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The 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, ankyloses, 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 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 о
  • BIOFOAM® coated o
  • Available in Solid or Quad configurations o
  • Outer Diameter sizes 42mm to 68mm in 2mm increments O
• Acetabular Liners ●
  • Manufactured from A-CLASS® (highly crosslinked ultra-high molecular o weight polyethylene)
  • Lipped Available in in Standard, or Face-changing Lateralized O configurations with 12 anti-rotational tabs
  • Inner Diameter sizes 22mm to 44mm O
• Bone Screws ●
  • Manufactured from titanium alloy o
  • 6.5mm diameter O
  • 0 Available in lengths 15mm to 80mm in 5mm increments

The subject Acetabular Liner has undergone design changes in regard to the locking detail; all other design aspects, intended use, fundamental scientific technology, and material remain identical to the predicate K170444 Acetabular Liner.

This looks like a 510(k) summary for a medical device (Prime Acetabular Cup System), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with acceptance criteria.

As such, it does not contain the specific information requested in your prompt regarding acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment.

The document primarily provides:

• Device Description and Intended Use: Details the components of the Prime Acetabular Cup System (Acetabular Shells, Liners, Bone Screws) and their intended applications in total hip arthroplasty.
• Substantial Equivalence Justification: States that the device is substantially equivalent to predicate devices (PROCOTYL® PRIME Acetabular Cup System, K170444) based on identical indications for use, similar materials (for the liner, drawing on K052026), and unchanged design features for shells and screws since K170444.
• Nonclinical Testing: Lists bench tests performed on the subject device (liner push-out, lever-out, torque-out per ASTM F1820, ASTM STP1301) and references tests performed on the predicate device and deemed applicable (deformation, frictional torque, wear, fatigue, range of motion, screw properties).
• Clinical Testing: Explicitly states that clinical data was not provided for the subject devices.
• Biocompatibility: Justifies not performing specific biocompatibility tests on the subject implants as their materials and patient contact are identical to predicate devices.
• Compatibility Tables: Details compatibility with other MicroPort Orthopedics products.
• Sterilization Residuals: Discusses previous evaluations and current applicability.

Therefore, I cannot populate the requested table and answer your questions directly from the provided text. The document does not describe a study with acceptance criteria in the context of clinical performance or diagnostic accuracy, which is implied by your prompt's questions. It focuses on engineering and material equivalence testing for an orthopedic implant.

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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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