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The IMTEC/TitaniumMesh consists of a laser cut segment of precision expanded, flattened and annealed Titanium Mesh of a specific size dimension and pore dimension. The device will be marketed sterile.
I apologize, but the provided text from the K970841 510(k) summary does not contain any information regarding clinical studies, device performance, acceptance criteria, ground truth, or sample sizes.
The document is a 510(k) summary that focuses on:
- Submission Information: Submitter's contact details, FDA registration, date of submission.
- Device Classification and Naming: Classification name, common name, proprietary name.
- Predicate Devices: A list of previously cleared devices to which the IMTEC/TitaniumMesh is substantially equivalent.
- Device Description: A brief physical description of the IMTEC/TitaniumMesh (laser cut, expanded, flattened, annealed titanium mesh of specific size/pore, marketed sterile).
Therefore, I cannot fulfill your request for the detailed information asked in your prompt based on the provided text. To answer your questions, I would need a section of the 510(k) addressing performance data, clinical testing, or evidence of substantial equivalence based on performance.
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510 (k) Summary of Safety and Effectiveness
SUBMITTED BY:
M. K. Patterson, Jr. PhD Sr Vice President Regulatory Affairs IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401 (405) 223-4456
F.D.A Registration Number: 1645158 Owner / Operator Number: 9003407
Date Submitted: March 5,1997
CLASSIFICATION/COMMON OR USUAL NAME/ DEVICE NAME:
Classification Name: Precision expanded Titanium foil (CFR 878.3300) Common/ Usual Name: Titanium Mesh. Proprietary Name: IMTEC/ TitaniumMesh
PREDICATE DEVICE:
Leibinger, Micro-Titanium Augmentation Mesh ( M-TAM™) K 862532 Osteomed. , Osteomed MSS (Ti Ridge Augmentation Material) K963394 Walter Lorenz Surgical, Inc., Ti Mini Bone Plate and Screws, K862482 TiMesh Inc., Reconstructive Surgery System,K923491
DEVICE DESCRIPTION:
The IMTEC/TitaniumMesh consists of a laser cut segment of precision expanded, flattened and annealed Titanium Mesh of a specific size dimension and pore dimension. The device will be marketed sterile.
§ 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.