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Candidates for total knee replacement include patients with a severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

The ATTUNE Cemented Tibial Base, Fixed Bearing (FB) are available in sizes 1-10. The fixation surface incorporates a stem and keel to provide additional stability as well as recessed undercut cement pockets and a grit blasted surface for enhanced cement fixation. The tibial base utilizes a central universal locking mechanism to capture the tibial insert. The ATTUNE Cemented Tibial Base, FB is manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. Additionally, the ATTUNE Cemented Tibial Base, FB utilizes a previously cleared Base Protector assembled with the device to minimize potential marring of the proximal bearing surface of the tibial base during impaction. After impaction is completed, the Base Protector is then removed and discarded prior to inserting the ATTUNE Fixed Bearing Insert.

The ATTUNE CR Total Knee is designed to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion.

The ATTUNE PS Total Knee is designed to accommodate knee flexion to 145 degrees in those patients able to attain a high degree of knee flexion.

This document describes the premarket notification (510(k)) for the ATTUNE Cemented Tibial Base, Fixed Bearing, a component of a total knee replacement system. The application seeks to demonstrate substantial equivalence to previously cleared predicate devices.

Acceptance Criteria and Device Performance (based on provided text):

The acceptance criteria are implicitly derived from the successful completion of the non-clinical tests and the product's ability to maintain performance comparable to its predicate devices. The study concludes that the device meets these criteria by demonstrating substantial equivalence.

• Fatigue Testing per ASTM F 1800 (Cyclic Testing of Metal Tibial Tray Components)
• Intraoperative Range of Motion (ROM) simulation and pull-off testing with lipid and marrow
• Surgeon validation |
  | Biocompatibility: Device materials are biocompatible. | Inherently Met: The device uses the same materials as the previously cleared ATTUNE Cemented Tibial Base (K101433) and is stated to have the same biocompatibility. |
  | Bacterial Endotoxin Levels: Device meets bacterial endotoxin requirements. | Successful Bacterial Endotoxin Testing: The proposed devices meet the requirement of Bacterial endotoxin testing as specified in ANSI AAMI ST-72:2011. |
  | Manufacturing, Packaging, Sterilization: Methods are consistent with predicate devices. | Inherently Met: The device has the same manufacturing methods, packaging configurations, and sterilization methods as the previously cleared ATTUNE Cemented Tibial Base (K101433). |
  | Indications & Intended Use: Consistent with predicate devices. | Inherently Met: The device has the same indications and intended use as the previously cleared ATTUNE Cemented Tibial Base (K101433). |

Detailed Study Information:

1. Sample size used for the test set and the data provenance:

   • The document does not specify the exact sample sizes (e.g., number of units tested) for the non-clinical tests (Fatigue Testing, ROM/pull-off testing, bacterial endotoxin testing).
   • Data provenance: The testing was "non-clinical" and appears to be experimental, rather than based on patient data. This is typically laboratory or bench testing. No country of origin for the data is explicitly mentioned, but the submitter is based in Indiana, USA. The study is not retrospective or prospective in the sense of patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document mentions "Surgeon validation" as part of the non-clinical testing. However, it does not specify the number of surgeons, their qualifications, or how their "validation" contributed to establishing a "ground truth" in the context of the device's functional integrity. In this type of device submission, "surgeon validation" typically refers to confirmation of usability or fit, not necessarily establishing a clinical ground truth like in diagnostic AI.

3. Adjudication method for the test set:

   • Not applicable. This is a non-clinical, bench-top and materials testing study, not a study involving human readers or cases needing adjudication.

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:

   • No MRMC comparative effectiveness study was done. This document describes a submission for a knee implant component, not an AI or diagnostic device that would involve human readers.

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

   • Not applicable. This is a mechanical/material device, not an algorithm.

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

   • The "ground truth" for this device's performance is established by engineering and biomechanical standards (e.g., ASTM F1800, ANSI AAMI ST-72:2011) and by comparison to the established performance of legally marketed predicate devices. The "truths" are determined by adherence to these standards and demonstrated equivalence in functional testing.

7. The sample size for the training set:

   • Not applicable. This is a medical device (implant component) submission, not an AI or machine learning device that requires a training set. The device itself is the product being evaluated.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

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Candidates for total knee replacement include patients with:

• A severely painful and/or severely disabled joint resulting from osteoarthritis, post-● traumatic arthritis, or rheumatoid arthritis
• Moderate valgus, varus, or flexion deformities
• Avascular necrosis of the femoral condyle
• A previous unsuccessful knee replacement, osteotomy, or other knee procedure ●

ATTUNE Revision Knee System implants are designed for use in total knee arthroplasty for patients with:

• Absence or loss of both cruciate ligaments ●
• Moderate varus-valgus or flexion instability that requires a bearing surface with increased ● constraint in the clinical judgment of the surgeon
• Bone loss that requires supplemental fixation in the clinical judgment of the surgeon

The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications.

Any non porous-coated components are intended for cemented use only.

The ATTUNE® Revision Knee System is a total knee replacement prosthesis consisting of various components including ATTUNE REVISION CRS FEMORAL COMPONENTS, ATTUNE REVISION CRS FIXED BEARING INSERTS, ATTUNE REVISION FIXED BEARING TIBIAL BASES, ATTUNE REVISION STEMS, ATTUNE REVISION FEMORAL SLEEVES, ATTUNE REVISION FEMORAL AUGMENTS, ATTUNE REVISION TIBIAL AUGMENTS, and ATTUNE REVISION OFFSET ADAPTOR. These components are made from materials such as cast Co-Cr-Mo alloy, UHMWPE, and Ti-6Al-4V ELI alloy. The system is designed for use in total knee arthroplasty to replace the damaged knee joint articulation.

The provided document is a 510(k) Premarket Notification for a medical device, the ATTUNE® Revision Knee System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets clinical acceptance criteria through a formal clinical study with ground truth and expert consensus. The FDA document explicitly states, “Clinical testing was not necessary to determine substantial equivalence between the ATTUNE Revision Knee System and the predicate devices.”

Therefore, the requested information regarding acceptance criteria, study data, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types cannot be found in this document.

The document primarily focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices. Below is a summary of the non-clinical performance information provided.

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

The document describes functional testing performed in compliance with FDA Guidance for Knee Joint Prostheses. While explicit numerical acceptance criteria values are not provided, the general statement below indicates that the measured performance met the necessary thresholds.

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. This document refers to non-clinical, in-vitro mechanical and material testing, not human-subject testing involving datasets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth based on expert review was established in this submission.

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. No MRMC comparative effectiveness study was performed or required for this device.

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

Not applicable. This is a knee implant, not an AI/algorithm device.

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

Not applicable. The "ground truth" in this context is adherence to established engineering standards (ASTM F75, F136, F648, F620, F1537, F799, ANSI AAMI ST-72:2011) and FDA Guidance for mechanical performance testing for knee prostheses.

8. The sample size for the training set:

Not applicable. No training set for an algorithm was used.

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

Not applicable.

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The Sigma XLK Tibial Inserts are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.

The DePuy Sigma XLK Tibial Inserts are posterior lipped, cruciate retaining or stabilized tibial inserts with the same design and intended use as the tibial inserts cleared in K033272. The subject inserts are manufactured from XLK Crossfinked Polycthylene. The Sigma XLK Tibial Inserts are intended for use with the Sigma Co-Cr Tibial Trays previously cleared in K032151, and the Darwin femoral components, previously cleared in K943462.

The provided document is a 510(k) premarket notification for a medical device (DePuy Sigma XLK Tibial Inserts) and focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical wear testing. It does not contain information about a clinical study involving human readers or the components typically found in such a study (like acceptance criteria for diagnostic accuracy, expert review, training sets, etc.).

However, I can extract the information provided regarding the mechanical wear performance.

Acceptance Criteria and Study for DePuy Sigma XLK Tibial Inserts

The study described is an in-vitro knee simulator wear test, not a clinical study involving human readers or diagnostic performance. The "acceptance criteria" here relate to the wear performance of the device compared to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "The results of in-vitro wear tests have not been shown to correlate with clinical wear mechanisms." This is an important disclaimer.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (Wear Test):
  • DePuy Sigma XLK Tibial Inserts: n = 3 (Size 3, 10mm cruciate retaining)
  • Johnson & Johnson Darwin (PFC Sigma) Tibial Inserts (predicate): n = 6 (Size 3, 10mm cruciate retaining)
• Data Provenance: The data is from an in-vitro knee simulator wear study conducted by the manufacturer, DePuy Orthopaedics, Inc. (USA). This is a laboratory-based study, not a clinical study involving human patients or data from a specific country of origin in the context of clinical outcomes.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this document. The study described is an in-vitro mechanical wear test, not a study requiring expert consensus for a ground truth.

4. Adjudication Method for the Test Set

This information is not applicable to this document, as there was no expert review or adjudication in this in-vitro mechanical study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document focuses on the mechanical performance and substantial equivalence of a medical implant, not the diagnostic efficacy of an imaging device or AI algorithm.

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

Not applicable. This document is about a knee implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measured gravimetric wear of the tibial inserts under controlled laboratory conditions using a knee joint simulator, based on physical material loss.

8. The Sample Size for the Training Set

Not applicable. This study is not an AI algorithm study and therefore has no training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set mentioned, there is no ground truth to establish for it in this context.

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The Sigma Tibial Inserts are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.

The DePuy Sigma Tibial Inserts are posterior lipped, cruciate retaining or stabilized UHMWPE tibial inserts with the same articular surface and basic geometry as the tibial inserts cleared in K943462, K950010, K961685 and K971189. Compared to the predicate inserts, the Sigma inserts have a larger distal mating surface to provide a tighter fit with the Sigma Tibial Trays. The locking mechanism has also been modified to reduce micromotion between the tibial insert and the tibial tray components. The Sigma Tibial Inserts are intended for use with the Sigma Co-Cr Tibial Trays previously cleared in K032151, and the Darwin femoral components, previously cleared in K943462.

This document is a 510(k) premarket notification for the DePuy Sigma Tibial Inserts. It does not contain information about studies proving the device meets acceptance criteria, an AI/algorithm, or performance metrics in a way that would allow for the filling out of the requested table and study details.

Here's why and what information is provided:

Explanation Regarding the Lack of Requested Information:

The provided document is a Summary of Safety and Effectiveness for a medical device seeking 510(k) clearance from the FDA. For Class II devices like this knee implant component, 510(k) clearance primarily relies on demonstrating substantial equivalence to a predicate device already on the market. This often involves:

• Comparing design features, materials, and intended use.
• Performing bench testing (e.g., mechanical strength, wear) to show that the new device performs at least as well as the predicate, or that minor modifications do not negatively impact safety and effectiveness.
• It generally does not require extensive clinical trials with human subjects, AI performance studies, or detailed statistical analyses of classification metrics (like sensitivity, specificity, AUC) normally associated with AI/CADe devices.

Therefore, the document does not include:

• A table of acceptance criteria and reported device performance in the context of clinical outcomes or AI metrics.
• Details about sample sizes for test sets, data provenance, or numbers/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or standalone AI performance studies.
• Specific ground truth types (like pathology or outcomes data) in the context of diagnostic accuracy.
• Training set sample sizes or ground truth establishment for training.

Information Available in the Document:

While I cannot fill out the requested table directly, here's what the document does provide:

• Device Name: DePuy Sigma Tibial Inserts
• Common Name: Total Knee Joint Replacement Prosthesis
• Classification: Class II, knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
• Intended Use/Indications: For use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.
• Basis of Substantial Equivalence:
  • The Sigma Tibial Inserts have the same basic design and intended use as the tibial inserts of the Darwin Knee System (predicate devices: K943462, K950010, K961685, K971189).
  • Minor design modifications were made to the tibial inserts to provide a tighter fit with the Sigma Co-Cr Tibial Trays and a modified locking mechanism to reduce micromotion.
  • Substantial equivalence is based on similarities in design, material, manufacturing method, and intended use.

If this were an AI or CADe device, the type of information you requested would typically be present. However, for a mechanical implant seeking 510(k) clearance, the focus is on substantial equivalence through design, material, manufacturing, and often bench testing, not clinical performance metrics in the same way an AI diagnostic tool would be evaluated.

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