Amy H. Mommaerts

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the Office of additionally 809.10 for in Vitro diagnostic no nother promotion and advertising of your device, (301) 594-4659. Additionally, for questions of the pressent the regulation please contact the Office of Compliance at (301) ->++0.5: "(21 CFR 807.97). Other general
entitled, "Misbranding by reference to premarks obteined from the Division of Small entitled, "Misbranding by reference up perilance. Inonited from the Division of Small
information on your responsibilities under the Act may be obtained from the Division of information on your responsibilites under (800) 638-2041 or at (301) 443-6597, or at its
Manufacturers Assistance at its toll-free 111 Mandracturers 715siblantes av fda.gov/cdrh/dsmamain.html".

Sincerely yours,

L. Mark N. Milkman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) NUMBER (IF KNOWN): K003496

DEVICE NAME: Cannulated Screw

INDICATIONS FOR USE:

The Cannulated Screw System by Pioneer will be indicated for use in long and small bone fracture fixation, which may include the following:

1. Fractures of the tarsals and metatarsals;
1. Metatarsal and phalangeal osteotomies;
1. Fractures of the carpals and metacarpals;
1. Carpal and metacarpal arthrodesis;
1. Small fragments of the hand and wrist;
1. Ligament fixation as appropriate;
1. Sacroiliac joint disruptions;
1. Fractures of the distal femur and proximal tibia;
1. Intracapsular fractures of the hip;
1. Ankle arthrodesis; and
1. Pelvis and acetabulum fractures;

This system is not indicated for use in the spine. The Cannulated Screw System by Pioneer will be offered both sterile and non-sterile and is a single use device.

AhMounacb- 01/22/01

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)

for Mark N Melkers
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

K003496

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.