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MicroPort total hip systems are 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.

The subject MicroPort Orthopedics (MPO) CoCr femoral heads are spherical in shape and manufactured from low carbon cobalt chromium molybdenum alloy. The outer surface of the subject devices articulates against a polyethylene acetabular liner. The subject femoral heads possess an outer articulating surface finish of ≤3μin. The subject femoral heads are provided sterile. The proposed MPO femoral heads fill a gap in the current CoCr head offering. MicroPort CoCr heads are currently offered with short (S), medium (M), long (L) and extra-long (XL) offset for 32mm and 36mm diameter heads. The proposed new product offering in extra short (XS) and extra - long (XXL) offset will bring the CoCr heads offering into alignment with the current market presence of 32mm and 36mm heads.

The sole purpose for this traditional 510(k) is to seek clearance for the additional offering (XS and XXL) of the CoCr femoral heads in 32mm and 36mm sizes.

The provided text describes the 510(k) summary for MicroPort CoCr Femoral Heads, focusing on substantial equivalence to predicate devices rather than proving a device meets specific clinical performance criteria for an AI/ML algorithm. Therefore, many of the requested elements for describing an acceptance criterion for an AI/ML device and the study proving it cannot be extracted from this document.

The document primarily focuses on mechanical testing and material compatibility to demonstrate substantial equivalence for a medical device (hip implant components). It does not involve any Artificial Intelligence/Machine Learning (AI/ML) components, nor does it conduct studies that would establish "ground truth" through expert consensus or measure the effect size of AI assistance on human readers.

Below is a breakdown of what can be extracted and what cannot, based on the provided text:

What Can Be Extracted (Pertaining to Device Acceptance/Testing in General):

• Acceptance Criteria (General): While not explicitly stated as "acceptance criteria" for an AI/ML device, the document implies acceptance based on meeting mechanical testing requirements as outlined in various ASTM and ISO standards for hip joint prostheses, and non-pyrogenicity endotoxin testing (20 EU/device). The overarching "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device.
• Reported Device Performance (Mechanical/Biological):
  • Mechanical Testing: "The mechanical testing verifies that the subject components are substantially equivalent to the predicate devices currently on the market and have met all mechanical testing requirements based on the worst case construct testing." Specific numerical performance metrics (e.g., wear rate, torque values) are not provided in this summary, only that they met requirements.
  • Non-Pyrogenicity Endotoxin Testing: "Testing was successfully performed and it was confirmed that the subject implants meet the 20 EU/device testing limit." This explicitly mentions meeting a specific numerical limit.
• Device Type: MicroPort CoCr Femoral Heads (hip implant components).
• Study Type: Non-clinical (mechanical and biological bench testing).

What Cannot Be Extracted (Specific to AI/ML Device Acceptance Criteria and Study Design):

Most of the requested information is not applicable to this document as it describes a physical medical device (hip implant components) and not an AI/ML algorithm or software as a medical device.

1. A table of acceptance criteria and the reported device performance (for AI/ML): Not applicable. The document describes mechanical/biological acceptance, not AI/ML performance metrics like sensitivity, specificity, AUC, etc.
2. Sample sized used for the test set and the data provenance: Not applicable in the context of AI/ML. The "test set" here refers to physical implant samples for mechanical/endotoxin testing, not a dataset for AI evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no "ground truth" in the AI/ML sense (e.g., expert-annotated images) for this type of device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device would be physical properties and biocompatibility, verified by standard testing methodologies.
8. The sample size for the training set: Not applicable. There is no AI training set.
9. How the ground truth for the training set was established: Not applicable. There is no AI training set.

Summary Table (Limited to Applicable Information):

Details Not Applicable to This Device (No AI/ML):

• Sample Size (Test Set): Not a "data set"; refers to physical samples for lab tests. Data provenance, experts for ground truth, adjudication, MRMC studies, standalone performance, and AI-specific ground truth are not relevant for this physical device.
• Training Set: Not applicable as there is no AI/ML component.

Therefore, the provided document does not contain the information needed to describe acceptance criteria and a study proving an AI/ML device meets those criteria. It describes the regulatory clearance process for a traditional, physical medical device.

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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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