(85 days)
MicroPort total hip systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- correction of functional deformity; and, 3.
- revision procedures where other treatments or devices have failed 4.
Modular shells with porous metal bead coating may be used in either cemented or uncemented arthroplasty. Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.
The DYNASTY® Acetabular System with Ceramic contains femoral heads in size 28mm manufactured from alumina matrix composite, mating acetabular liners manufactured from crosslinked polyethylene, and beaded acetabular shells manufactured from titanium alloy.
The provided 510(k) summary for the DYNASTY® Acetabular System with Ceramic does not contain information related to acceptance criteria for a device, nor does it describe a study that proves the device meets specific acceptance criteria in the manner typically associated with AI/software devices.
Instead, this document describes a traditional medical device (an orthopedic implant) and focuses on demonstrating substantial equivalence to previously cleared predicate devices. The "study" mentioned is purely for mechanical and tribological (wear) evaluation, not clinical or performance criteria as would be relevant for software or AI.
Therefore, I cannot extract the requested information in the format provided because it's not present in the document.
Here's why and what the document does provide:
- Type of Device: The DYNASTY® Acetabular System with Ceramic is a physical orthopedic implant (acetabular shell, liner, and femoral head for total hip replacement). It is not a software device or an AI algorithm.
- Regulatory Pathway: This is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as for a PMA.
- "Acceptance Criteria" in this context: For a physical implant like this, "acceptance criteria" relate to engineering specifications, material properties, biocompatibility, mechanical strength, wear resistance, and manufacturing quality. These are typically assessed through bench testing and adherence to recognized standards.
- "Study" in this context: The "study" mentioned is non-clinical mechanical and tribological testing.
Specific answers based on the provided text, explaining why other points are not applicable:
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A table of acceptance criteria and the reported device performance:
- Not Applicable. The document does not provide a table of acceptance criteria or performance metrics in the way one would for a software or AI device (e.g., sensitivity, specificity, AUC). It discusses mechanical and tribological evaluations and comparisons to predicate devices rather than specific performance targets against clinical gold standards.
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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. This refers to mechanical testing, not a clinical study involving a test set of data. The "subject size 28mm ceramic head was used as a worst case" for burst, post-fatigue burst, rotational stability, and pull-off force testing, implying a limited number of physical samples (likely one or a few) were subjected to these mechanical tests. No patient data or clinical retrospective/prospective studies were conducted.
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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. This device is not a diagnostic or AI tool requiring expert ground truth for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This is not a clinical study requiring adjudication of expert opinions.
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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 physical medical device, not an AI system.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. For mechanical testing, the "ground truth" would be the physical properties derived from standardized test methods (e.g., force measured at failure, wear volume). The document states:
- "The subject DYNASTY® Acetabular System with Ceramic was evaluated mechanically and tribologically."
- "The mechanical testing on the subject and predicate devices was performed on wrought Cobalt Chrome modular neck spigots cleared under K091423 and K100866."
- "The subject size 28mm ceramic head was used as a worst case in burst, post-fatigue burst, rotational stability, and pull off force testing."
- "Wear testing compared the subject size 28mm femoral heads to the K130376 DYNASTY® Acetabular System."
- "Range of motion evaluation compared the subject system to the predicate K052026 in three planes."
- This implies physical engineering measurements as the "ground truth" for evaluating the device's mechanical characteristics.
- Not Applicable. For mechanical testing, the "ground truth" would be the physical properties derived from standardized test methods (e.g., force measured at failure, wear volume). The document states:
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The sample size for the training set:
- Not Applicable. This is not an AI/ML device requiring a training set.
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How the ground truth for the training set was established:
- Not Applicable. This is not an AI/ML device requiring a training set.
In summary, the provided document describes a "Traditional 510(k)" pathway for a physical orthopedic implant. The demonstration of safety and effectiveness relies on substantial equivalence to predicate devices and non-clinical bench testing, not clinical studies or performance criteria typically associated with software/AI medical devices.
§ 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.