(47 days)
The CER-MET™ III Acetabular Cup System is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.
The CER-MET™ III Acetabular Cup System is a non-cemented acetabular cup system with a complete assortment of neutral and 10° hooded poly inserts as well as acetabular screws and screw hole covers (screw hole occluders).
Here's an analysis of the provided text regarding the CER-MET™ III Acetabular Cup System, focusing on the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biomechanical Equivalence to legally marketed predicate devices for in-vivo loading. | "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading." |
| Material Equivalence to legally marketed predicate devices. | "The CER-MET™ III Acetabular Cup System is equivalent to other legally marketed acetabular cup systems in design, materials and intended use." |
| Design Equivalence to legally marketed predicate devices. | "The CER-MET™ III Acetabular Cup System is equivalent to other legally marketed acetabular cup systems in design, materials and intended use." |
| Intended Use Equivalence to legally marketed predicate devices. | "The CER-MET™ III Acetabular Cup System is equivalent to other legally marketed acetabular cup systems in design, materials and intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided text does not specify the sample size used for the biomechanical tests. It only states that "Biomechanical tests have been performed."
The document also does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. 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)
The provided text does not mention the use of experts to establish ground truth for the biomechanical tests. The evaluation appears to be based on physical material and design testing rather than expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The provided text does not mention any adjudication method for the test set, as the study described is biomechanical testing, not a clinical study involving human interpretation.
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
A multi-reader, multi-case (MRMC) comparative effectiveness study was not performed. This document describes the premarket notification for a medical device (acetabular cup system), which primarily relies on biomechanical testing and equivalence to predicate devices, not AI assistance or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device described is a physical implant (acetabular cup system), not an algorithm or AI system. Therefore, standalone algorithm performance testing was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biomechanical tests, the ground truth would be established by engineering standards and established performance metrics for acetabular cups, comparing the device's performance against these predetermined benchmarks and against the performance of the identified predicate devices. It is based on physical measurements and mechanical properties, not clinical or pathological outcomes directly.
8. The sample size for the training set
This question is not applicable. The device is a physical implant and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This question 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.