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Smith & Nephew's VISIONAIRE Patient Matched Cutting Blocks are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks are intended for use with the following existing Smith & Nephew, Inc. Knee Systems and their cleared indications for use:

• Genesis II Knee System
• Legion Knee System
• Journey BCS Knee System
• Journey II Knee System

The Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks are intended for single use only.

The subject of this premarket notification is to seek FDA clearance of a software component to be used in the design and manufacture of the VISIONAIRE Patient Matched Cutting Blocks. Also within this notification is an extension of the subject device's shelf life. Patient Matched Cutting Blocks were previously cleared for market via premarket notifications- K082358, K130708 and K170282.

The provided document is a 510(k) premarket notification for Smith & Nephew Patient Matched Cutting Blocks. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study with specific acceptance criteria and performance data for a new device.

The document states:

• "No new mechanical testing was performed. No implants or new blocks are being introduced in this premarket notification. There are no changes to the block design, packaging, material composition or manufacturing of Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks as a result of these changes described in the premarket notification."
• "Clinical data was not needed to support the safety and effectiveness of the subject device(s)."
• "Software verification and validation testing was completed in line with FDA's guidance document entitled, 'General Principles of Software Validation; Final Guidance for Industry and FDA Staff,' dated January 11, 2002. A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject device and the software will perform as intended."
• "Based on the documentation within this premarket notification, there are no new issues related to the safety and effectiveness of the subject device. Clinical data was not needed to support the safety and effectiveness of the subject device."

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving device performance in the way typically associated with a new clinical or AI performance study. Instead, it relies on demonstrating that there are no significant changes to the previously cleared device and that software verification meets internal standards.

Based on the provided text, I cannot complete the requested tables and sections because the document does not describe a new study with explicit acceptance criteria and corresponding device performance metrics for the reasons stated above.

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