(94 days)
The Medacta Total Hip Prosthesis System - Quadra C Femoral Stems are intended for cemented use in total or partial hip arthroplasty and in primary or revision surgery.
Hip replacement is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia
- Avascular necrosis of the femoral head
- Acute traumatic fracture of the femoral head or neck
- Failure of previous hip surgery, joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Size 0 implants should not be implanted in patients with a mass of 65 kg or greater.
The Medacta Total Hip Prosthesis System – Quadra C femoral stem is a highly polished, collarless femoral component manufactured from forged stainless steel according to ISO 5832-9. The Quadra C femoral stem is a straight quadratic stem with a triple taper shape. The Quadra C femoral stems come in eight sizes with a standard offset and seven sizes with a lateral offset. The proximal portion of the stem has a standard 12/14 taper for mechanical attachment to cleared Medacta International metallic or ceramic femoral heads.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Medacta Total Hip Prosthesis – Quadra C femoral stems:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance tested in accordance with various international standards and FDA guidance documents. | Quadra C femoral stems were tested as part of design verification to written protocols. |
| Pre-defined acceptance criteria based on international standards and FDA guidance. | Testing met all acceptance criteria. |
| Testing conducted on the worst-case component size and option/design. | Testing was conducted on the worst-case component size and option/design. |
| Performance demonstrates substantial equivalence to predicate devices (Sulzer Orthopedics MS-30 standard and lateral femoral stems, and Medacta Total Hip Prosthesis System - Quadra S femoral stems). | Testing verifies that the performance of the Medacta Total Hip Prosthesis- Quadra C femoral stems are substantially equivalent to the predicate devices. |
Study Information
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Sample size used for the test set and the data provenance:
- The document states that "Testing was conducted on the worst-case component size and option/design." No specific numerical sample size (e.g., number of stems tested) for the test set is provided.
- Data Provenance: The study was conducted as "design verification" by the manufacturer, Medacta International SA (Switzerland). The testing was for the purpose of demonstrating substantial equivalence to predicate devices for FDA clearance in the USA. The specific location where the physical testing occurred is not explicitly stated beyond the manufacturer's country of origin. The data is prospective as it was generated specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a mechanical implant, and its performance is evaluated against engineering and material standards through physical testing, not against expert interpretation of data like images or patient outcomes. Ground truth is established by the relevant engineering standards and FDA guidance.
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Adjudication method for the test set:
- Not applicable. As described above, the evaluation is based on objective measurements against engineering standards, not subjective expert judgment requiring adjudication.
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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 device (hip prosthesis), not an AI/software device that assists human readers with interpretation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (hip prosthesis), not an AI/software device. The performance testing described is inherently "standalone" in the sense that it's testing the physical device itself against pre-defined engineering criteria.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is based on pre-defined acceptance criteria derived from international standards (e.g., ISO 5832-9) and FDA guidance documents for orthopedic implant performance. These standards specify mechanical, material, and biocompatibility requirements.
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The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for a physical medical device.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.