(118 days)
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.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.