The Titanium Telegraph® Humeral Nail is designed to be inserted in the proximal extremity of the humerus. It is made of titanium (according to ASTM 136) and is available in two models: the short humeral nail (150mm) and the long humeral nail (from 210 to 310mm). All models are available in three diameters (7, 8, 9 and 10mm). These two Humeral Nail are intended to be used with cancellous screws and selfthreating cortical cotter screws, supplied by FH Industrie.

This special 510(k) is being submitted to propose clearance of the titanium selfthreating cortical cotter screws intended to be used with the Titanium Telegraph® Humeral Nail cleared in K042332. FH Industrie will manufacture and commercialize these screws.

These screws are made of titanium (according to ISO 5832 and ASTM F-136) and are available in 4 lengths (24, 28, 30, 32mm) and with a 4mm diameter

AI/ML Overview

This document is a 510(k) summary for a medical device, the Titanium TELEGRAPH® HUMERAL NAIL. It is not a study report or clinical trial. Therefore, it does not contain the detailed information needed to answer many of your questions about acceptance criteria and study methodologies.

This 510(k) submission is for a modification to an already cleared device, specifically changing the material of certain screws and also making them sterile and supplied with the device. The core of this submission is to demonstrate "substantial equivalence" to predicate devices, not to present novel performance data from a new clinical study.

Here's an attempt to answer your questions based on the provided text, with clear indications where the information is not available in the document:

A table of acceptance criteria and the reported device performance

This information is not available in the provided 510(k) summary. The document does not describe specific acceptance criteria in terms of quantitative performance metrics (e.g., tensile strength, fatigue life) or clinical outcomes. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that it performs equivalently to the predicate devices due to shared design and materials for the nail itself, and the new screws also being made of medical-grade titanium with similar design, diameters, and lengths as existing screws.
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available. No specific test sets or clinical data are presented as part of this 510(k) summary. The "performance data" section only states: "Risk to health have been addressed through the specified materials, Processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations." This indicates that the safety and effectiveness are established through adherence to manufacturing standards and material specifications, rather than through a dedicated clinical or non-clinical study with a defined sample size.
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)

This information is not available. No test set requiring expert ground truth establishment is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available. No test set requiring adjudication is described.
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

This information is not available. This device is a surgical implant (humeral nail) and not an AI-powered diagnostic tool. Therefore, an MRMC study with AI assistance is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not available. This device is a surgical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not available. As explained in point 2, no specific performance study generating ground truth data is described. The "ground truth" for demonstrating safety and effectiveness in this 510(k) relies on the established safety and effectiveness of the predicate devices and the material and design specifications of the new components.
The sample size for the training set

This information is not available. There is no mention of a "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established

This information is not available. There is no mention of a "training set" or its ground truth.

Summary

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K052058

AUG 2 2 2005

510 (K) SUMMARY - Titanium TELEGRAPH® HUMERAL NAIL

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

SUBMITTER:

Fournitures Hospitalières Industrie 6 Rue Nobel, Z.I. de Kernevez 29000 QUIMPER, France

COMPANY CONTACT:

C.Ouendez Regulatory Affairs Manager Phone number: 33.2.98.55.68.95 Fax number: 33.2.98.53.42.13

July 27th 2005 DATE PREPARED:

DEVICE NAME:

Trade Name: Common name: Classification name: Titanium TELEGRAPH® HUMERAL NAIL Humeral Nail Intramedullary Rod

PREDICATE DEVICES:

Titanium TELEGRAPH® HUMERAL NAIL Fournitures Hospitalieres Industrie K042332

TELEGRAPH® HUMERAL NAIL. Fournitures Hospitalieres Industrie K033510

DEVICE DESCRIPTION :

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These screws are made of titanium (according to ISO 5832 and ASTM F-136) and are available in 4 lengths (24, 28, 30, 32mm) and with a 4mm diameter

INTENDED USE :

The titanium Telegraph® humeral nail is indicated for proximal and/or diaphyseal fractures of the humerus

TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICES :

The proposed Titanium Telegraph® Humeral nail is now provided with sterile cancellous screws and sterile self-threating cortical cotter screws. It has exactly the same intended use and same design as the predicate devices. No change was made on the design and material and of the humeral nail. Diameters and lengths remain unchanged.

The main difference between the new and the previous devices is that these self-threating cortical cotter screws will be manufactured in titanium and supplied with the device. The screws are all made of the same material (titanium), have the same design and are available in similar diameters and lengths.

PERFORMANCE DATA:

Risk to health have been addressed through the specified materials, Processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations.

CONCLUSION:

All these elements show the safety and effectiveness of our product. The titanium Telegraph® Humeral Nail is substantially equivalent to the selected predicate devices in terms of intended use, safety, and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2005

Ms. Christine Quendez Regulatory Affairs Manager Fournitures Hospitaliéres Industrie ZI de Kernevez, 6 Rue Nobel 29000 Quimper, France

Re: K052058

Trade/Device Name: TITANIUM TELEGRAPH HUMERAL NAIL Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: July 27, 2005 Received: August 3, 2005

Dear Ms. Quendez:

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. Christine Quendez

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse FDA finding of substantial equivalence of your device to a legally premated 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 11 you assno specific and 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 other golferal micronational 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,

Aubau Inelund

for

Mark N. Melkerson Acting 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

KOC2058 510(k) Number (if known): TITANIUM TELEGRAPH HUMERAL NAIL Device Name:

The titanium Telegraph humerail nail is indicated for Indications for Use: proximal and/or diaphyseal fractures of the humerus

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

Over the counter Use (21 CFR 801 Subpart C)

510(k) Number_

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)	Barbara Bruetus for MK(Division Sign-Off)Division of General, Restorative,and Neurological Devices
510(k) Number	K052058

Regulation Number and Section

N/A