(76 days)
Micro Dynamic Mesh is intended to stabilize fractures, grafts and elective osteotomies for the reconstruction of the bones of the craniomaxillofacial skeleton, and the oral cavity (including the mandible and maxilla).
The Leibinger® Micro Dynamic Mesh is a titanium mesh available in different shapes, thicknesses, and perforation patterns to treat a variety of clinical applications. The material can be cut with scissors for precision fit, is malleable for three-dimensional adaptations, and is perforated to permit fluid exchange. The mesh is attached to bone by screws. The titanium construction allows for radiological identification but produces negligible artifacts on CT or MRI.
The provided text is a 510(k) summary for the Micro Dynamic Mesh, a titanium mesh used for craniomaxillofacial skeletal reconstruction. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving performance against specific acceptance criteria. Therefore, most of the requested information cannot be extracted directly from this document.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not detail specific acceptance criteria or performance metrics for the Micro Dynamic Mesh. Instead, it relies on demonstrating substantial equivalence to already marketed predicate devices. This means the device is considered acceptable if its intended use, materials, design, and operational principles are equivalent to the predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document beyond substantial equivalence to predicates. | Not specified in the document beyond substantial equivalence to predicates. |
2. Sample size used for the test set and the data provenance
No specific test set or clinical study data is provided in this 510(k) summary. The demonstration of substantial equivalence typically relies on comparative analysis with predicate devices and possibly bench testing, but not clinical trials with sample sizes for performance evaluation in the way requested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set requiring expert ground truth establishment for performance evaluation is described.
4. Adjudication method for the test set
Not applicable. No test set requiring 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 device is a physical titanium mesh, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical titanium mesh, not an algorithm.
7. The type of ground truth used
Not applicable in the context of a performance study for this type of device. The "ground truth" for a 510(k) submission like this is primarily the established safety and effectiveness of the predicate devices. The new device aims to be "substantially equivalent" to those.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would have a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
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DEC 2 3 1998
K9f8332df
510(k) Summary
Proprietary Name: Micro Dynamic Mesh Common Name: Titanium Mesh Classification Name & Reference: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories (21 CFR 888.3030) Requiatory Class:
Device Product Code:
Class II HRS
For information contact:
Vivian Kellv Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford. NJ 07070 Phone: (201) 507-7830 Fax: (201) 507-6870
Date Prepared:
October 7, 1998
The Leibinger® Micro Dynamic Mesh is a titanium mesh available in different shapes, thicknesses, and perforation patterns to treat a variety of clinical applications. The material can be cut with scissors for precision fit, is malleable for three-dimensional adaptations, and is perforated to permit fluid exchange. The mesh is attached to bone by screws. The titanium construction allows for radiological identification but produces negligible artifacts on CT or MRI.
Micro Dynamic Mesh is intended to stabilize fractures, grafts and elective osteotomies for the reconstruction of the bones of the craniomaxillofacial skeleton, and oral cavity (including the mandible and maxilla).
The substantial equivalence of this device is based on the equivalence in intended use, materials, design, and operational principles to the currently marketed predicate devices such as TiMesh™ System (TiMesh Inc. & Sofamor Danek USA), 1.5/2.0 Combination Titanium Osteosynthesis System (Walter Lorenz) and Osteomed's TRAM™ .
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Image /page/1/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" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 1998
Ms. Vivian Kelly Manager, Regulatory Affairs Howmedica, Incorporated 359 Veterans Boulevard Rutherford, New Jersey 07070
K983528 Re: Micro Dynamic Mesh Trade Name: Regulatory Class: II Product Code: JEY Dated: October 7, 1998 October 8, 1998 Received:
Dear Ms. Kelly:
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਚ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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
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Page 2 - Ms. Kelly
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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) 594-4692. 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" (21CFR 807.97). Other qeneral 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/dsma/dsmamain.html".
Sincerel yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Leibinger® Micro Dynamic Mesh
Indications for Use:
Micro Dynamic Mesh is intended to stabilize fractures, grafts and elective osteotomies for the reconstruction of the bones of the craniomaxillofacial skeleton, and the oral cavity(including the mandible and maxilla).
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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use_V OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-C Division of Dental, Infection Control, and General Hospital Devices
510(k) Number
(Division Sign-Off) Division of General Restorative Devices 510(k) Number _
§ 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.