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The SMS system 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 arthrosis, 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, 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 15 sizes from size 1 to 15); and ●
• SMS Cementless Solid Lateralized Stem (available in 15 sizes from size 1 to 15). .
  Both are available on the US market via the clearance - K181693 and K201673.
  SMS collared solid version, has been introduced as a product range extension to the stems currently marketed as the SMS product line (K181693 and K201673). Quadra P is the collared stem currently marked in US K192827.
  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 and K201673).
  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).

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the SMS Cementless Stem.

It's important to note that this document is a 510(k) summary for a medical device (hip implant), not an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (such as effect size of human readers with AI assistance, standalone algorithm performance, ground truth for training set, training set size) are not applicable to this submission.

Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list "acceptance criteria" in a quantitative manner as one might find for an AI/ML device (e.g., target specificity/sensitivity). Instead, the criteria are implicitly derived from the performance tests conducted to demonstrate substantial equivalence to predicate devices. The device's performance is demonstrated through satisfying these tests.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

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

• Sample Size for Test Set: Not explicitly stated in terms of number of devices. The "tests" here refer to mechanical and material property tests (e.g., fatigue testing, pull-off force, coating adherence). These tests are typically performed on a statistically relevant number of samples of the device and its components, but the exact count isn't in this summary.
• Data Provenance: The data is derived from non-clinical studies (laboratory testing) and in comparison to predicate devices. There is no mention of human subject data, so concepts like "country of origin" or "retrospective/prospective" don't directly apply in the clinical sense. These are engineering specifications leveraged from previously cleared devices.

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

• This question is not applicable. For this type of device (hip implant), ground truth isn't established by human experts reviewing medical images or patient data in the typical sense of AI/ML device evaluation. The "ground truth" or standard for performance is established by recognized international and national standards (e.g., ISO, ASTM) for the mechanical and material properties of orthopedic implants.

4. Adjudication method for the test set

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human reviewers (experts) in establishing ground truth for diagnostic or prognostic studies, which is not the nature of the evaluation for this hip implant. The "adjudication" for mechanical tests would be adherence to the specified test methods and criteria outlined in the 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

• No MRMC study was done. This study concerns a physical orthopedic implant, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no "effect size of human readers improving with AI assistance."

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

• Not applicable. This device is a physical hip implant, not an algorithm.

7. The type of ground truth used

• The "ground truth" for the performance evaluation of this device is based on established engineering and material standards (ISO 21535, ISO 7206, ASTM F2009, ASTM F1147, ISO 13779, European Pharmacopoeia, USP). The device is deemed safe and effective and "substantially equivalent" if it meets the performance requirements stipulated by these standards, generally by demonstrating that it performs as well as, or better than, the predicate devices for which these criteria were previously established.

8. The sample size for the training set

• Not applicable. This submission is for a physical medical device, not an AI/ML model that requires a training set. The "training" for this device would refer to the design and manufacturing process, which adheres to quality systems regulations.

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

• Not applicable. As above, there is no "training set" in the context of an AI/ML algorithm. The design and manufacturing of the device follow established engineering principles and standards.

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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.

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