The Hex Button device is intended for use where wire, cable, or band cerclage is used in combination with bone screws and/or plates, of the same material type, to provide internal fixation of fractured bone.

The Hex Button device is indicated for use where wire or cable is used in conjunction with bone screws and/or plating. The Hex Button device is intended for use where wire, cable, or band cerclage is used in combination with bone screws and/or plates, of the same material type, to provide internal fixation of fractured bone. The system is designed to provide increased compression as compared to only a screw and/or plate in situations where there is inadequate bone stock, multiple fractures or butterfly fragments

Device Description

The Hex Button is a device that is used with a cerclage device and bone screws. The Hex Button and the artists a device that is used while a cerclage device and bone screws. The Flex Button device links the cable and bone screw together. The button is position

hex recess of a bone screw. The cerclage cable is passed through the button and around the bone, afterwhich the cerclage device is crimped to lock the cable in place.

AI/ML Overview

Here's an analysis of the provided text regarding the Hex Button Device's acceptance criteria and study, structured to answer your questions:

The provided 510(k) summary for the Hex Button device (K992617) does not contain information about clinical studies with human readers or AI assistance. The performance data section describes engineering tests to demonstrate the device's mechanical integrity. Therefore, some of your requested information, particularly regarding AI performance, human reader studies, and ground truth for training/testing sets, cannot be extracted from this document as it pertains to a physical medical device, not an AI/Software as a Medical Device (SaMD).

However, I will extract the relevant information that is available:

Acceptance Criteria and Device Performance (Engineering Tests)

Acceptance Criteria Category	Specific Test/Performance	Reported Device Performance
Mechanical Integrity	Static Yield	Cerclage cable was the failure mode. Hex Button showed little to no wear. In no test cases did the Hex Button fail.
Corrosion Resistance	Crevice Corrosion Fatigue	Cerclage cable was the failure mode. Hex Button showed little to no wear. In no test cases did the Hex Button fail.

Study Details (Based on Available Information)

Sample Size used for the test set and the data provenance:
- The document describes engineering tests, not studies with a "test set" in the context of diagnostic performance (e.g., images for AI).
- The sample size for these mechanical tests is not explicitly stated (e.g., "N=X Hex Buttons were tested").
- Data provenance is not applicable since these are laboratory mechanical tests of the physical device components.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in this context refers to the outcome of mechanical stress and corrosion tests, evaluated by engineering standards rather than expert clinical consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. These were engineering tests with predefined failure criteria for mechanical properties, not diagnostic performance with subjective interpretation.
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:
- No. This is a physical medical device (a surgical hardware component), not an AI/SaMD. MRMC studies are not relevant for this type of device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a physical medical device, not an algorithm. Standalone performance is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the engineering tests, the "ground truth" was the mechanical failure point observed during static yield and corrosion fatigue tests, as well as the absence of wear/failure on the Hex Button itself. This is determined by material science and engineering principles and measurements.
The sample size for the training set:
- Not applicable. The device is a physical component, not an AI model, so there is no training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

Summary regarding the nature of the study:

The Hex Button device is a surgical implant component. The "study" described in the 510(k) summary (Performance Data section) consists of benchtop engineering tests for static yield and crevice corrosion fatigue. These tests aimed to demonstrate the physical and mechanical integrity of the Hex Button itself when used in conjunction with a cerclage cable, specifically showing that the Hex Button did not fail and exhibited minimal wear, while the cerclage cable (the component connecting through the button) was the intended failure point under stress.

The submission relies on substantial equivalence to an existing predicate device (Cerclage Cable with Hex Button Device, K974016), leveraging the prior testing and clearance of that predicate. The "Performance Data" is provided to confirm that the Hex Button material and design in this new submission behave identically or acceptably to the previously cleared device.

Summary

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K992617

Pioneer Laboratories

Hex Button Device

Indications for Use

The Hex Button device is indicated for fractures that may not be securely held by either a screw or a cerclage device alone.

Prescription Use
(Per 21 CFR 801.109)

Pcotufo 8

(Division Sign-Off) Division of General Restorative Devices Kgg2b 510(k) Numbe

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OCT 2 7 1999

V. 510(K) SUMMARY

K992617

Pioneer Laboratories 510(K) Notification Summary For Hex Button

Administrative Information

Manufacturer Identification and Sponsor:	Pioneer Laboratories375 River Park CircleMarquette, MI 49855-1781Telephone: 906-226-9909FAX: 906-226-9932
Official Contact:	Burns Severson
Official Contact:	Burns SeversonVice President, Regulatory Affairs/Quality Assurance
Date Prepared:	August 3. 1999

August 3, 1999

Device Identification

Proprietary Name:	Hex Button
Common Name:	Washer, Bolt, Nut, Orthopedic
Classification Name and Reference:	Washer, Bolt, Nut, Orthopedic
Regulation Number:	CFR 888.3030
Classification Number:	87HTN
Device Class:	II
Devices on Which Substantial Equivalence is Claimed:

Cerclage Cable with Hex Button Device (K974016)

Device Description

The Hex Button is a device that is used with a cerclage device and bone screws. The Hex Button and the artists a device that is used while a cerclage device and bone screws. The Flex
Button device links the cable and bone screw together. The button is position

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510(K) SUMMARY (Continued) V.

hex recess of a bone screw. The cerclage cable is passed through the button and around the bone, afterwhich the cerclage device is crimped to lock the cable in place.

Intended Use

Technological Characteristic Compared to Predicate Device

The Hex Button device is the same button used in the predicate Cerclage cable with Hex Button device (K974016). For both devices, a cerclaging device is passed through the hole in the Hex Button after the button is positioned in the hex recess of a seated bone screw.

Performance Data

The Hex Button device was predicated on the use of the Cerclage cable with Hex Button device (K974016). The Cerclage cable with Hex Button device (K974016) was tested in static yicld and crevice corrosion fatigue. In both tests, the cerclage cable was the failure mode with the Hex Button showing little if no wear. In no test cases did the Hex Button fail.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures, possibly representing a family or community, with their arms raised in a gesture of support or unity.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 7 1999

Mr. Burns O. Severson nr. Barns of belident, Regulatory Affairs/Quality Assurance Pioneer Surqical Technology 375 River Park Circle Marquette, Michigan 49855

Re : K992617 Trade Name: Hex Button Requlatory Class: II Product Code: HTN Dated: August 2, 1999 Received: August 4, 1999

Dear Mr. Severson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Burns O. Severson

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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.