(356 days)
The Ceramic Spherical CMC Implant is intended to be used as an adjunct to resection arthroplasty of the carpometacarpal (CMC) joint in cases of degenerative arthritis or posttraumatic arthritis limited to that joint. It acts as a spacer to preserve joint relationship and allow appropriate capsuloligamentous reconstruction to correct deformities. The implant will rest in a spherical cavity created by two hemispherical shapes in the trapezium and the first metacarpal. The implant will articulate directly on bone.
Use of the CMC Implant may be considered in cases of isolated carpometacarpal joint involvement from either degenerative or post-traumatic arthritis presenting:
- Localized pain and palpable crepation during circumduction movement with axial compression of involved thumb ("grind test").
- Decreased motion, normal pinch and grip strength.
- X-ray evidence of arthritic changes and/or subluxation of the carpometacarpal ioint.
- Associated unstable, stiff, or painful distal joints.
The Ceramic Spherical CMC Implant is made from alumina or zirconia ceramic.
I cannot provide information about acceptance criteria and study data for the Ceramic Spherical CMC Implant based on the text you provided. The document you shared is a 510(k) summary from 1996 for the Ceramic Spherical CMC Implant, which is a medical device.
The provided text only includes:
- Product Information: Trade/proprietary name, common name, product nomenclature, classification, and predicate device.
- Description/Intended Use: Explains what the device is, its purpose, and the conditions for which it's indicated.
- A very brief statement about testing: "The Ceramic Spherical (MC Implant demonstrates acceptable material strength."
It does not contain any of the specific information you requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or their data provenance.
- Details about experts or ground truth establishment.
- Adjudication methods.
- Results of multi-reader multi-case studies or standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set or how its ground truth was established.
This type of detailed performance data would typically be found in the full 510(k) submission, clinical study reports, or post-market surveillance data, none of which are present in this summary.
If you have access to the full 510(k) submission or related clinical trial documentation for this device, I might be able to extract some of the requested information.
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Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology, Inc. The logo includes the company name in a bold, sans-serif font, with the words "MEDICAL TECHNOLOGY, INC." appearing in a smaller font size below. The address "5677 Airline Road, Arlington, TN 38002" is printed below the company name, followed by the phone number "901-867-9971".
Contact Person: l)ate:
Cliff Kline February 14, 1996
510(k) SUMMARY
FEB - 6 1997
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C'eramic Spherical CMC Implant Carpometacarpal (CMC) implant Prosthesis, wrist, carpal trapezium Class II Swanson Titanium Condylar Implant
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Description/Intended Use
The Ceramic Spherical CMC Implant is intended to be used as an adjunct to resection arthroplasty of the carpometacarpal (CMC) joint in cases of degenerative arthritis or posttraumatic arthritis limited to that joint. It acts as a spacer to preserve joint relationship and allow appropriate capsuloligamentous reconstruction to correct deformities. The implant will rest in a spherical cavity created by two hemispherical shapes in the trapezium and the first metacarpal. The implant will articulate directly on bone.
Use of the CMC Implant may be considered in cases of isolated carpometacarpal joint involvement from either degenerative or post-traumatic arthritis presenting:
- ♪ Localized pain and palpable crepitation during circumduction movement with axial compression of involved thumb ("grind test").
- ﺮ Decreased motion, normal pinch and grip strength.
- ♪ X-ray evidence of arthritic changes and/or subluxation of the carpometacarpal ioint.
- ♪ Associated unstable, stiff, or painful distal joints.
The Ceramic Spherical CMC Implant is made from alumina or zirconia ceramic.
Testing
The Ceramic Spherical ( MC Implant demonstrates acceptable material strength.
§ 888.3770 Wrist joint carpal trapezium polymer prosthesis.
(a)
Identification. A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.(b)
Classification. Class II.