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The hip prosthesis AMIStem-H, AMIStem-H collared, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P collared are designed for cementless use in total or partial hip arthroplasty for 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, 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 AMIStem-H Proximal Coating, AMIStem-P, and AMIStem-P Collared implants are line extensions to the Medacta Total Hip Prosthesis system family AMIStem H, Quadra S and Quadra H femoral stems (K093944), AMIStem C & Quadra C SN (K103189), AMIStem and Quadra - Line Extension (K121011), and AMIStem-H Proximal Coating (K161635).

The AMIStem-H Proximal Coating, AMIStem-P, and AMIStem-P Collared implants subject of this submission are comprised of the following products:

• AMIStem-H Proximal Coating STD, Stem sizes 00 and 0; ●
• AMIStem-H Proximal Coating LAT, Stem size 0;
• AMIStem-P STD, Stem sizes 00 9; ●
• AMIStem-P LAT, Stem sizes 0 - 8;
• AMIStem-P Collared STD, Stem sizes 00 9; and ●
• AMIStem-P Collared LAT, Stem sizes 0 - 8.

The AMIStem-H Proximal Coating, AMIStem-P, and AMIStem-P Collared implants are part of the brand, Medacta Total Hip Prosthesis system for total and partial hip arthroplasty. The Medacta Total Hip Prosthesis system family consists of femoral stems, modular femoral heads, and acetabular components.

The provided text describes a 510(k) premarket notification for hip joint prostheses, specifically the AMIStem-H Proximal Coating, AMIStem-P, and AMIStem-P Collared. It focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and performance data.

However, the provided text does not contain any information regarding the acceptance criteria or study details for an artificial intelligence (AI) device. The "Performance Data" section solely lists non-clinical mechanical and pyrogenicity tests for the hip prostheses, which are physical medical devices, not AI software or algorithms.

Therefore, I cannot provide the requested information about acceptance criteria and studies related to an AI device using the provided text.

Here's why I cannot fulfill your request:

• No AI Device Mentioned: The document is a 510(k) submission for physical hip implants, not an AI or software as a medical device (SaMD).
• Performance Data Irrelevant to AI: The performance tests listed (range of motion, fatigue testing, pull-off force, pyrogenicity) are standard for orthopedic implants, not for evaluating AI performance metrics like diagnostic accuracy, sensitivity, specificity, etc.
• Missing AI-Specific Details: All your specific questions (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are entirely related to AI model evaluation, which is absent from this document.

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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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