(21 days)
The Synthes Ti-15Mo Locking Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
The Synthes Ti-15Mo Locking Distal Radius Plating System consists of machined metallic plates and screws that offer screw to plate locking designed for various fracture modes of the distal end of the radius.
The provided text is a 510(k) summary for the Synthes Ti-15Mo Locking Distal Radius Plating System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance-based acceptance criteria for AI/ML-enabled software.
Therefore, this document does not contain the information requested in the prompt regarding acceptance criteria and performance studies for an AI/ML device. The device described is a physical implant (bone plate and screws), not a software or AI/ML product.
Here's why the requested information is absent:
- Acceptance Criteria and Performance: The document aims to establish that the new device is as safe and effective as a previously marketed predicate device. It doesn't define quantitative performance acceptance criteria or report performance against such criteria.
- Sample Sizes (Test/Training Data), Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth: These are all concepts relevant to the validation of AI/ML algorithms using clinical data. A physical implant like a bone plate does not undergo these types of studies for 510(k) clearance. Its equivalence is typically based on material properties, design, and intended use compared to the predicate.
In summary, the provided text describes a medical device, but it is not an AI/ML device, and thus the requested information regarding acceptance criteria and studies for AI/ML performance is not present.
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JUN 2 4 2003
K031725
page 1 of 1
3. 510(k) Summary
| Sponsor | Synthes (USA)1690 Russell RoadPaoli, PA 19301 |
|---|---|
| Contact Name | Bonnie Smith |
| Name of the Device | Synthes Ti-15Mo Locking Distal Radius Plating System |
| Device Classification(s) | Class II, §888.3030 - Plate, Fixation, BoneClass II, §888.3040 - Screw, Fixation, Bone |
| Predicate Device | Synthes Distal Radius Plate System |
| Device Description | The Synthes Ti-15Mo Locking Distal Radius Plating Systemconsists of machined metallic plates and screws that offerscrew to plate locking designed for various fracture modes ofthe distal end of the radius. |
| Indications | The Synthes Ti-15Mo Locking Distal Radius Plating Systemis intended for fixation of complex intra- and extra-articularfractures and osteotomies of the distal radius and other smallbones. |
| Materials | Titanium-15% molybdenum |
| Substantial Equivalence | Documentation is provided which demonstrates that theSynthes Ti-15Mo Locking Distal Radius Plating System issubstantially equivalent* to other legally marketed Synthesdevices. |
| * The term "substantial equivalence" as used in this 510(k)notification is limited to the definition of substantialequivalence found in the Food, Drug and Cosmetic Act, asamended and as applied under 21 CFR 807, Subpart E, underwhich a device can be marketed without pre-market approvalor reclassification. A determination of substantialequivalency under this notification is not intended to have anybearing whatsoever on the resolution of patent infringementsuits or any other patent matters. No statements related to, orin support of substantial equivalence herein shall be construedas an admission against interest under the US Patent Laws ortheir application by the courts. |
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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three horizontal lines above a wavy line, which is the department's symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2003
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. PA 19301
Re: K031725
Trade/Device Name: Synthes Ti-15Mo Locking Distal Radius Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: June 2, 2003 Received: June 3, 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
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Page 2 - Ms. Bonnie J. Smith
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. 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,
Mark A. Millerson
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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Indications for Use Statement 2.
510(k) Number (if known):
Device Name:
Indications for Use:
3172)5
Synthes Ti-15Mo Locking Distal Radius Plating System_
The Synthes Ti-15Mo Locking Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
(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)
OR Over-The-Counter Use
Alhals A. Miller
Division Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number K03
10004
§ 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.