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A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
B. Failed osteotomy or unicompartmental replacements.
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
D. The non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement.
E. The porous coated (CoCr beads with Titanium) components may be used with or without cement.

Device Description

The Consensus Knee System (CKS) modular tibial baseplate is a non-porous (uncoated), anatomic, fixed-bearing design made from cast CoCrMo (ASTM F75). Its boss-and-fin type keel employs a modular 12/14 female taper for assembly with Consensus Revision Knee System (RKS) stems or the RKS taper plug. The CKS modular baseplate is offered in pegged, pegless, and holed configurations. Holed configurations are supplied with preassembled cement dams manufactured from UHMWPE (ASTM F648). All configurations are supplied with a distal plug intended for assembly in the operating room when stems are not desired. Distal plugs are manufactured from UHMWPE (ASTM F648). Other components compatible with the CKS modular baseplate include all CKS tibial inserts, femoral components, and patella components; all RKS femoral components; and the 6.5mm cancellous bone screw used with CKS holed baseplates.

AI/ML Overview

This document is a 510(k) premarket notification for the "Consensus Knee System Modular Tibial Baseplate." It demonstrates the device's substantial equivalence to previously marketed devices rather than providing a study demonstrating the device meets a set of acceptance criteria in the typical sense of a clinical trial for an AI/CAD product.

Therefore, the requested information elements related to AI/CAD system performance (e.g., sample size for test set, experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this regulatory submission.

However, I can extract the closest analogous information regarding the evaluation of this medical device.

1. A table of Acceptance Criteria and the Reported Device Performance:

The document describes non-clinical performance data (bench testing) to verify the device's safety and effectiveness. The "acceptance criteria" are implied by the standards used for testing (ASTM F1800-12) and the stated objective to ensure no failure or involuntary dislocation.

Acceptance Criteria (Implied)	Reported Device Performance
Baseplate Tray Region: No failure under fatigue when fully supported by its lateral compartment (per ASTM F1800-12).	Tested per ASTM F1800-12 to ensure the tray would not fail under fatigue when fully supported by its lateral compartment. (Specific results like load cycles or maximum load are not provided in this summary, but the general statement implies successful testing.)
Keel and Taper Connection: No failure under fatigue when fully supported by an intramedullary stem (per ASTM F1800-12).	Tested per ASTM F1800-12 to verify that the keel would not fail under fatigue when fully supported by an intramedullary stem. (Specific results not provided, but implies successful testing.)
Distal Plug Dislocation: Resists involuntary dislocation from the keel.	Tested to ensure it would resist involuntary dislocation from the keel. (Implies successful resistance.)
Distal Plug Insertion/Extraction: Manual insertion and extraction possible in the operating room using available instrumentation.	Tested to ensure it could be manually inserted and extracted in the operating room using available instrumentation. (Implies successful functionality.)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Sample Size: Not specified in terms of clinical cases or patient data, as this is bench testing. For bench testing, "sample size" would refer to the number of device components tested, which is not detailed in this summary.
Data Provenance: Non-clinical bench testing. The country of origin of testing is not specified, but the device is manufactured by a US-based company (Consensus Orthopedics, Inc., El Dorado Hills, California).
Retrospective/Prospective: Not applicable. This is non-clinical bench testing.

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. Ground truth in this context refers to the physical properties and performance of the device component itself, evaluated through engineering tests, not interpretation by medical experts.

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

Not applicable. This refers to the adjudication of clinical outcomes or diagnostic interpretations, not bench testing results.

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 is a conventional medical device, not an AI/CAD system.

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

Not applicable. This is a conventional medical device, not an AI/CAD system.

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

The "ground truth" for this device's evaluation is derived from engineering specifications and the established performance standards of ASTM F1800-12 for fatigue testing, as well as functional testing for the distal plug's retention and operability.

8. The sample size for the training set:

Not applicable. This is a conventional medical device, not an AI/CAD system.

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

Not applicable. This is a conventional medical device, not an AI/CAD system.

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