Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device