(135 days)
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No
The summary describes a physical mesh device for bone reinforcement and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The device is intended to reinforce bone, which is a structural or supportive function, not a therapeutic one (i.e., treating or curing a disease or condition).
No
The device, Exeter Mesh, is described as reinforcing bone and providing support, with no mention of detecting, monitoring, or diagnosing medical conditions. Its function is structural reinforcement, not diagnostic.
No
The device description clearly states it is a physical mesh available in different styles and includes screws for fixation, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Exeter Mesh Function: The description clearly states the Exeter Mesh is intended to "reinforce bone when additional strengthening and support is required." It is a physical implant used within the body to provide structural support.
The intended use and device description are consistent with a surgical implant, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
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.
Product codes
JDJ
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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).