The Cerclage Cable with Hex Button device is indicated for use where wire, cable, or band cerclage is used in combination with plates. The Cerclage Cable with Hex Button device is intended for long bone fractures and is to be used with commercially available bone screws of the same general material type as the plate.

Device Description

The Cerclage with Hex Button is a cerclage cable and a button device that links the cable and bone screw together . The button is positioned in the hex of a bone screw. The cerclage cable is passed through the button and around the bone. The cerclage is crimped to lock the cable in place.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cerclage Cable with Hex Button.

Important Note: The provided text is a 510(k) summary for a medical device. These summaries often focus on demonstrating equivalence to existing devices rather than exhaustive performance studies on novel devices. Therefore, some of the requested information (like detailed AI-specific studies, multi-reader multi-case studies, or specific training set details) is unlikely to be present as this is a mechanical medical device, not an AI/software device.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on static yield loading values. The core acceptance criterion is that the new device's performance in this metric is equivalent to or better than the predicate devices.

Acceptance Criteria	Reported Device Performance
Static yield loading values equivalent to predicate devices	The Cerclage Cable with Hex Button device's static yield
	loading values were found to be equivalent to the values of the three predicate devices.

Study Details

Given the nature of the device (a mechanical cerclage system) and the regulatory submission type (510(k)), the "study" described is a comparative performance test against predicate devices, specifically focusing on mechanical properties.

Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated. The summary mentions "static yield loading values" which implies a series of mechanical tests were conducted on prototypes of the new device and the predicate devices. However, the exact number of units tested is not provided.
- Data provenance: Not explicitly stated, but it would be laboratory testing conducted by Pioneer Laboratories (retrospective in the sense that the testing was completed before the submission). There is no indication of country of origin for data as it's a mechanical test, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the "ground truth" for a mechanical device's performance is established by engineering specifications and mechanical testing standards, not expert consensus. Performance is measured against physical properties like yield strength.
Adjudication method for the test set:
- Not applicable. Mechanical tests involve objective measurements, not subjective interpretation requiring adjudication among experts.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices where human interpretation is involved. The Cerclage Cable with Hex Button is a mechanical implant, not an AI system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. This device is a physical medical implant, not an algorithm or software. Its performance is inherent to its mechanical design and materials, not an algorithm's output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this type of device's performance is based on engineering standards and mechanical test results (e.g., force applied, deformation measured, point of yield). The predicate devices' established performance in these tests serves as the benchmark for equivalence.
The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
How the ground truth for the training set was established:
- Not applicable. There is no training set for this mechanical device.

Summary of Device Equivalence Claim

The 510(k) summary clearly states that equivalence is predicated on the similar intended use and technological characteristics (cables, crimps, bone plates, tensioning mechanisms) to the predicate devices. The key performance data provided to affirm this equivalence is the static yield loading values, which were found to be comparable between the new device and the predicate devices. This demonstrates that under relevant mechanical stress, the new device performs similarly to devices already on the market.

Summary

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510(K) Summary 5.

Pioneer Laboratories 510(K) Notification Summary For Cerclage Cable with Hex Button

Administrative Information

Manufacturer Identification and Sponsor:

Pioneer Laboratories 375 River Park Circle Marquette, MI 49855-1781 Telephone: 906-226-9909 FAX: 906-226-9932

Official Contact:

Burns Severson Vice President, Regulatory Affairs/Quality Assurance

Date Prepared:

Device Identification

Proprietary Name: Cerclage Cable with Hex Button

Common Name Plate, Fixation, Bone

Classification Name and Reference: Cerclage, Bone fixation Regulation Number: CFR 888.3010 Classification Number: 87JDQII

Plate, Fixation, Bone Regulation Number: CFR 888.3030 Classification Number: 87JDQII

Devices on which substantial equivalence is claimed:

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Device Description

Intended Use

The Cerclage Cable with Hex Button device is indicated for use where wire or cable is used in conjunction with bone screws and/or plating. 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. The Cerclage Cable with Hex Button device is intended for long bone fractures and is to be used with commercially available bone screws of the same general material type as the plate.

Technological Characteristic Compared to Predicate Device

All the devices use cables, crimps, and a bone plate as a system used for long bone fracture fixation. Each system uses a tensioner and crimp to apply compression, and lock the cable. Each system has a stabilizing feature that limits longitudinal movement of the cable. The Dall-Miles Broad Bone Plate device places the rectangular crimp and cable over the bone plate. The Pioneer Laboratories Bone Plate with Cerclage Cable device has the crimp internal to the plate. The Bone Plate with Cable device has the oval crimp adjacent to the plate with the cable passing through a hole in the plate.

The Cerclage with Hex Button has a cerclage adiacent to the plate with the cable passing through a hole in the hex button that is positioned in the hex of the plate screw.

Performance Data

The Cerclage Cable with Hex Button device was predicated on the use of the Pioneer Laboratories Bone Plate with Cerclage Cable and Bone Plate with Cerclage Cable Device. The static vield loading values indicated that the Cerclage Cable with Hex Button device is equivalent to the values of the three predicate devices.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 19 1997

Mr. Burns Severson "Vice President, Regulatory Affairs/Quality Assurance Pioneer Laboratories 375 River Park Circle Marquette, Michigan 49855

K974016 Re: Cerclage Cable with Hex Button Requlatory Class: II Product Code: JDQ Dated: October 16, 1997 Received: October 22, 1997

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 Regulations, 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 Requlation (QS) for Medical Devices: General requlation (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 miqht 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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Paqe 2 - Mr. Burns 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,

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

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Pioneer Laboratories

Cerclage Cable with Hex Button Device

Indications for Use

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Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.