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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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The Sigma Co-Cr Tibial Trays 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 Sigma Co-Cr Tibial Trays are intended for cemented use only.

The DePuy Sigma Co-Cr Tibial Trays are Co-Cr-Mo alloy tibial trays similar in design to the Darwin tibial trays cleared in K943462. The Sigma Co-Cr Tibial Trays are intended for use with the Darwin (now PFC Sigma) femoral and patella components, previously cleared in K943462.

This document describes a medical device, the DePuy Sigma Co-Cr Tibial Trays, and its regulatory submission. It is a 510(k) premarket notification, which means the manufacturer is claiming that their new device is "substantially equivalent" to an existing, legally marketed device (the predicate device). This type of submission generally does not involve a clinical study to prove new acceptance criteria based on performance because the device is not claiming novel performance, but rather equivalence in safety and effectiveness to a predicate.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth for a device performance study is not applicable to this 510(k) submission.

Instead, the "acceptance criteria" and "study" in this context refer to the criteria for demonstrating substantial equivalence to the predicate device, which is a regulatory assessment rather than a performance study.

Here's how to address the questions given the nature of a 510(k) for substantial equivalence:

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

Since this is a substantial equivalence submission, the "acceptance criteria" are the demonstration of equivalence to the predicate, and the "performance" is a comparison to the predicate's known characteristics.

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 is a claim of substantial equivalence based on design, materials, manufacturing, and intended use comparison, not a clinical performance study with test sets or data provenance.

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. There was no "ground truth" to establish for a test set in the context of a clinical performance study. The "ground truth" here is the regulatory determination of substantial equivalence by the FDA, based on the submitted information and comparison to the predicate device.

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

Not applicable. There was no "test set" for clinical performance that would require an adjudication method.

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 a total knee joint replacement prosthesis (a physical implant), not a diagnostic device or AI system that would involve human readers or AI assistance.

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

Not applicable. This device is a physical implant, not an algorithm.

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

Not applicable to a clinical performance study. The "ground truth" in this regulatory context is the established safety and effectiveness profile of the predicate device, to which the new device is compared for equivalence.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an algorithm that requires a training set.

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

Not applicable. As above, this is a physical medical device, not an algorithm.

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