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Mpact 3D Metal Augments are intended for cementless use to the bone interface and are affixed to a compatible Medacta Acetabular shell using bone cement in hip replacement surgeries.

Mpact 3D Metal Augments are indicated in cases of:

• Acetabular dysplasia;
• Acetabular fractures;
• Revision of previous implants in the presence of insufficient bone quality or seriously altered bone structures.

The Mpact 3D Metal Augment II is an acetabular implant intended to be used in Total Hip Arthroplasty cemented to its Medacta compatible Acetabular Shell. It is provided sterile and individually packaged to the end user.

The devices subject of this submission are:

• Mpact 3D Metal Augments II from size Ø46 to Ø80, made of Ti6Al4V according to ASTM F2924;
• Double Augment Technique Screw, made of Ti6Al4V according to ISO 5832-3.

The Mpact 3D Metal Augments II represent the second generation of the Mpact 3D Metal Augments cleared within K171966.

This FDA 510(k) clearance letter pertains to a medical device, specifically the Mpact 3D Metal Augments II, which are implants for hip replacement surgeries. The document focuses on establishing substantial equivalence to existing predicate devices based on design and performance testing. However, it does not describe a clinical study in the traditional sense, especially not one that involves human subjects or assesses AI performance.

The provided text details non-clinical performance data and validations to support the device's substantial equivalence to its predicate. It does not contain information about acceptance criteria for AI performance, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

Therefore, many of the requested sections (including specific tables for acceptance criteria and device performance based on AI metrics, details about test sets, ground truth establishment for AI, MRMC studies, and standalone performance) cannot be filled from the provided document.

Here's a breakdown of the information that is available:

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

The document describes performance testing as "Fatigue testing in single and double augment configurations" and "Rationale of comparison – EBM Additive Manufacturing Technology." It also mentions "Design Validation on Mpact 3D metal Augments II." However, it does not disclose specific acceptance criteria or quantitative performance results for these tests. It only states that "testing activities were conducted to written protocols" and these validations are "provided in support of the substantial equivalence determination." This is typical for a 510(k) summary, which generally summarizes the data rather than providing all raw or detailed results.

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

This information is not provided in the document. The "tests" here refer to non-clinical laboratory and material tests, not clinical studies involving patient data.

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)

This is not applicable to the type of device and study described. There's no "ground truth" to be established by experts in the context of material fatigue or design validation for an orthopedic implant as presented here.

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

This is not applicable to the type of device and study described. Adjudication methods are typically used in clinical trials or studies involving expert review of medical images or outcomes.

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

There is no MRMC or comparative effectiveness study mentioned, as this is a physical medical device (hip augments), not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The device is an orthopedic implant, not an algorithm.

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

This is not applicable in the sense of medical diagnosis or AI performance. The "truth" for these non-clinical tests would be the physical properties and performance characteristics determined by established engineering and materials testing standards.

8. The sample size for the training set

This is not applicable, as there is no "training set" for an AI algorithm mentioned in this document.

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

This is not applicable, as there is no "training set" or "ground truth" for it in the context of AI.

Summary of what the document does provide regarding the study/testing:

The document describes non-clinical testing and validations performed to demonstrate the substantial equivalence of the Mpact 3D Metal Augments II to its predicate devices. These tests include:

• Design Validation: Performed on Mpact 3D Metal Augments II (details not provided).
• Performance Testing:
  • Fatigue testing in single and double augment configurations.
  • Rationale of comparison – EBM Additive Manufacturing Technology.
• Pyrogenicity: Control validated using bacterial endotoxin test (LAL test) per ISO11737-3 and European Pharmacopoeia §2.6.14, and in-vivo evaluation in rabbits per USP .
• Biocompatibility assessment.
• Shelf-life evaluation.

The document states that Medacta International S.A., based in Switzerland, submitted this 510(k). The tests are non-clinical, so data provenance regarding country of origin or retrospective/prospective does not apply in the same way as for clinical data. The studies are laboratory-based and conducted according to written protocols to ensure materials and design meet safety and performance standards for orthopedic implants.

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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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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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