(30 days)
The Synthes MatrixMANDIBLE plate and screw system is intended for oral, maxillofacial surgery:
- Trauma
- Reconstructive surgery
- Orthognathic surgery (surgical correction of dentofacial deformities)
The Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and sizes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient. System implants are manufactured in either titanium or titanium alloy and are intended for single use only.
The MatrixMANDIBLE screws that are the subject of this premarket notification are made from titanium alloy (Ti-6Al-7Nb) and are available in a diameter of 2.0 mm and lengths ranging from 4 mm to 8 mm, and have a thread pitch of 0.5 mm. These screws work with all plates within the MatrixMANDIBLE Plate and Screw System.
These devices are offered non-sterile and must be sterilized prior to use. MatrixMANDIBLE screws are intended for single use.
Here's an analysis of the provided text regarding the Synthes MatrixMANDIBLE Plate and Screw System, focusing on acceptance criteria and the supporting study:
The provided document describes a 510(k) premarket notification for a medical device. This type of submission generally relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy trials. Therefore, the "acceptance criteria" and "study" described will primarily revolve around mechanical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for the mechanical tests. Instead, it states that the performance of the proposed devices is "equivalent to or better than" the predicate devices. The reported device performance is presented as the results of the mechanical tests, which are implicitly compared against the predicate's performance.
| Test Parameter | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Strip-out resistance (N·m) | Equivalent to or better than predicate devices | Demonstrated equivalence or superiority to predicate devices (specific values not provided in summary) |
| Pull-out strength (N·m) | Equivalent to or better than predicate devices | Demonstrated equivalence or superiority to predicate devices (specific values not provided in summary) |
| Yield Torque (N·m) | Equivalent to or better than predicate devices | Demonstrated equivalence or superiority to predicate devices (specific values not provided in summary) |
| Insertion Torque (N·m) | Equivalent to or better than predicate devices | Demonstrated equivalence or superiority to predicate devices (specific values not provided in summary) |
| Insertion Factor of Safety | Equivalent to or better than predicate devices | Demonstrated equivalence or superiority to predicate devices (specific values not provided in summary) |
Note: The summary document only states that the device's performance was "equivalent to or better" than the predicate. Specific numerical values for the predicate or the proposed device's performance are not provided in this 510(k) summary. For a full understanding of the acceptance criteria (e.g., specific thresholds or statistical equivalence margins) and the detailed results, one would typically need access to the full test report submitted to the FDA.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for each mechanical test (e.g., how many screws were tested for pull-out strength).
- Data Provenance: The testing was "Non-Clinical Testing" performed by the submitter, Synthes (USA), which is based in West Chester, PA, United States of America. The data is retrospective in the sense that it's generated for the submission, but it's new data specific to the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the study described is non-clinical mechanical testing, not a clinical study involving expert judgment of medical images or patient outcomes. The "ground truth" here is objective physical force measurements.
4. Adjudication Method for the Test Set
This section is not applicable for non-clinical mechanical testing. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations in clinical or image-based studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical testing was performed to support this submission."
6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study
This section is not applicable. This device is a bone plate and screw system, a physical medical device, not an AI algorithm. Therefore, "algorithm only" or "human-in-the-loop" performance are not relevant concepts here.
7. Type of Ground Truth Used
The ground truth used for the non-clinical testing was objective physical measurements of mechanical properties (e.g., force, torque) under controlled laboratory conditions, as defined by engineering standards. The "truth" is established by the direct measurement of these physical properties rather than by expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
This section is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as #8.
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JUN 2 g 2012
| 5 | 510(k) Summary | Page 1 of 2 |
|---|---|---|
| --- | ---------------- | ------------- |
| Date Prepared | April 23, 2012 |
|---|---|
| Submitter | Synthes (USA) |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| United States of America | |
| Contact | Alan T. Haley |
| haley.alan@synthes.com | |
| (484) 356-9763 | |
| Trade Name | MatrixMANDIBLE Plate and Screw System |
| Common Name | Bone Plate |
| Classification Name | Bone Plate, 21 CFR 872.4760, Product Code JEY |
| Predicate Devices | MatrixMANDIBLE Plate and Screw System (K063790) |
| Synthes Mandibular Modular Fixation System (K954385) | |
| Intended Use | The Synthes MatrixMANDIBLE plate and screw system is intended for oral, maxillofacial surgery: |
- Trauma
- Reconstructive surgery
- Orthognathic surgery (surgical correction of dentofacial deformities)
Device Description
The Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and sizes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient. System implants are manufactured in either titanium or titanium alloy and are intended for single use only.
The MatrixMANDIBLE screws that are the subject of this premarket notification are made from titanium alloy (Ti-6Al-7Nb) and are available in a diameter of 2.0 mm and lengths ranging from 4 mm to 8 mm, and have a thread pitch of 0.5 mm. These screws work with all plates within the MatrixMANDIBLE Plate and Screw System.
These devices are offered non-sterile and must be sterilized prior to use. MatrixMANDIBLE screws are intended for single use.
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Image /page/1/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a circle with a design inside. To the right of the word is a small circle with an R inside, indicating a registered trademark. A horizontal line is present under the logo and the word.
510(k) Summary
Page 2 of 2
Technological Characteristics
The proposed MatrixMANDIBLE devices are similar to the predicate devices in terms of indications, dimensions, principles of operation, and design (i.e. cortex screws for internal fixation of bone). The non-clinical testing data discussed below show that the subject devices have equivalent or better mechanical performance when compared to the predicate devices and that the minor differences in device geometry do not raise new issues of safety and effectiveness.
Clinical Testing
No clinical testing was performed to support this submission.
Non-Clinical Testing
Mechanical testing was performed to compare the proposed devices to the predicates to measure:
- . Strip-out resistance (N m)
- . Pull-out strength (N·m)
- . Yield Torque (N·m)
- . Insertion Torque (N·m)
- Insertion Factor of Safety .
The non-clinical test results demonstrate that the mechanical performance of the proposed Synthes MatrixMANDIBLE screws is equivalent to or better than the predicate devices and support the substantial equivalence to the predicate devices.
Substantial Equivalence to Predicate Devices
In conclusion, the proposed Synthes MatrixMANDIBLE Plate and Screw System devices have the same intended use as, and technological characteristics similar to, the legally marketed predicate devices. Non-clinical testing data demonstrate that differences in the technological characteristics do not affect safety or effectiveness. The information presented supports substantial equivalence of the proposed devices to the predicate devices.
(end of summary)
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Alan T. Haley Regulatory Affairs Specialist Synthes. Incorporated 1301 Goshen Parkway West Chester, Pennsylvania 19380
JUN 2 9 2012
Re: K121574
Trade/Device Name: MatrixMANDIBLE Plate and Screw System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: May 25, 2012 Received: May 30, 2012
Dear Mr. Haley:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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- Mr. Haley
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 yours.
hn fac
Anthony D. Watson, B.S., M.S., M.B.A. 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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Image /page/4/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line is present below the word "SYNTHES". The "®" symbol is located to the right of the word.
Indications for Use Statement 4
510(k) Number (if known):
Device Name:
Indications for Use:
MatrixMANDIBLE Plate and Screw System
The Synthes MatrixMANDIBLE plate and screw system is intended for oral, maxillofacial surgery:
- . Trauma
- Reconstructive surgery .
- Orthognathic surgery (surgical correction of dentofacial ● deformities)
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number: K121574
14
§ 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.