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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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

The M-Vizion Femoral Revision System Extension implants are a range extension to the already cleared M-Vizion Femoral Revision System (K191816 and K170690). The range extension includes proximal bodies with holes and distal stems 4°.

The M-Vizion Femoral Revision System a is modular cementless stem intended to be used for hip arthroplasty, primary or revision. The system is composed of proximal body, distal stem and 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 locking screw provided with the subject proximal bodies is the same component cleared with the predicate devices. M-Vizion Femoral Revision System K191816 and K170690.

The proximal body is made of titanium alloy (Ti6A17Nb) according to ISO 5832-11 Second Edition 2014-09-15: Implants for Surgery - Metallic Materials - Part 11: Wrought Titanium 6-Aluminium 7-Niobium Alloy and coated with a titanium coating, TiGrowth®-C (Medacta commercial name: Mectagrip). The distal stem is made of titanium alloy while the locking screw is made of titanium alloy and coated with TiNbN.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called the "M-Vizion Femoral Revision System Extension." It is for a hip prosthesis.

The provided text does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device. This document is for a traditional medical device (hip prosthesis) and focuses on demonstrating substantial equivalence to previously cleared predicate devices through materials, design, and mechanical testing, rather than algorithmic performance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample size used for the test set and data provenance.
3. Number of experts to establish ground truth and qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The "Performance Data" section explicitly states:

• "No clinical studies were conducted."
• Performance data provided is related to "DESIGN VALIDATION and CHARACTERIZATION TESTING" for mechanical properties (e.g., fatigue tests) and "PYROGENICITY" testing, not AI/ML model performance.

This document clearly pertains to a physical orthopedic implant, not a software-driven device requiring performance evaluation based on AI/ML metrics.

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Monolithic cementless stems are indicated for use in partial or total hip arthroplasty and they are intended for press-fit (uncemented) use.

When used in total hip arthroplasty, monolithic cementless stems are with modular heads and compatible acetabular cups.

When used in partial hip arthroplasty, they are intended for use with bipolar heads.

Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

· non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and dysplasia;

• rheumatoid arthritis;

· revisions in cases of good remaining femoral bone stock;

· treatment of femoral head and neck fractures.

The C2 femoral stem is intended for partial or total hip arthroplasty in cementless use in primary or revision cases. It is a monolithic collarless stem available in 14 sizes for both standard and lateralized versions and 8 sizes in revision version.

When used in total hip arthroplasty C2 femoral stems are coupled to previously cleared Limacorporate components:

• . Biolox Delta femoral heads or Limacorporate Femoral Heads articulating with Limacorporate Cemented Cups or
• Biolox Delta heads or Limacorporate Femoral Heads articulating with Delta TT ● Acetabular System.

When used in partial hip arthroplasty the C2 femoral stem is coupled to previously cleared Limacorporate Lock Bipolar Heads.

The C2 femoral stem is made of Ti6Al4V conforming to the specifications ASTM F1472 - ISO 5832-3. The stem is characterized by a 12/14 conical taper to be coupled to Limacorporate Femoral Heads, Biolox Delta femoral heads or Lock Bipolar Heads. In addition necks are mirror-polished to reduce abrasion of the UHMWPE cups in case of abnormal contact. The stem has a rectangular section and is characterized by a "V" shaped A-P profile to improve adaptability to the most common bone morphologies and to facilitate insertion of the stem in the canal.

The C2 femoral stem is suitable for both first implant and revision versions. The first implant versions are available in standard and lateralized versions with different CCD angles (131° and 134°), offsets and stem lengths.

This document is a 510(k) premarket notification for a medical device called the "C2 femoral stem." It is a submission to the FDA to demonstrate substantial equivalence to previously marketed devices. Therefore, it does not describe an AI/ML powered device, an acceptance criteria table with reported device performance, or a study to prove an AI/ML device meets acceptance criteria.

The document details the device's intended use, description, and comparison to predicate devices, and refers to non-clinical testing for fatigue resistance as part of demonstrating substantial equivalence.

Here's the information that is available in the document, which primarily focuses on the regulatory submission process for a traditional medical device:

1. A table of acceptance criteria and the reported device performance:
* Not Applicable. This document is for a traditional medical device (a femoral stem implant), not an AI/ML powered device. Therefore, no acceptance criteria for AI/ML performance metrics (like sensitivity, specificity, AUC) are presented.
* The document mentions fatigue resistance tests according to ISO 7206-4 and ISO 7206-6. It states, "The tests results demonstrated the device's ability to perform under expected clinical conditions." However, no specific quantitative acceptance criteria or reported performance values (e.g., cycles to failure, load limits) are provided in this summary.

2. Sample size used for the test set and the data provenance:
* Not Applicable for an AI/ML test set. For the non-clinical fatigue testing, the document states, "All mechanical tests were performed on worst case components or constructs." The specific number of samples (e.g., number of stems tested) for these mechanical tests is not disclosed in this summary. Data provenance is not relevant in the context of these physical component tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not Applicable. This is not an AI/ML device requiring expert-established ground truth.

4. Adjudication method for the test set:
* Not Applicable. This is not an AI/ML device.

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 is not an AI/ML device and therefore no MRMC study was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not Applicable. This is not an AI/ML device.

7. The type of ground truth used:
* For the non-clinical fatigue testing, the "ground truth" would be the engineering specifications and ISO standards (ISO 7206-4, ISO 7206-6) for fatigue performance. Meeting these standards demonstrates the device's mechanical integrity.

8. The sample size for the training set:
* Not Applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established:
* Not Applicable. This is not an AI/ML device.

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