(275 days)
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
This Special 510(k) application supports the substantial equivalency of the Ziramic™ Zirconia (Zyranox®) 12/14 Femoral Heads relative to Exactech's predicate 12/14 Alumina (BIOLOX® forte) Ceramic Femoral Heads (#K032964). The design modifications include a change in the ceramic material composition from alumina to zirconia, and the addition of +7mm and +10 mm skirted heads for the 28mm, 32 mm and 36 mm outer diameter sizes. The proposed Ceramic Femoral Heads are composed of Morgan Advanced Ceramic's Zyranox® zirconia material and have a European 12/14 taper design.
The provided text is related to a 510(k) submission for a medical device, specifically Ziramic™ Zirconia 12/14 Femoral Heads. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on new acceptance criteria and a study to prove meeting them in the way one might for a novel diagnostic or AI-driven device.
Therefore, the information regarding acceptance criteria and studies demonstrating device performance, as typically requested for AI/diagnostic devices, is not present in the provided document. This document focuses on the material change from alumina to zirconia ceramic and the addition of specific skirted head sizes, and claims substantial equivalence based on testing and engineering evaluations.
Here's how to interpret the request in the context of the provided document:
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A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the document in the format requested. The document mentions "successful results" from "Testing and engineering evaluations" but does not detail the specific acceptance criteria for these evaluations or their quantitative performance. The "device performance" here refers to the material properties of Zyranox® zirconia, which are described in FDA Master File MAF-343, but not explicitly in this summary.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable or not provided. The "tests" mentioned are likely mechanical and material property tests on the femoral heads themselves, not clinical trials with human subjects or data sets in the typical sense for AI/diagnostic devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in this context would relate to the material science and mechanical properties, not expert clinical assessment of a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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 device is a component of a hip replacement system, not an AI diagnostic tool involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device would be established through material science testing, biomechanical testing, and engineering evaluations to ensure the zirconia material meets performance standards for orthopedic implants. The document states "The material properties of Zyranox® are described in FDA Master File MAF-343," indicating that the properties were characterized and documented.
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The sample size for the training set: Not applicable. This is not an AI/machine learning device that uses training sets.
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How the ground truth for the training set was established: Not applicable.
Summary based on the provided document:
The document describes a Special 510(k) submission for the Exactech® Ziramic™ Zirconia 12/14 Femoral Heads. The study proving the device meets acceptance criteria is implied through "Testing and engineering evaluations." The regulatory pathway taken (510(k)) aims to demonstrate substantial equivalence to a predicate device (Exactech 12/14 Alumina Ceramic Femoral Head #K032964), rather than proving new efficacy or safety claims against specific quantitative acceptance criteria in a clinical trial format.
The primary change for this submission is a change in material composition from alumina to zirconia and the addition of new skirted head sizes. The "material properties of Zyranox®" (the zirconia material) are referenced in an FDA Master File (MAF-343). The conclusion states that "Based on successful results we conclude that the proposed devices are substantially equivalent..."
Without access to the actual "Testing and engineering evaluations" and the FDA Master File MAF-343, the specific acceptance criteria and detailed performance data cannot be extracted from this summary document. This document is a regulatory summary, not a detailed technical report or clinical study publication.
§ 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.