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The Pinnacle Duofix™ HA Acetabular Cup Prosthesis is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for cementless application.

The Pinnacle Duofix HA Acetabular Cup Prosthesis is a sintered, porous-coated (Porocoat®) hemispherical outer acetabular shell manufactured from titanium alloy (Ti-6Al-4V) with a thin layer of hydroxyapatite (HA) coating applied. The interior of the acetabular cup is designed with a groove and a taper for use with either an ultra-high molecular weight polyethylene (UHMWPE) or metal acetabular cup liner, which lock into the shell. Articulation occurs between the liner, and a femoral head with the appropriately sized diameter. The shells contain an apical threaded hole to allow the surgeon to attach the shell insertion instrument and grasp the shell during implantation. An optional titanium alloy (Ti-6Al-4V) apical hole plug is available to screw into the threaded apical hole of the shell. The plug is intended to occlude the apical hole in order to prevent particulate migration and provide polyethylene support. The Pinnacle Duofix HA Acetabular Cup Prosthesis is provided in shell diameter sizes 48mm through 66mm in both the "No Hole" (100 series) and the "Cluster Hole” (Sector series) configurations.

This document is a 510(k) Premarket Notification for the DePuy Pinnacle Duofix™ HA Acetabular Cup Prosthesis. It aims to demonstrate substantial equivalence to previously cleared devices (K000306 and K031495) rather than proving a specific medical device meets acceptance criteria through clinical studies.

Therefore, the information requested in your prompt for a study proving a device meets acceptance criteria, including specifics about an AI/human reader study, ground truth establishment, and sample sizes for training/test sets, is not present in this document.

This submission is focused on:

• Demonstrating equivalence: The primary purpose is to show that the modified device (manufacturing location, sterilization sites, and packaging change) is as safe and effective as previously cleared predicate devices.
• Non-clinical testing: The performance data listed are non-clinical (biological safety, sterilization validation, HA coating characterization).
• No clinical tests: The document explicitly states, "No clinical tests were conducted to demonstrate substantial equivalence."

In summary, there is no study described in this document that proves the device meets explicit acceptance criteria through the types of clinical or AI performance studies your prompt asks about.

If you have a document discussing an AI/medical device performance study, please provide that, and I can attempt to extract the relevant information.

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The Pinnacle Duofix™ HA Acetabular Cup Prosthesis is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for cementless application.

The Pinnacle Duofix HA Acetabular Cup Prosthesis is a sintered, porous-coated (Porocoat®) hemispherical outer acetabular shell manufactured from titanium alloy (Ti-6Al-4V) with a thin layer of hydroxyapatite (HA) coating applied.

The interior of the acetabular cup is designed with a groove and a taper for use with either an ultra-high molecular weight polyethylene (UHMWPE) or metal acetabular cup liner, which lock into the shell. Articulation occurs between the liner, and a femoral head with the appropriately sized diameter.

The shells contain an apical threaded hole to allow the surgeon to attach the shell insertion instrument and grasp the shell during implantation. An optional titanium alloy (Ti-6Al-4V) apical hole plug is available to screw into the threaded apical hole of the shell. The plug is intended to occlude the apical hole in order to prevent particulate migration and provide polyethylene support.

The Pinnacle Duofix HA Acetabular Cup Prosthesis is provided in shell diameter sizes 48mm through 66mm in both the "No Hole" (100 series) and the "Cluster Hole" (Sector series) configurations.

The provided text is a 510(k) summary for a medical device (Pinnacle Duofix™ HA Acetabular Cup Prosthesis). It describes the device, its intended use, and claims substantial equivalence to previously cleared devices.

However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/software as a medical device (SaMD) submission.

The 510(k) process for this type of implantable device relies on demonstrating substantial equivalence to a predicate device based on similarities in design, materials, manufacturing processes, and intended use. Performance is typically established through non-clinical testing (e.g., mechanical testing, biocompatibility) rather than clinical studies with human participants in the context of diagnostic accuracy.

Therefore, many of the requested categories related to acceptance criteria and study design (especially those pertinent to AI/SaMD) cannot be extracted from this document, as they are not applicable to the type of submission provided.

Here's a breakdown of what can be inferred or directly stated from the document, and what cannot:

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

• Not Applicable in this format. This 510(k) summary for an orthopedic implant does not define specific "acceptance criteria" in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or provide a table of such criteria against reported performance as would be seen for an AI/SaMD.
• Instead, the "performance" is implicitly deemed acceptable by demonstrating substantial equivalence to a predicate device (Pinnacle Acetabular System, K000306 and TriFlange Acetabular Cup, K001277) based on similarities in design, materials, and intended use. The performance is related to the physical and biological characteristics of the implant, which are assumed to be "met" by being equivalent to the proven predicate.

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. There is no "test set" in the context of clinical diagnostic performance. This device is a physical implant, not a diagnostic tool requiring a test set of data for performance evaluation.

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 information is irrelevant for a physical orthopedic implant.

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

• Not applicable. There is no "test set" or diagnostic adjudication process.

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 implantable medical device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is an implantable medical device, not an algorithm.

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

• Not applicable. For a physical implant, "ground truth" typically relates to its material properties, mechanical integrity, and biocompatibility, which are assessed through laboratory testing and established standards, not diagnostic outcomes. The "ground truth" for its safety and effectiveness is primarily established through the long-term clinical history and regulatory clearance of its predicate devices.

8. The sample size for the training set

• Not applicable. No training set for an algorithm is involved.

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

• Not applicable. No training set for an algorithm is involved.

Summary of Relevant Information from the Document:

• Device Name: Pinnacle Duofix™ HA Acetabular Cup Prosthesis
• Intended Use: Total hip replacement procedures for various conditions (rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, nonunion of femoral fractures, revision arthroplasty, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, disability due to previous fusion where bone stock is inadequate). Indicated for cementless application.
• Basis of "Acceptance" / Substantial Equivalence: Demonstrated through similarities of design, materials, sterilization processes, and the same intended use to:
  • Predicate Device 1 (Acetabular Cup): DePuy Pinnacle Acetabular System, K000306
  • Predicate Device 2 (HA Porous Coating): DePuy TriFlange Acetabular Cup K001277
• Device Performance (Implicit): The device is considered to perform equivalently to its predicate devices due to the demonstrated similarities. The performance of the predicate device (K000306) and the HA coating (K001277) would have established their safety and effectiveness through their prior regulatory clearances, which forms the basis for accepting the current device's performance. This type of submission relies on the existing evidence for the predicate rather than new, extensive clinical studies for the new device unless significant differences are present.

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