The Osteo IC Retrograde/Antegrade Femoral Nail and its accessories are indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:

. Open and closed femoral fractures.
. Pseudarthrosis and correction osteotomy.
. Pathologic fractures, impending pathologic fractures, and tumor resections.
. Supracondylar fractures, including those with intra-articular extension.
. Ipsilateral femur/tibia fractures.
. Fractures proximal to a total knee arthroplasty.
. Fractures distal to a hip implant.
Nonunions and malunions. .

Device Description

The nut and washer for the Osteo IC Retrograde/Antegrade Femoral Nail are manufactured from ASTM F136-96 titanium alloy (Ti6Al-4V) and are anodized with a Type II coating process. The washer is 1.2mm thick, has a total diameter of 12mm, and a through-hole diameter of 5.2mm. The nut is T-shaped with an outer shaft diameter of 7mm, and inner shaft diameter of 5.5mm and a total length of 12mm. The head of the nut had a diameter of 12mm. The inner shaft of the nut is threaded in order to accommodate the threads of a locking screw. The washer is placed between the head of the locking screw and the bone surface. The nut is placed on the distal end of the screw. The 7mm diameter shaft of the nut sits below the surface of the bone, and the rounded 12mm diameter head of the nut will sit on the surface of the bone. All components of the Osteo IC Retrograde Femoral Nail are provided both sterile and non-sterile.

AI/ML Overview

This appears to be a 510(k) summary for a medical device (Osteo IC Retrograde/Antegrade Femoral Nail - Accessories), specifically focusing on a nut and washer component.

Based on the provided text, there is no information about acceptance criteria or a study proving that the device meets acceptance criteria in the context of device performance metrics (e.g., accuracy, sensitivity, specificity, or any clinical outcomes). The document is a premarket notification for substantial equivalence, which primarily addresses device design, materials, and intended use in comparison to a predicate device.

Let's break down why the requested information cannot be provided from this text:

A table of acceptance criteria and the reported device performance: This document explicitly states, "The design and function of the Osteo IC Retrograde Femoral Nail nut and washer is substantially equivalent to the nut and washer of the predicate Richards Retrograde Nail." Substantial equivalence is the pathway being used here, not a performance study against predefined criteria. No performance criteria (e.g., strength, durability, biocompatibility) or reported performance against such criteria are present in this summary.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or associated data is described. The focus is on demonstrating equivalence based on design and materials.
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, as no test set requiring ground truth establishment is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set requiring adjudication is mentioned.
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 mechanical orthopedic implant (nut and washer), not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth is established for performance evaluation in this document.
The sample size for the training set: Not applicable. This is not a machine learning device.
How the ground truth for the training set was established: Not applicable. This is not a machine learning device.

In summary, the provided text is a 510(k) Pre-Market Notification Summary for substantial equivalence of a medical device (an orthopedic nut and washer), not a clinical or performance study report. Therefore, it does not contain the information requested regarding acceptance criteria and device performance studies commonly associated with diagnostic or AI-powered devices. The "proof" here is the assertion of substantial equivalence to a legally marketed predicate device based on design, materials, and intended use, which the FDA has accepted.

Summary

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Summ

K990152

510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS Osteo IC Retrograde/Antegrade Femoral Nail - Accessories

Submission Information
Name and Address of the Sponsorof the 510(k) Submission:	Howmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677201-825-4900
Contact Person:	Kate Sutton (or Marybeth Naughton)Regulatory Affairs Specialist
Date Summary Prepared:	January 12, 1999
Device Identification
Proprietary Name:	Osteo IC Retrograde/Antegrade Femoral Nail
Common Name:	Intramedullary Nail, Femoral Nail
Classification Name and Reference:	Intramedullary Fixation Rod21 CFR §888.3020

Predicate Device Identification

The design and function of the Osteo IC Retrograde Femoral Nail nut and washer is substantially equivalent to the nut and washer of the predicate Richards Retrograde Nail. The subject and predicate systems offer femoral nails in varying lengths, and utilize a combination of locking screws, end caps, nuts, and washers.

Device Description

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Intended Use

The Osteo IC Retrograde/Antegrade Femoral Nail and its accessories are indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:

. Open and closed femoral fractures
Pseudoarthrosis and correction osteotomy
Pathologic fractures, impending pathologic fractures, and tumor resections .
Supracondylar fractures, including those with intra-articular extension
Ipsilateral femur/tibia fractures
. Fractures proximal to a total knee arthroplasty
Fractures distal to a hip implant
. Nonunions and malunions

Statement of Technological Comparison

The subject Osteo IC Retrograde Femoral Nail nut and washer are substantially equivalent in design and intended use to the predicate nut and washer offered by Richards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its body or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 1090

Ms. Elizabeth A. Staub Director, Quality Assurance and Regulatory Affairs Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

K990152 Re: . Osteo IC Retrograde/Antegrade Femoral Nail - Accessories Requlatory Class: II Product Code: HSB Dated: January 12, 1999 Received: January 19, 1999

Dear Ms. Staub:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Ms. Elizabeth A. Staub

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D.

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

Enclosure

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510(k) Number (if known): K 99015 2

Device Name: Osteo IC Retrograde/Antegrade Femoral Nail - Accessories

Indications For Use:

The Osteo IC Retrograde/Antegrade Femoral Nail and its accessories are indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:

. Open and closed femoral fractures.
. Pseudarthrosis and correction osteotomy.
. Pathologic fractures, impending pathologic fractures, and tumor resections.
. Supracondylar fractures, including those with intra-articular extension.
. Ipsilateral femur/tibia fractures.
. Fractures proximal to a total knee arthroplasty.
. Fractures distal to a hip implant.
Nonunions and malunions. .

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

Concurrence of CDRH, Office of Device Eva

vice Evaluation (ODE)

(Division Sign-Off) √
Division of General Restorative Devices
510(k) Number K990152

Prescription Use_ X

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

N/A