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FOR HEMI-HIP RESURFACING ARTHROPLASTY:

The Durom Hip Resurfacing system femoral component, when used for hemi-hip arthroplasty, has been designed for cemented use in patients who are likely to outlive a conventional hip prosthesis. Femoral hip resurfacing hemi arthroplasty is most appropriate for patients with good bone quality in the femoral head and acetabulum, where the bearing surface and supportive bone structure of the acetabulum is normal, and where acetabular replacement is neither required nor desirable. Such patients will generally be under the age of 65.

• Non inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis if remaining bone stock is adequate, and osteoarthritis
• Inflammatory joint disease (IJD), e.g. rheumatoid arthritis
• Joint replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives

Additional indications include other abnormalities where major pathology affects the femoral head; where the bearing surface and supportive bone structure of the acetabulum is normal; and where acetabular replacement is neither required nor desirable

• WARNING: The Durom Femoral component is not approved for use with the Durom Acetabular cup for total hip surface replacement arthroplasty in the USA.

The Durom® Hip Resurfacing System femoral component consists of a monoblock head and slim-line femoral guide pin. The head is an extended hemisphere (greater than 180°). It is available in 12 sizes with Outside Diameters (ODs) ranging from 38mm to 60mm. The spherecity of the head is tightly controlled to less than 10 microns. The underside of the head has recesses for controlled pressurization of cement into the cancellous bone, and for rotational stability after implantation.

The provided text describes the Zimmer Durom® Hip Resurfacing System's femoral components and its FDA 510(k) clearance. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement as typically found in studies for AI/software devices.

This document is a traditional 510(k) premarket notification for a physical medical device (a hip resurfacing system), not a software or AI device. Therefore, the types of performance data and study methodologies you're asking about (e.g., test sets, ground truth by experts, MRMC studies, standalone algorithm performance) are not applicable or present in this filing.

Instead, the "Performance Data (Non-clinical)" section briefly mentions:
"The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective."

This statement implies that the device underwent engineering and biomechanical testing typical for orthopedic implants, such as fatigue testing, wear testing, material characterization, and possibly cadaveric studies or computational modeling, to ensure its structural integrity, biocompatibility, and mechanical performance under simulated physiological conditions. However, the specific details, results, and acceptance criteria for these tests are not included in this summary.

In summary, based only on the provided text, I cannot answer the questions as they pertain to a software or AI device's performance study. The document outlines the device's description, intended use, and substantial equivalence to predicate devices based on material, design, and similar performance characteristics evident from non-clinical laboratory testing.

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Indications for use include a severe disabling and/or painful hip associated with the following indications: 1) Osteoarthritis, 2) Traumatic arthritis, 3) Rheumatoid arthritis, 4) Advanced avascular necrosis, 5) Congentital hip dysplasia, and 6) Slipped captial femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

The all-metal cobalt chrome TARA Resurfacing device is a single unit component and is porous coated on the inner cylindrical wall and ceiling only. The cobalt chrome porous coating is a -45 +60 Mesh x .030" thick surface coating. The all-metal TARA is only avaiable in the short stem version, again with nine head sizes from 38mm to 55mm in 2 mm increments. The all-metal TARA is fixed to the bone with cement.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The provided text is a 510(k) summary and an FDA clearance letter for the BIOPRO TARA Femoral Resurfacing Component. These documents outline the device's substantial equivalence to predicate devices, its intended use, and its classification. They do not detail specific performance acceptance criteria or report on studies designed to demonstrate the device meets such criteria. Typically, performance data and acceptance criteria are found in a separate section of the 510(k) submission, not summarized in these publicly available portions.

Therefore, I cannot provide the requested information based on the given text.

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