The subject Osteo IC Femoral and Tibial Nails are similar to the predicate Osteo IC Femoral and Tibial Nails. The major difference is that the subject devices are made from Titanium Alloy, while the predicate devices were made from Stainless Steel. The subject Osteo IC Femoral and Tibial Nails in Titanium share the same basic design as the Osteo IC Femoral and Tibial Nails in Stainless Steel, except that they feature an additional groove and come in some additional sizes.

AI/ML Overview

The provided text describes a 510(k) submission for the Osteo IC Femoral and Tibial Nails in Titanium Alloy. However, it does not contain information regarding acceptance criteria, specific performance data, or a detailed study of the device's performance against such criteria.

The document states:
"The subject devices are so similar to the predicate devices cited in terms of design, materials, intended use, and size range, that additional testing was not thought necessary to demonstrate their Substantial Equivalence."

This indicates that the manufacturer relied on substantial equivalence to predicate devices rather than conducting a new performance study with specific acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.

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

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

Cannot be provided. The document explicitly states that "additional testing was not thought necessary." There are no reported acceptance criteria or device performance data for this specific device.

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

Cannot be provided. No new test set was used for this 510(k) submission, as no new testing was deemed necessary.

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)

Cannot be provided. No new test set with ground truth established by experts was used.

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

Cannot be provided. No new 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

Cannot be provided. This device is an intramedullary nail, not an AI or imaging device, so an MRMC study is not relevant.

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

Cannot be provided. This device is an intramedullary nail, not an algorithm.

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

Cannot be provided. No new ground truth was established for this device, as no new performance testing was conducted. The equivalence is based on the previously established performance and safety of the predicate devices.

8. The sample size for the training set

Cannot be provided. There is no mention of a training set as this is not an AI/algorithm device.

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

Cannot be provided. There is no mention of a training set or ground truth establishment relevant to this device.

Summary of what is available from the document:

Rationale for demonstrating equivalence: The subject Osteo IC Femoral and Tibial Nails in Titanium Alloy are considered "so similar" to predicate devices (Osteo IC Femoral and Tibial Nails in Stainless Steel and Howmedica Alta Femoral and Tibial Rod System in Titanium Alloy) in terms of design, materials, intended use, and size range, that additional testing was not deemed necessary.

This document serves as a 510(k) summary relying on substantial equivalence, which bypasses the need for new performance studies and acceptance criteria for the specific device under review.

Summary

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K992063
1 OF 2

510(k) SUMMARY Osteo IC Femoral and Tibial Nails in Titanium Alloy

Submission Information
Name and Address of the Sponsor of the 510(k) Submission:	Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 201-825-4900
Contact Person:	Marybeth Naughton Regulatory Affairs Specialist
Date Summary Prepared:	June 15, 1999
Device Identification
Proprietary Name:	Osteo IC Femoral and Tibial Nails in Titanium Alloy
Common Name:	Intramedullary Nail, Tibial Nail
Classification Name and Reference:	Intramedullary Fixation Rod 21 CFR §888.3020

Predicate Device Identification

The subject Osteo IC Femoral and Tibial Nails in Titanium Alloy are compared to the following predicate devices:

. Osteo IC Femoral and Tibial Nails in Stainless Steel
. Howmedica Alta Femoral and Tibial Rod System in Titanium Alloy

Device Description

Intended Use

The intended uses of the subject Osteo IC Femoral and Tibial Nails are the same as those of the predicate Osteo IC Femoral and Tibial Nails. The nails are single use devices. They are intended for the fixation, correction, or stabilization of tibial and femoral bones. The nails may be locked statically, dynamically, or with active primary compression. The indications for use of the subject

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K 992063
20Fd

510(k) Summary Osteo IC Femoral and Tibial Nails in Titanium Alloy

Osteo IC Femoral and Tibial Nails are the same as those of the predicate Osteo IC Femoral and Tibial Nails:

. Closed and open femoral and tibial shaft fractures
. Pseudarthrosis and correction osteotomies in the shaft area
. Pathological fractures and tumor resections of the shaft area
. Change of procedure following external fixation

Statement of Technological Comparison

The subject Osteo IC Femoral and Tibial Nails in Titanium share the same basic design as the Osteo IC Femoral and Tibial Nails in Stainless Steel, except that they feature an additional groove and come in some additional sizes. The predicate Howmedica Alta Nails, presented as one of the comparison devices for substantial equivalence, are manufactured from Titanium and come in a wider range of sizes than presented for the subject devices.

Performance Data:

The subject devices are so similar to the predicate devices cited in terms of design, materials, intended use, and size range, that additional testing was not thought necessary to demonstrate their Substantial Equivalence.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.

3 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K992063

Trade Name: Osteo IC Femoral and Tibial Nails in Titanium Alloy Regulatory Class: II Product Code: HSB Dated: June 15, 1999 Received: June 18, 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 control provisions of the Act. The general control 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 (Premarket Approval), 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 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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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 regulations.

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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., 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_______

Device Name: Osteo IC Femoral and Tibial Nails in Titanium Alloy

Indications For Use:

The indications for the use of the Osteo IC Femoral and Tibial Nails in Titanium Alloy are as follows:

. Closed and open femoral and tibial shaft fractures
Pseudarthrosis and correction osteotomies in the shaft area ●
Pathological fractures and tumor resections of the shaft area .
. Change of procedure following external fixation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K992063
Prescription Use	X
(Per 21 CFR 801.109)
	OR
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.