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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 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 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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