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Smith & Nephew's VISIONAIRE™ Disposable Instruments are intended to be used to further prepare the bone and assist in the positioning of total knee replacement components intraoperatively. Smith & Nephew VISIONAIRE™ Disposable Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Genesis II and Legion knee systems and their cleared Indications for Use.

The contraindications, potential adverse events, precautions, and warnings for the knee systems can be found in the Smith & Nephew Knee System package insert. The VISIONAIRE™ Patient Matched Cutting Blocks and Disposable instruments are intended for single use only. Do not reuse due to risks of breakage, failure or patient infection.

Per U.S. Food and Drug Administration (FDA) regulation, device-specific instruments are accessory devices and take on the classification of the device(s) with which they are used. Although these instruments are similar in design to 510(k)-exempt orthopaedic manual instruments classified under 21 CFR 888.4540, instruments which assist in the implantation of Class II Smith & Nephew Total Knee Systems and are classified as Class II devices are subject to pre-market notifications and regulations.

The Smith & Nephew Disposable Instruments include line additions to the Smith & Nephew Disposable Knee Instruments that were cleared in K123159. The subject devices are intended prepare the bone for Total Knee Arthroplasty.

The provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria, as it relates to a typical AI/ML device submission for medical imaging. The document is an FDA 510(k) clearance letter for VISIONAIRE™ Disposable Instruments, which are surgical instruments used for total knee replacement.

The clearance is based on substantial equivalence to predicate devices, not on meeting specific performance criteria through a study in the sense typically associated with AI/ML device evaluation (e.g., accuracy, sensitivity, specificity on a test set).

Here's a breakdown of why the requested information cannot be extracted and what information is available:

• Device Type: This is a physical surgical instrument, not an AI/ML software device.
• Approval Basis: The approval is based on "substantial equivalence" to existing legally marketed predicate devices, meaning it is similar in intended use, technological characteristics, and safety and effectiveness.
• Clinical Data: The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices." This further confirms that a performance study as would be done for an AI/ML device was not conducted or required for this clearance.

Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, study design, ground truth, or expert involvement, as these elements are not relevant to the 510(k) clearance process for this type of medical device as described in the provided text.

The closest information available related to "performance" is:

• "Biocompatibility testing for the new colorants and materials was conducted per the recommendations of ISO 10993-1."
• "A review of the results indicates that the Disposable Instruments are equivalent to existing, legally marketed predicate instrumentation with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices."

This refers to engineering and material testing, not a clinical performance study using a test set against a ground truth as would be relevant for an AI/ML diagnostic or prognostic tool.

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