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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

• 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.

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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:

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.

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