(37 days)
Avenir® Müller Stem is intended for:
Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.Acute traumatic fracture of the femoral head or neck.Avascular necrosis of the femoral head.
Avenir® Müller Stems are for cementless use only.
The Avenir® Cemented Hip Stem is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of:
Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseasesFailed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR)Acute traumatic fracture of the femoral head or neckAvascular necrosis of the femoral head.
The Avenir® Müller Stem is a titanium alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design and features a three dimensional proximal-to-distal taper. The stem and neck are a single unit and the stem features proximal ribs on the anterior and posterior surfaces which are designed to increase stability. Except for the polished neck area, the surface of the stem is coated with Ti-6Al-4V titanium alloy plasma spray and oversprayed by a hydroxyapatite coating. The stem is available as both a lateralized and standard version.
The Avenir® Cemented Hip Stem is a stainless steel alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design and features a three dimensional proximal-to-distal taper. The stem and neck are a single unit. The stem is highly polished and available as both a lateralized and standard version.
This document, K193030, is a 510(k) premarket notification for Zimmer GmbH's Avenir Müller Stem and Avenir Cemented Hip Stem. It's a submission for hip prostheses, and the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating AI performance as would be expected for a software-based device.
Based on the provided text, the device in question is a medical implant (hip stem), not an AI/software device. Therefore, the questions about "effect size of how much human readers improve with AI vs without AI assistance," "standalone (algorithm only without human-in-the-loop performance)," "training set," and "ground truth for the training set" are not applicable to this submission. The "acceptance criteria" here relate to the physical and mechanical properties of the implant and its packaging.
Here's an analysis of the provided information regarding 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 (What was tested) | Reported Device Performance (Conclusion) |
|---|---|
| Packaging Configuration Change: | |
| - Maintenance of sterile barrier system integrity up to the point of use. | Packaging performance testing was performed to verify that packaging configuration maintains integrity of the sterile barrier system up to the point of use. |
| - Adequate protection of the product through hazards of sterilization, handling, distribution, and storage. | Packaging performance testing was performed to verify that packaging configuration provides adequate protection to the product through the hazards of sterilization, handling, distribution, and storage. |
| Correction of Instrument Classification from Class I to Class II (for certain system-specific Class II instruments): | |
| - Verification of mechanical integrity. | Amendment of Design Controls with verification of mechanical integrity was performed. |
| - Verification of resistance. | Amendment of Design Controls with verification of resistance was performed. |
| Overall Conclusion Regarding Substantial Equivalence: | The performance data and analyses demonstrate that: |
- any differences (modifications) do not raise new questions of safety and effectiveness as established with performance testing; and
- the subject devices are at least as safe and effective as the legally marketed predicate device. The devices have the same intended use and similar indications for use, use the same operating principle, incorporate the same basic design and labeling, and are manufactured and sterilized using the same materials and processes as the predicate device. |
2. Sample sized used for the test set and the data provenance
- Sample Size:
- For Packaging Configuration testing: "Packaging Configuration testing was conducted by representative worst-case products." A specific number is not provided, but the approach indicates a focus on challenging scenarios to ensure robustness.
- For Instrument Classification (mechanical integrity and resistance): Not explicitly stated, but implies testing of the instruments.
- Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective, as these are non-clinical (laboratory/engineering) tests rather than human subject studies. Such tests are typically conducted in a controlled lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as this submission is for a physical medical device (hip stem) and its associated instruments and packaging, not an AI/software device that requires expert-established ground truth from medical images. The "ground truth" here is compliance with engineering standards and performance specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation (e.g., of medical images) where there might be disagreements among human readers. This submission describes non-clinical engineering and packaging tests.
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
This question is not applicable. This describes a physical medical device, not an AI-assisted diagnostic or treatment planning tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This describes a physical medical device, not a software algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's acceptance criteria is based on established engineering standards and regulatory requirements for the performance of medical device packaging (e.g., ISO 11607-1:2006 and ISO 11607-2:2006) and the mechanical integrity of instruments. These are objective, measurable criteria, not subjective expert consensus or clinical outcomes data.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of a 510(k) submission for a physical medical device. This term is relevant to AI/machine learning models.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 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.