(90 days)
The intended use for the 22.2/-4 Femoral Head is to complete the assembly of a Ti-6Al-4V semicanus and I he mended tise for the 22.27-4 rendral to the tapen of the Morphonetic Hip, manufactures by Medinov-AMP. The indications for use are artintis, arthrosis or any joint disease at the hip level, of wromans is, failed previous surgery or joint reconstruction.
The 22.2/44 Femoral Head is designed to fit on a 9/11 taper. It is 22.2mm in diameter and has a neck length of +4. It is available in zirconia or cobalt chrome alloy.
This device is a physical medical device (femoral head) and not an AI/ML powered device, therefore most of the requested information is not applicable. I will provide the information that is available.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence in burst load to the predicate device. | The burst load average for both the zirconia and cobalt chrome heads is substantially equivalent to that of the predicate device. |
2. Sample size used for the test set and data provenance
Not applicable. This is a physical device, and the testing described is mechanical, not based on data.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
Not applicable. Ground truth for mechanical properties is typically established through direct measurement and testing, not expert consensus in the clinical sense.
4. Adjudication method for the test set
Not applicable.
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 is not an AI/ML powered device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used
The ground truth used for mechanical testing like burst load is typically derived from physical measurements and destructive testing of the devices themselves, adhering to established engineering standards for medical implants.
8. The sample size for the training set
Not applicable. This is a physical device, and "training set" is not relevant in this context.
9. How the ground truth for the training set was established
Not applicable.
§ 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.