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The Bi-Metric CoCr Head/Neck Replacement Hip Stem is intended for use in cases with a diagnoses of:
a) Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
b) Rheumatoid arthritis
c) Correction of functional deformities
d) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
e) Revisions of hip replacement components
The Bi-Metric CoCr Head/Neck Replacement Hip Stem is intended for cemented application and is a single use device.

The Bi-Metric CoCr Head/Neck Replacement Hip Stem is a cobalt alloy (Co-Cr-Mo) femoral stem which is designed to articulate with a commercially available acetabular component. It has no linkage across the joint. The medial portion is built up to compensate for bone of severe bone loss. It is further enhanced by a keel, which allows transfer of the proximal load to the calcar region, and resists torsion. There are suture holes in the lateral flange of the proximal platform for reattaching and securing the greater trochanter in cases where a trochanteric osteotomy is needed. The platform inside the collar is "bead blasted"; the stem outside the collar distally is "grit blasted" providing for an improved fixation between the stem/cement interface.
There are three resection levels: 34mm, 45mm, and 55mm with four diameters: 9mm, 11mm, 13, and 15mm. The stems are available in 150mm, 200mm, and 250mm lengths. The 150mm and 200mm stems are straight and the 250mm stems are bowed right and left specific.

The provided text is a 510(k) summary for the Bi-Metric CoCr Head/Neck Replacement Hip Stem. It describes the device, its intended use, potential risks, and a claim of substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, any study proving the device meets those criteria, or details regarding test sets, ground truth establishment, or human reader performance.

The document focuses on regulatory approval based on substantial equivalence, implying that the device's safety and effectiveness are established by its similarity to an already approved device rather than through novel performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The following points represent the absence of this information in the provided document:

1. A table of acceptance criteria and the reported device performance: Not available. The document does not define specific acceptance criteria for performance; instead, it relies on substantial equivalence.
2. Sample size used for the test set and the data provenance: Not available. No performance studies are described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. No performance studies are described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available. No performance studies are described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a hip stem, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hip stem.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available. No performance studies are described.
8. The sample size for the training set: Not applicable. This device is a hip stem, not an AI model.
9. How the ground truth for the training set was established: Not applicable. This device is a hip stem, not an AI model.

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