The Unreamed Interlocking Nail System is provided non-sterile. The implants are inserted into the medullary(bone marrow) canal of long bones(femur, and tibia) for the fixation of fractures.

Device Description

The interlocking system makes up of Femoral, Tibial Nail and bolt screws. The bolt screws are utilized with the different interlocking nail. The interlocking nails have the same features such as: Dynamic locking: Using the proximal oval hole permits axial loading with A rotational stability. A Anatomical design: Femur: The 1.6m radius of the Unreamed Femoral Nail corresponds closely with the average anatomical curvature of the femur. Tibia: The curvature of 8° in the upper third of the Unreamed Tibial Nail allows for easy insertion and good anatomical fit. A Distal locking: Through two medial holes, additional locking is also possible in the anatomical seat. Easy insertion: The curvature of the posterior aspect of the nail reduces damage to the interior posterior cortical surface during insertion. The dimension of the unreamed interlocking nail ranges in diameter from 8 to 12 mm and total length 255 to 480 mm. The locking bolt screws have high strength, self-tapping and easy locking technique. The dimension of the bolt screw ranges in thread diameter from 3.9, 4.9, and 5.0mm and total length 20 to 125 mm.

AI/ML Overview

The provided text describes a 510(k) submission for a non-sterile unreamed interlocking nail system. This document focuses on establishing substantial equivalence to a predicate device already on the market, rather than a study proving the device meets specific acceptance criteria through performance testing with human subjects or a clinical study.

Therefore, many of the requested elements (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth information) are not present in this type of submission.

Here's an output based on the information available in the provided text, while also explicitly stating what cannot be extracted due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the 510(k) summary. A 510(k) submission for this type of device typically demonstrates substantial equivalence through material properties, design features, and intended use compared to a predicate device, rather than performance against pre-defined clinical acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable and not provided. This document relies on comparison to a predicate device, not a performance study with a test set of data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable and not provided. Ground truth establishment for a test set is relevant for performance studies, which are not detailed in this 510(k) submission.

4. Adjudication Method for the Test Set

This information is not applicable and not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) submission. The submission focuses on substantial equivalence to a predicate device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and not provided. This device is a surgical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

This information is not applicable and not provided. The "ground truth" in the context of this 510(k) is the established safety and effectiveness of the predicate device (Synthes-Titanium Unreamed Femoral Nail) to which the Syntec-Taichung device is deemed substantially equivalent. The substantial equivalence is based on:

Design: Shared features like dynamic locking, anatomical design (femur curvature and tibial curvature), and distal locking.
Sizes: Similar overall dimensions (diameter, length of nails and screws).
Material: Both devices use commercially 316LS stainless steel and titanium alloy (Ti-6Al-4V).
Appliance (Intended Use): Both are for fixation of fractures in the medullary canal of long bones.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This document does not describe a training set for an AI/algorithm driven device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided.

Summary of the Study (as described in the 510(k) document):

The "study" presented in this 510(k) is a comparison to a predicate device to establish substantial equivalence.

Predicate Device: Synthes-Titanium Unreamed Femoral Nail.
Comparison Basis: Design, sizes, material, and intended use ("appliance").
Conclusion: Syntec-Taichung (Taiwan) believes that its non-sterile Unreamed Interlocking Nail System is substantially equivalent to the Synthes-Titanium Unreamed Femoral Nail. The FDA concurred with this assessment, allowing the device to be marketed.

This approach is common for medical devices seeking 510(k) clearance, where a direct comparison to an already legally marketed device demonstrates safety and effectiveness without requiring extensive new clinical trials or performance studies that define specific acceptance criteria.

Summary

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3/5/99

510(k) Summary of Safety and effectiveness

Sponsor: Syntec-Taichung Medical Instruments Co., Ltd. 2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang, Chang Hua, Taiwan. 509 Phone / FAX: 886-4-7987099 / 886-4-7987077 Contact Person: Ted Y. Shi
K98 4602
A Proprietary Name : Syntec-Taichung Non-sterile Unreamed Interlocking Nail System
A Common Name : Various Types of Unreamed Intramedullary Fixation Implants
Classification Status : Class II, CFR 888.3020
Device Product Code : 87 HSB
A Material: This device is manufactured from commercially 316LS stainless steel and titanium alloy (Ti-6Al-4V).

> Indication for Use :

The Unreamed Interlocking Nail System is provided non-sterile. The implants are inserted into the medullary(bone marrow) canal of long bones(femur, and tibia) for the fixation of fractures.

A Description of the Device :

The interlocking system makes up of Femoral, Tibial Nail and bolt screws. The bolt screws are utilized with the different interlocking nail. The interlocking nails have the same features such as:

Dynamic locking: Using the proximal oval hole permits axial loading with A rotational stability.
A Anatomical design:
- Femur: The 1.6m radius of the Unreamed Femoral Nail corresponds closely with the average anatomical curvature of the femur.
- Tibia: The curvature of 8° in the upper third of the Unreamed Tibial Nail allows � for easy insertion and good anatomical fit.
A Distal locking: Through two medial holes, additional locking is also possible in the

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anatomical seat.

Easy insertion: The curvature of the posterior aspect of the nail reduces damage to > the interior posterior cortical surface during insertion.
The dimension of the unreamed interlocking nail ranges in diameter from 8 to 12 mm and total length 255 to 480 mm.

The locking bolt screws have high strength, self-tapping and easy locking technique. The dimension of the bolt screw ranges in thread diameter from 3.9, 4.9, and 5.0mm and total length 20 to 125 mm.

> Basis of Substantial Equivalence :

A comparison of the non-sterile Unreamed Interlocking Nail System described in this submission and Synthes-Titanium Unreamed Femoral Nail has been commercial device that they are very similar or identical in terms of design, sizes, material and appliance. Based on this information, Syntec-Taichung (Taiwan) believes that the non-sterile Unreamed Interlocking Nail System is substantially equivalent to Synthes-Titanium Unreamed Femoral Nail.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 1999

Mr. Ted Y. Shi President Syntec-Taichung Medical Instruments Company Limited 2, Kung San Road, Chuan Shing Industrial Zone Shen Kang, Chang Hua, Taiwan 509

Re: K984602 Syntec-Taichung (Taiwan) Non-sterile Unreamed Interlocking Nail System Regulatory Class: II Product Code: HSB Dated: December 22, 1998
Received: December 28, 1998

Dear Mr. Shi:

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, good manufacturing practice, labeling, and prohibitions aqainst 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 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 regulations.

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Page 2 - Mr. Ted Y. Shi

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,

Aunell J. Kayr

Jr Celía 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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Page 1 of 1

510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for use:

The Unreamed Interlocking Nail System is provided non-sterile. The implants are inserted into the medullary(bone marrow) canal of long bones(femur, and tibia) for the fixation of fractures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use _ (Per 21 CFR 801.109)

Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)

Ren Vayor Incan

sion Sign-Up)
ision of General Restorative Devices
(k) Number K984602

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.