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The Consensus® Posterior Stabilized Knee system employs a router device to remove the intercondylar bone from the distal portion of the femur. This bone must be removed to accommodate the spine of the posterior stabilized tibial insert. This procedure occurs after all bone resections of the distal femur have been completed in the traditional manner with the existing Consensus® Knee instruments.

A template is placed on the distal femur. This template is made from stainless steel (17-4PH SS @ H900). The template contains a central groove with adequate markings that ensure proper guidance of the router.

The router itself consists of a router bit (17-4PH SS @ H900), the shank of which is encased in a plastic body (Ultem® 4000) that acts as a handle for the surgeon and as a journal bearing for the shaft of the router bit.

The base of the body has a large diametrical flange that rests on the superior surface of the template. This flange acts to stabilize the router against torsional forces created by the router bit. The superior end of the router shank is attached to a standard flexible shaft. A standard Zimmer fitting is integrally machined to the superior side of the flexible shaft in order to accommodate a standard operating room power drill (Stryker, 3M, etc.).

The router body and bit are available in one size. The template is available in three sizes; size 1/2, size 3/4, and size 5/6. This accommodates the range of Consensus® Knee posterior stabilized femoral components.

This document is a 510(k) summary for a medical device called the Consensus® Posterior Stabilized Knee-Intercondylar Notch Router. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document explicitly states:

• "No performance data exists for this device."
• "Clinical Data: None Required"
• "Conclusions from Non-clinical and Clinical Data: None Required"

Therefore, I cannot provide the requested information. The submission appears to be based on substantial equivalence to predicate devices rather than new performance data.

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The Consensus® Posterior Stabilized Knee is indicated for use in:

• 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis in the absense of the posterior cruciate ligament.
• 2. Failed osteotomy or unicompartmental replacements
• 3. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.

The Consensus® PS Knee tibial insert component is manufactured from ultra-high molecular weight polyethylene (UHMWPE, ASTM F648), and is designed to articulate with the Consensus® PS femoral component. The insert has a spine on the central eminence which engages the crossbar of the PS femoral component. The spine is positioned so that the crossbar of the PS femoral component engages at approximately 65° flexion. The inferior surface of each component employs dovetail grooves for positive interlocking with the Consensus® Primary Knee tibial baseplate. The design is available in three sizes and each size is available in five thicknesses.

The Consensus® PS Femoral component is made of CoCrMo alloy (ASTM F75). Both the outer articulating surface and the inner box geometry of the Consensus® PS femoral component are identical to the respective surfaces of the Consensus® Primary Knee femoral component. Therefore, the PS femoral component contains the same deepened patella groove as the Consensus® Primary Knee femoral component for increased range of motion, utilizes the same instrumentation as the Consensus® Knee for preparing the distal femur, and employs smooth distal pegs for added Medial/Lateral stability. The Consensus® PS femoral component has a shortened patella groove to accommodate the spine of the Consensus® PS tibial insert. It also contains a stabilizing bar located between the posterior condyles which engages the spine of the Consensus® PS tibial insert at high flexion angles.

The Consensus® Posterior Stabilized Knee System will be provided sterile.

The Consensus® Posterior Stabilized Knee is designed for use with the following Consensus® Total Knee System components:

Consensus® All Poly or metal back Patellar component
Consensus® Porous Titanium Stemmed Tibial Baseplate
Consensus® Nonporous Titanium Stemmed Tibial Baseplate
Consensus® CoCr Stemmed Tibial Baseplate

This document describes a medical device, the Consensus® Posterior Stabilized Knee System, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically understood in the context of diagnostic or AI-driven devices.

The provided text focuses on:

• Device Description: What the Consensus® PS Knee System is made of and how its components interact.
• Intended Use: The medical conditions it is designed to treat.
• Technological Characteristics: Specific design features.
• Substantial Equivalence: The primary regulatory pathway, comparing it to an existing approved device (Johnson&Johnson PFC® Modular Knee System).

Therefore, I cannot populate the requested table or answer the specific questions related to acceptance criteria, test sets, ground truth, expert opinions, or MRMC studies, as this information is not present in the provided text.

Here's why and what kind of information would be needed to answer your request:

• Acceptance Criteria & Performance: For a diagnostic or AI device, this would typically involve metrics like sensitivity, specificity, accuracy, precision, recall, AUC, etc., demonstrated against a clinical ground truth. The Consensus® PS Knee System is a surgical implant, not a diagnostic tool. Its "performance" is assessed differently (e.g., mechanical testing, wear resistance, biocompatibility, long-term clinical outcomes which are typically evaluated post-market or through clinical trials beyond initial 510(k) clearance).
• Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Performance: These are all concepts relevant to evaluating diagnostic accuracy, particularly for AI/CAD devices where human interpretation is assisted or replaced. They are not applicable to the pre-market submission of a knee implant based on substantial equivalence.

In summary, the provided document does not contain the information required to answer your specific questions, as the device and its regulatory submission paradigm are different from what your questions anticipate.

If the request was for a device where these criteria are relevant, the input document would need to include details about:

• Specific performance metrics (e.g., sensitivity, specificity for detecting a condition).
• A clinical study protocol and results.
• The dataset used (e.g., images, patient records).
• How ground truth was established for that dataset.
• Details about reader studies if human interaction is involved.

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