(228 days)
The Synthes MatrixMANDIBLE Subcondylar Plates are intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.
The Synthes MatrixMANDIBLE Subcondylar Plates are designed specifically to match the anatomy of the subcondylar region of the mandible. These plates are designed for use with Synthes MatrixMANDIBLE screws that come in multiple diameters and lengths to meet the anatomical needs of the patient. System components are manufactured in either titanium or titanium alloy and are intended for single use only.
The provided text is a 510(k) summary for the Synthes MatrixMANDIBLE Subcondylar Plates. It describes the device, its intended use, and states its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or specific studies that prove the device meets performance criteria.
The 510(k) process for medical devices typically focuses on demonstrating substantial equivalence to a predicate device already on the market. This often involves comparing design features, materials, and intended use, and sometimes includes mechanical testing to show similar performance characteristics. However, detailed clinical studies with acceptance criteria, sample sizes, and ground truth establishment, as described in your request, are more commonly associated with PMA (Premarket Approval) applications for novel, high-risk devices, or specific performance studies for new technologies like AI algorithms.
Therefore, for your request, I can only state that the document does not provide the requested information:
- 1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on substantial equivalence based on design and intended use, not on specific performance metrics against pre-defined acceptance criteria.
- 2. Sample sized used for the test set and the data provenance: Not provided. No test sets or data provenance are mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. No ground truth establishment is described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided. No test set adjudication is described.
- 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: Not applicable. This is a traditional medical device (bone plate), not an AI-powered diagnostic or assistive tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a traditional medical device (bone plate).
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided. No ground truth is established as there are no diagnostic claims requiring such validation.
- 8. The sample size for the training set: Not applicable. This is a manufactured device; there is no "training set" in the context of an AI algorithm.
- 9. How the ground truth for the training set was established: Not applicable.
Summary from the provided document:
The document states that "Information presented supports substantial equivalence" regarding the Synthes MatrixMANDIBLE Subcondylar Plates to the Synthes MatrixMANDIBLE Plate and Screw System and the MODUS® Titanium Osteosynthesis System. This implies that the device is considered safe and effective because it is similar to devices already legally marketed, rather than through meeting specific, novel performance acceptance criteria via extensive new studies.
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Image /page/0/Picture/0 description: The image shows the Synthes logo. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. The circular symbol appears to be a stylized representation of a medical device or implant. A small circle with an R inside is located at the top right of the word "SYNTHES".
3.0
DEC 1 1 2009
1091233
ら
510(k) Summary Page _________________________________________________________________________________________________________________________________________________________________________ Sponsor: Synthes 1301 Goshen Parkway West Chester, PA 19380 Contact: Contact: Andrea M. Tasker tasker.andrea@synthes.com (610) 719-6290 Device Name: Synthes MatrixMANDIBLE Subcondylar Plates Classification: Class 11, 21 CFR §872.4760, Bone plate Predicate Synthes MatrixMANDIBLE Plate and Screw System Devices: MODUS® Titanium Osteosynthesis System The Synthes MatrixMANDIBLE Subcondylar Plates are designed Device Description: specifically to match the anatomy of the subcondylar region of the mandible. These plates are designed for use with Synthes MatrixMANDIBLE screws that come in multiple diameters and lengths to meet the anatomical needs of the patient. System components are manufactured in either titanium or titanium alloy and are intended for single use only. Intended Use: The Synthes MatrixMANDIBLE Subcondylar Plates are intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible. Substantial Information presented supports substantial equivalence. Equivalence:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized image of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
DEC 1 1 2009
Ms. Andrea M. Tasker CMF Regulatory Affairs Manager Synthes (USA) 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K091233
Trade/Device Name: Synthes MatrixMANDIBLE Subcondylar Plates Regulation Number: 21CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: November 23, 2009 Received: November 25, 2009
Dear Ms. Tasker:
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 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.
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Page 2- Ms. Tasker
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Susan Rinner
Anthony D. Watson, BS, MS, MBA Director
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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SYNTHES®
2.0 Indications for Use
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K091233 |
| Device Name: | Synthes MatrixMANDIBLE Subcondylar Plates |
INDICATIONS FOR USE:
The Synthes MatrixMANDIBLE Subcondylar Plates are intended for
oral, maxillofacial surgery; trauma and reconstructive surgery,
specifically for fractures of the subcondylar region of the mandible and
fractures of the condylar basis region of the mandible.
| Labels | Values |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | X |
AND/OR Over-The-Counter Use
(21 CFR 807 Subpart C)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K091232
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.