The Synthes Synsonic Ulna Nail System consists of intramedullary nails with end caps and locking tacks designed to treat fractures of the ulna. The system makes use of an ultrasonic generator to deliver energy through a handpiece to securely fasten the locking tacks to the surface of the nail. The handpiece features a force sensor mechanism that provides feedback to the surgeon on the amount of load applied to the locking tack. An audible tone indicates when the correct pressure range is achieved to allow fixation of the tack to the nail. The ulnar nail and locking tack implants are composed of PEEK-Optima® polymer material and implant grade stainless steel. Locking of the tack to the nail creates a fixed angle construct that provides rotational alignment, torsional stability and axial control of the fractured ulna.

AI/ML Overview

The provided text describes the 510(k) summary for the Synthes Synsonic Ulna Nail System. This document focuses on the mechanical and electrical safety of the device, rather than its performance in an AI/diagnostic context. Therefore, the questions related to AI-specific elements like sample sizes for training/test sets, ground truth establishment by experts, and MRMC studies are not applicable.

Here's the information that can be extracted from the provided text regarding the device's acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines the types of tests conducted to support the substantial equivalence of the Synthes Synsonic Ulna Nail System to predicate devices and to ensure its safe use. Specific acceptance criteria are mentioned for some tests.

Test Type	Acceptance Criteria	Reported Device Performance
Bench Testing for Substantial Equivalence
Static Cantilever Bend Testing	Implicit: Performance comparable to predicate devices.	The results of the bench testing indicate that the performance of the proposed Synsonic Ulna Nail System supports its substantial equivalence to the predicate devices.
Cyclic Torsion Testing	Implicit: Performance comparable to predicate devices.	The results of the bench testing indicate that the performance of the proposed Synsonic Ulna Nail System supports its substantial equivalence to the predicate devices.
Tack Removal Testing	Implicit: Performance comparable to predicate devices.	The results of the bench testing indicate that the performance of the proposed Synsonic Ulna Nail System supports its substantial equivalence to the predicate devices.
Nail Removal Testing	Implicit: Performance comparable to predicate devices.	The results of the bench testing indicate that the performance of the proposed Synsonic Ulna Nail System supports its substantial equivalence to the predicate devices.
Design Verification Testing (Risk Analysis)
Thermal Profile Testing	Compared to criteria for thermal bone injury documented in clinical literature.	The results of the safety tests conducted on the subject system met the established criteria and conform to the requirements of the relevant standards.
Electrical Safety	In accordance with IEC 60601-1.	The results of the safety tests conducted on the subject system met the established criteria and conform to the requirements of the relevant standards.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated in terms of number of devices or units tested for each benchmark test. The document mentions "the subject device construct" for bench testing and "all of the components of proposed system" for electrical safety.
Data Provenance: The tests were "conducted on the subject device construct" and "on the proposed Synsonic Ulna Nail System," implying that the testing was performed directly on the manufactured device components. The location of the testing is not specified, but the applicant (Synthes) is based in West Chester, PA, USA. This is a prospective experimental study (lab testing) rather than a retrospective analysis of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is a medical implant system and its evaluation focuses on mechanical and electrical safety and performance, not on diagnostic accuracy requiring expert interpretation of data or images. The "ground truth" for the thermal profile testing was "criteria for thermal bone injury documented in clinical literature," which represents established medical knowledge rather than expert consensus on a specific test set.

4. Adjudication method for the test set:

Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication. The tests involve quantifiable measurements against established engineering and safety standards.

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-assisted diagnostic or imaging device.

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

Not applicable. This device does not involve an algorithm for standalone performance evaluation in the context of AI.

7. The type of ground truth used:

The ground truth for the mechanical bench testing appears to be the performance characteristics of the predicate devices, against which the new device's performance was compared to establish "substantial equivalence."
For thermal profile testing, the ground truth was "criteria for thermal bone injury documented in clinical literature."
For electrical safety, the ground truth was the requirements specified in "IEC 60601-1" standard.

8. The sample size for the training set:

Not applicable. This device does not utilize machine learning or AI that would require a "training set."

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

Not applicable. As there is no training set for an AI/ML model, this question is not relevant.

Summary

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MAR 3 1 2014

6.0 - 510(k) Summary

Date Prepared: June 28, 2013

Sponsor:	SynthesAngela F. Lassandro1301 Goshen ParkwayWest Chester, PA 19380Office: (610) 719-6854Fax: (484)-356-9682
ProprietaryName:	Synthes Synsonic Ulna Nail System
Classification:	Classification: 888.3020Product Code: HSB
PredicateDevice:	Synthes Titanium Elastic Intramedullary Nail System (K042135)Synthes Olecranon Osteotomy Nail System (K073402)Bonutti Research, Inc. Unity Ultrasonic System (K090175)
DeviceDescription:	The Synthes Synsonic Ulna Nail System consists of intramedullary nails withend caps and locking tacks designed to treat fractures of the ulna. The systemmakes use of an ultrasonic generator to deliver energy through a handpiece tosecurely fasten the locking tacks to the surface of the nail. The handpiecefeatures a force sensor mechanism that provides feedback to the surgeon onthe amount of load applied to the locking tack. An audible tone indicateswhen the correct pressure range is achieved to allow fixation of the tack to thenail.The ulnar nail and locking tack implants are composed of PEEK-Optima® polymer material and implant grade stainless steel. Locking of the tack to the nail creates a fixed angle construct that provides rotational alignment,torsional stability and axial control of the fractured ulna.
Indicationsfor Use:	The Synthes Synsonic Ulna Nail System is intended to treat shaft fractures ofthe ulna, impending pathological fractures, malunions, and nonunions.
	The summary information presented supports the substantial equivalence of
Substantial	the Synthes Synsonic Ulna Nail System to the predicate devices. The
Equivalence:	proposed system has the same intended use, similar indications for use and
	employs the same technology.
	Bench testing was conducted on the subject device construct to support
	substantial equivalence to the predicate devices including:
	Static Cantilever Bend Testing
	Cyclic Torsion Testing
	Tack Removal Testing
	Nail Removal Testing
	Design verification testing was conducted as part of the risk analysis to ensurethe safe use of the subject device. This testing included:
	Thermal Profile Testing: Conducted to analyze temperatures inducedby the welding cycle and compared to criteria for thermal bone injurydocumented in clinical literature.
	The ultrasonic generator, handpiece, and footswitch components the proposedSynsonic Ulna Nail System were evaluated for electrical safety in accordancewith the IEC 60601-1.
	The testing evaluated all of the components of proposed system, including theSynthes Synsonic Ultrasonic Generator, Handpiece, and Footswitch.
	The results of the bench testing indicate that the performance of the proposedSynsonic Ulna Nail System support its substantial equivalence to thepredicate devices and will present no new issues with regard to safety oreffectiveness. Additionally, the results of the safety tests conducted on thesubject system met the established criteria and conform to the requirements ofthe relevant standards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

March 31, 2014

Synthes Ms. Angela F. Lassandro Regulatory Affairs Manager 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K131984

Trade/Device Name: Synthes Synsonic Ulna Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: March 7, 2014 Received: March 10, 2014

Dear Ms. Lassandro:

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.

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

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Page 2 - Angela F. Lassandro

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Medica|Devices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Lori A. Wiggins

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5.0 - Indications for Use Statement

K131984 510(k) Number (if known):

Device Name: Synthes Synsonic Ulna Nail System

Indications for Use:

The Synthes Synsonic Ulna Nail System is intended to treat shaft fractures of the ulna. impending pathological fractures, malunions, and nonunions.

Prescription Use _ X (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.