The THP™ Hip Fracture Plating System is indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures.

Device Description

THP Hip Fracture Plating System is a set of metal plates and associated screws designed to affix to the lateral aspect of the proximal femur and provide fracture stabilization for femoral neck fractures and intertrochanteric fractures. The THP 5.0mm Cortical Screws are both locking and non-locking. The locking screws contain external threads that can be used to lock the threaded holes on the plate body, while the non-locking screws do not include the external threads to complete this task.

AI/ML Overview

The provided document is a 510(k) premarket notification for the "THP™ Hip Fracture Plating System" by Biomet, Inc. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily addressing design modifications (specifically related to 5.0mm cortical screws and plate modifications) and confirming that these changes do not adversely affect the device's safety and effectiveness.

Crucially, this document does not describe a study involving an AI/Machine Learning device or a diagnostic device that would require the typical performance metrics of sensitivity, specificity, or reader studies. Instead, it describes mechanical and biocompatibility testing of a physical implantable medical device.

Therefore, most of the requested information (acceptance criteria for AI, sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this submission.

Here's how to address the request based on the provided document:

Acceptance Criteria and Study for the "THP™ Hip Fracture Plating System"

This 510(k) submission for the THP™ Hip Fracture Plating System focuses on demonstrating substantial equivalence to predicate devices, particularly in light of design modifications to address a head breakage issue in previously cleared screws and enhancements to the plates. The "acceptance criteria" in this context are primarily related to the mechanical performance and biocompatibility of the revised components being equivalent or superior to the predicate devices, ensuring no new safety or effectiveness concerns are introduced.

1. Table of Acceptance Criteria and Reported Device Performance

Test/Criterion	Acceptance Criteria (Defined by substantially equivalent performance)	Reported Device Performance
Mechanical Performance: Shaft Screws (FX00080-09) - Max Failure Torque (for 5.0mm cortical screws)	To demonstrate that the mechanical strength of the proposed 5.0mm cortical screws is statistically equivalent to or superior to the predicate 4.5mm cortical screws (from K140018) and CHS screws (from K813554), specifically addressing the head breakage issue.	Improved Strength: The 5.0mm cortical screws were found to be 106.6% stronger than the equivalent 4.5mm TSP (predicate K140018) in max failure torque, and had an increase of 21.1% in max failure torque when compared to the equivalent CHS screws (predicate K813554). This not only eliminated the head breakage issue but also demonstrated superior strength. Conclusion: "This study demonstrated that the mechanical strength of the proposed device is statistically equivalent to that of the predicate devices." (Note: "equivalent" here implies at least as good, with demonstrated superiority in key metrics.)
Hip FX Plate Construct Fatigue Testing (FX00080-10)	To demonstrate that the proposed device (plate construct) can withstand a cyclic moment load equal to or greater than the predicate device.	"This study demonstrated that the proposed device can withstand a cyclic moment load equal to or greater than the predicate device."
Hip Fx vs. CHS Plate Construct Fatigue Test (FX00080-05)	To demonstrate that the proposed device (plate construct) can withstand a fatigue load, of the 2 Screw and 3 Screw constructs in a simulated bone with an intertrochanteric fracture, equal to or greater than the predicate device.	"This study demonstrated that the proposed device can withstand a fatigue load, of the 2 Screw and 3 Screw constructs in a simulated bone with an intertrochanteric fracture, equal to or greater than the predicate device."
Biocompatibility:	To ensure that the minor changes in geometry do not affect the biological safety of the plates, screws, and instruments. Based on prior testing of similar materials.	"The minor changes in geometry do not affect the biological safety of the plates, screws, and instruments in this submission. The original Biocompatibility testing was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed."
Sterilization (Shelf Life):	To verify the minimum sterilization dose.	"The minimum sterilization dose was verified using method VDmax 25 per ISO 11137-2:2013, 'Sterilization of health care products – Radiation Part 2: Establishing Radiation Dose'."
Bacterial Endotoxin Test (BET):	To establish product non-pyrogenicity.	"Testing has been performed to establish product non-pyrogenicity."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the exact sample sizes (e.g., number of screws or plates) used for each mechanical test. This level of detail is typically found in the full test reports, which are part of the detailed submission but not typically summarized in the 510(k) summary. However, the studies were sufficient for the FDA to draw conclusions of substantial equivalence.
Data Provenance: The data is non-clinical performance data generated through mechanical and chemical testing of the device components (screws and plates). The location of the testing is not specified, but it would have been conducted under controlled laboratory conditions, likely by or for the manufacturer (Biomet, Inc., Warsaw, Indiana, USA). This is retrospective testing in the sense that it evaluates manufactured device components against predefined standards or predicate device performance. It is not human clinical data or patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable. This is not a diagnostic device or an AI/ML device requiring human expert annotation or ground truth derived from clinical interpretation. The "ground truth" for these mechanical tests is established by published ISO standards (e.g., ISO 11137-2:2013 for sterilization, ISO 10993-1 for biocompatibility) and direct physical measurements/testing against specified engineering parameters or predicate device performance.

4. Adjudication Method for the Test Set:

Not Applicable. No human adjudication method is relevant for these non-clinical, objective mechanical and chemical tests. The results are quantitative measurements interpreted against pre-defined performance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images). This submission is for a physical implantable orthopedic device, not a diagnostic imaging device or an AI component.

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

Not Applicable. This is not an algorithm or an AI device. The "performance" discussed is the physical, mechanical, and biological performance of an implantable metallic device.

7. The Type of Ground Truth Used:

Engineering Specifications / Predicate Device Performance / ISO Standards. The "ground truth" for the mechanical tests is the measured performance of the predicate devices or established engineering specifications for strength and fatigue resistance. For biocompatibility and sterilization, the ground truth is adherence to international standards (ISO 10993-1, ISO 11137-2:2013) and cGMP (21 CFR 58 for GLP). It is not expert consensus, pathology, or outcomes data in the sense of clinical studies.

8. The Sample Size for the Training Set:

Not Applicable. There is no "training set" in the context of an AI/ML algorithm here. The device itself is the product under evaluation, and its properties are tested directly.

9. How the Ground Truth for the Training Set was Established:

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

In summary, the provided FDA 510(k) document is for a traditional physical medical device (an orthopedic implant) and primarily demonstrates substantial equivalence through non-clinical mechanical and biocompatibility testing. The questions posed in the prompt are largely designed for AI/Machine Learning diagnostic devices and therefore do not directly apply to this specific submission.

Summary

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February 7, 2018

Biomet, Inc. Annette Minthorn Regulatory Affairs Sr. Specialist 56 East Bell Drive Warsaw, Indiana 46582

Re: K173826

Trade/Device Name: THPTM Hip Fracture Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDO, KTT, HWC Dated: December 15, 2017 Received: December 18, 2017

Dear Ms. Minthorn:

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -S

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

Enclosure

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Indications for Use

510(k) Number (if known)

K173826

Device Name

THPTM Hip Fracture Plating System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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BIOM ET

Traditional 510(k) Premarket Notification

510(k) Summary

Sponsor:	Biomet, Inc.56 East Bell DriveP.O. Box 587Warsaw, IN 46581Establishment Registration Number: 1825034
Contact Person:	Annette MinthornSr. Specialist, Trauma Regulatory AffairsTelephone: 574-372-4294Fax: (574) 372-4605
Date:	15 December 2017
Trade Name:	THP TM Hip Fracture Plating System
Common Name:	Fracture Plates and Cortical Screws
Classification Namesand References:	JDO - Device, fixation, proximal femoral, implant(21 CFR § 888.3030)KTT - Single/multiple component metallic bone fixationappliances and accessories (21 CFR § 888.3030)HWC - Smooth or threaded metallic bone fixation fastener(21 CFR § 888.3040)
Classification Panel:	Orthopedics/87
Predicate Device(s):	Biomet Hip Fracture Plating System (Biomet, K140018,cleared 04-April-2014)Captured Hip Screw System (Biomet, K813554, cleared12-January-1982)
Purpose and DeviceDescription:	THP Hip Fracture Plating System is a set of metal platesand associated screws designed to affix to the lateralaspect of the proximal femur and provide fracturestabilization for femoral neck fractures andintertrochanteric fractures.

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	The THP 5.0mm Cortical Screws are both locking andnon-locking. The locking screws contain external threadsthat can be used to lock the threaded holes on the platebody, while the non-locking screws do not include theexternal threads to complete this task.
Intended Use:	The THP Hip Fracture Plating System is indicated for usein the open reduction and internal fixation of a widevariety of fractures of the proximal femur: intracapsularfractures and intertrochanteric fractures.
Comparison to Predicate Device:	The THP Hip Fracture Plating System 5.0mm corticalscrews are subject of this submission in part to a correctiveaction. These screws will replace the 4.5mm corticalscrews that were cleared in K140018 with the TSPFracture Plates. These screws were found to have a headbreakage issue and thus were recalled. The 5.0mmcortical screws were designed to address the headbreakage issue, tested and proven not only eliminate thehead breakage, but were also found to be 106.6% strongerthan the equivalent 4.5mm TSP in max failure torque, aswell as an increase of 21.1% in max failure torque whencompared to the equivalent CHS screws (cleared inK813554).In addition, the THP Hip Fracture Plating System platesunderwent the following modifications: removed theposterior guide wire hole, updated anterior guide wire holeto accept 2.5mm guide wire, added proximal sweep foranatomical fit, and replaced compression hole withlocking hole (4 hole only). These modifications are thesubject of this submission. The original THP plates werecleared in K140018. These plates were not part of therecall. The modifications made are to enhance the platesand do not represent a new worse case.
Performance Data (Nonclinicaland/or Clinical):	Non-Clinical Performance and Conclusions:Shelf Life - The minimum sterilization dose was verifiedusing method VDmax 25 per ISO 11137-2:2013,"Sterilization of health care products – RadiationPart 2: Establishing Radiation Dose".Biocompatibility – The minor changes in geometry donot affect the biological safety of the plates, screws,and instruments in this submission. The original

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Biocompatibility testing was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed.

. Bacterial Endotoxin Test (BET) - Testing has been performed to establish product non-pyrogenicity.
Performance Evaluation -Testing conducted on the proposed device is summarized below.

Mechanical Testing - Shaft Screws FX00080-09 . This study demonstrated that the mechanical strength of the proposed device is statistically equivalent to that of the predicate devices.

Hip FX Plate Construct Fatigue Testing FX00080-. 10 - This study demonstrated that the proposed device can withstand a cyclic moment load equal to or greater than the predicate device.

. Hip Fx vs. CHS Plate Construct Fatigue Test FX00080-05 - This study demonstrated that the proposed device can withstand a fatigue load, of the 2 Screw and 3 Screw constructs in a simulated bone with an intertrochanteric fracture, equal to or greater than the predicate device.

Conclusions: The data presented in this submission show that the changes do not affect the safety and/or effectiveness of the subject devices and that the subject devices will perform in a substantially equivalent manner to the predicate devices.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for these devices to show substantial equivalence.

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.