ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL by ZIMMER, INC.

The ITST is used to provide reduction and internal fracture fixation of the femoral head and neck and has an intramedullary nail that is curved and tapered anatomically to accommodate the curvature of the intramedullary canal.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Zimmer ITST™ Intertrochanteric Subtrochanteric Intramedullary Femoral Nail:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance and Conclusions
Substantial Equivalence to Predicate Device (M/DN Intramedullary Fixation System, K965098) in terms of safety and effectiveness.	"Performance testing completed as part of the design assurance procedure demonstrated that this device is safe and effective and substantially equivalent to the predicate device.""Except for modifications to facilitate easier insertion, accommodate a larger lag screw and the addition of sliding and locking nail caps, ITST components are identical to the predicate device. The modifications do not change the intended use or the fundamental scientific technology. The device is packaged and sterilized using the same materials and processes."
No change in intended use.	"The modifications do not change the intended use..."
No change in fundamental scientific technology.	"...or the fundamental scientific technology."
Packaging and sterilization materials and processes are the same as the predicate device.	"The device is packaged and sterilized using the same materials and processes."

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

Sample size for the test set: Not applicable (N/A). The document explicitly states: "Clinical data and conclusions were not needed for this device." The evaluation was based on non-clinical performance testing.
Data provenance: N/A, as clinical data was not used. The non-clinical performance testing would have been conducted by the manufacturer, Zimmer, Inc. The document doesn't specify country of origin for the non-clinical tests but implies it was internal to Zimmer.

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

N/A. Clinical data with expert-established ground truth was not utilized for this 510(k) submission.

4. Adjudication method for the test set

N/A. Clinical data and expert adjudication were not part of this submission. The evaluation relied on non-clinical performance 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

N/A. This device is a physical medical implant (intramedullary nail), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

N/A. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this submission was the established performance and safety profile of the predicate device (M/DN Intramedullary Fixation System, K965098). The non-clinical performance testing (e.g., mechanical testing) aimed to demonstrate that the modified device performed equivalently to the predicate's known performance.

8. The sample size for the training set

N/A. As this is not an AI/machine learning device, there is no "training set" in that context. The "training data" for the design of the device would broadly be engineering principles, material science data, and possibly clinical experience with similar devices, but this is not quantifiable as a "sample size" in the conventional sense for AI.

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

N/A. Given that this is not an AI/machine learning device, the concept of a "ground truth for a training set" as it applies to software or diagnostic algorithms is not applicable. The design and development would be informed by established engineering standards, biomechanical principles, and the performance characteristics of the predicate device.

Summary

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Summary of Safety and Effectiveness

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Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Stephen H. McKelveyManager, Regulatory AffairsTelephone: (574) 372-4944Fax: (574) 372-4605
Date:	July 31, 2003
Trade Name:	ITST ™ Intertrochanteric SubtrochantericIntramedullary Femoral Nail
Common Name:	Intramedullary Nail
Classification Nameand Reference:	Intramedullary Fixation Rod21 CFR § 888.3020
Predicate Device:	M/DN Intramedullary Fixation System,manufactured by Zimmer, K965098, clearedFebruary 28, 1997.
Device Description:	The ITST is used to provide reduction and internalfracture fixation of the femoral head and neck andhas an intramedullary nail that is curved and taperedanatomically to accommodate the curvature of theintramedullary canal.
Intended Use:	The ITST Intramedullary Nail is indicated for use ina variety of femoral fractures, such as:• Subtrochanteric Fractures• Intertrochanteric Fractures• Comminuted Fractures• Segmental Fractures• Fractures with Bone Loss• Proximal and Distal Fractures• Nonunions

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Comparison to Predicate Device:

Except for modifications to facilitate easier insertion, accommodate a larger lag screw and the addition of sliding and locking nail caps, ITST components are identical to the predicate device. The modifications do not change the intended use or the fundamental scientific technology. The device is packaged and sterilized using the same materials and processes.

Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

Performance testing completed as part of the design assurance procedure demonstrated that this device is safe and effective and substantially equivalent to the predicate device.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2003

Mr. Stephen H. McKelvey Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

Re: K032367

Trade/Device Name: ITST Intertrochanteric Subtrochanteric Intramedullary Femoral Nail Regulation Numbers: 21 CFR 888.3020 Regulation Names: Intramedullary fixation rod Regulatory Class: II Product Codes: HSB Dated: July 31, 2003 Received: August 1, 2003

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Mr. Stephen H. McKelvey

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ulan Witt

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

KO 32367

Page I of I

510(k) Number (if known):

Device Name:

ITST" Intertrochanteric Subtrochanteric Intramedullary Femoral Nail

Indications for Use:

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 ●

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Concurrence of CDRH, Office of Deyice Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number_k032367

Prescription Use
(Per 21 CFR 801.109)

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Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.