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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 Interface™ Acetabular Cup Liners are intended for use with the Interface™ Acetabular Cup, in combination with the Apex Modular™, Apex K2™, or Apex K1™ Hip Stem in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:

• . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• e Rheumatoid arthritis:
• . Correction of functional deformity;
• . Congenital dislocation:
• . Revision procedures where other treatments or devices have failed;
• Femoral neck and trochanteric fractures of the proximal femur. .

The Interface™ Acetabular Cup Liners are manufactured of compression molded ultrahigh molecular weight polyethylene, sterilized using ethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or alumina ceramic, 28 mm, 32 mm or 36 mm diameter. The subject device adds an option for a 20° elevated rim that was not previously offered.

The provided text describes a 510(k) premarket notification for the "Interface™ Acetabular Cup Liners." This submission focuses on establishing substantial equivalence to previously marketed predicate devices, rather than presenting a study of the device's clinical performance against specific acceptance criteria in the manner of a clinical trial for an AI/ML medical device.

Therefore, the specific information requested about acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and training sets (relevant to AI/ML device studies) is not applicable to this 510(k) submission for a physical orthopedic implant.

Here's why and what information is available:

• Nature of the Device: The Interface™ Acetabular Cup Liners are physical medical devices (orthopedic implants) used in total hip replacement procedures. They are not an AI/ML algorithm or software that performs diagnostic or prognostic functions.
• Regulatory Pathway (510(k)): A 510(k) submission demonstrates "substantial equivalence" to a legally marketed predicate device. This typically involves comparing design, materials, manufacturing processes, intended use, and performance characteristics (often mechanical testing for implants) to established, safe, and effective devices. It does not generally require new clinical trials or performance studies against predefined clinical acceptance criteria in the same way an AI/ML device would.

What is provided in the document and how it relates to "acceptance criteria" for a physical device:

The "acceptance criteria" in this context are primarily the demonstration of substantial equivalence to predicate devices. The study proving this involves detailed comparisons rather than a clinical performance study.

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" here are implicitly meeting the design, material, and functional equivalence to the predicates. The "reported device performance" is the comparison showing these equivalences.

2. Sample size used for the test set and the data provenance: Not applicable. This is not a clinical study involving a test set of patient data. The "test" is the comparison of device characteristics to predicates.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the clinical sense, is not established for this type of submission. The "ground truth" is the established safety and effectiveness of the predicate devices.

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 an orthopedic implant, not an AI-assisted diagnostic tool.

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 in the context of AI/ML. For this 510(k) submission, the "ground truth" (or basis of comparison) is the known safety and effectiveness profiles of the predicate devices (Interface™ (K031110), ApeX-LNK Poly™ (K062489 and K073150), and Zimmer Trilogy® Acetabular System (K934765, K953490, and K972774) UHMWPE cup liners) as determined by their prior FDA clearances and long-standing use in the market.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) premarket notification that demonstrates substantial equivalence for a physical medical device (acetabular cup liners). The "study" proving it meets "acceptance criteria" involves a detailed comparison of its design, materials, and intended use against already cleared predicate devices. The concepts of test sets, training sets, expert ground truth, and AI-assisted performance are not relevant to this type of regulatory submission.

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