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Smith & Nephew Journey II XR Instruments are accessory devices intended to be used to assist in the implantation of Smith & Nephew Journey II XR Knee System and their cleared Indications for Use.

Total knee components are indicated for rheumatoid arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.

The Journey II XR Knee system components are indicated for use only with cement and are single use devices.

Subject of this Special Premarket Notification are modified Journey II XR Instruments. The subject devices are modifications of existing instrumentation cleared for use with the Journey II XR Knee system.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. This document is a 510(k) premarket notification clearance letter from the FDA for the JOURNEY II XR Knee Instruments.

It primarily states that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar indications for use, design features, and operational principles, and therefore does not require clinical data to support its safety and effectiveness.

Here's what the document does state regarding performance and testing:

• Biocompatibility assessments were conducted per ISO 10993-1 and FDA guidance (June 16, 2016).
• Testing was performed to evaluate impact resistance of the proposed tibial impactor design compared to a previously tested current design.
• Testing was performed to evaluate the performance of modified keel prep instruments as compared to predicate keel prep instruments.

The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices." This implies that no studies involving human subjects or extensive clinical trials with specific acceptance criteria as you've outlined were conducted or required for this particular submission.

Therefore, for your requested information points, most would be "N/A" or "Not provided in this document" as a standalone study with acceptance criteria and results as typically described for efficacy or performance claims was not part of this 510(k) clearance process.

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