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The indications for use for the Repicci II™ Unicondylar Knee System are for painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is for use with bone cement.

The Repicci II™ Unicondylar Porous Knee is the same as the predicate, the Repicci III™ Unicondylar Knee (K971938), except for the additions of an intermediate sized femoral component -- 51mm and Ti-6Al-4V plasma spray porous coating to the interior of the components.

The provided document is a 510(k) premarket notification for a medical device (Repicci II™ Unicondylar Knee System) and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead, it's a submission for substantial equivalence to a legally marketed predicate device. This means the manufacturer is asserting their device is as safe and effective as a device already on the market, rather than presenting novel performance data against predefined criteria.

Here's why the requested information cannot be extracted from this document:

1. No Acceptance Criteria or Reported Device Performance: The document doesn't define any specific performance metrics (e.g., accuracy, sensitivity, specificity, mechanical thresholds) that the device needs to meet, nor does it report any such performance data for the Repicci II™ Unicondylar Knee System.
2. No Clinical Testing Provided as a Basis for Substantial Equivalence: The document explicitly states: "Clinical Testing: No clinical testing was provided as a basis for substantial equivalence."
3. Non-Clinical Testing was a Finite Element Analysis (FEA): The non-clinical testing mentioned was an FEA combined with engineering justification to demonstrate no new risks compared to the predicate device. This is a computational analysis, not a study involving a test set, ground truth, or human readers.

Therefore, I cannot populate the table or answer the specific questions about sample size, data provenance, experts, adjudication, MRMC studies, standalone performance, or training set details because this type of information is not present in the provided text.

The core of this submission is establishing substantial equivalence to a predicate device (Repicci II™ Unicondylar Knee, K971938) based on similarities in materials, design, sizing, and indications for use, with the primary difference being an added intermediate sized femoral component and a porous coating, which were justified through non-clinical FEA.

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