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The PROCOTYL® PRIME Acetabular Cup System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli. and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed.
   Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

The PROCOTYL® PRIME Acetabular Cup System includes acetabular shells, acetabular liners, and optional cancellous bone screws. The design features are summarized below:

• Acetabular Shells
  • Manufactured from titanium alloy
  • BIOFOAM® coated
  • Available in Solid or Quad configurations
  • Outer Diameter sizes 42mm to 68mm in 2mm increments
• Acetabular Liners
  • Manufactured from A-CLASS® highly crosslinked ultra high molecular weight polyethylene)
  • Available in Standard. Lipped Face-changing or Lateralized configurations
  • Inner Diameter sizes 22mm to 44mm
• Bone Screws
  • Manufactured from titanium alloy
  • 6.5mm diameter
  • Available in lengths 15mm to 80mm in 5mm increments

This document is a 510(k) summary for the PROCOTYL® PRIME Acetabular Cup System, a medical device for total hip arthroplasty. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided text in relation to your request about acceptance criteria and studies:

Crucially, this document is a 510(k) Pre-Market Notification, which is a regulatory submission to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. It is not a detailed clinical study report or a publication presenting performance metrics against specific acceptance criteria for an AI/ML device.

Therefore, most of the information you are requesting about acceptance criteria, specific performance metrics, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance for an AI/ML device is not present in this document. This document concerns a physical orthopedic implant.

However, I can extract the information that is available and clarify what is missing based on your request.

Summary of Device Acceptance Criteria and Performance (Based on available information):

Missing Information (as per your request, because this is not an AI/ML device nor a typical clinical study report):

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical components tested in a lab, not a diagnostic dataset. The document does not specify sample sizes (e.g., number of cups, liners, or screws) for any of the nonclinical tests. Data provenance, in the sense of country of origin or retrospective/prospective for patient data, is also not applicable here.
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 an orthopedic implant's mechanical properties is typically established through recognized engineering standards (e.g., ASTM) and validated testing methodologies, not expert medical consensus on diagnostic images.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This applies to human review of diagnostic outputs, not mechanical 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/ML diagnostic device with human-in-the-loop.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the specifications and performance standards (e.g., ASTM standards) that the device must meet. For biocompatibility, it's defined by the pyrogen limit specification (≤ 20 EU/device). It's not based on expert consensus, pathology, or outcomes data in the conventional sense used for diagnostic devices.
7. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

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MicroPort total hip systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
• inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
• correction of functional deformity; and, 3.
• revision procedures where other treatments or devices have failed 4.

Modular shells with porous metal bead coating may be used in either cemented or uncemented arthroplasty. Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

The DYNASTY® Acetabular System with Ceramic contains femoral heads in size 28mm manufactured from alumina matrix composite, mating acetabular liners manufactured from crosslinked polyethylene, and beaded acetabular shells manufactured from titanium alloy.

The provided 510(k) summary for the DYNASTY® Acetabular System with Ceramic does not contain information related to acceptance criteria for a device, nor does it describe a study that proves the device meets specific acceptance criteria in the manner typically associated with AI/software devices.

Instead, this document describes a traditional medical device (an orthopedic implant) and focuses on demonstrating substantial equivalence to previously cleared predicate devices. The "study" mentioned is purely for mechanical and tribological (wear) evaluation, not clinical or performance criteria as would be relevant for software or AI.

Therefore, I cannot extract the requested information in the format provided because it's not present in the document.

Here's why and what the document does provide:

• Type of Device: The DYNASTY® Acetabular System with Ceramic is a physical orthopedic implant (acetabular shell, liner, and femoral head for total hip replacement). It is not a software device or an AI algorithm.
• Regulatory Pathway: This is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as for a PMA.
• "Acceptance Criteria" in this context: For a physical implant like this, "acceptance criteria" relate to engineering specifications, material properties, biocompatibility, mechanical strength, wear resistance, and manufacturing quality. These are typically assessed through bench testing and adherence to recognized standards.
• "Study" in this context: The "study" mentioned is non-clinical mechanical and tribological testing.

Specific answers based on the provided text, explaining why other points are not applicable:

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

   • Not Applicable. The document does not provide a table of acceptance criteria or performance metrics in the way one would for a software or AI device (e.g., sensitivity, specificity, AUC). It discusses mechanical and tribological evaluations and comparisons to predicate devices rather than specific performance targets against clinical gold standards.

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

   • Not Applicable. This refers to mechanical testing, not a clinical study involving a test set of data. The "subject size 28mm ceramic head was used as a worst case" for burst, post-fatigue burst, rotational stability, and pull-off force testing, implying a limited number of physical samples (likely one or a few) were subjected to these mechanical tests. No patient data or clinical retrospective/prospective studies were conducted.

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. This device is not a diagnostic or AI tool requiring expert ground truth for a test set.

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

   • Not Applicable. This is not a clinical study requiring adjudication of expert opinions.

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 is a physical medical device, not an AI system.

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

   • Not Applicable. This is a physical medical device, not an AI algorithm.

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

   • Not Applicable. For mechanical testing, the "ground truth" would be the physical properties derived from standardized test methods (e.g., force measured at failure, wear volume). The document states:
     • "The subject DYNASTY® Acetabular System with Ceramic was evaluated mechanically and tribologically."
     • "The mechanical testing on the subject and predicate devices was performed on wrought Cobalt Chrome modular neck spigots cleared under K091423 and K100866."
     • "The subject size 28mm ceramic head was used as a worst case in burst, post-fatigue burst, rotational stability, and pull off force testing."
     • "Wear testing compared the subject size 28mm femoral heads to the K130376 DYNASTY® Acetabular System."
     • "Range of motion evaluation compared the subject system to the predicate K052026 in three planes."
     • This implies physical engineering measurements as the "ground truth" for evaluating the device's mechanical characteristics.

8. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device requiring a training set.

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

   • Not Applicable. This is not an AI/ML device requiring a training set.

In summary, the provided document describes a "Traditional 510(k)" pathway for a physical orthopedic implant. The demonstration of safety and effectiveness relies on substantial equivalence to predicate devices and non-clinical bench testing, not clinical studies or performance criteria typically associated with software/AI medical devices.

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Wright Medical total hip systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed

The DYNASTY® Acetabular System with Ceramic is manufactured from alumina matrix composite. The components are offered in sizes ranging from 32mm to 40mm.

The provided text describes a 510(k) summary for the DYNASTY® Acetabular System with Ceramic, focusing on its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to an AI/ML algorithm.

Therefore, I cannot provide the requested information in the format of a table describing acceptance criteria and device performance for an AI/ML device, nor can I answer questions regarding sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The document states:

• "Clinical data was not provided for the subject devices." This explicitly indicates that no clinical study was performed to assess the device's performance in humans.
• "The subject DYNASTY® Acetabular System with Ceramic was evaluated mechanically, tribologically, and chemically." This suggests non-clinical (laboratory) testing was conducted, but the details of acceptance criteria for these tests and their results are not provided in a summary format. The document mentions that the testing "shows that it can be concluded that the subject ceramic material can be expected to perform well under normal physiological chemical and mechanical conditions," implying the tests were successful in demonstrating performance without specifying the criteria or results.
• The entire submission hinges on "Substantial Equivalence Information" to predicate devices. This means the device is considered safe and effective because it is very similar to devices already cleared by the FDA, rather than proving its effectiveness through new clinical trials against specific performance criteria.

In summary, the provided text does not contain the information needed to answer your questions regarding acceptance criteria and performance studies for an AI/ML device.

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The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• correction of functional deformity; and.
• revision procedures where other treatments or devices have failed

The PROFEMUR® Z Titanium Plasma Sprayed Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.

The modular PROFEMUR® Z Titanium Plasma Sprayed hip stem is an uncemented distal femoral implant designed to couple with Wright Medical Technology's PROFEMUR® CoCr modular necks. The stem design was developed from the previously marketed PROFEMUR® Z Hip Stem ('STEM' K021346) and features the identical modular neck taper socket and is made of the identical Titanium alloy (ASTM F620) as previous hip stem designs by Wright. The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem features the identical substrate cross-sectional geometry as the PROFEMUR® Z Hip Stem (K0213146) with the addition of titanium plasma spray coating conforming to ASTM F1580 applied according to WMT specifications which covers the proximal 1/3 of the stem.

The provided text describes the PROFEMUR® Z Titanium Plasma Sprayed Hip Stem. As a Class III medical device, its clearance is primarily based on demonstrating substantial equivalence to predicate devices rather than meeting specific performance acceptance criteria through clinical or advanced non-clinical studies. The information available focuses on the device's design, materials, and manufacturing being identical or highly similar to previously cleared devices.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets those (or is substantially equivalent):

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The "test set" for this device, as described, primarily refers to non-clinical (bench) testing performed on the device itself, comparing its physical and mechanical properties to established standards and predicate devices.

• Sample Size: Not explicitly stated for each test, but standard engineering tests would involve a sufficient number of samples to ensure statistical validity for the specific test (e.g., typically N=3 to N=5 or more for destructive tests like fatigue).
• Data Provenance: The tests are performed on the manufactured PROFEMUR® Z Titanium Plasma Sprayed Hip Stem. This is prospective testing of the device's physical samples. No human or animal data is described for these non-clinical tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable in the context of this 510(k) submission. The "ground truth" for the non-clinical tests is established by recognized international standards (ISO, ASTM) and the specifications of the predicate device, not by expert medical opinion on a test set.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication typically refers to the process of resolving discrepancies in expert human reviews for clinical or image-based studies. For non-clinical tests, compliance with standard test methods and evaluation against defined specifications are the "adjudication" mechanism.

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

No MRMC study was done. This device is a mechanical implant, not an AI-powered diagnostic or assistive tool.

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

No standalone algorithm performance study was done. This device is a mechanical implant, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on:

• Engineering Standards: ISO 7206-4, 6, and 8 (for fatigue), ASTM F1875 (fretting corrosion), ASTM F2009 (axial disassembly), ASTM F1580 (titanium plasma spray coating).
• Predicate Device Specifications: The design, materials, and surface finish are compared directly to previously cleared predicate devices (e.g., K021346, K012091).
• WMT Specifications: Internal company specifications for manufacturing and coating application.

8. The Sample Size for the Training Set

There is no training set in the context of this 510(k) submission. This is not a machine learning or AI device. The process relies on demonstrating equivalence through engineering analysis and non-clinical testing.

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

Since there is no training set, this question is not applicable.

Summary of the Study Proving Acceptance Criteria (Substantial Equivalence):

The device's "acceptance" for market clearance (through 510(k)) is predicated on demonstrating substantial equivalence to legally marketed predicate devices. The "study" involves a comprehensive comparison and non-clinical testing program:

• Design & Material Comparison: A detailed analysis showing that the PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is identical in material (ASTM F620), substrate cross-sectional geometry, modular neck taper socket, and non-coated surface finish to predicate devices (K021346).
• Coating Equivalence: The titanium plasma spray coating is shown to conform to ASTM F1580, applied to WMT specifications, and is "identical" to the coating used on another cleared predicate (K012091). This is supported by testing referenced in a vendor Master File (though specific results are not included in this summary).
• Mechanical Performance Testing: The coated stem underwent standard fatigue tests (ISO 7206-4, 6, and 8) and fretting corrosion and axial disassembly force tests (ASTM F1875 and F2009). While specific pass/fail criteria or results are not detailed in this summary, the completion of these tests in accordance with relevant standards implicitly demonstrates that the device performs acceptably and equivalently to current standards for hip stems.
• Intended Use & Indications Equivalence: The device's intended use and indications for use are stated to be "identical" to existing Wright PROFEMUR® hip stems, which have multiple prior 510(k) clearances.

In essence, the study demonstrating "acceptance" for this device is the body of evidence provided in the 510(k) submission that systematically compares the new device against its predicates and relevant engineering standards, asserting that any differences do not raise new questions of safety or effectiveness. No clinical testing was provided to support this Class III modular hip stem.

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Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

This femoral stem is for cementless use only.

The Zimmer M/L Taper Hip Prosthesis with Modular Neck Technology is a modular, wedgeshaped stem that is coated with commercially pure titanium alloy plasma spray that is available with and without Calcicoat Ceramic Coating. This stem is designed for cementless use only.

The modular neck option allows for soft tissue balancing and easier restoration of the hip joint center of rotation. The modularity feature will allow surgeons to independently equalize leg length and optimize offset while, at the same time, maximizing joint stability for a variety of different patients' anatomies.

The provided text describes a 510(k) premarket notification for a medical device, the Zimmer® M/L Taper Hip Prosthesis with Modular Neck Technology. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish independent safety and effectiveness.

Therefore, the requested information regarding acceptance criteria for a device's performance, a study proving it meets these criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies is not applicable in this context.

Here's why and what the document does provide:

1. Acceptance Criteria and Reported Device Performance:

   • Not applicable for this type of submission. A 510(k) does not typically involve setting specific performance acceptance criteria for a new device's performance that then needs to be met by a study. Instead, the device's design, materials, manufacturing, and intended use are compared to an existing predicate.
   • The document states: "Non-clinical testing demonstrated that the M/L Taper Hip Prosthesis with Modular Neck Technology met performance requirements and is as safe and effective as the predicate devices." This is a general statement indicating comparative performance, not performance against independent numerical acceptance criteria.

2. Sample Size for Test Set and Data Provenance:

   • Not applicable. There is no "test set" in the sense of a clinical or retrospective dataset used to directly evaluate the device's performance against specific metrics. The non-clinical testing refers to bench testing (e.g., mechanical, fatigue, wear) to ensure the device performs similarly to the predicate under simulated conditions. The document does not specify sample sizes for these tests.

3. Number of Experts and Qualifications for Ground Truth:

   • Not applicable. There is no "ground truth" to establish in the context of expert review for diagnostic accuracy or similar performance metrics. The assessment is primarily engineering-based for mechanical properties and a comparison to the predicate's known safety and efficacy profile.

4. Adjudication Method:

   • Not applicable. No human adjudication of results is described, as there isn't a complex diagnostic or outcome assessment being performed by human readers for the device itself.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Not applicable. MRMC studies are used to assess the diagnostic accuracy or effectiveness of an imaging algorithm or diagnostic device, often comparing human reader performance with and without AI assistance. This device is a hip implant, not an imaging or diagnostic AI device.

6. Standalone Performance Study:

   • Not applicable. A "standalone" study typically refers to the algorithmic performance of an AI or diagnostic device without human interaction. This device is a physical implant.

7. Type of Ground Truth Used:

   • Not applicable. Ground truth for clinical outcomes or diagnostic accuracy is not relevant here. The "proof" is based on non-clinical engineering testing and the demonstrated conceptual equivalence to established predicate devices.

8. Sample Size for Training Set:

   • Not applicable. This device is a physical hip implant, not a machine learning algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established:

   • Not applicable. As above, no training set for an algorithm is involved.

In summary, the provided document is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of materials, design, and intended use, rather than detailed clinical studies with specific performance acceptance criteria, expert adjudication, or AI algorithm evaluation.

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