(215 days)
The Consensus® Posterior Stabilized Knee is indicated for use in:
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- Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis in the absense of the posterior cruciate ligament.
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- Failed osteotomy or unicompartmental replacements
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- 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.
§ 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.