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The DePuy Pinnacle Acetabular System is intended to resurface the acetabular socket in cemented or cementless total hip arthroplasty.

The Pinnacle Acetabular System is indicated for total hip replacement in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

All Pinnacle porous-coated acetabular shells are indicated for cementless application.

The Pinnacle Acetabular System is part of a modular system for use in total hip replacement. The acetabular component is provided as two separate units, a porous coated hemispherical outer shell manufactured from titanium alloy (Ti-6Al-4V) and a liner manufactured from ultra high molecular weight polyetheylene (UHMWPE), which locks into the outer shell. The liner component articulates with a femoral head of an appropriate diameter.

This document, K001534, is a 510(k) premarket notification for the Pinnacle Acetabular System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a novel AI/software device.

Therefore, much of the requested information regarding acceptance criteria, study methodologies, ground truth establishment, sample sizes, and expert involvement is not present in this document because it outlines a regulatory submission for a medical device (an acetabular cup prosthesis) and not an AI or diagnostic software. The "basis of substantial equivalence" is the key here, not a performance study against acceptance criteria.

However, based on the provided text, I can infer and state what is available and what is explicitly not available.

Acceptance Criteria and Study for K001534: Pinnacle Acetabular System

This 510(k) submission (K001534) for the DePuy Orthopaedics Pinnacle Acetabular System is primarily focused on demonstrating substantial equivalence to a predicate device (K000306), rather than presenting a performance study against a predefined set of quantitative acceptance criteria in the context of an AI or diagnostic device.

The "acceptance criteria" in this context refer to the characteristics and performance aspects that allowed the device to be considered substantially equivalent to a legally marketed predicate device. The "study" proving this largely relies on comparisons of design, materials, manufacturing, and intended use as described below.

1. Table of Acceptance Criteria and Reported Device Performance

The following information is NOT available in the provided document:

2. Sample size used for the test set and the data provenance: Not applicable. This is a submission for an implantable device, not an AI/software. There is no "test set" of data in the sense of patient images or specific clinical outcomes data analyzed in this document for algorithm performance. The "test" here refers to demonstrating physical characteristics and equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/diagnostic software is not relevant here. The ground truth for the device's physical properties and performance would be established through engineering testing and material science, not clinical expert consensus on diagnostic data.

4. Adjudication method for the test set: Not applicable for the reasons stated above.

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 device is an orthopedic implant, not an AI / diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an orthopedic implant, not an algorithm.

7. The type of ground truth used: For this device, the "ground truth" would relate to the physical and chemical properties of the materials, the mechanical performance (e.g., wear, fatigue, pull-out strength), and biocompatibility, as evaluated through engineering design controls and established predicate device performance. It is not expert consensus, pathology, or outcomes data in the context of diagnostics.

8. The sample size for the training set: Not applicable. This device is an orthopedic implant; there is no "training set" in the machine learning sense.

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

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The Pinnacle Acetabular System 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. All Pinnacle porous-coated acetabular shells are indicated for cementless application.

The Pinnacle Acetabular System is part of a modular system for use in total hip replacement. The acetabular component is provided as two separate units, a porous coated hemispherical outer shell manufactured from titanium alloy (Ti-6Al-4V) and a liner manufactured from ultra high molecular weight polyetheylene (UHMWPE), which locks into the outer shell. The liner component articulates with a femoral head of an appropriate diameter.

The provided text describes the DePuy Orthopaedics, Inc. Pinnacle Acetabular System, which is an acetabular cup prosthesis used in total hip replacement procedures. The submission is a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study with pre-defined acceptance criteria. Therefore, the information requested in points 1-9, which typically relates to clinical studies with specific acceptance criteria and detailed study designs, is not explicitly available in this type of submission.

However, based on the provided text, we can infer some aspects related to "acceptance criteria" in the context of a 510(k) submission.

Summary of Acceptance Criteria and Device Performance (Inferred from 510(k) Equivalence)

Since this is a 510(k) submission, the "acceptance criteria" are primarily established by demonstrating substantial equivalence to a predicate device, as opposed to proving a new clinical performance claim against a pre-defined threshold. The "device performance" is therefore considered equivalent to the predicate.

Detailed Information based on the provided text:

1. A table of acceptance criteria and the reported device performance:
   (As provided in the table above, inferred from the basis of substantial equivalence).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document does not detail a specific "test set" or clinical study with a sample size for performance evaluation. The basis of substantial equivalence relies on comparison of design, materials, manufacturing, and intended use with a predicate device (SUMMIT™ Acetabular System, cleared in K983014). Clinical trials with specific test sets and data provenance are generally not required for 510(k) submissions unless the FDA determines that clinical data are necessary to demonstrate substantial equivalence, which is not indicated here.

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 (N/A). This information would be relevant for clinical studies involving expert assessment of data (e.g., image interpretation), which is not described in this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   N/A. Adjudication methods are typically used in clinical trials where multiple experts assess outcomes and discrepancies need to be resolved. This information is not present as no such clinical trial is described.

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:
   N/A. This device is an orthopedic implant, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   N/A. This refers to the performance of an algorithm or AI system, which is not applicable to a physical medical device like an acetabular prosthesis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   N/A for a direct clinical performance study. For a 510(k) submission, the "ground truth" for demonstrating equivalence largely relies on objective engineering and material testing data, design specifications, and comparison to the known performance of the predicate device. The document explicitly states "The Pinnacle Acetabular System demonstrated equivalent performance to the predicate device," implying that performance metrics (likely mechanical, material, and perhaps some in-vitro wear studies, though not detailed here) were compared and found equivalent.

8. The sample size for the training set:
   N/A. This is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established:
   N/A. As there is no training set mentioned or implied, this question is not applicable.

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