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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 cementless two part modular system that consists of a distal anchorage module and proximal revision module, connected by a multistage tapered coupling, secured by a cylindrical screw.

A total of 96 different anatomically-matched stems can be combined for the left and right hips by using 24 distal and 6 proximal modules.

The Modular PLUS stem system is manufactured from Ti-6Al-4V alloy that conforms to ASTM F136. The surface is grit blasted with corundum to produce a surface roughness of 4-6um.

This document is a 510(k) premarket notification for a medical device and, as such, does not contain information about acceptance criteria or a study proving the device meets said criteria.

The 510(k) summary (Input {0}) and the FDA clearance letter (Input {1} to {3}) are primarily concerned with demonstrating "substantial equivalence" to a predicate device already on the market, rather than presenting efficacy study results against predefined acceptance criteria for the new device.

Therefore, I cannot extract the requested information from the provided text.

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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:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. 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.

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