(77 days)
The MectaCer BIOLOX® forte 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® forte Femoral 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® forte Femoral Heads consist of High Purity Aluminium Oxyde Ceramic, Al2 O3 per standard ISO 6474:1994, Implants for surgery --Ceramics materials based on high purity alumina, Type A. The MectaCer BIOLOX® forte Femoral Heads are available in various sizes from 28, 32 and up to 36 mm diameters.
Here's an analysis of the provided text regarding the MectaCer BIOLOX® forte Femoral Heads, focusing on acceptance criteria and supporting studies:
This submission (K073337) is a 510(k) Premarket Notification, which demonstrates substantial equivalence to legally marketed predicate devices, rather than a clinical trial proving device efficacy against specific acceptance criteria for performance. Therefore, the information provided primarily refers to bench testing and adherence to international standards for the device's material and mechanical properties, not a study evaluating clinical performance (e.g., patient outcomes, diagnostic accuracy).
The document does not describe a study in the traditional sense of evaluating an algorithm or AI's performance against specific clinical acceptance criteria for diagnosis or treatment. Instead, it details the engineering and material performance of a hip implant component.
Here's a breakdown of the requested information based on the provided text, with notes where information is not applicable to this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria here are standards for the material and mechanical performance of the femoral head, not diagnostic or clinical accuracy. The "reported device performance" is that the device conforms to these standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 6474:1994 (Implants for surgery -- Ceramic materials based on high purity alumina) | MectaCer BIOLOX® forte Femoral Heads consist of High Purity Aluminium Oxyde Ceramic, Al2 O3 per standard ISO 6474:1994, Implants for surgery --Ceramics materials based on high purity alumina, Type A. |
| ISO 7206-10, 2003 (Implants for surgery Partial and total hip-joint prosthesis - Part 10: Determination of resistance to static load of modular femoral heads) | Performance testing was conducted in accordance with this standard. |
| ASTM F-2009-00 (Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses) | Performance testing was conducted in accordance with this standard. |
| AAMI/ANSI/ISO 11137 (Sterilization of health care products – Radiation) | Performance testing was conducted in accordance with this standard. |
| FDA's "Guidance Documents for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems", January 10, 1995 | Performance testing was conducted in accordance with this guidance document. |
| Conclusion from Manufacturer | "Actual device performance as tested conforms to applicable standards and FDA guidance." |
| Substantial Equivalence to Predicate Devices | The device is "substantially equivalent to Plus Ceramic Ball Heads 28, 32 & 36, and Exactach® 12/14 Alumina Femoral Heads with respect to indications for use and technological characteristics." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in the context of clinical data or patient cases. The testing described is bench testing of the physical device. Therefore, the "sample size" would refer to the number of femoral head units subjected to mechanical and material tests. This number is not provided in the summary.
- Data Provenance: The data provenance is from laboratory testing/bench testing conducted by the manufacturer, MEDACTA International SA, located in Switzerland. It is not retrospective or prospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a physical device (hip implant component) and the "ground truth" is established by adherence to engineering and material standards, not by expert consensus on clinical findings or images. The "ground truth" for the material composition and mechanical properties is based on the specifications within the cited ISO and ASTM standards.
4. Adjudication Method for the Test Set
- Not Applicable. As the testing is for physical properties against defined standards, there is no need for expert adjudication in the same way as with diagnostic image interpretation. The "adjudication" is met by demonstrating conformity to the specified technical parameters of the standards.
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 device is a passive hip implant component, not an AI or diagnostic tool. Therefore, no MRMC study involving human readers and AI assistance was conducted or would be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This device is a passive hip implant component, not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" is based on established international standards for ceramic materials (ISO 6474), mechanical testing of hip prostheses (ISO 7206-10), and taper connections (ASTM F-2009-00), as well as sterilization (AAMI/ANSI/ISO 11137). These standards define the expected physical and material properties that the device must meet.
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. As there is no training set, this question is not relevant.
§ 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.