The FastFrame External Fixation System - Distal Radius is indicated for use in treatment of appropriately sized long bone (wrist and hand) fractures. Specifically, the system is intended for:

-Stabilization of open or closed fractures, 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;
Stabilization of non-unions; and
Intraoperative temporary stabilization to assist with indirect reduction.

Device Description

The systems consists of fixation half- pins attached to rigid clamps connected by adjustable telescoping tubes (bars) and are intended for use in the treatment of long bone fractures that require external fixation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the FastFrame™ External Fixation System - Distal Radius. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a study with acceptance criteria in the context of AI/software performance.

Therefore, the information required to answer your specific questions about acceptance criteria, device performance, ground truth establishment, sample sizes, expert adjudication, and MRMC studies for an AI/software device is not present in this document. The document pertains to a physical medical device (an external fixation system) and its mechanical and physical performance.

Here's how the provided information relates to your questions, highlighting what is not available:

1. A table of acceptance criteria and the reported device performance:

Not available in the context of AI/software performance.
The document mentions "Performance Evaluation – The mechanical testing confirmed that the subject device performs substantially equivalent in full construct rigidity and interconnection performance as compared to the predicate device." This refers to physical, mechanical properties (e.g., strength, stiffness), not diagnostic or AI performance metrics like sensitivity, specificity, or AUC.
The device was found to be MRI Conditional, tested against ASTM standards (F2052-14, F2213-06, F2182-11a, F2119-07). These are physical safety and compatibility standards, not AI performance metrics.

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

Not applicable/Not available. This is a physical device; there is no "test set" of data in the sense of medical images or patient records for an AI algorithm. Mechanical testing would involve a certain number of physical units, but that's not the "sample size" you're asking about for AI validation.

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

Not applicable/Not available. Ground truth as it relates to AI performance (e.g., disease presence in an image) is not relevant for this physical device.

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

Not applicable/Not available.

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:

No, an MRMC study was not done. This type of study is for evaluating the impact of AI assistance on human reader performance, which is not relevant for a physical external fixation system.

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

No, this is a physical device, not an algorithm.

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

Not applicable/Not available. The "ground truth" for a physical device like this relates to its material properties and mechanical performance, established by engineering tests and adherence to standards, not medical diagnostic labels.

8. The sample size for the training set:

Not applicable/Not available. This is not an AI/ML device.

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

Not applicable/Not available.

In summary: The provided 510(k) notification for the FastFrame™ External Fixation System - Distal Radius demonstrates substantial equivalence primarily through non-clinical performance data (mechanical testing). It explicitly states that "Clinical data and conclusions were not needed for these devices to show substantial equivalence." This type of submission does not involve acceptance criteria or studies related to AI/software performance, image analysis, or human reader assistance.

Summary

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

December 4, 2015

Zimmer, Incorporated Sujith M. Kallur Regulatory Affairs Specialist P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K152484

Trade/Device Name: FastFrame™ External Fixation System - Distal Radius Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: KTT, JDW Dated: November 11, 2015 Received: November 12, 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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" (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 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K152484

Device Name

FastFrame External Fixation System - Distal Radius

Indications for Use (Describe)

The FastFrame External Fixation System - Distal Radius is indicated for use in treatment of appropriately sized long bone (wrist and hand) fractures. Specifically, the system is intended for:

-Stabilization of open or closed fractures, 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;
Stabilization of non-unions; 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/1 description: The image contains the logo for Zimmer Biomet. The logo features a stylized blue letter "Z" enclosed within a blue circle. Below the circle, the word "zimmer" is written in lowercase, using a modern, sans-serif font, also in blue.

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:	08/28/2015
Trade Name:	FastFrame™ External Fixation System - Distal Radius
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 Small External Fixation System by Zimmer Inc.K131413, cleared 28-Jan-2014-XtraFix Small External Fixation System by Zimmer Inc.K141697, cleared 18-Sep-2014
Purpose andDevice Description:	The purpose of this 510(k) is to obtain marketingclearance for the new device, the FastFrame ExternalFixation System - Distal Radius. The systems consists offixation half- pins attached to rigid clamps connected byadjustable telescoping tubes (bars) and are intended foruse in the treatment of long bone fractures that requireexternal fixation.
Intended Use/Indications for Use:	The FastFrame External Fixation System - Distal Radiusis indicated for use in treatment of appropriately sized long

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	bone (wrist and hand) fractures. Specifically, the system is intended for:
	- Stabilization of open or closed fractures, 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;
	- Stabilization of non-unions; and
	- Intraoperative temporary stabilization to assist with indirect reduction.
Comparison to Predicate Device:	Both the subject and predicate systems can be used to reduce and fix long bone anatomy of the wrist and hand. Both systems use bars, clamps, and fixation pins to achieve the clinical end result. Both systems allow for length distraction and polyaxial motion between clamp bodies.
	The major difference between the subject and predicate systems is that predicate system frame needs to be built intra-operatively. The FastFrame External Fixation System contains a frame which comes with clamps and bars (telescoping tubes) pre-assembled, and are not dissassemblable by the end user. The subject FastFrame External Fixation System is provided in a sterile kit as compared to the predicate system that is provided non-sterile, and must be steam sterilized prior to use.
Performance Data (Nonclinical and/or Clinical):	Non-Clinical Performance and Conclusions:
	Performance Evaluation – The mechanical testing confirmed that the subject device performs substantially equivalent in full construct rigidity and interconnection performance as compared to the predicate device. In addition, the FastFrame External Fixation System – Distal Radius was 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, ASTM F2052-14, ASTM F2213-06 (2011), ASTM F2182-11a, and ASTM F2119-07 (2013).

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Conclusions: The results demonstrate that the device is substantially equivalent to the predicate device.

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.