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The Intuitive Surgical da Vinci SP SureForm 45 Stapler, SP SureForm 45 Curved-Tip Stapler, and SureForm 45 Reloads and other accessories are intended to be used with the da Vinci SP Surgical System for resection, transection, and/or creation of anastomoses in Urologic, Thoracic, and Colorectal surgery.

The da Vinci SP SureForm 45 Curved Tip Stapler and da Vinci SP SureForm 45 Stapler, with the existing SureForm 45 Reloads (cleared via K183224 and K190999) are designed for use exclusively with compatible Intuitive da Vinci SP Surgical Systems (Model SP1098). It is intended for resection, transection and/or creation of anastomoses in surgery. The instrument achieves its intended use by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The SP SureForm 45 Curved Tip Stapler and SP SureForm 45 Stapler Instruments are disposable, fully wristed articulating devices and are compatible with the existing, Intuitive manufactured SureForm 45 mm Gray, White, Blue, Green, and Black reloads (hereinafter referred to as SureForm 45 Reloads). The SP SureForm 45 Reloads consist of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless-steel knife.

The provided text describes the regulatory clearance of a surgical stapling device, the da Vinci SP SureForm 45 Staplers and Reloads, but does not contain information about an AI/ML powered medical device or the specific metrics, studies, and expert review processes associated with such devices.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) as it pertains to AI/ML device evaluations.

The document discusses the following types of studies:

• Design Verification (Bench Testing): Included physical specifications, mechanical requirements, electrical requirements, user interface requirements, equipment interface requirements, reliability, and packaging/labeling. The device met all acceptance criteria.
• Design Validation (Animal Studies): Acute validation studies using simulated clinical models (animal) to evaluate performance. This included:
  • Staple Line Performance: Assessed staple line performance and staple formation.
  • Leak Onset Pressure: Assessed leak onset pressure performance on ex vivo tissue.
  • Design Validation Testing: Performed in a clinical laboratory setting.
• Human Factors Evaluation: Included analysis of use-related issues (MAUDE database), Comparative Task Analysis (CTA), Use-Related Risk Analysis (URRA), formative usability evaluations, and summative usability validations.

These studies are typical for mechanical surgical devices and do not involve AI/ML performance metrics or associated ground truth establishment by experts in the context of diagnostic or interpretive tasks.

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