(122 days)
Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemi-arthroplasty or total hip replacement (THR). 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® Müller stem is a titanium alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. Except for the polished neck area, the surface of the stem is coated with air plasma sprayed (APS)-Ti and oversprayed by a hydroxyapatite coating. It is a wedge-shaped, collarless design with a proximal-to-distal taper. The stem is available as both a lateralized and standard version.
The provided document is a 510(k) summary for the Zimmer Biomet Avenir® Müller Stem, a hip prosthesis. This document describes the device and its substantial equivalence to predicate devices, focusing on non-clinical performance data. It explicitly states that clinical data and conclusions were not needed for this device.
Therefore, I cannot provide information on acceptance criteria based on clinical studies, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment related to clinical outcomes, as the submission did not include such studies.
Here's what can be extracted from the document regarding non-clinical performance:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide specific numerical acceptance criteria or performance values for each test. Instead, it makes a general statement: "The results of non-clinical (lab) performance testing demonstrate the devices are safe and effective and substantially equivalent to the predicate devices."
The types of non-clinical performance tests conducted were:
| Acceptance Criteria Focus (Implied) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Strength/Durability | Demonstrates safety, effectiveness, and substantial equivalence to predicate devices. |
| Coating Integrity | Demonstrates safety, effectiveness, and substantial equivalence to predicate devices. |
| Biocompatibility (implied by materials) | Demonstrates safety, effectiveness, and substantial equivalence to predicate devices. |
| Functional range | Demonstrates safety, effectiveness, and substantial equivalence to predicate devices. |
Note: The actual numerical acceptance limits and test results are not detailed in this summary document.
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not specified for non-clinical tests. Non-clinical tests typically involve a specific number of samples (e.g., n=5 or n=10 per test) as per relevant ISO or ASTM standards, but this detail is not in the summary.
- Data Provenance: The tests were "non-clinical (lab) performance testing" and conducted "in-house" or by contract labs following established test protocols. The country of origin of the data is implicitly Switzerland (Zimmer, GmbH is in Winterthur, Switzerland), though specific test locations are not detailed. These were prospective tests performed on the device prototypes/samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. Non-clinical performance tests for medical devices are evaluated against engineering specifications and industry standards, not typically against expert-established ground truth in the same way clinical data is. The "ground truth" would be the successful demonstration of meeting predetermined engineering specifications/standards.
4. Adjudication method for the test set:
Not applicable for non-clinical tests. Evaluation is based on objective measurements against pass/fail criteria defined in engineering specifications and test protocols.
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 hip implant, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device (hip implant), not an algorithm.
7. The type of ground truth used:
For non-clinical tests, the "ground truth" is adherence to established engineering specifications, relevant ASTM/ISO standards, and performance comparable to predicate devices. It is based on objective physical measurements and material characterization, rather than clinical outcomes or expert consensus.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI algorithm requiring a training set. If "training set" refers to design iterations or material selection, those details are not provided in this summary.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" in the context of this device's submission. The design and manufacturing process would follow established quality systems and engineering principles, with validation against specifications.
§ 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.