The ITST Intramedullary Nail is indicated for use in a variety of femoral fractures, such as: Subtrochanteric Fractures, Intertrochanteric Fractures, Comminuted Fractures, Segmental Fractures, Fractures with Bone Loss, Proximal and Distal Fractures, and Nonunions

Device Description

The ITST Intertrochanteric/ Subtrochanteric Fixation System is used for closed nailing of the femur. The system includes femoral intramedullary nails, lag strews, anti-rotation screws, cortical screws and nail caps. Cortical screws are used for distal locking of the nail.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the ITST® Intertrochanteric/Subtrochanteric Fixation System, specifically a line extension to add 4.5mm Cortical Screws. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way one would describe for an AI/software device.

The document focuses on demonstrating substantial equivalence to a predicate device (M/DN® Intramedullary Fixation) for regulatory purposes, not on specific performance (e.g., accuracy, sensitivity, specificity) against acceptance criteria.

Therefore, for most of your requested points, the answer derived from the provided text will be "Not applicable" or "Not specified."

Here's a breakdown of what can and cannot be answered based on the provided text:

Acceptance Criteria and Device Performance (Not Applicable for this Device Type and Document):

The document does not define quantitative acceptance criteria for device performance (e.g., in terms of diagnostic accuracy, image quality, algorithm output). This is because the device is a mechanical implant (cortical screws) and its "performance" is assessed through material properties, dimensional integrity, and biocompatibility, rather than an AI model's output metrics.

Acceptance Criteria	Reported Device Performance
Not Specified	Not Specified

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

As explained above, this section is not applicable in the context of the provided document. The "performance" assessment is described qualitatively: "The dimensional evaluation demonstrated that the subject ITST 4.5mm Cortical Screws are safe and effective and substantially equivalent to the predicate M/DN 4.2mm Cortical Screws."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample size for test set: Not applicable and not specified. The "test set" in this context would likely refer to samples used in non-clinical performance evaluations (e.g., mechanical testing, dimensional analysis). The document states "dimensional evaluation," but no sample size is given.
Data provenance: Not applicable and not specified. There is no "data provenance" information as one would typically find for a clinical or imaging study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. Ground truth as typically understood for AI/software devices (e.g., expert consensus on clinical findings) is not relevant for this mechanical device. The "ground truth" for non-clinical testing is based on engineering specifications and validated test methods.

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

Not applicable. Adjudication methods are typically employed in clinical studies or expert review processes for complex data interpretation, which is not described here.

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 surgical implant, not an AI or diagnostic tool that assists human readers.

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

Not applicable. This is a hardware device, not an algorithm.

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

Not applicable. The "ground truth" for the non-clinical performance evaluation mentioned (dimensional evaluation, biocompatibility, shelf life) would be based on engineering specifications, material standards, and validated laboratory test results.

8. The sample size for the training set:

Not applicable. There is no AI algorithm being trained for this device.

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

Not applicable. There is no AI algorithm being trained for this device.

Summary of relevant details for this specific device and document:

Device: ITST® Intertrochanteric/Subtrochanteric Fixation System (specifically a line extension to add 4.5mm Cortical Screws).
Purpose of Submission: To obtain FDA clearance for a line extension by demonstrating substantial equivalence to a predicate device.
Predicate Device: M/DN® Intramedullary Fixation, manufactured by Zimmer (K142281).
Performance Data (Non-Clinical):
- Shelf Life: Accelerated aging testing showed a shelf life of 10 years.
- Biocompatibility: Testing conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58) passed.
- Performance Evaluation: Dimensional evaluation demonstrated that the subject ITST 4.5mm Cortical Screws are safe and effective and substantially equivalent to the predicate M/DN 4.2mm Cortical Screws.
Clinical Data: No clinical trial data was needed or submitted to show substantial equivalence for this particular line extension.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, representing the department's focus on health and well-being. The logo is simple, clean, and easily recognizable.

May 29, 2015

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

Zimmer, Incorporated Mr. Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581

Re: K143321

Trade/Device Name: ITST® Intertrochanteric/Subtrochanteric Fixation System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: April 27, 2015 Received: April 29, 2015

Dear Mr. McKelvey:

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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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/Resourcesfor You/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 vours.

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) K143321

Device Name

ITST® Intertrochanteric/Subtrochanteric Fixation System

Indications for Use (Describe)

The ITST Intramedullary Nail is indicated for use in a variety of femoral fractures, such as:

· Subtrochanteric Fractures
· Intertrochanteric Fractures
Comminuted Fractures
· Segmental Fractures
· Fractures with Bone Loss
Proximal and Distal Fractures
Nonunions

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a blue letter Z inside of a blue circle. Below the circle is the word "zimmer" in a lowercase, sans-serif, blue font.

P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131

510(k) Summary

Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Stephen H. McKelvey, MA, RACSenior Project Manager, Regulatory AffairsTelephone: 574-372-4944Fax: (574) 372-4605
Date:	November 18, 2014
Trade Name:	ITST® Intertrochanteric/Subtrochanteric Fixation System
Common Name:	Rod. Fixation, Intramedullary and Accessories
Classification Namesand References:	Intramedullary fixation rod(21 CFR 888.3020, HSB)
Classification Panel:	Orthopedics/87
Predicate Device(s):	M/DN® Intramedullary Fixation, manufactured by Zimmer(K142281, cleared October 22, 2014).
Purpose and DeviceDescription:	The purpose of this submission is to obtain clearance for aline extension to add 4.5mm Cortical Screws to the ITSTsystem. The ITST Intertrochanteric/ SubtrochantericFixation System is used for closed nailing of the femur.The system includes femoral intramedullary nails, lagstrews, anti-rotation screws, cortical screws and nail caps.Cortical screws are used for distal locking of the nail.
Intended Use:	The ITST Intramedullary Nail is indicated for use in avariety of femoral fractures, such as: SubtrochantericFractures, Intertrochanteric Fractures, ComminutedFractures, Segmental Fractures, Fractures with Bone Loss,Proximal and Distal Fractures, and Nonunions

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Comparison to Predicate Devices:	Both the subject ITST 4.5mm and predicate M/DN 4.2mmdevices are cortical screws with similar diameters. Thesubject ITST 4.5mm Cortical Screws have identicallengths to the predicate M/DN 4.2mm Cortical Screws.Both devices are made from the same material and haveindications for use.
Performance Data (Nonclinicaland/or Clinical):	Non-Clinical Performance and Conclusions:Shelf Life - Accelerated aging testing conductedshows that the sterile devices included in thissubmission have a shelf life of 10 years.Biocompatibility – Biocompatibility testing of thesubject devices was conducted per ISO 10993-1 andGood Laboratory Practices (21 CFR 58). All testingpassed.Performance Evaluation -The dimensional

evaluation demonstrated that the subject ITST 4.5mm Cortical Screws are safe and effective and substantially equivalent to the predicate M/DN 4.2mm Cortical Screws.
Conclusions: The data presented in this submission show that the changes do not affect the safety and/or effectiveness of the subject devices and that the subject ITST devices will perform in a substantially equivalent manner to the predicate devices.

Clinical Performance and Conclusions:

Clinical trial data and conclusions were not needed for these devices to show substantial equivalence.

Regulation Number and Section

N/A