Search Results

The V40 "/C-Taper Adapter Sleeve is intended to allow either a Howmedica Osteonics C-Taper Alumina Head or a Howmedica Osteonics C-Taper Biolox® Delta Ceramic Femoral Head to mate with a Howmedica Osteonics femoral stem with a V40" taper. The V40" /C-Taper Adapter Sleeve is a single-use device.

Indications for Use:

For Use as a Total Hip Replacement:

• Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid . arthritis, post-traumatic arthritis or late stage vascular necrosis.
• Revision of previous cup arthroplasty or other procedures. .
• Clinical management problems where arthrodesis or alternative reconstructive techniques are . less likely to achieve satisfactory results.

For Use as a Bipolar Hip Replacement

• Femoral head/neck fractures or non-unions. .
• . Aseptic necrosis of the femoral head.
• Osteo- rheumatoid, and post traumatic arthritis of the hip with minimal acetabular . involvement or distortion.

Other Considerations:

• Pathological considerations or age considerations which indicate a more conservative . acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty. .

The subject V-40" /C-Taper Adapter Sleeve is a tapered sleeve component with a female V-40" taper to provide locking with a Howmedica Osteonics femoral stem with a V-40 * taper. In addition, the sleeve has a tapered male exterior surface that provides locking with Howmedica Osteonics C-Taper Alumina Ceramic Heads.

The provided document is a 510(k) Premarket Notification for a medical device, specifically a "Line Extension to the V-40™/C-Taper Adaptor Sleeve." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a study in the way a clinical trial would.

Therefore, the document does not contain the information requested for acceptance criteria and a study that proves the device meets those criteria, as it would for a new AI/diagnostic device.

Here's why and what the document does address:

• Type of Device: The device is a mechanical component for hip replacement surgery (an adapter sleeve for femoral heads). It's not a diagnostic AI or imaging device that would typically have performance metrics like sensitivity, specificity, or reader improvement studies.
• Regulatory Pathway: A 510(k) submission primarily focuses on demonstrating "substantial equivalence" to a predicate device. This means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness as a device already on the market.
• "Study" Equivalence: The "study" mentioned in the document refers to mechanical testing to demonstrate substantial equivalence, not a clinical study involving human patients or ground truth derived from expert consensus. Key phrases supporting this are: "Mechanical testing demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength."

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, sample size, ground truth, experts, or MRMC studies because this information is not applicable to the type of device and regulatory submission presented in the input.

The document does provide:

• Intended Use and Indications for Use: These describe the clinical conditions for which the device is designed.
• Substantial Equivalence Statement: This is the core argument of a 510(k), stating the device is similar to existing ones based on intended use, materials, and design, supported by mechanical testing.

Ask a specific question about this device

Ask a specific question about this device