The VAN Hip Fracture System is indicated for fixation of fractures of the femur, including intertrochanteric fractures, pertrochanteric fractures, subtrochanteric fractures and combinations of these fractures, pathological fractures in both diaphyseal and trochanteric areas, and nonunion or malunion.

Device Description

The VAN Hip Fracture System includes short and long intramedullary nails, lag screws and distal locking cortical bone screws. The nail contains an angle adjust feature that allows for the neck/shaft angle to be adjusted to accommodate anatomical variations in the femoral neck angle.

AI/ML Overview

The provided text describes a medical device, the VAN Hip Fracture System, and its regulatory clearance process, focusing on substantial equivalence to predicate devices. It does not contain information related to an AI/ML powered device, nor does it detail a study with acceptance criteria, device performance, or human reader effectiveness in the way typically associated with such devices.

Therefore, I cannot fulfill your request for the specific information points you've outlined, as they are not present in the provided document. The document describes a traditional medical device (an intramedullary fixation rod) and its pre-clinical mechanical testing, not a diagnostic or prognostic AI/ML system.

The "Preclinical Testing" section {1} states:
"Static and dynamic mechanical testing was performed on the VAN Hip Fracture System in accordance with ASTM F384, Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices. The results demonstrate that the VAN Hip Fracture System is substantially equivalent to a predicate device in side-by-side testing."

This indicates that:

Acceptance Criteria: Based on "substantial equivalence" to a predicate device in mechanical performance as defined by ASTM F384. The specific numerical criteria for static and dynamic mechanical properties are not detailed in the provided text, but would be expected to match or exceed those of the predicate.
Device Performance: The device's performance "demonstrate[s] that the VAN Hip Fracture System is substantially equivalent to a predicate device." Again, specific numerical performance metrics are not provided.
Study Type: Mechanical testing, not a clinical or AI-centric study.

Given the nature of the document, the following points you requested cannot be addressed:

Table of acceptance criteria and reported device performance: Not explicitly stated in the provided text (only general statement of "substantial equivalence").
Sample sized used for the test set and the data provenance: Not applicable; this was mechanical testing, not a data-driven study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
MRMC comparative effectiveness study, effect size: Not applicable.
Standalone (algorithm only) performance: Not applicable.
Type of ground truth used: Not applicable (mechanical properties compared to a predicate, not clinical ground truth).
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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MAR 1 0 2014

5. 510(k) Summary

Device Trade Name:	VAN Hip Fracture System
Manufacturer:	EPIX Orthopaedic, Corp.191 Pine LaneLos Altos, CA 94022
Contact:	Ms. Michelle McDonoughMusculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798
Date Prepared:	September 30, 2013
Common Name:	Intramedullary Fixation Rod
Classification:	21 CFR 888.3020, Intramedullary fixation rod.
Class:	II
Product Code:	HSB

Indications For Use:

Device Description:

Predicate Device:

The VAN Hip Fracture System is substantially equivalent to the Stryker Howmedica Osteonics Gamma 3 Nail System (K032244), Biomet Vari-Angle Hip Screw (VHS) System (K964880), and Disc-O-Tech Fixion Nail (K010988).

{1}------------------------------------------------

Preclinical Testing:

Static and dynamic mechanical testing was performed on the VAN Hip Fracture System in accordance with ASTM F384, Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices. The results demonstrate that the VAN Hip Fracture System is substantially equivalent to a predicate device in side-by-side testing.

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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

March 10, 2014

EPIX Orthopaedic, Corp. % Ms. Michelle McDonough Senior Associate, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisors 1331 H Street, NW, 12th Floor Washington, DC 20005

Re: K133104

Trade/Device Name: VAN Hip Fracture System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: January 27, 2014 Received: January 28, 2014

Dear Ms. McDonough:

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 complics 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 sct

{3}------------------------------------------------

Page 2 - Ms. Michelle McDonough

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" (21CFR 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/MedicalDevices/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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Indications for Use 4.

510(k) Number (if known):

Device Name: VAN Hip Fracture System

The VAN Hip Fracture System is indicated for fixation of fractures of the femur, including intertrochanterie fractures, pertrochanterie fractures, subtrochanterie fractures and combinations of these fractures, pathological fractures in both diaphyscal and trochanteric areas, and nonunion or malunion.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR
C
{

Over-The-Counter Use (21 CFR 801 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.