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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 is designed for cementless use in total hip arthroplasty in primary or revision surgery.

The patient should be skeletally mature.

The patient's condition should be due to one or more of:

· Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or

psoriactic arthritis, Congenital hip dysplasia, Ankylosing spondylitis.

· 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, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

The Versafitcup CC Trio family of acetabular components is designed to be used with the Medacta Total Hip Prosthesis System. The Medacta Total Hip Prosthesis system includes the Quadra S, H, R, and C Stems and CoCrMo and ceramic ball heads (K072857, K073337, K080885, K082792, K083558, and K112115). The AMIStem femoral stems also work with the Medacta Total Hip Prosthesis System (K093944, K103189). The Medacta Total Hip Prosthesis System is a total hip replacement system consisting of the femoral stem made of metal, a modular femoral head made of metal or ceramic, and acetabular components. The Versafitcup CC Trio extension that are the subject of this 510(k) consist of new sizes of flat and hooded liners, new sizes of the two-hole acetabular shell, and no-hole acetabular shells. The liners are made from either ultra-high molecular weight polyethylene (UHMWPE) or HighCross® highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE) conforming to ISO 5834. The acetabular shells are made from titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3. The outside of the metal component has macrostructures in the equatorial region. The outer surface of the metallic cup has a dual laver of coatings: Ti (ASTM F 1580) plasma spray and Hydroxyapatite (ASTM F 1185).

All the Versafitcup CC Trio extension components are supplied sterile in single-use individual packages.

The provided text describes a 510(k) premarket notification for a medical device, the Versafitcup CC Trio extension, which is an acetabular component for total hip arthroplasty. The submission focuses on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study with acceptance criteria in the typical sense of a diagnostic or AI device.

Therefore, the information requested for AI/diagnostic devices, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment, is not applicable or available in this document.

Instead, the performance testing described is focused on mechanical characteristics, comparing the new device components to "worst case liners and acetabular shells of the predicate devices."

Here's an attempt to extract the relevant information based on the provided text, while acknowledging the limitations:

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

Note: The document does not provide specific numerical acceptance criteria or performance metrics (e.g., maximum allowable wear per year, specific range of motion values). The acceptance is implicitly based on being comparable to or not worse than the predicate devices' "worst case" performance for these mechanical tests.

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

• Sample Size: Not specified. The testing is described as mechanical testing of the device components, not involving human subjects or clinical data in the form of a test set.
• Data Provenance: Not applicable in the context of clinical data provenance. The testing is laboratory-based mechanical testing.

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)

• Not applicable. The "ground truth" here is based on engineering specifications and mechanical test results, not expert interpretation of clinical data.

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

• Not applicable. This refers to adjudication of expert opinions for clinical ground truth.

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

• Not applicable. This type of study is for diagnostic or AI-assisted interpretation, which is outside the scope of this device's submission.

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

• Not applicable. This device is an implanted medical device, not a diagnostic algorithm.

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

• The "ground truth" or basis for evaluation is compliance with mechanical testing standards and comparison to the performance of predicate devices for parameters like range of motion, connection stability, and wear. These are engineering and material science metrics.

8. The sample size for the training set

• Not applicable. This refers to training data for an AI algorithm.

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

• Not applicable. This refers to establishing ground truth for AI training data.

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The hip prosthesis is designed for cementless use in total hip arthroplasty in primary or revision surgery.

The patient should be skeletally mature.

The patient's condition should be due to one or more of:

· Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis. rheumatoid arthritis or

psoriactic arthritis. Congenital hip dysplasia, Ankylosing spondylitis.

· 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, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

The Versafitcup® CC Trio family of acetabular components is designed to be used with the Medacta Total Hip Prosthesis System. The Medacta Total Hip Prosthesis system includes the Quadra S, H, R, and C Stems and CoCrMo and ceramic ball heads (K072857, K073337, K080885, K082792, K083558, and K112115). The AMStem femoral stems also work with the Medacta Total Hip Prosthesis System (K093944, K103189). The Medacta Total Hip Prosthesis System is a total hip replacement system consisting of the femoral stem made of metal, a modular femoral head made of metal or ceramic, and acetabular components. The Versafitcup® CC Trio acetabular components that are the subject of this 510(k) consist of two new flat fixed liners that are made of HighCross® highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE).

All the Versafitcup® CC Trio components are supplied sterile in single-use individual packages.

The provided document is a 510(k) summary for a medical device (Versafitcup CC Trio - Additional Liners) and, as such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance metrics typically found in clinical trials for new drug or high-risk device approvals.

Therefore, many of the requested elements (e.g., sample size for test sets and training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone AI performance) are not applicable or not provided in this type of regulatory submission. The device is a physical medical device (hip implant liners), not a software/AI device, which explains why many of these questions about AI performance and expert review are not relevant to this document.

Here's a breakdown of the available information:

Acceptance Criteria and Device Performance

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance: Not applicable. This is a physical device. Performance was assessed through mechanical testing, not a test set of data. The document refers to "worst-case liners of the predicate devices" for comparison.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical properties is established through standardized engineering tests, not expert consensus in the clinical sense.
3. Adjudication method for the test set: Not applicable. Mechanical tests for physical devices do not involve clinical adjudication.
4. 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: Not applicable. This is a physical hip implant liner, not an AI diagnostic or assistive device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical hip implant liner, not a software device.
6. The type of ground truth used: Mechanical test results, compared against established standards or predicate device performance.
7. The sample size for the training set: Not applicable. This is a physical device, not an AI model.
8. How the ground truth for the training set was established: Not applicable.

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The MectaCer BIOLOX® forte femoral heads and the MectaCer BIOLOX® delta femoral heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for total or partial hip arthroplasty in primary or revision surgery.

The patient should be skeletally mature.

The patient's condition should be due to one or more of the following:

• Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic . arthritis, rheumatoid arthritis, or psoriatic arthritis,
• Congenital hip dysplasia, .
• Ankylosing spondylitis, .
• 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, . hemiarthroplasty, surface replacement arthroplasty or total hip replacement where sufficient bone stock is present.

The MectaCer Biolox Delta Heads are ceramic ball heads intended for mechanical fixation to a mating hip stem and indicated for the treatment of patients who are candidates for total or partial hip arthroplasty to provide increased patient mobility and reduced pain by replacing the damaged hip joint, in primary or revision surgery. The MectaCer Biolox Delta Heads are an aluminum oxide matrix composite ceramic consisting of approximately 75% alumina (Al₂O₃), 24% zirconia (ZrO₂) and other trace elements. The pink color is due to the chromium oxide (Cr2O3) that improves the hardness of the composite material. The MectaCer Biolox Delta Heads are designed to mate with a 12/14 stem taper. The MectaCer Biolox Delta Heads are available in head diameters of 28, 32, 36, 40, and 44 mm and in neck lengths of Small, Medium, Large, and Extra Large.

Here's a breakdown of the acceptance criteria and study information for the MectaCer Biolox Delta Heads, based on the provided text:

Important Note: This document describes a medical device clearance (510(k)) based on substantial equivalence, not a clinical trial proving a new therapeutic benefit. The "device performance" in this context refers to mechanical properties and comparison to predicate devices, not clinical outcomes.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: The document explicitly mentions "5 samples" for the Pull-Off Test. For other tests (Burst, Fatigue, Post-Fatigue, Rotational Stability), the exact number of samples is not specified, but it states "The testing was conducted on the worst case size MectaCer Biolox Delta and Forte Heads."
   • Data Provenance: The testing was conducted by or for Medacta International SA, a Swiss manufacturer. The tests themselves are based on international standards (ISO) and manufacturer-specific procedures (CeramTec). This is in vitro mechanical testing, not human subject data.

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

   • This is not applicable as this study involves in vitro mechanical testing against established engineering standards and specifications, not human expert interpretation of clinical data. The "ground truth" is the performance defined by the ISO standards and CeramTec procedures.

3. Adjudication method for the test set:

   • This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of clinical images or data. For mechanical testing, adherence to the pre-defined criteria of the test standards serves as the "adjudication."

4. 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, an MRMC comparative effectiveness study was not done. This is a 510(k) submission for a hip implant component, not an AI-assisted diagnostic device.

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

   • Not applicable, as this is neither an algorithm nor a device with a human-in-the-loop component in the way usually meant in AI/diagnostic discussions. It is a standalone mechanical component for surgical implantation. The "standalone performance" here refers to its mechanical integrity under specified loads.

6. The type of ground truth used:

   • The "ground truth" for this device's performance in mechanical testing is based on pre-defined acceptance criteria set by international standards (ISO 7206-10) and established internal manufacturer test procedures (CeramTec AA 02 10 0807, VP-KU-0180, VP-KU-0210). These standards prescribe the methodology and expected outcomes for material strength, fatigue resistance, and stability under load.

7. The sample size for the training set:

   • This concept is not applicable here. There is no "training set" in the context of mechanical testing for a medical device implant. The device design and materials are based on established engineering principles and prior device history, not on machine learning training data.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set." The "ground truth" for the device's design and manufacturing is established through extensive engineering research, material science, and adherence to medical device design requirements, industry standards, and regulatory guidance for orthopedic implants.

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The Mpact® Acetabular System is intended for cementless use in total hip arthroplasty and in primary or revision surgery. The patient should be skeletally mature. The patient's condition should be due to one or more of:

• Severely painful and/or disabled joint: as a result of osteoarthritis, post-. traumatic arthritis, rheumatoid arthritis or psoriactic arthritis, congenital hip dysplasia, or ankylosing spondylitis.
• . 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, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

The Mpact® Acetabular System components are designed to be used with the Medacta Total Hip Prosthesis System. The Medacta Total Hip Prosthesis system includes the Quadra S, H, R, and C Stems and CoCrMo and ceramic ball heads (K072857, K073337, K080885, K082792, and K083558). The AMIStem femoral stems also work with the Medacta Total Hip Prosthesis System (K093944). The Medacta Total Hip Prosthesis System is a total hip replacement system consisting of the femoral stem made of metal, a modular femoral head made of metal or ceramic, and acetabular components. The Mpact® Acetabular System acetabular components that are the subject of this 510(k) consist of a metal cup made of Titanium alloy and a fixed liner that is made of ultra-high molecular weight polyethylene (UHMWPE) or HighCross® highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE).

The metal acetabular component or shell is machined from titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 and ASTM F136. The outside of the metal component is a hemispherical design. The outer surface of the metallic cup has a porous coating called TiGrowth made of pure titanium conforming to ASTM F1580. The polyethylene liner is a fixed liner made of UHMWPE conforming to ISO 5834-2. The liner has a minimum thickness of at least 5.5 mm when made of standard UHMWPE and of least 4 mm when made of HXUHMWPE.

If supplemental bone screw fixation is needed, cancellous bone screws made of titanium alloy (Ti-6Al-4V) can be inserted through screw holes. Screw hole covers made of titanium alloy (Ti-6Al-4V) are also provided for the central hole.

Also included in this submission are additional Medacta ball heads made of CoCrMo in the 40 mm diameter to augment the Medacta ball heads previously cleared in K072857, K073337 and K080885.

The metal acetabular component is available in 11 sizes and is for use with polyethylene liners that accept both CoCrMo with diameters of 22, 28, 32, and 36 mm and MectaCer BIOLOX® forte Ceramic ball heads with diameters of 28, 32, and 36 mm. They also work with the Medacta 40 mm CoCrMo ball heads. The fixed liners are available in both flat and hooded options in a range of sizes.

All the Mpact® Acetabular System components and Medacta 40 mm ball heads are supplied sterile in single-use individual packages.

Here's an analysis of the provided text regarding the acceptance criteria and study to prove the device meets them, structured as requested:

Device: Mpact® Acetabular System and Medacta 40 mm Ball heads (specifically focusing on HighCross™ highly crosslinked UHMWPE liners due to the detailed wear claim)

Acceptance Criteria and Reported Device Performance

• Average gravimetric wear rate: 6.28 mg +/- 1.68 mg per million cycles
• Average volumetric wear rate: 7.8 mm³ per million cycles
• Average total wear for 5 million cycles: 31.54 mg (for 40 mm inner diameter liners)

(Note: "The in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.") |
| Mechanical Stability | Pre-defined acceptance criteria for:

• Push out
• Lever out
• Rotational stability of the modular connection of the fixed liner to the metal shell | "The testing met all acceptance criteria" (referring to push out, lever out, and rotational stability). No specific numerical values are provided for these tests in the summary. |
  | Coating Validation | Pre-defined acceptance criteria for coating validation. | "The testing met all acceptance criteria" (referring to coating validation). No specific details provided. |
  | Shell Deformation | Pre-defined acceptance criteria for metal shell deformation resistance during impaction. | "The testing met all acceptance criteria" (referring to metal shell deformation resistance). No specific details provided. |
  | Range of Motion | Pre-defined acceptance criteria for range of motion. | "The testing met all acceptance criteria" (referring to range of motion). No specific details provided. |
  | Bone Screw Testing | Pre-defined acceptance criteria for bone screw testing. | "The testing met all acceptance criteria" (referring to bone screw testing). No specific details provided. |
  | Substantial Equivalence | Demonstrating substantial equivalence to predicate devices in indications for use, design, materials, coatings, and technological characteristics. | Concluded to be substantially equivalent to predicates (DePuy Pinnacle®, Smith & Nephew REFLECTION 3, Medacta Bone Screws, Versafitcup® Double Mobility, Apex Modular heads) based on indications for use and technological characteristics, and for wear performance of the HighCross® UHMWPE liners. |

Study Information

Due to the nature of this submission (510(k) summary for an orthopedic implant), the studies described are in vitro performance tests, not clinical efficacy studies with human subjects. Therefore, some requested categories (like "adjudication method" or "effect size of human readers") are not applicable.

1. Sample size used for the test set and the data provenance:

   • Wear Testing:

     • Sample Size: 3 liners (for the HighCross™ highly crosslinked UHMWPE liners).
     • Data Provenance: In-vitro mechanical testing conducted by the manufacturer (Medacta International SA), likely at their facilities or a contracted lab. Country of origin not explicitly stated, but the manufacturer is based in Switzerland. The testing is retrospective in the sense that it's performed after design finalization to demonstrate performance characteristics.

   • Other Performance Testing (Push out, Lever out, Rotational stability, Coating validation, Shell deformation, Range of motion, Bone screw testing):

     • Sample Size: Not explicitly stated, but "worst case component size and option/design" were tested.
     • Data Provenance: In-vitro mechanical testing conducted by the manufacturer. Retrospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are in vitro mechanical tests, not studies requiring expert interpretation of medical images or clinical outcomes. The "ground truth" is defined by the physical properties and performance characteristics measured according to established engineering standards.

3. Adjudication method for the test set: Not applicable, as this refers to expert review of clinical data or images, which is not part of this in vitro performance testing.

4. 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: Not applicable. This is not an AI/imaging device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical implant, not an algorithm.

6. The type of ground truth used:

   • Wear Testing: Gravimetric and volumetric wear measurements, defined by physical changes (mass loss, volume loss) and measured using precise laboratory techniques (e.g., weighing, 3D profiling).
   • Other Performance Testing: Engineering specifications and mechanical properties (e.g., force required for push-out, deformation limits), measured according to international standards (e.g., ISO, ASTM).

7. The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set.

8. How the ground truth for the training set was established: Not applicable.

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The Versafitcup® CC Trio is intended for cementless use in total hip arthroplasty and in primary or revision surgery. The patient should be skeletally mature. The patient's condition should be due to one or more of:

• . Severely painful and/or disabled joint: as a result of osteoarthritis, posttraumatic arthritis, rheumatoid arthritis or psoriactic arthritis, congenital hip dysplasia, or ankylosing spondylitis.
• 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, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

The Versafitcup® CC Trio family of acetabular components is designed to be used with the Medacta Total Hip Prosthesis System. The Medacta Total Hip Prosthesis system includes the Quadra S, H, R, and C Stems and CoCrMo and ceramic ball heads (K072857, K073337, K080885, K082792, and K083558). The AMIStem femoral stems also work with the Medacta Total Hip Prosthesis System (K093944). The Medacta Total Hip Prosthesis System is a total hip replacement system consisting of the femoral stem made of metal, a modular femoral head made of metal or ceramic, and acetabular components. The Versafitcup® CC Trio acetabular components that are the subject of this 510(k) consist of a metal cup made of Titanium alloy and a fixed liner that is made of ultra-high molecular weight polyethylene (UHMWPE) or HighCross® highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). The metal acetabular component or shell is machined from titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3. The outside of the metal component has macrostructures in the equatorial region. The outer surface of the metallic cup has a dual layer of coatings: Ti plasma spray and Hydroxyapatite. The polyethylene liner is a fixed liner made of UHMWPE conforming to ISO 5834. The liner has a minimum thickness of at least 5mm. If supplemental bone screw fixation is needed, cancellous screws made of titanium allov (Ti-6Al-4V) can be inserted through screw holes. Screw hole covers made of titanium alloy (Ti-6Al-4V) are also provided. The metal acetabular component is available is 10 sizes which accept both CoCrMo and MectaCer BIOLOX® forte Ceramic ball heads with diameters of 28, 32 and 36 mm. The fixed liners are available in both flat and hooded options in a range of sizes. All the Versafitcup® CC Trio components are supplied sterile in single-use individual packages.

The provided 510(k) summary (K103352) describes performance testing for a medical device, the Versafitcup® CC Trio, which is a total hip acetabular component. However, the document does not present the information in a way that directly maps to the requested categories for AI/algorithm performance studies.

Here's an analysis based on the provided text, addressing each point as much as possible, with explanations where information is missing or not applicable:

Description of Acceptance Criteria and Device Performance Study for Versafitcup® CC Trio (K103352)

This document describes performance testing for an orthopedic implant (hip replacement component), not an AI/software device. Therefore, many of the requested categories related to AI/algorithm performance are not applicable or the information is not present in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary states that "The Versafitcup® CC Trio was tested as part of design verification to written protocols with pre-defined acceptance criteria." and that "The testing met all acceptance criteria". However, the specific acceptance criteria and the quantitative results of the individual tests are not detailed in this summary. It only broadly reports that the criteria were met.

2. Sample Size for the Test Set and Data Provenance

The document mentions that testing was "conducted on the worst case component size and option/design." This implies a limited sample size, focusing on challenging configurations to demonstrate robust performance.

• Sample Size: Not specified quantitatively. "Worst case component size and option/design" suggests a small, representative sample.
• Data Provenance: Not applicable in the context of clinical data for an AI. The testing constitutes physical/mechanical bench testing of manufactured devices, likely performed in a lab setting by the manufacturer or contractors. It's not data derived from human subjects or clinical environments in the way an AI study would be.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This request is not applicable. This is a physical device (hip implant), and ground truth is established through engineering and materials science principles and measurements, not through expert clinical consensus on images or other diagnostic data. The "ground truth" would be the measured physical properties and mechanical performance against established engineering standards.

4. Adjudication Method for the Test Set

This request is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. For mechanical testing, outcomes are typically objectively measured against defined engineering specifications.

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

This request is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI algorithms where human readers interpret medical cases. This document concerns a physical orthopedic implant.

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

This request is not applicable. This document does not describe an algorithm or AI. The testing described is for the standalone performance of a physical hip implant component in a mechanical test environment.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is defined by:

• Established engineering standards: Performance criteria derived from ISO standards (e.g., ISO 5832-3 for Ti alloy, ISO 5834 for UHMWPE) and FDA guidance documents.
• Pre-defined acceptance criteria: Specific quantitative thresholds for various mechanical properties (e.g., push out force, lever out force, rotational stability, deformation resistance, range of motion).
• Objective measurements: The actual measurements obtained during the mechanical tests (e.g., force, displacement, wear).

8. Sample Size for the Training Set

This request is not applicable. This is not an AI/machine learning study, so there is no "training set." The described testing is a design verification process for a physical medical device.

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

This request is not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant to the provided document.

Summary Explanation:

The K103352 document is a submission for a Preamarket Notification (510(k)) for a conventional medical device (a hip implant). The "performance testing" described refers to benchtop mechanical and material testing to ensure the device meets engineering specifications and is substantially equivalent to predicate devices. It does not involve software algorithms, image analysis, or clinical interpretation data, which are the contexts for the performance criteria and study details requested in your prompt. Therefore, much of the requested information regarding AI/algorithm performance studies does not apply to this specific document.

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