(135 days)
The Exeter Mesh is intended to be used to reinforce bone when additional strengthening and support is required.
The Exeter Mesh is available in four (4) styles to fit a variety of anatomical requirements. The mesh is intended to be either cemented in place or affixed with screws. Screws are provided that are 3.5mm in diameter and range in length from 10mm to 35mm.
It appears you've provided information about a 510(k) summary for a medical device called "Exeter Mesh K963946," specifically an Acetabular Mesh. However, the provided text does NOT contain any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement, which are all necessary to answer the questions in your prompt.
The 510(k) summary focuses on general device information, intended use, and substantial equivalence to previously marketed devices. It does not include the type of detailed performance study data you're requesting.
Therefore, I cannot fulfill your request with the information provided. To answer your questions, I would need a different type of document, such as a clinical study report, a detailed performance data summary, or regulatory submission documents that specifically discuss:
- Acceptance criteria: What performance metrics were required for the device to be considered safe and effective?
- Reported device performance: What were the results of tests against these criteria?
- Study design details: Information on sample sizes, data provenance, ground truth establishment (experts, pathology), adjudication, mrmc studies, and standalone performance.
If you can provide a different document that contains this type of information, I would be happy to analyze it and answer your questions.
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FFR 13 1997
510(k) Summary
Proprietary Name: Exeter Mesh K963946
Common Name: Prosthesis, Hip, Acetabular Mesh
Classification Name and Reference: 21 CFR 878.3300 Prosthesis, Hip, Acetabular Mesh
Proposed Requlatory Class: Class II Device Product Code: OR(87) JDJ રપા ( 79)
Frank Maas For information contact: Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 9-30-96
The Exeter Mesh is intended to be used to reinforce bone when additional strengthening and support is required. The Exeter Mesh is available in four (4) styles to fit a variety of The mesh is intended to be either anatomical requirements. Screws are provided cemented in place or affixed with screws. that are 3.5mm in diameter and range in length from 10mm to 35mm.
Substantial equivalence of the Exeter Mesh is based on the equivalence in intended use, materials, design, operational principles, and indications and contraindications to Howmedica's Acetabular mesh (preamendment), and mesh marketed by Osteonics (K925883) and Intermedics (K890450).
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.