(74 days)
The MectaCer BIOLOX® forte femoral heads and the MectaCer BIOLOX® delta femoral heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for total or partial hip arthroplasty in primary or revision surgery.
The patient should be skeletally mature.
The patient's condition should be due to one or more of the following:
- Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic . arthritis, rheumatoid arthritis, or psoriatic arthritis,
- Congenital hip dysplasia, .
- Ankylosing spondylitis, .
- 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 where sufficient bone stock is present.
The MectaCer Biolox Delta Heads are ceramic ball heads intended for mechanical fixation to a mating hip stem and indicated for the treatment of patients who are candidates for total or partial hip arthroplasty to provide increased patient mobility and reduced pain by replacing the damaged hip joint, in primary or revision surgery. The MectaCer Biolox Delta Heads are an aluminum oxide matrix composite ceramic consisting of approximately 75% alumina (Al₂O₃), 24% zirconia (ZrO₂) and other trace elements. The pink color is due to the chromium oxide (Cr2O3) that improves the hardness of the composite material. The MectaCer Biolox Delta Heads are designed to mate with a 12/14 stem taper. The MectaCer Biolox Delta Heads are available in head diameters of 28, 32, 36, 40, and 44 mm and in neck lengths of Small, Medium, Large, and Extra Large.
Here's a breakdown of the acceptance criteria and study information for the MectaCer Biolox Delta Heads, based on the provided text:
Important Note: This document describes a medical device clearance (510(k)) based on substantial equivalence, not a clinical trial proving a new therapeutic benefit. The "device performance" in this context refers to mechanical properties and comparison to predicate devices, not clinical outcomes.
Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Burst Test | Defined by ISO 7206-10: Implants for surgery – Partial and total hip joint prostheses – Part 10: Determination of resistance to static load of femoral heads. The modular connection between the ball and the stem of a hip prosthesis is loaded until failure. | Met all acceptance criteria. The MectaCer Biolox Delta Heads were found to be adequate for anticipated in vivo loading. (Specifically, the testing demonstrated that the MectaCer Biolox Forte Heads remain worst-case in comparison to the MectaCer Biolox Delta Heads, implying the Delta heads exceed the Forte's performance or at least meet its criteria). |
| Fatigue Test | Defined by CeramTec test procedure AA 02 10 0807. The modular connection between the ball and the stem of a hip prosthesis is loaded with a sinusoidal axial force at 10 million cycles. | Met all acceptance criteria. The MectaCer Biolox Delta Heads were found to be adequate for anticipated in vivo loading. |
| Post-Fatigue Test | Defined by ISO 7206-10: Implants for surgery – Partial and total hip joint prostheses – Part 10: Determination of resistance to static load of femoral heads. The modular connection between the ball and the stem of a hip prosthesis is loaded until failure after the fatigue test. | Met all acceptance criteria. The MectaCer Biolox Delta Heads were found to be adequate for anticipated in vivo loading. |
| Rotational Stability Test ("Torsion Test") | Defined by Ceramtec procedure VP-KU-0180. A modular fitting between ball and stem is subjected to frictional torsion until movement occurs. | Met all acceptance criteria. The MectaCer Biolox Delta Heads were found to be adequate for anticipated in vivo loading. |
| Pull-Off Test | Defined by CeramTec procedure VP-KU-0210, with 5 samples (as per FDA recommendations). Corresponds to ISO 7206-10. The femoral head is pressed onto a taper using an axial force of 2 kN and pulled off axially using a loading rate of 1mm/min. | Met all acceptance criteria. The MectaCer Biolox Delta Heads were found to be adequate for anticipated in vivo loading. |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document explicitly mentions "5 samples" for the Pull-Off Test. For other tests (Burst, Fatigue, Post-Fatigue, Rotational Stability), the exact number of samples is not specified, but it states "The testing was conducted on the worst case size MectaCer Biolox Delta and Forte Heads."
- Data Provenance: The testing was conducted by or for Medacta International SA, a Swiss manufacturer. The tests themselves are based on international standards (ISO) and manufacturer-specific procedures (CeramTec). This is in vitro mechanical testing, not human subject data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as this study involves in vitro mechanical testing against established engineering standards and specifications, not human expert interpretation of clinical data. The "ground truth" is the performance defined by the ISO standards and CeramTec procedures.
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Adjudication method for the test set:
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of clinical images or data. For mechanical testing, adherence to the pre-defined criteria of the test standards serves as the "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:
- No, an MRMC comparative effectiveness study was not done. This is a 510(k) submission for a hip implant component, not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is neither an algorithm nor a device with a human-in-the-loop component in the way usually meant in AI/diagnostic discussions. It is a standalone mechanical component for surgical implantation. The "standalone performance" here refers to its mechanical integrity under specified loads.
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The type of ground truth used:
- The "ground truth" for this device's performance in mechanical testing is based on pre-defined acceptance criteria set by international standards (ISO 7206-10) and established internal manufacturer test procedures (CeramTec AA 02 10 0807, VP-KU-0180, VP-KU-0210). These standards prescribe the methodology and expected outcomes for material strength, fatigue resistance, and stability under load.
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The sample size for the training set:
- This concept is not applicable here. There is no "training set" in the context of mechanical testing for a medical device implant. The device design and materials are based on established engineering principles and prior device history, not on machine learning training data.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set." The "ground truth" for the device's design and manufacturing is established through extensive engineering research, material science, and adherence to medical device design requirements, industry standards, and regulatory guidance for orthopedic implants.
§ 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.