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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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This device is indicated in 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 function deformity;
4. Revision procedures where other treatments or devices have failed;
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.

This device is a single use implant and intended for cementless use only except cemented stem which is designed for cemented use only.

There are two purposes in current submission, the fist one is to expand the Indications for Use of two cleared products: U2 Hip System (K111546) and Femoral Heads, +2.5 & +7.5 mm Offset (K122504), which have been expanded to a population with similar demographic, diagnosis and prognosis as the original. The second purpose of this submission is to reword the statement of Indications for Use of six cleared "UNITED" hip products including U1 Hip System (K994078), U2 Hip Stem, Ti porous coated (K003237), U2 Acetabular Cup and Femoral Head (K022520), U2 Acetabular Component (K050262), U2 Hip Stem and Ti Plasma Spray (K062978) and U2 Acetabular Cup, Plasma Spray (K121777). Through this submission, the Indications for Use of above listed devices are unified as one version, and the components, materials, design, processing methods, sterilization methods, biocompatibility, safety and effectiveness of above listed devices are unchanged by this submission.

The provided text describes a 510(k) summary for the "U2 Hip System, Expanded Indications for Use". This document focuses on establishing substantial equivalence to previously cleared predicate devices for the indications for use of a hip implant system, rather than proving the performance of a newly designed device through explicit acceptance criteria and a detailed study.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth was established is not applicable in this context.

Here's why and what the document does provide:

• Type of Device: This is a hip prosthesis (total hip replacement system).
• Regulatory Pathway: This is a 510(k) premarket notification. The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics (design, materials, packaging, sterilization) and intended use, rather than conducting new clinical performance studies against specific acceptance criteria for a novel device.
• Purpose of the Submission:
  1. Expand Indications for Use: For two existing products (U2 Hip System K111546 and Femoral Heads K122504) to include a similar patient demographic, diagnosis, and prognosis.
  2. Reword/Unify Indications for Use: For six other cleared "UNITED" hip products to a single, unified version.
• Basis for Substantial Equivalence: The submission states that the components, design, materials, packaging, and sterilization method of the "U2 Hip System - Expanded Indications for Use" are identical to cleared predicate devices. The only difference is the integration of indications for use.
• Non-Clinical and Clinical Testing: The document explicitly states:
  • "Non-clinical laboratory testing is not provided as a basis for substantial equivalence."
  • "Clinical Testing None provided as a basis for substantial equivalence."

Conclusion:

This submission does not contain information about a study designed to prove the device meets specific acceptance criteria in the manner requested because it relies on demonstrating substantial equivalence to pre-existing, legally marketed devices. The performance and safety of the device are implicitly linked to the predicate devices it is compared against, not to new performance data generated for this specific submission.

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

The purpose of this submission is to add a monolithic femoral neck option to the PROFEMUR® Z Hip System. The PROFEMUR® Z Classic Stems are monolithic stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® Z Classic Stems are available in 9 sizes (1-9) and are available in two surface finish options: gritblast or titanium plasma spray conforming to ASTM F1580. Each size is available with either a long or short fixed femoral neck and all sizes are available in two neck offset options, Standard (neutral) and Extended (varus). The surface finish options, neck lengths, and neck offset are designed to create options identical to those available with the predicate modular devices.

The provided text describes the PROFEMUR® Z Classic Stems and a special 510(k) submission. It focuses on the comparison of the new device to predicate devices for substantial equivalence, primarily through nonclinical testing.

Here's an analysis of the provided information regarding acceptance criteria and studies:

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

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

The document explicitly states: "Clinical data was not provided for the subject devices."
Therefore, there is no test set of clinical data for human performance, and thus no information on sample size or data provenance in that regard. The "test set" here refers to the physical devices undergoing nonclinical testing. The sample sizes for these physical tests are not specified in the document.

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 an orthopedic implant, and the ground truth for its performance is established through engineering and biomechanical testing (nonclinical), not expert interpretation of clinical data in the way medical imaging devices might require.

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

Not applicable. As noted above, the "test set" refers to physical devices undergoing nonclinical testing, not clinical cases requiring expert adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical imaging or diagnostic devices where human readers interpret data, often with or without AI assistance. This document pertains to a hip stem implant, which does not involve human readers interpreting AI output.

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

Not applicable. This is not an AI algorithm or a diagnostic device. The "standalone" performance here refers to the physical device's mechanical integrity and range of motion, which was evaluated through nonclinical testing as described in section (b)(1).

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

The ground truth for the device's performance is based on:

• Engineering specifications and standards: Adherence to ISO 7206-4, 6, and 8 for fatigue tests, and ISO 21535 for range of motion.
• Manufacturer specifications: Conformity to Wright Medical Technology (WMT) specifications for the titanium plasma spray coating, and comparison to predicate device material and design characteristics (ASTM F620 for titanium alloy).
• Vendor Master File: Verification of the titanium plasma spray coating through testing summarized in a vendor Master File.

8. The sample size for the training set

Not applicable. The document explicitly states "Clinical data was not provided for the subject devices." There is no mention of an AI model or a training set for an algorithm.

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

Not applicable, as there is no training set for an AI algorithm mentioned in the document.

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