The Extremity Medical IP Fusion System is designed to allow arthrodesis of the interphalangeal joints of the hand. The system has two intra-operative configurations: a cannulated or non-cannulated lag screw, and an intramedullary Post for engaging the lag screw. The Post consists of a threaded cylinder with an eyelet through the head at to accommodate the lag screw. The axis of the eyelet and the lag screw couple at an oblique angle, which forms a reference angle for the intended fusion. The system includes common instrumentation for application of surgical bone screws within the human body, such as drills, guide wires, countersinks, reamers, drill and guide wire guides, and a screwdriver.

AI/ML Overview

The provided text describes the EXTREMITY MEDICAL IP Fusion System, a device intended for arthrodesis of the interphalangeal joints of the hand. However, it does not explicitly state acceptance criteria in the form of quantitative performance metrics, nor does it detail a study that "proves the device meets the acceptance criteria" in the way one might expect for a diagnostic or AI-driven medical device.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through a comparison of design, materials, indications for use, and mechanical properties. The "study" mentioned primarily consists of non-clinical bench testing and clinical simulations in cadavers.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria for device performance. The "reported device performance" is described qualitatively as being "substantially equivalent" to predicate devices, based on the testing performed.

Acceptance Criterion	Reported Device Performance
Mechanical Performance:
Pull-out strength	Performed and compared to predicate devices; found to have equivalent mechanical properties.
Torque	Performed and compared to predicate devices; found to have equivalent mechanical properties.
Static bending	Performed and compared to predicate devices; found to have equivalent mechanical properties.
Dynamic bending	Performed and compared to predicate devices; found to have equivalent mechanical properties.
Surgical Technique Verification:	Performed in cadavers to verify the surgical technique.

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

Sample Size for Bench Testing: Not specified.
Sample Size for Cadaver Simulations: Not specified.
Data Provenance: The testing was conducted by Extremity Medical. The document does not specify country of origin for the data or whether the data was retrospective or prospective, though bench testing and cadaver simulations are by nature prospective for the purpose of device evaluation.

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

This information is not provided in the document. The "ground truth" for mechanical testing would be engineering standards and for cadaver simulations, it would be the successful application of the surgical technique. No external experts for "ground truth" establishment are mentioned.

4. Adjudication Method for the Test Set

An adjudication method is not described, as the testing involves direct measurement and observation rather than expert consensus on complex interpretations.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical implant, not a diagnostic or AI-assisted interpretation tool. The document explicitly states: "No clinical testing was performed."

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

This question is not applicable. The EXTREMITY MEDICAL IP Fusion System is a medical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

For bench testing: Engineering specifications and comparison against predicate device performance serve as the "ground truth" for mechanical properties.
For cadaver simulations: Successful demonstration of the surgical technique and proper device placement within anatomical structures serves as the "ground truth."

8. The Sample Size for the Training Set

This concept is not applicable as the device is a physical product and not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as point 8.

Summary

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K130120

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510(k) Summary of Safety and Effectiveness:

EXTREMITY MEDICAL IP Fusion System

APR 1 1 2013

Submitter:	EXTREMITY MEDICAL300 Interpace ParkwaySuite 410Parsippany, NJ 07054
Contact Person	Brian SmekalDirector, Regulatory AffairsPhone: (973) 588-8988Email: bsmekal@extremitymedical.com
Date Prepared	March 26, 2013
Trade Name	EXTREMITY MEDICAL IP Fusion System
Classification Nameand Number	Smooth or threaded metallic bone fixation fastener21 CFR 888.3040
Product Code	HWC
Predicate Devices	1. Kirschner Wires K0736742. Osteomed Hand Fusion System K1114193. EXTREMITY MEDICAL Screw System, Extremity Medical K121417
Device Description	The Extremity Medical IP Fusion System is designed to allow arthrodesis ofthe interphalangeal joints of the hand. The system has two intra-operativeconfigurations: a cannulated or non-cannulated lag screw, and anintramedullary Post for engaging the lag screw. The Post consists of a threadedcylinder with an eyelet through the head at to accommodate the lag screw. Theaxis of the eyelet and the lag screw couple at an oblique angle, which forms areference angle for the intended fusion. The system includes commoninstrumentation for application of surgical bone screws within the humanbody, such as drills, guide wires, countersinks, reamers, drill and guide wireguides, and a screwdriver.
Indications for use	The Extremity Medical IP Fusion System is intended for reduction and internalfixation of arthrodesis of the interphalangeal joints of the hand.
Statement ofTechnologicalComparison	The EXTREMITY MEDICAL IP Fusion System and its predicate deviceshave the same indications for use; have a similar design; are made of similarmaterials, and have equivalent mechanical properties.
Non-clinical Testing	Bench testing, including pull-out strength, torque, and static and dynamicbending was performed and compared to the predicate devices. Clinical
	simulations in cadavers were performed to verify the surgical technique.
Clinical Testing	No clinical testing was performed.
Conclusion	The EXTREMITY MEDICAL IP Fusion System is substantially equivalent to its predicate devices. This conclusion is based upon indications for use, materials, design, test data and principles of operation.

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K130120

complete with the state the states

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized eagle emblem, consisting of three curved lines that resemble the wings and body of an eagle.

Public Health Service

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

Letter dated: April 11, 2013

Extremity Medical, LLC. % Mr. Brian Smekal Director, Regulatory Affairs 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054

Re: K130120

Trade/Device Name: EXTREMITY MEDICAL IP Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: January 28, 2013 Received: January 30, 2013

Dear Mr. Smekal:

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 – Mr. Brian Smekal

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

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): K130120 EXTREMITY MEDICAL IP Fusion System Device Name: Indications for Use:

The Extremity Medical IP Fusion System is intended for reduction and internal fixation of arthrodesis of the interphalangeal joints of the hand.

Prescription Use X AND/OR Over-the-counter (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth Lygrank -S

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.