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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, traumatoid 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, surface replacement arthroplasty, or total hip replacement.

The M-Vizion Monobloc is a range extension to the already cleared M-Vizion Femoral Revision System (K201471, K191816 and K170690).

The M-VIZION Monobloc Stem is a monobloc cementless stem intended to be used for hip arthroplasty, in primary or revision surgeries. It shows a fluted tapered distal portion made of forged Ti-6Al-7Nb alloy according to ISO 5832-11 Second Edition 2014-09-15: Implants for Surgery - Metallic Materials - Part 11: Wrought Titanium 6- Aluminium 7-Niobium Alloy coated with a titanium coating. TiGrowth®-C (Medacta commercial name: Mectagrip); a proximal portion coated with Titanium Ti ASTM F 1580 and it is sandblasted distally.

The available size are:

• Length L190 mm ø12-26 mm STD/LAT; .
• Length L240 mm ø12-26 mm STD/LAT;
• Length L290 mm ø12-26 mm STD/LAT. ●

The two versions STD/LAT have the following geometrical details:

• STD: CCD angle 132°, offset 37 mm; .
• LAT: CCD angle 132°, offset 43 mm. ●

The M-VIZION Monobloc Stem is a range extension of the M-VIZION Modular Stem, from which it leverages most of the geometrical features such as the stem taper angle, the flutes design, the shape of the neck and proximal portion, and the Ti coating. Differently from the M-VIZION Monobloc Stem, the M- VIZION Modular Stem includes also a Locking Screw to fix the two parts.

The provided text is a 510(k) summary for the M-Vizion Monobloc hip prosthesis. It describes the device, its indications for use, comparison to predicate devices, and performance data. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/algorithm performance.

The document states: "No clinical studies were conducted." and focuses on non-clinical performance tests (Range of motion, FEM analysis) and biocompatibility for the physical implant. It is a submission for a medical device, not an AI/algorithm-driven product where acceptance criteria and performance metrics (like sensitivity, specificity, etc.) for an AI would be relevant.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Here is a breakdown of why each requested point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not available. The document is for a physical hip prosthesis, and the "performance data" refers to mechanical properties and biocompatibility, not AI performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable. There is no AI test set mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no AI ground truth establishment mentioned.
4. Adjudication method: Not applicable. No expert adjudication is mentioned relevant to AI performance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "No clinical studies were conducted."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used: Not applicable. No AI ground truth is mentioned.
8. The sample size for the training set: Not applicable. No AI training set is mentioned.
9. How the ground truth for the training set was established: Not applicable. No AI training set ground truth is mentioned.

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