SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS by SYNTHES (USA)

The Sterile Adjustable Distal Radius Fixator is a pre-assembled mechanically adjustable external wrist fixator. It is a one-piece construct, which consists of plastic and metal components. The device is applied to the bone with four self-drilling Schanz screws that lock into two fixator clamps. The device operates by turning screws, which operate gears, to achieve incremental movement. The sterile packaged ADRF is packaged with Synthes 4.0 mm/3.0 mm stainless steel, self-drilling Schanz screws or Synthes 4.0 mm/3.0 mm titanium self-drilling Schanz Screws.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Synthes Sterile Adjustable Distal Radius Fixator (ADRF)". This document is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this type of document.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the 510(k) summary. A 510(k) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting detailed performance acceptance criteria and results from a new study against those criteria. It states: "Documentation is provided which demonstrates that the Synthes Sterile Adjustable Distal Radius Fixator is substantially equivalent to its predicate device."

2. Sample size used for the test set and the data provenance:

This information is not provided. The document describes a medical device, not a study involving a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. This document does not describe a study involving expert-established ground truth.

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

This information is not provided.

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:

This information is not provided. The device is a physical medical device (an external fixator), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is not applicable.

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

This information is not provided. This is not an algorithm-based device.

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

This information is not provided. This document does not describe a study that required a ground truth determination.

8. The sample size for the training set:

This information is not provided. This is not an AI/machine learning device, and therefore, there is no training set mentioned.

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

This information is not provided. As above, there is no training set for this type of device.

In summary, the provided 510(k) document is for a physical medical device (an external fixator) seeking approval based on substantial equivalence to a predicate device, not for a software or AI-based diagnostic tool that would typically involve the types of studies and criteria requested in your prompt.

Summary

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NOV 26 2003

K033411
page 1 of 1

3. Summary of Safety and Effectiveness Information [510(k) Summary]

Submitter:	Synthes (USA)1690 Russell RoadPaoli, PA 19301
Company Contact:	Bonnie Smith(610) 647-9700
Name of the Device:	Synthes (USA)Sterile Adjustable Distal Radius Fixator (ADRF) with4.0 mm/3.0 mm Self-Drilling Schanz Screws
Classification:	Class II, 21 CFR 888.3030 and 888.3040
Common or Usual Name:	External Fixation Frame
Predicate (unmodified) Device:	Synthes (USA)Articulating ("Adjustable") Distal Radius Fixator (ADRF)
Device Description:	The Sterile Adjustable Distal Radius Fixator is a pre-assembled mechanically adjustable external wrist fixator. Itis a one-piece construct, which consists of plastic and metalcomponents. The device is applied to the bone with fourself-drilling Schanz screws that lock into two fixator clamps.The device operates by turning screws, which operate gears,to achieve incremental movement.The sterile packaged ADRF is packaged with Synthes4.0 mm/3.0 mm stainless steel, self-drilling Schanz screws orSynthes 4.0 mm/3.0 mm titanium self-drilling Schanz Screws.
Intended Use:	Synthes Sterile Adjustable Distal Radius Fixator (ADRF) isintended for fixation of the distal radius.
Material:	Polyetherimide, stainless steel, and titanium alloy
Substantial Equivalency:	Documentation is provided which demonstrates that theSynthes Sterile Adjustable Distal Radius Fixator issubstantially equivalent to its predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of flowing lines, possibly representing health and well-being.

NOV 26 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

Re: K033411

Trade/Device Name: Synthes Sterile Adjustable Distal Radius Fixator (ADRF) Regulation Numbers: 21 CFR 888.3030 and 888.3040 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories, and Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: KTT and HWC Dated: October 24, 2003 Received: October 27, 2003

Dear Ms. Smith:

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. Bonnie J. Smith

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 (301) 594-4659. 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 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,

for Mark N. Millman

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

Enclosure

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2. Indications for Use

Special 510(k) Device Modification

INTENDED USE STATEMENT

03341

510(k) Number (if known):

Device Name:

Indications:

Synthes Sterile Adjustable Distal Radius Fixator (ADRF)

Synthes Sterile Adjustable Distal Radius Fixator System is intended for stabilizing fractures of the distal radius.

fo Mark N. Milhurn

ivision Sign-Off) Division of General. Restorative and Neurological Levices

K033411 "10(k) Number_________________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use

Synthes (USA) Special 510(k): Synthes Sterile ADRF 000004

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.