Search Results

The hip prosthesis M-Vizion is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.

Hip Replacement is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

The M-Vizion Femoral Revision System is a modular cementless stem intended to be used for hip arthroplasty in primary or revision surgery. The system is composed of the proximal body, the distal stem, and the locking screw. The proximal body and the distal stem are intended to be assembled together on a conical coupling and tightened by the locking screw.

The proximal body is made of titanium alloy and coated with a titanium coating, TiGrowth -C (Medacta commercial name: Mectagrip). The distal stem is a straight stem made of titanium alloy and the principal feature consists of shard fins that potentially increase the rotation stability. The locking screw is made of titanium alloy and coated with TiNbN.

The provided text describes the M-Vizion Femoral Revision System, a medical device, and its demonstrated substantial equivalence to predicate devices. However, it does not include specific acceptance criteria with numerical values for performance, nor does it detail a standalone study that directly proves the device meets such criteria in a comparative effectiveness manner with effect sizes or human reader performance.

The document primarily focuses on non-clinical performance tests performed to demonstrate substantial equivalence, rather than establishing acceptance criteria or reporting performance against them in a table format.

Therefore, much of the requested information cannot be extracted directly from the provided text. Below, I will present the information that can be inferred or directly stated, and clearly indicate what is not available.

1. A table of acceptance criteria and the reported device performance

The document lists performance tests conducted but does not specify the numerical acceptance criteria for these tests or provide specific reported numerical performance values. It only states that the tests "met the acceptance criteria that were based on standards."

2. Sample sizes used for the test set and the data provenance

The document does not specify the sample sizes (e.g., number of devices tested) for the non-clinical performance tests. All testing appears to be non-clinical (laboratory-based) with no human data involved, so provenance like "country of origin of data" or "retrospective/prospective" is not applicable in the human data sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The tests are non-clinical, mechanical, and material characteristic tests against established international standards. There is no "ground truth" in the sense of expert medical diagnosis or interpretation.

4. Adjudication method for the test set

Not applicable. There is no human adjudication for non-clinical performance tests against standards. Compliance is typically determined by test engineers and quality control personnel.

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-powered diagnostic or assistive tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a hip implant. The "standalone" performance refers to the device's mechanical and material properties as tested against industry standards.

7. The type of ground truth used

The "ground truth" for the non-clinical performance tests were the specifications and requirements defined in the referenced international standards (e.g., EN ISO 21535:2009, ISO 7206-4, ISO 7206-6, ASTM F2009-00). For the Bacterial Endotoxin Test, the ground truth was the specified endotoxin limit of <20 EU/device.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/ML-based device.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of medical device.

Ask a specific question about this device