(160 days)
The MectaCer BIOLOX® OPTION 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; ioint reconstruction, internal fixation. arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement where sufficient bone stock is present.
The Mectacer Biolox Option Heads consist of a metal sleeve made of titanium alloy Ti-6AI4V according to ISO 5832-3 and ASTM F136 in neck lengths of S, M, L, and XL with an inner 12/14 taper and a MectaCer BIOLOX® OPTION ceramic femoral head (made of BIOLOX® delta ceramic) with head diameters of 28, 32, 36, 40, and 44mm with a conical bore which matches with the external taper of the sleeve. The MectaCer BIOLOX® OPTION femoral heads are made of high-purity aluminium oxide Al2 03-ZrO2 ceramic compound according to ISO 6474-2. The pink color is due to the chromium oxide (Cr2O3) that improves the hardness of the composite material.
This document describes the performance testing for the "Mectacer Biolox Option Heads." As this is a medical device application (510(k) summary), the "acceptance criteria" are not reported as specific numerical targets for metrics like sensitivity or specificity. Instead, the acceptance criteria are implicitly that the device's mechanical performance is equivalent to, and capable of withstanding expected in vivo loading without failure, as compared to predicate devices. The study is a set of mechanical tests rather than a clinical trial with human subjects.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical integrity and durability to withstand in vivo loading | The Mectacer Biolox Option Heads were tested for fretting corrosion of the metallic sleeve and the tapers of the femoral stems. These tests were conducted on Ti6Al7Nb (ISO 5832-11) femoral stems. In addition, the Mectacer Biolox Option Heads were tested for burst strength, fatigue, post-fatigue, pull-off and rotational stability. |
| Equivalent to currently cleared devices | "A review of the mechanical data indicates that the MectaCer Biolox Delta Heads are equivalent to devices currently cleared for use and are capable of withstanding expected in vivo loading without failure." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of units or samples used for each mechanical test. It generally references "the Mectacer Biolox Option Heads" being tested.
- Data Provenance: The data provenance is mechanical testing conducted on the device components. It is not human subject data. Therefore, concepts like country of origin or retrospective/prospective do not apply in the same way. The tests were performed in a lab setting to assess the device's physical properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question refers to the establishment of ground truth for clinical data, which is not applicable here as the study is a set of mechanical tests of a physical device. The "ground truth" for these tests would be established by validated engineering standards (e.g., ISO 5832-3, ASTM F136, ISO 6474-2, ISO 5832-11) and the expertise of mechanical engineers/test lab personnel. The document does not specify the number or qualifications of experts involved in conducting or interpreting the mechanical tests beyond mentioning "A review of the mechanical data indicates..." which implies engineering review.
4. Adjudication Method for the Test Set
This is not applicable as it relates to expert review of clinical cases. The "adjudication" for mechanical testing would involve comparing the test results against established performance standards and predicate device data.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the diagnostic performance of algorithms with human readers, which is not relevant for a mechanical hip implant component.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is not for software or AI, but for a physical medical device.
7. The type of ground truth used
The ground truth used for this device's performance evaluation is based on established mechanical engineering standards (e.g., ISO and ASTM standards for materials and components) and comparison to predicate devices that have demonstrated safety and effectiveness in clinical use. The "truth" is that the device physically withstands specific forces and conditions as designed and as required for its intended use, without failure, and similarly to its predecessors.
8. The Sample Size for the Training Set
This concept is not applicable. There is no "training set" in the context of mechanical device testing for a 510(k) submission. This refers to machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as #8.
§ 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.