(149 days)
The MODULAR-PLUS® Revision Stem is intended for cementless use in fractures of the femur where a long section of bone is damaged and the stem must anchor into the distal half of the femur.
The MODULAR-PLUS Revision Stem is a cement-less, two-part modular system that consists of a distal anchorage module and a proximal revision module. These two modules are connected with a multi-staged conical coupling and fitted with a safety screw. Taken together, the two modules again form a long, quadrilateral, conical stem prosthesis, which can be anchored in the distal half of the femur. The range consists of 12 distal and 6 proximal modules of various sizes. The distal module has a symmetrical curve matching the forward curve of the femur, suitable for the right and left femur. The proximal module offers a choice of standard and long modules in order to achieve the appropriate geometry of the stem and acetabulum. It is placed on top of the firmly embedded distal module and is fully adjustable to the appropriate degree of anteversion. Both modules (proximal and distal) and the safety screw are made of titanium (TiAl6Nb7) in conformance with ASTM-F 1295-92 and ISO 5832-11.
The provided text describes a medical device, the MODULAR-PLUS Revision Stem, and its FDA 510(k) clearance. However, it does not contain the specific information required to complete the requested table and study details.
The document states: "Performance data: Biomechanical Testing has been provided." but it does not include the actual results of this testing, nor does it specify acceptance criteria for the device's performance.
Therefore, I cannot fulfill the request as there is no data in the input text regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory approval letter based on "substantial equivalence" to a predicate device, not a detailed technical report of the device's performance studies.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.