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The hip prosthesis MasterLoc™ 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 MasterLoc" Stem Extension is a line extension to Medacta's MasterLoc" Stem product line (cleared under K151531; K160289 and K173267). The MasterLoc™ Stem Extension implants offer two additional and bigger sizes (sizes 13 and 14) to the product range currently on the market, for both the MasterLoc™ LAT (K151531 and K160289) and the MasterLoc™ LAT Plus (K173267) product lines. The MasterLoc™ Stem Extension implants have been designed with the same shape, design, and substrate material as the previously cleared MasterLoc™ Stem devices (K151531; K160289 and K173267).

The MasterLoc™ Stem Extension implants are made with a titanium alloy substrate (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. The surface treatment consists of Ti coating in the proximal 2/3 of the shaft to improve proximal fixation. The distal portion of the stems are uncoated with a satin finish which is obtained from glass bead blasting.

The MasterLoc™ Stem Extension implants consist of two new additional sizes (13 and 14), with a stem length of 149.5 mm and 151.5 mm, respectively. The stems have a Eurocone (12/14 taper with an angle of 5°42′30″} and the necks are polished, as well as the above mentioned predicate devices.

This document does not describe a study involving device performance, acceptance criteria, or an AI algorithm. It is a 510(k) premarket notification summary for a medical device called the "MasterLoc™ Stem Extension," which is a hip prosthesis.

The document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving performance against specific acceptance criteria through a new study.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert adjudication, or AI performance is not applicable or available in this document.

Here's an attempt to answer the questions based on the provided text, highlighting what is not applicable (N/A) given the nature of this submission:

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

   • Not Applicable. This document does not present acceptance criteria for a new device performance study. Instead, it argues that the new device (MasterLoc™ Stem Extension) is substantially equivalent to previously cleared predicate devices (MasterLoc™ Stems) due to similar design, materials, and technological characteristics. The performance is inferred from the established performance and safety of the predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not Applicable. No new test set or data provenance is mentioned as no new performance study was conducted. The submission relies on an "Engineering Rationale" and comparative analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not Applicable. No ground truth establishment by experts is mentioned as no new clinical or performance test set was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not Applicable. No adjudication method is mentioned as no new test set requiring expert review was used.

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 a hip prosthesis, not a medical imaging AI device. No MRMC study or AI assistance is mentioned.

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

   • Not Applicable. This is a hip prosthesis, not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   • Not Applicable. No new ground truth data was generated for this 510(k) submission. The "ground truth" for the safety and effectiveness of the device is implicitly based on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

   • Not Applicable. This is a hip prosthesis, not an AI algorithm requiring a training set.

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

   • Not Applicable. This is a hip prosthesis, not an AI algorithm.

Summary of the document's approach:

The device, MasterLoc™ Stem Extension, is a line extension of an existing product. It introduces two new, larger sizes (13 and 14) to the MasterLoc™ Stem product range. The submission argues for substantial equivalence primarily based on:

• Identical design principles: Same shape, design, and substrate material as previously cleared MasterLoc™ Stem devices.
• Identical material: Titanium alloy (Ti6A17Nb) with the same coating and surface treatment.
• Minor differences: Only the sizes (larger) and lengths (longer) are different.
• Engineering Rationale: A comparative analysis determined that the longer stem body lengths do not create a "new worst-case product size" or introduce new risks from a clinical or biomechanical performance perspective. The neck length, a critical biomechanical dimension, is identical to a previously cleared size 12 predicate.
• Reliance on predicate device data: Since the new sizes do not represent a worst case and the materials are the same, "no additional mechanical testing or design validation was undertaken." The biocompatibility of the materials is supported by testing conducted on the predicate devices.

In essence, the "study" proving the device meets criteria is a comparative analysis and engineering rationale demonstrating that the new device iterations (larger sizes) do not introduce new questions of safety or effectiveness beyond what has already been established for the predicate devices.

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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, 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."

Ask a specific question about this device