(57 days)
MicroPort total hip systems are intended 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, ankylosis, protrusio acetabuli, and painful hip dysplasia:
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- inflammatory degenerative joint disease such as rheumatoid arthritis;
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- correction of functional deformity; and,
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- revision procedures where other treatments or devices have failed.
The modular Ceramic Femoral Head is composed of alumina matrix composite, manufactured as per ISO 6474-2. It has a 12/14 taper which is identical to the taper on MicroPort Orthopedics' range of femoral heads. The device articulates with an acetabular liner and is compatible for use across any of MicroPort Orthopedics' total hip component range.
This document is a 510(k) premarket notification summary for a medical device, specifically a "Ceramic Femoral Head." This type of document is used to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and human-in-the-loop studies.
Therefore, the information requested in your prompt regarding acceptance criteria for an AI/device, human reader studies, and ground truth establishment for such studies, is not applicable to this specific document.
The document primarily focuses on non-clinical (mechanical) testing to demonstrate that the new Ceramic Femoral Head, manufactured from a different material (Permallon Tru by CoorsTek), performs equivalently or better than the predicate device.
Here's a breakdown of what is available in the document, related to the general concept of "acceptance criteria" for the device's mechanical performance:
1. A table of acceptance criteria and the reported device performance:
The document general states: "Non-clinical (mechanical) testing results met the applicable acceptance criteria; therefore, acceptable mechanical performance is expected of the Ceramic Femoral Head manufactured by CoorsTek."
While a table of specific numerical acceptance criteria and their corresponding reported performance values is not explicitly presented, the document lists the types of tests performed:
- Axial compression test
- Fatigue test
- Post-fatigue ultimate compression strength test
- Static pull off test
- Static torsion test
- MR Safety Evaluation (per ASTM F2182-19, FDA Guidance, ASTM F2052-21, ASTM F2119-07)
The "acceptance criteria" for these tests would inherently be standard specifications or thresholds defined within the referenced ASTM standards and FDA guidance for orthopedic implants, ensuring the device's mechanical integrity and MR compatibility. The "reported device performance" is summarized as having "met the applicable acceptance criteria."
2. Sample size used for the test set and the data provenance:
- Test Set (Mechanical Testing): The specific sample sizes for each mechanical test are not mentioned in this summary document. These would typically be specified in the full test reports, but are not required for the 510(k) summary. Given these are mechanical tests on physical devices, the "provenance" is the manufacturing process of the Ceramic Femoral Head by CoorsTek.
- Data Provenance: The data comes from engineering evaluations performed by the manufacturer, MicroPort Orthopedics, Inc. These are laboratory-based mechanical tests, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document describes mechanical testing of a physical medical device, not an AI or diagnostic device that requires expert human interpretation for "ground truth." The "ground truth" here is the physical performance measured against established engineering standards.
4. Adjudication method for the test set:
- Not applicable. There is no "adjudication" in the context of mechanical testing. The results are objective measurements from laboratory equipment.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No. This is not an MRMC study. MRMC studies compare human reader performance with and without AI assistance, which is irrelevant to verifying the mechanical properties of a ceramic femoral head.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm, but a physical implant.
7. The type of ground truth used:
- For mechanical testing, the "ground truth" is defined by established engineering standards and material properties (e.g., ISO 6474-2, ASTM F2182-19, ASTM F2052-21, ASTM F2119-07). The device's performance is measured against the requirements of these standards and compared to the predicate device's established performance under these standards.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI or machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
In summary, this 510(k) notification focuses on demonstrating substantial equivalence of a physical medical implant through established non-clinical mechanical testing, not through AI performance evaluation or human clinical studies.
§ 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.