(257 days)
The XtraFix Small External Fixation System is indicated for use in construction of an external fixation frame for treatment of appropriately sized long bone (foot, arm, wrist and hand) fractures that require external fixation. 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 limbs after removal of total joint arthroplasty for infection or other failure:
- Stabilization of non-unions; and
- Intraoperative temporary stabilization tool to assist with indirect reduction.
The XtraFix Small External Fixation System subject of this 510(k) submission includes the following elements: Clamps (Bar/Pin to Bar/Pin, Integrated Multi-Pin); Bars; and Half Pins. The XtraFix Small External Fixation System is designed in such a way that several different types of frames can be assembled. Pins are inserted into bone, and then clamps are assembled to the pins. Bars are assembled to the clamps and a frame is constructed. After reducing the fracture, all clamps are tightened to hold the frame in place.
The provided document describes a 510(k) premarket notification for the Zimmer XtraFix® Small External Fixation System, which is a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific acceptance criteria, studies, and ground truth establishment are not applicable.
The document discusses the substantial equivalence of the XtraFix® Small External Fixation System to previously cleared predicate devices based on technological characteristics and performance data.
Here's the relevant information based on the provided text, adapted for a medical device rather than an AI system:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Data) | Reported Device Performance |
|---|---|
| Interconnection strength & system rigidity (per ASTM F1541-02(2007) and FDA Guidance) | Confirmed substantial equivalence to predicate devices. |
| MRI Conditional Claim: Force generated for worst component in 3T MRI | 43% the force of gravity |
| MRI Conditional Claim: Measurable torque in 3T static field | No measurable torque |
| MRI Conditional Claim: Heating for 15 minutes at a SAR of 3.1 W/kg | At most 4.7 ℃ |
| MRI Conditional Claim: Image artifact extension | Approximately 53-63mm from the device |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI/ML system. Instead, it refers to non-clinical performance data obtained through characterization and evaluation.
- Sample Size: Not explicitly stated for specific tests (e.g., how many devices were tested for MRI compatibility or mechanical strength). The evaluation was conducted on the "XtraFix Small External Fixation System," implying various components and configurations were subject to testing.
- Data Provenance: The tests were conducted according to established standards (ASTM F1541-02(2007)) and FDA guidance documents. This indicates laboratory testing and analysis, not data collected from human subjects (prospective or retrospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device, and ground truth, in this context, is established through standardized engineering tests, not expert consensus on medical images or diagnoses.
4. Adjudication method for the test set
Not applicable. This is not an AI/ML device. Performance is determined by meeting physical and material standards measured by equipment, not by human adjudication of results.
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 is not an AI/ML device. The study focused on the physical performance and safety characteristics of the device itself, not on human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the device itself in a standalone capacity, as its function is mechanical/structural, not diagnostic or AI-driven. The "performance data (nonclinical)" presented (interconnection strength, system rigidity, MRI compatibility) reflects the intrinsic properties and behavior of the device without human interaction once installed or during the MR environment.
7. The type of ground truth used
The "ground truth" for this device is based on:
- Engineering Standards and Specifications: Adherence to requirements outlined in ASTM F1541-02(2007) for external fixation devices.
- FDA Guidance Documents: Specific guidelines for orthopedic external fixation devices and establishing safety/compatibility of passive implants in MRI environments.
- Measured Physical Properties: Quantified measurements for force, torque, heating, and image artifact extension in MRI, compared against predefined safety thresholds.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set in that sense.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML system, this question is not relevant.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter Z inside it. Below the circle, the word "zimmer" is written in a blocky, sans-serif font.
P.O. Box 708 Warsaw. IN 46581-0708 574 267-6131
510(k) Summary
JAN 28 2014
Zimmer. Inc. Sponsor: P.O. Box 708 Warsaw, IN 46581-0708 Contact Person: Marcos Velez-Duran President. M Squared Associates, Inc. Telephone: 703-562-9800 (x 206) Fax: 703-562-9797 Date Summary Prepared: 05/15/2013 Trade Name: XtraFix® Small External Fixation System Common Name: External Fixation Frame Components Classification Name 21 CFR 888.3030 Single/multiple component metallic bone fixation and Reference: appliances and accessories 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener Product Code: KTT and JDW Classification Panel: Orthopedic/87 -XtraFix External Fixation System Line Additions. Zimmer. Predicate Device(s): K 113383 cleared on 06/26/2012 -TransFx External Fixation System. Zimmer, K984357 cleared on 3/4/1999 and K990848 cleared on 5/17/1999 -External Fixation, Small and Large MR Conditional, Synthes, K031724 cleared on 07/14/2003 and K082650 cleared on 11/18/2008 Purpose and The XiraFix Small External Fixation System subject of this 510(k) Device Description: submission includes the following elements: Clamps (Bar/Pin to Bar/Pin. Integrated Multi-Pin); Bars; and Half Pins. The Xrafix Small External Fixation System is designed in such a way that several different types of frames can be assembled. Pins are inserted
into bone. and then clamps are assembled to the pins. Bars are
{1}------------------------------------------------
Intended Use:
assembled to the clamps and a frame is constructed. After reducing the fracture. all clamps are tightened to hold the frame in place.
The XtraFix Small External Fixation System is indicated for use in construction of an external fixation frame for treatment of appropriately sized long bone (foot. arm. wrist and hand) fractures that require external fixation. 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 limbs after removal of total joint arthroplasty for infection or other failure:
- Stabilization of non-unions; and -
- Intraoperative temporary stabilization tool to assist with indirect reduction.
Summary of Technological Characteristics:
The subject XIraFix Small External Fixation System has the same technological characteristics as the predicate XiraFix External Fixation System. The elements are smaller versions of the elements in the larger system and they are manufactured using the same materials. In addition, the XraFix External Fixation System is similar to the Synthes External Fixation System and the TramsFx External Fixation System.
- Performance Data (Nonclinical and/or Clinical):
The XraFix Small External Fixation System was characterized and evaluated according to the requirements outlined in ASTM F1541-02(2007). FDA Guidance Documents: Standard Specification and Test Methods for External Fixation Devices, FDA Reviewers Guidance Checklist for Orthonedic External Fixation Devices, and Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. Interconnection strength and system rigidity testing and analyses confirmed that the subject device is substantially equivalent to the predicate devices. In addition, the XtraFix Small External Fixation System was found to be MRI Conditional per the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" issued on August 21. 2008. The following results support the MRI Conditional claim:
{2}------------------------------------------------
Force generated for worst component in a 3T MRI is 43% the force l ) of gravity:
No measurable torque was demonstrated in a 3T static field; 2)
-
Heating was at most 4.7 ℃ for 15 minutes at a SAR of 3.1 W/kg:
-
Image artifact extended approximately 53-63mm from the device.
Clinical data and conclusions were not needed to show substantial equivalence.
Substantial Equivalence Information:
The XtraFix Small External Fixation System is similar to legally marketed devices listed previously in that they share similar indications for use and incorporate similar technological characteristics. All evaluations determined that the XrraFix Small External Fixation System is substantially equivalent to the predicate devices.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, often associated with health and medicine.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 28, 2014
Zimmer, Incorporated % Mr. Romil Sheth Specialist, Trauma Regulatory Affairs Zimmer, Incorporated P.O. Box 780 Warsaw, Indiana 46581
Re: K131413
Trade/Device Name: XtraFix Small External Fixation System 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: December 23, 2013 Received: December 24, 2013
Dear Mr. Sheth:
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
{4}------------------------------------------------
Page 2 - Mr. Romil Sheth
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 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/Resourcesfor You/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 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 vours.
Vincen Doevlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
.
Indications for Use
510(k) Number (if known):
Device Name:
XtraFix® Small External Fixation System
Indications for Use:
The XiraFix Small External Fixation System is indicated for use in construction of an external fixation frame for treatment of appropriately sized long bone (foot, arm, wrist and hand) fractures that require external fixation. 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 limbs after removal of total joint arthroplasty for infection or other ・ failure:
- Stabilization of non-unions: and ー
- Intraoperative temporary stabilization tool to assist with indirect reduction.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Image /page/5/Picture/18 description: The image shows the text "Casey L. Hanley, Ph.D." above a horizontal line. Below the line is the text "Division of Orthopedic Devices". The text is part of a logo that includes geometric shapes above and below the text.
§ 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.