The intended use of the subject Trochanteric Gamma 3 Nail is identical to that of the predicate Trochanteric Dyax 8 and Gamma® Nails. The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur.

Device Description

This Special 510(k) submission is a line extension to the Trochanteric Dyax® and Gamma® Nail Systems. This line extension is intended to address a material modification and design modifications to the predicate Trochanteric Dyax® and Gamma® Nail Systems. Both the subject and predicate systems offer trochanteric nails, and offer various accessories such as lag screws, locking screws, and end caps. The Trochanteric Gamma 3 Nail in the Gamma 3 Nail System also has the same basic design concepts as the currently available Trochanteric Dyax and Gamma® Nail Systems.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Gamma 3 Nail System), not a study evaluating an AI device, therefore the requested information fields are not applicable in this context. The document describes a "line extension" meaning minor changes to a previously approved device. The "study" mentioned in the document is a "mechanical testing" to show that the new device has comparable mechanical properties to the predicate device.

Here's why most of your requested fields are not applicable:

No AI component: This document is about an intramedullary nail system, a physical implant for fracture stabilization. There is no mention of any AI or software component.
No diagnostic or prognostic claims: The device is a treatment system, not a diagnostic tool. Therefore, there are no claims related to diagnostic accuracy (like sensitivity, specificity, or AUC) that would require a test set, ground truth established by experts, or MRMC studies.
Predicate Device Comparison (510(k) pathway): The FDA 510(k) pathway relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving de novo safety and effectiveness through extensive clinical trials for every iteration. The "study" in this context refers to engineering or bench testing to ensure the modified device performs similarly to the predicate.

Given these points, I cannot fill out the requested table and sections as they are designed for performance evaluation of AI-powered diagnostic/prognostic devices.

However, I can extract information related to the device and its assessment within the context of this 510(k) submission:

1. Acceptance Criteria and Reported Device Performance (as inferred from the document):

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Mechanical properties are comparable to legally marketed predicate (Trochanteric Dyax® and Gamma® Nail Systems).	"Mechanical testing demonstrated comparable mechanical properties to the predicate components."
Intended use is identical to the predicate device.	"The intended use of the subject Trochanteric Gamma 3 Nail is identical to that of the predicate Trochanteric Dyax® and Gamma® Nails. The device is intended for use in stabilizing various types of intertrochanteric fractures of the femur."
Basic design concepts are the same as the predicate device.	"The Trochanteric Gamma 3 Nail in the Gamma 3 Nail System also has the same basic design concepts as the currently available Trochanteric Dyax and Gamma® Nail Systems."

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to "mechanical testing" which typically involves laboratory-based tests on device samples, not patient data. The "test set" in an AI context (e.g., patient images or clinical data) is not relevant here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI, relates to the correct diagnosis or outcome. For a physical device undergoing mechanical testing, the "ground truth" is established by engineering specifications and physical measurements, not expert clinical consensus.

4. Adjudication method for the test set: Not applicable.

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, this is not an MRMC study. This device is a surgical implant, not an AI diagnostic tool that would assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.

7. The type of ground truth used: For mechanical testing, the "ground truth" would be the measured physical properties (e.g., strength, durability, fatigue life) against established engineering standards or the properties of the predicate device. The document only generally states "comparable mechanical properties."

8. The sample size for the training set: Not applicable for a physical device undergoing mechanical testing.

9. How the ground truth for the training set was established: Not applicable.

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 a stylized eagle with its wings spread, and the words "HUMAN SERVICES - USA" are arranged in a circular pattern above the eagle. The words "DEPARTMENT OF" are arranged in a circular pattern below the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2005

Ms. Vivian Kelly Regulatory Affairs Consultant Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677

Re: K032244

Trade/Device Name: Gamma 3 Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: July 16,2003 Received: July 22,2003

Dear Ms. Kelly:

This letter corrects our substantially equivalent letter of August 8, 2003 regarding the Regulation Number, Regulation Name and Product Code of the above device. The correct information is listed above.

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 (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 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

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limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

This letter will allow you to continue 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 (240) 276-0120. 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,

Stipk Rurla

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Nurnbcr (if known): K O 322

Device Name: Gamma 3 Nail System

Indications For Use:

Muriam C. Provost

Division Sign (Division of General, Restorative and Neurological Devices

-K632244 510(k) Number—

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE F NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use -

Over-The-Counter Use -

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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Special 510(k) Premarket Notification

AUG - 8 2003 Summary of Safety and Effectiveness

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Line Extension to the Trochanteric Dyax® & Gamma® Nail Systems

Submission Information

Name and Address of the Sponsorof the 510(k) Submission:	Howmedica Osteonics Corp59 Route 17Allendale, NJ 07401-1677
Contact Person:	Vivian KellyRegulatory Affairs ConsultantPhone: 201-831-5581Fax: 201-831-6038

Date of Summary Preparation: July 16, 2003

Device Identification

Proprietary Name:	Gamma 3 Nail System
Common Name:	Intramedullary Nail
Classification Name and Reference:	Intramedullary Fixation Rod, 21 CFR §888.3020

The intended use of the subject device is identical to that of the predicate Trochanteric Dyax Nails. The device is intended for use in stabilizing various types of intertrochanteric fractures of the femur. The Trochanteric Gamma 3 Nail in the Gamma 3 Nail System also has the same basic design concepts as the currently available Trochanteric Dyax and Gamma® Nail Systems. Mechanical testing demonstrated comparable mechanical properties to the predicate components.

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.