The Biomet Hip Fracture Plating Systems are 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. Fracture plates with six or more femoral shaft fixation screw holes are also indicated for subtrochanteric fractures as well as proximal femoral osteotomies.

Device Description

The TSP Hip Fracture Plating System consists of a series of side specific fracture plates designed to treat femoral neck, intertrochanteric and subtrochanteric fractures.

The TSP Hip Fracture Plating System incorporates fracture plates with multiple cortical screw hole configurations, three 7.5mm telescoping lag screws in lengths from 70mm to 130mm that are inserted into the femoral head and lock into the fracture plate, and 4.5mm cortical screws in lengths ranging from 14mm to 95mm with either locking or non-locking head designs. The plates, lag screws and cortical screws are all made of Ti-6A1-4V titanium alloy with a TiMax® Type II anodized finish.

Limited collapse sleeves are also available in 5mm, 10mm, 15mm and 20mm lengths to limit the amount of distraction of the telescoping lag screws.

AI/ML Overview

The provided document is a 510(k) summary for the TSP Hip Fracture Plating System, which is a medical device for fixing bone fractures. This type of regulatory submission generally focuses on demonstrating substantial equivalence to a predicate device through non-clinical (e.g., benchtop) testing, rather than detailed clinical trials with acceptance criteria and statistical analysis of performance metrics typically seen for AI/ML devices.

Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are highly relevant for AI/ML device evaluations, are not applicable or available in this document.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

This document does not specify quantitative acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity for a diagnostic or prognostic device. Instead, it concludes that the device performs "as well as the predicate hip screw systems" based on non-clinical tests.

Table of Acceptance Criteria and Reported Device Performance (Not Applicable in the traditional sense for this device):

Acceptance Criteria Category	Specific Metric	Threshold	Reported Performance
Non-Clinical Performance	Static Fatigue	Not explicitly stated (implied: comparable to predicate)	Performed as well as predicate hip screw systems
	Cyclic Fatigue	Not explicitly stated (implied: comparable to predicate)	Performed as well as predicate hip screw systems
	Lag Screw Torsional Properties	Not explicitly stated (implied: comparable to predicate)	Tested
	Lag Screw Insertion/Removal Torques	Not explicitly stated (implied: comparable to predicate)	Tested
	Lag Screw Pullout Strength	Not explicitly stated (implied: comparable to predicate)	Tested
	Cortical Screw Torsional Properties	Not explicitly stated (implied: comparable to predicate)	Tested
	Cortical Screw Insertion/Removal Torques	Not explicitly stated (implied: comparable to predicate)	Tested
	Cortical Screw Pullout Strength	Not explicitly stated (implied: comparable to predicate)	Tested

Study Details

1. Sample size used for the test set and the data provenance:
- Not Applicable. No clinical test set data from human subjects is mentioned. The testing focused on the physical device components.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no clinical data was used, no expert ground truth establishment for a test set was conducted.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set.
4. 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-enabled device; therefore, no MRMC study, human readers, or AI assistance is relevant.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical orthopedic implant system, not an algorithm, so standalone performance is not relevant in this context.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For non-clinical testing, "ground truth" would refer to engineering specifications, material properties, and established test standards for mechanical devices. The document implies comparison to industry standards and predicate device performance.
7. The sample size for the training set:
- Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
8. How the ground truth for the training set was established:
- Not Applicable. No training set exists for this type of device.

Conclusion from the Document

The 510(k) submission for the TSP Hip Fracture Plating System states that:
"Non-Clinical Testing: Testing of the TSP Hip Fracture Plating System included static and cyclic fatigue tests. Additionally, the lag screws and cortical screws were tested for torsional properties, insertion and removal torques and pullout strength. Testing indicated that the system would perform as well as the predicate hip screw systems."

"Clinical Testing: Clinical testing was not determined to be necessary to demonstrate substantial equivalence of the TSP Hip Fracture Plating System to the predicate hip fracture plating systems."

This clearly indicates that the substantial equivalence was demonstrated solely through benchtop, non-clinical testing, comparing the device's mechanical properties to those of existing, legally marketed predicate devices. The "acceptance criteria" were implicitly met by demonstrating comparable performance in these non-clinical tests to the predicate devices.

Summary

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K140018 page 1 of 2

510(k) Summary 08 January, 2014 Preparation Date: Applicant/Sponsor: Biomet Trauma 56 East Bell Drive P.O. Box 587 Warsaw, IN 46758 I Establishment Registration: Contact Person: Garv Baker Sr. Regulatory Specialist Tel: (574) 372-1568 Fax: (574) 371-1027 TSP Hip Fracture Plating System Proprietary Name:

Proximal Femoral Plating System Common Name:

Classification Name: 21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories. Product Code(s): JDO, KTT

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

K813554 - Ace/Kyle Captured Hip Screw - Biomet (Formerly DePuy) K080685 - HipLOC Compression Hip Screw - Biomet K972629 - TK2 Compression Hip Screw System - Biomet (Formerly DePuy) K082874 - BioDrive Cannulated Screw System - Biomet K092078 - OptiLock Periarticular Plating System - Biomet

Device Description:

The TSP Hip Fracture Plating System consists of a series of side specific fracture plates designed to treat femoral neck, intertrochanteric and subtrochanteric fractures.

Malling Address: P.O. Box 587 Warsaw, IN 46581-0587 Toll Free: 800.348.9500 Office: 574.267.6839 Main Fax: 574.267.8137 www.blomet.com

Shipping Address : 56 East Bell Drive Warsaw, IN 46582

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Limited collapse sleeves are also available in 5mm, 10mm, 15mm and 20mm lengths to limit the amount of distraction of the telescoping lag screws.

Indications For Use:

Summary of Technologies:

The TSP Hip Fracture Plating System incorporates fracture plates with multiple cortical screw hole configurations. Telescoping lag screws are inserted into the femoral head and lock into the fracture plate. Cortical screws with either locking or non-locking head designs secure the plate to the lateral femur. Limited collapse sleeves are also available to limit the amount of the telescoping lag screws.

Non-Clinical Testing:

Testing of the TSP Hip Fracture Plating System included static and cyclic fatigue tests. Additionally, the lag screws and cortical screws were tested for torsional properties, insertion and removal torques and pullout strength. Testing indicated that the system would perform as well as the predicate hip screw systems.

Clinical Testing:

Clinical testing was not determined to be necessary to demonstrate substantial equivalence of the TSP Hip Fracture Plating System to the predicate hip fracture plating systems.

Conclusions:

The TSP Hip Fracture Plating System plates and screws incorporate the same basic design, the same technologies and the same materials as the predicate devices. Based on these similarities, the TSP Hip Fracture Plating System does not raise any new questions of safety or efficacy, and is substantially equivalent to the predicate hip fracture plating systems.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the seal is a stylized symbol that resembles three overlapping human figures or abstract shapes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 4, 2014

Biomet Manufacturing Corporation Mr. Gary Baker Senior Regulatory Specialist, Biomet Trauma 56 East Bell Drive Warsaw, Indiana 46582

Re: K140018

Trade/Device Name: TSP 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 Dated: February 12, 2014 Received: February 14, 2014

Dear Mr. Baker:

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 of any I 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

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Page 2 - Mr. Gary Baker

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/ReportalProblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Ronald P. Jean -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

Page 1 of 1

K140018 510(k) Number (if known):

Device Name: TSP Hip Fracture Plating System

Indications For Use:

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (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)

Elizabeth Liftank -S

Division of Orthopedic Devices

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.