(18 days)
The indications for use for Biomet hip replacement prosthesis include: 1) noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional deformity; 4) treatment of non-union, femoral neck fracture, and throchanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5) revisions of hip replacement components. Standard surgical and rehabilitative procedures are indicted with this device. This device is for use with bone cement.
The Color Buffed Cemented Femorals are designed to replace a diseased or damaged femoral neck. A modular head attaches to trunion to complete the femoral side of a total hip. The stems are indicated for cement use and are distally tapered to provide better stress distribution through the cement mantle. A reduced superior lateral insures easier insertion while maintaining proximal canal filling. A reduced medial collar provides greater range of motion, stability, and prevention of component subsidence. Each stem is straight, thus eliminating the need for a left and right configurations. The stems utilize a modular head to provide an articulating surface with any commercially available acetabular component. These components are intended for use with bone cement, and as such. have PMMA spacers added to the stem to enhance stability within the cement mantle.
This document is a 510(k) premarket notification for a medical device and does not contain the requested information regarding acceptance criteria, study details, or performance metrics.
The provided text is a regulatory approval letter and device description for the "Color Buffed Cemented Femoral," a hip replacement component. It discusses the device's design, indications for use, potential risks, and its substantial equivalence to previously marketed devices.
To answer your request, a detailed performance study report would be required, which is typically a separate document and not included in this regulatory communication.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such study is described.
- Adjudication method for the test set: Not applicable.
- 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 is a medical implant, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document is purely a regulatory approval for marketing based on substantial equivalence, not a detailed performance study.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.