(24 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.
Not Found
The provided text does not contain information about acceptance criteria for a device's performance that can be presented in a table or a study proving that a device meets such criteria.
The document is a Special 510(k) Summary of Safety and Effectiveness for the Exactech Ziramic™ Zirconia 12/14 Femoral Heads. It focuses on demonstrating substantial equivalence to a previously marketed predicate device (#K050398) rather than presenting a study against pre-defined acceptance criteria for device performance.
Here's what can be extracted from the document regarding the "study" mentioned, which is more accurately described as "testing and engineering evaluations" for substantial equivalence:
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1. A table of acceptance criteria and the reported device performance: Not available. The document states: "Testing and engineering evaluations were conducted to verify adequate performance of the Exactech® Ziramic™ Zirconia 12/14 Femoral Heads for anticipated in vivo loading when mated with Exactech cobalt chrome alloy 12/14 Femoral Stems." It doesn't provide specific quantitative acceptance criteria or detailed performance results in the summary.
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2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available. The document mentions "testing and engineering evaluations" without specifying sample sizes or the nature of the data (e.g., in vitro, in vivo, etc.).
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3. 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. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical trials), not for engineering evaluations of a hip femoral head.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for engineering evaluations.
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5. 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 for AI/human reader studies.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithm performance.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for engineering evaluations of medical devices typically involves physical and mechanical properties being measured against established standards or performance expectations for the device's intended use. The document generally refers to "anticipated in vivo loading" as the context for performance.
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8. The sample size for the training set: Not applicable. No "training set" in the context of an AI/machine learning model is mentioned.
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9. How the ground truth for the training set was established: Not applicable.
§ 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.