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The ATTUNE Revision Hinge Knee is indicated in cases for cement use in patients who have reached skeletal maturity and for whom the surgeon has decided to resect both cruciate ligaments due to the following conditions:

1. Severe instability, gross deformity and/or bone loss
2. Failure of a previous knee reconstruction procedure.
3. Trauma or tumor resection
4. Absent or markedly insufficient collateral ligaments

The ATTUNE™ Revision Hinge Knee, comprised of a femoral, housing assembly, and tibial insert component, is compatible with devices of the ATTUNE Knee System and the ATTUNE Revision Knee System and is designed to replace the natural articulating surface of the knee joint in total knee arthroplasty. The femoral component is a metal/ultra-high molecular weight polyethylene (UHMWPE) implant intended for cemented use. The housing assembly component is composed of both metal and antioxidant (AOX) UHMWPE subcomponents. The tibial insert component is composed of AOX UHMWPE.

This document is a 510(k) Premarket Notification from the FDA for the "ATTUNE™ Revision Hinge Knee" device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in the context of an AI/software device.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies are not applicable to this particular document as it is for a mechanical implant and not an AI/software product. The information provided relates to the non-clinical testing of the physical implant's mechanical and material properties.

However, I can extract the relevant information regarding the tests performed for the determination of substantial equivalence (analogous to proving the device meets certain performance standards for a mechanical device).

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

The document does not explicitly state quantitative acceptance criteria with reported performance values in a direct side-by-side comparison. Instead, it states that "The following tests were performed in support of the to demonstrate substantial equivalence of safety and efficacy with the predicate devices." This implies that the device performed equivalently to the predicate devices in these tests, satisfying the FDA's requirement for substantial equivalence.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on specific sample sizes for these tests (e.g., how many specimens were shear-tested or fatigue-tested). It also does not mention data provenance as these are mechanical/materials tests, not human data studies.

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 is a submission for a mechanical medical device, not an AI/Software device requiring expert-established ground truth from medical images or clinical data. The "ground truth" for these tests would be the established engineering and material science standards.

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

Not applicable for a mechanical device submission.

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/software device.

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

Not applicable. This is not an AI/software device.

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

For the mechanical tests listed (Shear, Fatigue, Wear, Stability, Contact Pressure, Biocompatibility, MRI Safety Evaluation), the "ground truth" would be established engineering standards, material science specifications, and regulatory requirements relevant to orthopedic implants.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no training set mentioned.

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

Not applicable.

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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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