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The hip prostheses QUADRA-P and QUADRA-P collared are designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. The hip prosthesis QUADRA-P cemented is designed for cemented 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, 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, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty

The Quadra-P implant subject of this submission is a line extension to the currently cleared Ouadra-P implants (K181254 and K192827). The stem subject of this submission is a range extension of the Quadra-P Short Neck Standard stem cleared under K192827. The Quadra-P implant subject of this submission is the Quadra-P Short Neck STD stem size 00, a coated cementless stem, commercial reference 01.12.249. The Quadra-P 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. Ouadra-P family includes cementless and cemented stems. Quadra-P, Quadra-P Short Neck, and Quadra-P Collared implants are cementless stems made with a titanium alloy substrate (Ti6Al7Nb) 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 femoral stems have a Eurocone (12/14 taper) and polished necks. Quadra-P, Quadra-P Short Neck, and Quadra-P Collared implants have an air plasma sprayed Titanium Y367 and Hydroxyapatite Osprovit (HA) dual layer coating on the proximal end of the shaft. The dual coating covers approximately 50% of the stem length. The distal part of the stem is coated with hydroxyapatite after sandblasting. Also included in Quadra-P family, are the Quadra-P Cemented stems manufactured from High Nitrogen Stainless Steel. 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 Quadra-P implants can be combined with the CoCr Ball Heads (K072857 and K080885). Endo Head (K111145), MectaCer Biolox Option Heads (K131518), or MectaCer BIOLOX® Forte (K073337) or MectaCer BIOLOX® Delta Femoral Heads (K112115).

This document is a 510(k) Premarket Notification for a medical device (hip prosthesis). It does not contain information about an AI/ML-driven medical device or a study involving AI/ML performance. Therefore, it is impossible to extract the requested information regarding acceptance criteria and study details for an AI-driven device.

The document primarily focuses on demonstrating substantial equivalence of a new size of a Quadra-P hip prosthesis to previously cleared versions and other predicate devices. The "Performance Data" section details non-clinical mechanical studies (fatigue tests, range of motion, pull-off force, coating tests, pyrogenicity) conducted on the physical device, not on an algorithm's performance. It explicitly states: "No clinical studies were conducted."

To answer the user's request, I would need a document describing the validation of an AI/ML-driven medical device.

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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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The hip prostheses QUADRA-P and QUADRA-P collared are designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. The hip prosthesis QUADRA-P cemented is designed for cemented 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 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, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty.

The Quadra-P implants are line extensions to the currently cleared Quadra-P implants (K181254).

The Quadra-P implants in this submission are comprised of the following products:

• Quadra-P STD (Stem size 00); .
• Quadra-P Short Neck (STD Stem sizes 0 10 and LAT Stem sizes 0 10); ●
• . Quadra-P Collared (STD Stem sizes 00 - 10 and LAT Stem sizes 0 - 10); and
• Quadra-P Cemented (STD Stem sizes 0 8 and LAT Stem sizes 0 8). ●

The Quadra-P 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 Quadra-P, Quadra-P short neck, and Quadra-P Collared are cementless stems manufactured from Titanium-Niobium alloy with a Titanium plasma spray coating (MectaGrip) on the proximal area and HA coating on the shaft. The Quadra-P Cemented stems manufactured from high nitrogen stainless steel.

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, K120521 and K122911), Mpact (K103721 and K132879), Mpact 3D Metal (K171966), and Medacta Bipolar Head (K091967).

The Quadra-P implants can be combined with the CoCr Ball Heads (K072857 and K080885), Endo Head (K111145), or MectaCer BIOLOX® Forte (K073337) or MectaCer BIOLOX® Delta Femoral Heads (K112115). or MectaCer Biolox Option Heads (K131518).

MectaCer Biolox Option Heads (K131518) cannot be combined with Quadra-P cemented stems, but only with the Quadra-P cementless stems.

The provided text is related to a 510(k) submission for a medical device (Quadra-P hip prosthesis) and does not contain information about software or AI-powered devices. Therefore, it does not include the type of acceptance criteria and study details you've requested regarding AI performance.

The document discusses the substantial equivalence of modifications to an existing hip prosthesis to predicate devices, focusing on mechanical testing and biocompatibility assessments. It explicitly states: "No clinical studies were conducted."

To clarify, the information you've requested (acceptance criteria, sample size for test/training set, expert qualifications, adjudication, MRMC study, standalone performance, ground truth type) is typically found in submissions for AI/ML-powered medical devices, specifically for evaluating their diagnostic or prognostic performance. This document concerns a physical implantable device.

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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, 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 subject of this submission are comprised of the following products:

• SMS Cementless Solid Standard Stem (available in 11 sizes); and ●
• SMS Cementless Solid Lateralized Stem (available in 11 sizes).

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), and MiniMAX (K170845).

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 polvethylene (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 document describes the premarket notification (510(k)) for the SMS Femoral Stem, a cementless bone-preserving short stem designed for proximal fixation in total or partial hip arthroplasty.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies, though it's important to note that this is a medical device submission, not an AI/ML device submission, so the questions regarding human readers, training sets, etc., are not directly applicable here. The document focuses on mechanical performance and biocompatibility for a physical implant.

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

The document lists performance tests and the standards they adhere to, implying that meeting these standards constitutes the acceptance criteria. However, it does not explicitly state numerical acceptance criteria and does not present specific performance data values in a table format. It merely states that "Testing was conducted according to written protocols with acceptance criteria that were based on standards." and that the studies "demonstrated substantial equivalence."

Here's a generalized representation based on the provided information:

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

The document lists various non-clinical mechanical and coating tests, which typically involve physical samples of the device components. It does not specify the sample sizes (number of stems tested for fatigue, etc.) for each test. The provenance of the data is implicit: it's generated from laboratory testing of the device components. There is no clinical data or patient-derived data mentioned.

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 question is not applicable to this type of medical device submission. Ground truth and expert adjudication are relevant for AI/ML diagnostic devices, not for physical implants that undergo mechanical and material testing. The "ground truth" for these tests are the established scientific principles and measurement techniques outlined in the specified ISO and ASTM standards.

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

This question is not applicable for the same reasons as #3. Mechanical testing results are typically objectively measured and evaluated against a standard, not subject to expert adjudication in the same way as diagnostic interpretations.

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

This question is not applicable as this is not an AI/ML device. No MRMC study was conducted.

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

This question is not applicable as this is not an AI/ML device.

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

For the non-clinical tests, the "ground truth" is defined by the specifications and acceptable ranges outlined in the referenced international (ISO) and American (ASTM) standards. For instance, a fatigue test determines if the device can withstand a certain number of cycles at a specific load without failure, as per the standard's requirements. Pyrogenicity is determined by established biological testing methods (LAL test, USP pyrogen test).

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device. There is no concept of a "training set" for a physical implant undergoing mechanical and material characterization.

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

This question is not applicable as this is not an AI/ML device.

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The hip prosthesis QUADRA-P 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, arthroplasty, hip resurfacing replacement or total hip arthroplasty.

The Quadra-P 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); and AMIStem-H Proximal Coating (K161635).

The Quadra-P implants subject of this submission are comprised of the following products:

• . Quadra-P STD. Stem sizes 0 - 10;
• Quadra-P LAT, Stem sizes 0 - 10.
  The Quadra-P 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 Quadra-P implants can be combined with the CoCr Ball Heads (K072857 and K080885), Endo Head (K111145), MectaCer Biolox Option Heads (K131518), or with the MectaCer BIOLOX® Forte (K073337) or MectaCer BIOLOX® Delta Femoral Heads (K112115).

This document is a 510(k) premarket notification for the "Quadra-P" hip prosthesis, specifically describing the physical and mechanical testing performed to demonstrate substantial equivalence to previously cleared predicate devices. It does not contain information about the performance or acceptance criteria of an AI/Software device, nor does it describe a study involving humans or the establishment of ground truth for such a device.

Therefore, I cannot extract the information required to answer your questions about acceptance criteria and studies proving the device meets those criteria, as the provided document pertains to a physical medical device (hip prosthesis) and its mechanical engineering performance tests, not an AI or software-based medical device.

The document discusses:

• Device Name: Quadra-P (hip prosthesis)
• Regulation Number: 21 CFR 888.3353 (Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis)
• Performance Data (Non-Clinical Studies):
  • Range of Motion (ROM) testing (EN ISO 21535:2009)
  • Fatigue testing (ISO 7206-4 and ISO 7206-6)
  • Pull off force testing (ASTM F2009-00)
  • Pyrogenicity testing (European Pharmacopoeia §2.6.14/USP and USP )
• Clinical Studies: "No clinical studies were conducted."

Since the request is specifically about a device proving it meets acceptance criteria through a study involving a test set, expert ground truth, adjudication methods, and potentially human readers (which implies an AI/Software device or diagnostic device), the provided text is entirely irrelevant to those questions.

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The hip prosthesis AMIStem-H Collared, AMIStem-H Proximal Coating are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.

The hip prosthesis AMIStem-C is designed for cemented 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, theumatoid 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 AMIStem-H Proximal Coating femoral stems are line extensions to the Medacta Total Hip Prosthesis system and are comprised of the following products:

• AMIStem-H Proximal Coating STD, Stem #s 1 9 ●
• AMIStem-H Proximal Coating LAT, Stem #s 1 8 ●

These prostheses are straight femoral stems manufactured from titanium (Ti) alloy (ISO 5832-11:1994, Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminum 7niobium alloy). The subject devices have a titanium and hydroxyapatite dual layer coating at the proximal end of the shaft and a sandblasted surface at the distal end.

The instruments used with the AMIStem-H Proximal Coating stems were previously cleared as part of the AMIStem Implants family (K093944, K103189, and K121011). Additional instrumentation, included within the subject 510(k), can be used in lieu of the previously cleared instruments.

The provided document describes a 510(k) premarket notification for a hip prosthesis, the AMIStem-H Proximal Coating. This is a medical device traditionally regulated and does not fall under the purview of AI/ML-driven software as a medical device (SaMD). Therefore, the concepts of acceptance criteria, test sets, ground truth establishment, training sets, and MRMC studies, which are pertinent to validating performance of AI/ML models, do not apply to this document.

The document details the device's indications for use, material composition, design similarities, and differences to predicate devices, and the non-clinical studies conducted to support its substantial equivalence. These non-clinical studies primarily focus on mechanical and material performance rather than diagnostic accuracy or AI model performance.

Therefore, I cannot extract the requested information about acceptance criteria for AI/ML performance, sample sizes for AI test/training sets, expert consensus, adjudication methods, or MRMC studies, as these aspects are not relevant to the evaluation of this traditional medical device.

The closest analogue to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context would be:

Acceptance Criteria (General to the Device Type):

• Mechanical Integrity: The device must withstand anticipated physiological forces over its design life without fracture or significant deformation.
• Biocompatibility: The materials used must be safe for implantation in the human body.
• Coating Adhesion: The coating must adhere sufficiently to the substrate.
• Sterility: The device must be provided sterile.
• Fatigue Life: The device must demonstrate sufficient resistance to fatigue failure.

Study Proving Acceptance (from the document):
The document lists the following non-clinical studies that aim to demonstrate these general acceptance criteria:

• Fatigue testing: In accordance with ISO 7206-4:2010 and ISO 7206-6:1992.
• Range of Motion Analysis: In accordance with EN ISO 21535:2009 (specifically Tilting and Rotation Stability).
• Pull Off Testing: In accordance with ASTM F2009-00 (likely for coating adhesion).
• Coating Tests: To evaluate coating properties.
• Cleaning and Sterilization Validation: To ensure the device can be properly sterilized.
• Bacterial endotoxin testing: To ensure it meets pyrogenicity standards.
• Shelf-life studies: To determine the stability of the device over time.

No human reader studies, AI model performance metrics, or related data are presented in this document.

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