The FastFrame External Fixation System - Ankle Spanning is indicated for use in treatment of distal tibia and foot fractures. Specifically, the system is intended for:

Stabilization of open or closed fractures about the Ankle, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated;
Arthrodesis and osteotomies with associated soft tissue problems about the ankle;
Stabilization of limbs after removal of total ankle arthroplasty for infection or other failure;
Stabilization of non-unions about the ankle; and
Intraoperative temporary stabilization to assist with indirect reduction.

Device Description

The purpose of this 510(k) is to obtain marketing clearance for the new device, the FastFrame External Fixation System - Ankle Spanning. The system consists of fixation half- pins and transfixing full-pins attached to rigid clamps connected by adjustable telescoping tubes (bars). The system is intended for use in the treatment of fractures about the ankle that require external fixation. The system also contains a separately sterile packaged FastFrame External Fixation System - Ankle Spanning Optional Clamp Assembly. This Optional Clamp Assembly is included as an optional accessory that allows the surgeon to hold the foot in a fixed position post- operatively, if desired.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the FastFrame™ External Fixation System - Ankle Spanning. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data. There is no information about acceptance criteria, a study proving the device meets acceptance criteria regarding AI/algorithm performance, or any MRMC/standalone studies as would be relevant for an AI/ML device.

The provided text only discusses the following regarding performance:

1. Acceptance Criteria and Device Performance (Mechanical Testing):

Since this is a mechanical fixation system, the acceptance criteria and performance are related to mechanical properties.

Acceptance Criteria (Derived from text)	Reported Device Performance
Performance equivalent to predicate device in full construct rigidity	The mechanical testing confirmed that the subject devices perform substantially equivalent in full construct rigidity as compared to the predicate device.
Performance equivalent to predicate device in interconnection performance	The mechanical testing confirmed that the subject devices perform substantially equivalent in interconnection performance as compared to the predicate device.
FastFrame External Fixation System – Ankle Spanning Optional Clamp Assembly holds a clinically relevant load over a specified period of time.	The FastFrame External Fixation System – Ankle Spanning Optional Clamp Assembly was proven to be able to hold a clinically relevant load over a specified period of time.
MRI Conditional according to FDA guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment"	The FastFrame External Fixation System – Ankle Spanning and FastFrame External Fixation System – Ankle Spanning when used with the FastFrame External Fixation System -Ankle Spanning Optional Clamp Assembly were found to be MRI Conditional per FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" issued on December 11, 2014.

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

The document states: "Non-Clinical Performance and Conclusions: • Performance Evaluation – The mechanical testing confirmed that the subject devices perform substantially equivalent in full construct rigidity and interconnection performance as compared to the predicate device."
There is no specific number provided for mechanical test "samples" or "test sets" in the context of materials/mechanical testing, nor is "data provenance" (like country of origin or retrospective/prospective nature) applicable to this type of non-clinical mechanical testing documentation.

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

Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement, not by expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication is not relevant for mechanical testing.

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 device is a physical external fixation system, not an AI/ML diagnostic or assistive tool for human readers.

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

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For this device, "ground truth" for non-clinical testing refers to established engineering specifications, mechanical testing standards, and direct measurements of properties like rigidity and load-bearing capacity.

8. The sample size for the training set:

Not applicable. There is no AI/ML training set for this device.

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

Not applicable. There is no AI/ML training set for this device.

Summary of what is in the provided text:

The document is a 510(k) clearance letter for a medical device (external fixation system). The study proving the device meets acceptance criteria is described as non-clinical mechanical performance testing. This testing confirmed the device's substantial equivalence to a predicate device in terms of "full construct rigidity," "interconnection performance," and the ability of an optional clamp assembly to "hold a clinically relevant load over a specified period of time." Additionally, the device was found to be MRI Conditional.

Crucially, this document does not pertain to an AI/ML device, and therefore, questions related to AI acceptance criteria, training/test sets for algorithms, expert ground truth labeling, MRMC studies, or standalone algorithm performance are not addressed.

Summary

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

December 21, 2015

Zimmer, Incorporated Sujith Kallur Regulatory Affairs Specialist P.O. Box 708 Warsaw, Indiana 46851-0708

Re: K152755

Trade/Device Name: FastFrame™ External Fixation System-Ankle Spanning Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, JDW Dated: September 23, 2015 Received: September 24, 2015

Dear Sujith Kallur:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K152755

Device Name

FastFrame External Fixation System - Ankle Spanning

Indications for Use (Describe)

The FastFrame External Fixation System - Ankle Spanning is indicated for use in treatment of distal tibia and foot fractures. Specifically, the system is intended for:

Stabilization of open or closed fractures about the ankle, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated;
Arthrodesis and osteotomies with associated soft tissue problems about the ankle;
Stabilization of limbs after removal of total ankle arthroplasty for infection or other failure;
Stabilization of non-unions about the ankle; and
Intraoperative temporary stabilization to assist with indirect reduction.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Sujith M KallurRegulatory Affairs Specialist, Trauma Regulatory AffairsTelephone: 574-453-6350Fax: 574-871-8760
Date:	09/23/2015
Trade Name:	FastFrame™ External Fixation System - Ankle Spanning
Common Name:	External Fixation Frame Components
Classification Namesand References:	Appliance, Fixation, Nail/Blade/Plate Combination,Multiple Components (KTT) per 21 CFR 888.3030,Single/multiple component metallic bone fixationappliances and accessories and Pin, Fixation, Threaded(JDW) per 21 CFR 888.3040, Smooth or threaded metallicbone fixation fastener
Classification Panel:	Orthopedics/87
Predicate Device(s):	XtraFix External Fixation System by Zimmer Inc.K113383, cleared 6/26/2012
Purpose andDevice Description:	The purpose of this 510(k) is to obtain marketingclearance for the new device, the FastFrame ExternalFixation System - Ankle Spanning. The system consists offixation half- pins and transfixing full-pins attached torigid clamps connected by adjustable telescoping tubes(bars). The system is intended for use in the treatment offractures about the ankle that require external fixation. Thesystem also contains a separately sterile packagedFastFrame External Fixation System - Ankle SpanningOptional Clamp Assembly. This Optional ClampAssembly is included as an optional accessory that allowsthe surgeon to hold the foot in a fixed position post-operatively, if desired.
Intended Use/Indications for Use:	The FastFrame External Fixation System - AnkleSpanning is indicated for use in treatment of distal tibiaand foot fractures. Specifically, the system is intended for:
	- Stabilization of open or closed fractures about theAnkle, typically in the context of polytrauma orwhere open or alternative closed treatment isundesirable or otherwise contraindicated;
	- Arthrodesis and osteotomies with associated softtissue problems about the ankle;
	- Stabilization of limbs after removal of total anklearthroplasty for infection or other failure;
	- Stabilization of non-unions about the ankle; and
	- Intraoperative temporary stabilization to assistwith indirect reduction.
Comparison to Predicate Device:	Both the subject and predicate systems can be used toreduce and fix tibial and foot anatomy. Both systems usebars, clamps, and fixation pins to achieve the clinical endresult. Both systems allow for length distraction andpolyaxial motion between clamp bodies.
	The major difference between the subject and predicatesystems is that predicate system frame needs to be builtintra-operatively. The FastFrame External FixationSystem contains a frame which comes with clamps andbars (telescoping tubes) pre-assembled, and are notdissassemblable by the end user. The subject FastFrameExternal Fixation System is provided in sterile kits ascompared to the predicate system that is provided non-sterile, and must be steam sterilized prior to use.
	The FastFrame External Fixation System – AnkleSpanning Optional Clamp Assembly was proven to be ableto hold a clinically relevant load over a specified period oftime.
Performance Data (Nonclinicaland/or Clinical):	Non-Clinical Performance and Conclusions:• Performance Evaluation – The mechanical testing
	confirmed that the subject devices performsubstantially equivalent in full construct rigidity andinterconnection performance as compared to thepredicate device. In addition, the FastFrame External

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Fixation System – Ankle Spanning and FastFrame External Fixation System – Ankle Spanning when used with the FastFrame External Fixation System -Ankle Spanning Optional Clamp Assembly were found to be MRI Conditional per FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" issued on December 11, 2014.

Conclusions: The results demonstrate that the devices are safe and effective and substantially equivalent 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.