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Mfinity femoral stems are indicated in patients requiring hip arthroplasty.

Total or partial hip arthroplasty is indicated in the following cases:

• Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic arthritis, inflammatory arthritis or hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute fracture of the femoral head.
• Acute fracture of the proximal femur, suitable to be treated by means of hip arthroplasty.
• Non-union of proximal femur fracture, suitable to be treated by means of hip arthroplasty.
• Primary pathology involving the femoral head but with a non-deformed acetabulum.
• Failure of previous hip surgery:
  • Conservative hip surgery.
  • Internal fixation.
  • Arthrodesis.
  • Partial or total hip arthroplasty.
  • Hip resurfacing replacement.

The Mfinity Femoral System includes implantable devices provided individually packed, sterile and single-use intended for cementless use in total or partial hip arthroplasty to replace the native femoral neck for primary or revision surgery. The product range is composed of three different versions (Mfinity collarless, Mfinity collared and Mfinity L) available in standard and lateral offset.

The Mfinity femoral stem can be combined with the CoCr ball head (K072857, K080885 and K103721), Endo Head (K111145), the MectaCer BIOLOX® forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).

The subject devices are made of titanium alloy according to ISO 5832-11 and coated with Titanium plasma spray according to ASTM F1580 and Hydroxyapatite according with ASTM F1185.

The provided text is an FDA 510(k) clearance letter for the Mfinity Femoral System, which is a hip prosthesis, not a diagnostic AI device. Therefore, the information requested regarding acceptance criteria and studies that prove a device meets those criteria, specifically concerning AI performance metrics, expert adjudication, training set, and test set details, is not applicable to this document.

The document discusses the substantial equivalence of the Mfinity Femoral System to predicate devices based on non-clinical performance data (fatigue tests, ROM evaluation, surface analyses, biocompatibility, shelf-life, pyrogenicity) and states that no clinical studies were conducted.

The acceptance criteria for this type of medical device (hip prosthesis) would typically involve demonstrating mechanical strength, durability, biocompatibility, and sterilization effectiveness based on recognized standards (e.g., ISO, ASTM, European Pharmacopoeia, USP). The "reported device performance" would consist of the results of these non-clinical tests meeting the specified limits of those standards.

Below is a general interpretation of what "acceptance criteria" and "reported device performance" would entail for a hip prosthesis based on the provided document, acknowledging that specific numerical details of these criteria and results are not explicitly stated in this letter but would be in the full 510(k) submission.

Based on the provided FDA 510(k) Clearance Letter for the Mfinity Femoral System:

This document describes the clearance of a hip prosthesis, not an AI-powered diagnostic device. Therefore, the typical elements of acceptance criteria and study designs relevant to AI (such as sensitivity, specificity, AUC, expert consensus, training/test set sizes, etc.) are not applicable to this submission.

The "acceptance criteria" for this device would generally refer to meeting established mechanical, material, and biological performance standards for medical implants. The "study that proves the device meets the acceptance criteria" refers to the non-clinical performance testing conducted.

Here's an attempt to populate the requested table and answer the questions based on the information available, while highlighting the irrelevance of AI-specific questions:

1. Table of Acceptance Criteria and the Reported Device Performance

• Pull-off strength of femoral head
• Range of Motion (ISO 21535) | - Mfinity Fatigue tests performed according to ISO 7206-4 and ISO 7206-6 (Results are assumed to have met specified limits)
• Pull-Off Test On CoCr Femoral Head performed (Results are assumed to have met specified limits)
• Evaluation of ROM according to ISO 21535 performed (Results are assumed to have met specified limits) |
  | Material Performance | - Coating characteristics (cross-section, SEM, XRD) | - Cross sectioned area evaluation of double coated implant surfaces performed
• Scanning Electron Microscopy pictures of double coated implant surfaces taken
• XRD analyses comparing HA coating on Mfinity stem and planar samples performed (Results are assumed to demonstrate acceptable coating properties) |
  | Biocompatibility | - Material safety
• Cytotoxicity, sensitization, irritation, genotoxicity, chronic toxicity, etc. | - Biocompatibility assessment performed (Results are assumed to demonstrate compliance with standards) |
  | Sterilization & Endotoxin| - Bacterial endotoxin levels (European Pharmacopoeia §2.6.14 / USP )
• Pyrogenicity (USP ) | - Bacterial endotoxin test (LAL test) performed
• Pyrogen test performed (Results are assumed to meet requirements, though note indicates not labeled as non-pyrogenic or pyrogen free) |
  | Shelf-Life | - Maintain integrity and performance over specified shelf-life | - Shelf-life evaluation performed (Results are assumed to demonstrate acceptable shelf-life) |

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

• Sample Size for Test Set: Not specified in the FDA letter. For non-clinical tests (like fatigue or material analysis), sample sizes would be determined by the specific ISO/ASTM standards referenced, but these are not diagnostic "test sets" in the AI context.
• Data Provenance: The data comes from the "Non-Clinical Studies" and "Performance Testing" conducted by Medacta International S.A. No country of origin is explicitly stated for the testing labs or data generation, but the company is based in Switzerland. The studies are by nature prospective in that they are conducted specifically to test the device's performance against standards.

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

• Not Applicable. This is a hip prosthesis, not an AI diagnostic device. There is no concept of "ground truth" established by experts in the context of interpreting images or medical conditions for this device. The "ground truth" for the performance tests would be the established scientific and engineering principles and the limits defined by the relevant ISO/ASTM standards.

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

• Not Applicable. As this is not an AI diagnostic device, no adjudication method was used. Performance is assessed directly against objective engineering and material standards.

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 an AI-assisted diagnostic tool. No MRMC study was performed, and there is no AI assistance involved. The letter explicitly states: "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 not an algorithm or AI device. The device (a physical implant) is evaluated standalone based on its inherent properties and performance against physical and material standards.

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

• The "ground truth" for the non-clinical performance tests is based on established engineering and material science standards and specifications (e.g., ISO 7206, ISO 21535, ASTM F1580, ASTM F1185, European Pharmacopoeia, USP). The device's performance is compared against the requirements and acceptance limits set forth in these standards.

8. The sample size for the training set

• Not Applicable. This device did not involve machine learning or a "training set."

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

• Not Applicable. This device did not involve machine learning or a "training set."

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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."

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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, 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.

A hip prosthesis consists of a femoral stem made of metal, a modular femoral head made of metal or ceramic, and acetabular components. The acetabular components consists of a metal cup, and a liner that is made of ultra-high molecular weight polyethylene (UHMWPE), or Highcross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Acetabular components can be: Versafitcup, Versafitcup CC Trio, Mpact, Medacta Bipolar Head.

All the auxiliary components of the prosthesis are supplied in single-use individual packages.

The MasterLoo® stems can be combined with the CoCr ball heads, Endo Head or with the MectaCer BIOLOX® forte or MectaCer BIOLOX® delta femoral heads. Refer to the MectaCer BIOLOX® forte or MectaCer BIOLOX® delta femoral heads package insert and to CoCr heads package insert for more information about ball heads.

The provided text is a 510(k) summary for the Medacta MasterLoc Stem, a hip prosthesis. It describes the device, its indications for use, and a comparison to a predicate device to demonstrate substantial equivalence. However, it does not describe acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device, which is what your request implies by questions about sample sizes for test/training sets, ground truth, experts, and MRMCs.

This document describes the regulatory clearance process for a physical medical device (hip implant) based on its similarity to existing, legally marketed predicate devices. The "performance testing" section refers to mechanical and material testing, not the performance of an AI algorithm.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance (for an AI/ML device): The document refers to mechanical engineering standards (e.g., ISO 7206-4, ISO 7206-6, ASTM F2009-00) for testing the physical implant's strength, durability, and stability. It states that "The new test successfully met acceptance criteria" without detailing the specific criteria or exact performance values, as these are related to the mechanical properties of the implant, not diagnostic accuracy of an AI.
2. Sample size used for the test set and data provenance: Not applicable, as this is not an AI/ML study.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: Not applicable.
6. If a standalone performance study was done: The document describes "Performance Testing" for the physical implant, which is a standalone evaluation of its mechanical properties against standards, not an AI algorithm's performance.
7. The type of ground truth used: For a physical implant, "ground truth" would be established by engineering standards and validated physical testing against those standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical hip implant, not an AI/ML medical device. Therefore, the specific questions you asked regarding AI/ML device validation and ground truth establishment are not addressed by this text.

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