Search Results

The Mpres stem is a cementless neck preserving stem designed for use in total or partial hip arthroplasty for primary or revision surgery.

Total Hip Arthroplasty with the Mpres stem is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis or congenital hip dysplasia.
· Avascular necrosis of the femoral head.

• · Acute traumatic fracture of the femoral head.
• Failure of previous hip surgery:
  o Conservative hip surgery,
  o Internal fixation,
  o Arthrodesis,
  o Hip resurfacing replacement.

Partial hip arthroplasty with the Mpres stem is indicated in the following cases:

• · Acute traumatic fracture of the femoral head.
• · Avascular necrosis of the femoral head.
  · Primary pathology involving the femoral head but with a non-deformed acetabulum.

The Mpres Neck Preserving Stem is a cementless short femoral stem intended to be used in total or partial hip arthroplasty for primary or revision surgery with minimally invasive hip replacement techniques. The Mpres Neck Preserving Stem is made of titanium alloy (Ti6Al7Nb) according to ISO 5832-11 and coated with Titanium plasma spray according to ASTM F1580 and Hydroxyapatite in compliance with ASTM F1185. It is available in 12 sizes (sizes 3-14) for each neck variation configuration: a standard 130° CCD angle or an high offset 123° CCD angle.

This document is a 510(k) Premarket Notification from the FDA regarding the "Mpres Neck Preserving Stem" hip prosthesis. This type of document is generally about establishing substantial equivalence to an existing predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a new drug or a novel AI diagnostic would.

Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or reader improvement with AI assistance, does not directly apply to this document's content.

The document focuses on demonstrating that the Mpres Neck Preserving Stem is substantially equivalent to legally marketed predicate devices based on technological characteristics and non-clinical performance data. It explicitly states that "No clinical studies were conducted."

However, I can extract information related to the performance data and the types of studies that were conducted to support the substantial equivalence claim.

Here's an adaptation of the requested information based on the provided text, highlighting what is available and what is not:

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

Since this is a substantial equivalence submission for a mechanical implant, performance is demonstrated through biomechanical testing and material characterization against established standards, rather than clinical performance metrics typically associated with diagnostic devices. The acceptance criteria are implicit in meeting the requirements of the cited ISO/ASTM standards.

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

• Sample Size for Test Set: Not explicitly stated in terms of specific numbers of devices tested for each non-clinical study. The reports cited (e.g., "Endolab Test Report," "CeramTec AG Test Reports," "Accentus Test Report") would contain this detail, but it's not present in this summary. For "cadaveric evaluation," the number of cadavers is not given.
• Data Provenance: The testing appears to have been conducted by various external and internal labs (e.g., EndoLab, CeramTec AG, Accentus). The company, Medacta International SA, is based in Switzerland, and Medacta USA is in Tennessee, USA. The standards cited are international (ISO, ASTM, EN) and US (USP, European Pharmacopoeia). This indicates a varied provenance tied to international standards for medical device testing.
• Retrospective or Prospective: These non-clinical performance tests are "prospective" in the sense that they are specifically performed for the purpose of this submission and validate the current design. They are not observational studies on existing 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 concept does not apply to this type of device submission. There is no "ground truth" established by experts in the context of diagnosing or interpreting images, as this is a hip implant, not an AI diagnostic device. The "ground truth" for these tests is the adherence to established engineering and material science standards.

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

This concept does not apply. Adjudication methods are relevant for clinical studies or studies involving expert interpretation, which were not performed here.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is designed for AI diagnostic aids, not for a hip implant. The document explicitly states: "No clinical studies were conducted."

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

This concept does not apply. A hip implant is a physical device, not an algorithm.

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

The "ground truth" here is the performance against established engineering and material science standards (e.g., ISO, ASTM, EN, USP). For example, a fatigue test must demonstrate that the device can withstand a certain number of cycles at a specific load without failure, as defined by the standard.

8. The sample size for the training set

This concept does not apply. There is no "training set" as this is not an AI/ML device.

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

This concept does not apply.

Ask a specific question about this device

The hip prosthesis SMS is designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. Hip replacement is indicated in the following cases:

· Severely painful and/or disabled joint as a result of 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, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty.

The SMS femoral stem is a cementless bone preserving short stem designed for proximal fixation in total or partial hip arthroplasty for primary or revision surgery.

The SMS implants are comprised of the following products:

• SMS Cementless Solid Standard Stem (available in 11 sizes from size 3 to 13); and ●
• . SMS Cementless Solid Lateralized Stem (available in 11 sizes - from size 3 to 13).

Both are available on the US market via the clearance - K181693.

Concerning the new sizes of the solid version: 1V2, 2V2, size 14, and size 15; both STD and LAT versions have been introduced as a product range extension to the stems currently marketed as the SMS product line (K181693).

The SMS implants are line extensions to Medacta's Total Hip Prosthesis - AMIStem-H, Quadra-S and Quadra-H Femoral Stems (K093944), AMIStem and Quadra - Line Extension (K121011), AMIStem-P, AMIStem-P Collared and AMIStem-H Proximal Coating Femoral Stems (K173794), Quadra-H and Quadra-R Femoral Stems (K082792), AMIStem-H Proximal Coating (K161635), MiniMAX (K170845), and SMS (K181693).

The SMS implants are part of the Medacta Total Hip Prosthesis system. The Medacta Total Hip Prosthesis system consists of femoral stems, modular femoral heads and acetabular components. The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE) or Highcross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352), Mpact (K103721 and K132879), Mpact 3D Metal (K171966) and Medacta Bipolar Head (K091967).

The SMS stems can be combined with the CoCr ball heads (K072857, K080885 and K103721), Endo Head (K111145) or with the MectaCer BIOLOX® Forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).

This is a 510(k) premarket notification for the "SMS Cementless Stem" (K201673), a hip prosthesis. The document details the device, its intended use, and a comparison to predicate devices, along with performance data.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document outlines various non-clinical performance tests conducted for the SMS Cementless Stem. However, it does not provide specific acceptance criteria values or the quantitative results of these tests in a table format. It only states that the testing was conducted "according to written protocols with acceptance criteria that were based on standards."

Here's what can be inferred for a table, but actual criteria values and results are missing in the document:

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical studies were conducted." Therefore, there is no test set in the context of human clinical data or patient outcomes. The "performance data" refers to non-clinical mechanical and material tests. The sample sizes for these mechanical tests are not provided in this summary. Data provenance is not applicable here as no human data was used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable as no clinical studies were conducted and no ground truth in the clinical sense was established. The "ground truth" for the non-clinical tests would be the specifications and requirements of the referenced ISO and ASTM standards.

4. Adjudication Method for the Test Set

Not applicable as no clinical studies were conducted which would require adjudication of expert opinions or outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No MRMC study was mentioned or performed, as "No clinical studies were conducted." This device is a mechanical implant, not an AI or diagnostic tool that would typically undergo MRMC studies.

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

Not applicable. This device is a hip implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical performance and coating tests, the "ground truth" implicitly refers to the
requirements and specifications outlined in the referenced international standards (ISO and ASTM) and the European Pharmacopoeia/USP chapters. The device is expected to meet these pre-defined engineering and material standards. This is a form of engineering/material specification compliance as ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical implant, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of medical device's approval.

Ask a specific question about this device