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Joint replacement is indicated for patients suffering from disability due to:

• · degenerative, post-traumatic or rheumatoid arthritis;
• · avascular necrosis of the femoral condyle;
• · post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
• · moderate valgus, varus or flexion deformities;
  This device may also be indicated in the salvage of previously failed surgical attempts.
  While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The modification system consists of a change to the Instructions for use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.

This document refers to an FDA 510(k) premarket notification for knee replacement components. The original submission (K063406) appears to be related to a change to the Instructions for Use for several existing devices, not a new device or significant modification requiring extensive clinical testing to prove safety and effectiveness.

Therefore, the typical structure for acceptance criteria and a study proving device performance (e.g., diagnostic accuracy, clinical outcomes) is not applicable here. This submission is about administrative changes to existing devices.

The key phrase in all provided documents is: "The modification system consists of a change to the Instructions for use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice."

The FDA's decision is stated in Document 4 and 5: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This indicates that the FDA deemed the changes to the Instructions for Use to not alter the fundamental safety or effectiveness of the previously cleared devices, and thus did not require new performance studies. The "acceptance criteria" here are instead related to regulatory equivalence.

If this were a true new device or a significant modification, the information requested would be relevant. However, for a change to an IFU, the "acceptance criteria" are:

• The revised Instructions for Use (IFU) do not introduce new risks.
• The revised IFU do not significantly alter the indications for use or mechanism of action.
• The revised IFU maintain substantial equivalence to the predicate device in terms of safety and effectiveness.

The "study that proves the device meets the acceptance criteria" in this context is the review by the FDA based on the provided documentation, which likely included:

• A comparison of the old IFU with the new IFU.
• A justification for the changes, perhaps referencing current clinical practice standards or updated scientific literature.
• Confirmation that the changes did not alter the intended use or fundamental performance characteristics of the physical device.

Therefore, I cannot provide the requested table and study details as they would typically apply to a performance study of a new or significantly modified medical device. This submission is primarily administrative and regulatory, not performance-based.

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