These devices are to be implanted into the femur for alignment, stabilization and fixation of fractures caused by trauma or disease, the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis.

Device Description

The Biomet® Femoral Locking Nail System is a set of intramedullary nails, designed for both antegrade and retrograde applications. Features include an internal locking/compression mechanism and numerous screw configurations to enable nail fixation.

AI/ML Overview

The provided document is a 510(k) summary for the Biomet® Femoral Locking Nail System. This type of regulatory submission is for a medical device, specifically an orthopedic implant (intramedullary nail), which falls under a different regulatory pathway than software or AI/ML-driven devices. Therefore, the questions regarding acceptance criteria and studies that prove the device meets these criteria, especially those pertaining to AI/ML performance, are not applicable here.

Here's why and what information is provided:

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

Not Applicable in the AI/ML context. For this orthopedic implant, "acceptance criteria" generally refers to meeting safety and effectiveness standards, primarily through demonstrating substantial equivalence to a legally marketed predicate device.
What is reported: The document states that "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This is the core performance claim for this type of device in a 510(k) submission.

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

Not Applicable in the AI/ML context. No "test set" in the sense of AI/ML evaluation (e.g., a dataset of images or patient records) was used.
What is reported: Non-clinical laboratory testing was performed. This typically involves mechanical testing (e.g., fatigue, static strength) of the device itself, not testing on human subjects or data sets.

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. No ground truth establishment by experts for a test set was performed.

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

Not Applicable. No adjudication method for a test set was used.

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 an orthopedic implant, not an AI/ML diagnostic or assistive device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be relevant.

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

No. This device is a physical implant; there is no algorithm or AI component.

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

Not Applicable. For this medical device, "ground truth" would relate to the physical and mechanical properties of the implant meeting engineering specifications and performance expectations, which are evaluated through non-clinical laboratory testing in comparison to predicate devices, not through expert consensus on medical data, pathology, or outcomes data in the context of an AI/ML model.

8. The sample size for the training set:

Not Applicable. No AI/ML model was trained.

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

Not Applicable. No AI/ML model was trained, therefore no ground truth for a training set was established.

In summary, the provided document relates to the regulatory approval of a physical orthopedic implant. The questions posed are designed for AI/ML-driven medical devices, and thus, do not directly apply to this submission.

The "study that proves the device meets the acceptance criteria" in this context is the "Non-Clinical Testing" which involved laboratory testing to demonstrate substantial equivalence to legally marketed predicate devices. The acceptance criteria essentially boil down to demonstrating that the new device is as safe and effective as the predicate devices based on these non-clinical tests.

Summary

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SEP 2 0 2007

510(k) Summary

Preparation Date:	August 3, 2007
Applicant/Sponsor:	Biomet Trauma (aka EBI; names may be used interchangeably)100 Interpace ParkwayParsippany, NJ 07054
Contact Person:	Becky Earl/Debra L. Bing
Proprietary Name:	Biomet® Femoral Locking Nail System
Common Name:	Titanium intramedullary nails
Classification Name:	Rod, Fixation, Intramedullary and Accessories (CFR 888.3020)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K983641, Holland Nail™ Ecgany Flamet); K982953, Uniflex® Nailing System (Biomet); and K023267, T2™ Supracondylar Nailing System (Howmedica/Stryker)

Device Description:

Intended Use:

The Biomet® Femoral Locking Nail is intended to be used as follows:

These devices are to be implanted into the femur for alignment, stabilization, fixation of fractures caused by trauma or disease, the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis.

Summary of Technologies:

Summary of Technological characteristics (materials, design, sizing, aritculating surface, indications) of the Biomet® Femoral Locking Nail System are similar or identical to the predicate devices.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc., except for the T2™ Supracondylar Nailing System which belongs to Howmedica/Styker

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted with three stripes forming its body and wing, and it faces to the right. The seal is in black and white.

SEP 2 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Manufacturing Corp. % Ms. Becky Earl P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K072161

Trade/Device Name: Biomet® Femoral Locking Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: August 3, 2007 Received: August 6, 2007

Dear Ms. Earl:

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 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.

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Page 2 - Ms. Becky Earl

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 (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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

ChavargBucelund

Mark N. Melkerso 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

510(k) Number (if known):_ K 0 7 2 1 6 l

Device Name: Biomet® Femoral Locking Nail System

Indications For Use: These devices are to be implanted into the femur for alignment, stabilization and fixation of fractures caused by trauma or disease, the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __NO (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)

Barbara Buehr

vision Sigr Division of General, Restorative, and Neurological Devices

510(k) Number. K072161

Page 1 of 1

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.