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The device is intended for use in hip arthroplasty in cemented and uncemented primary or revision applications whose indications include:

• 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis or post traumatic arthritis.
• 2. Proximal femoral neck fractures or dislocation.
• 3. Idiopathic avascular necrosis of the femoral head.
• 4. Non-union of proximal femoral neck fractures.
• 5. Treatment of fractures that are unmanageable using other forms of therapy.

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The provided text is a 510(k) clearance letter from the FDA for a medical device called "Pivot™ Bipolar Head." This document grants market clearance based on a finding of "substantial equivalence" to a predicate device.

It is critical to understand that this document does not contain acceptance criteria for the device's performance, nor does it describe a study proving the device meets performance criteria.

A 510(k) submission generally involves demonstrating that a new device is as safe and effective as a legally marketed predicate device. This often involves comparing technological characteristics and, sometimes, performance data. However, the FDA letter itself is the result of a review, not the detailed study report.

Therefore, I cannot provide the requested information from the given text. The FDA clearance letter acknowledges the submission and clearance but does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or data provenance.
• Number/qualifications of experts for ground truth or adjudication methods.
• Information on MRMC studies or standalone algorithm performance.
• The type of ground truth used.
• Sample size for the training set or how its ground truth was established.

This information would typically be found in the original 510(k) submission document or supporting technical reports, which are not provided here.

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This device is intended to be used for :

• femoral noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
• rheumatoid arthritis,
• correction of functional deformity,
• revision procedures where other treatments or devices have failed, and
• treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

A bipolar head which is preassembled. Outer head is made from Cobalt Chrome alloy ASTM F75 and sizes range from 38mm to 62mm in 1mm increments. An UHMW polyethylene insert will be pressed into the inner surface of the outer head during the manufacturing process. This polyethylene insert will articulate with an inner femoral head. The inner head diameter will be 22mm for outer head diameters from 38mm to 55mm and 26mm for outer diameters from 56mm to 62mm. The inner head will be pressed into the poly insert in the operating room using a bipolar head assembly device.

The provided text is a 510(k) summary for a medical device called the "Whiteside Biomechanics, Inc. Bipolar Femoral Head." It describes the device, its intended use, and confirms its substantial equivalence to a predicate device.

However, the document is a regulatory submission for a physical medical device (a hip prosthesis component), not an AI/ML-driven software device. Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) is not applicable or present in this type of regulatory document for a physical implant. The 510(k) process for such devices typically focuses on manufacturing, materials, and substantial equivalence to existing devices, rather than the performance metrics and studies you would find for a diagnostic or prognostic AI algorithm.

Therefore, I cannot extract the requested information as it is not contained within the provided input.

Ask a specific question about this device