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The Intuitive Surgical® da Vinci® Sinele-Site™ Instruments and Accessories used with the da Vinci® Si Surgical System (153000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clectrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectorny with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the Single-Site Port.

The Intuitive Surgical da Vinci@ XiTM Single-Site Instruments and Accessories used with the da Vinci Xi Surgical System (IS4000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clectrocautery, suction/irrigation and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo oophorectomy with the da Vinci Xi Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, clip appliers, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, 8 mm endoscope cannula, flexible and rigid blunt obturators, cannula seal, and the Single-Site Port.

The da Vinci IS3000 (Si) and IS4000 (Xi) Surgical Systems are used in conjunction with reusable da Vinci Single-Site Instruments and Accessories to achieve their intended use. This 510(k) is submitted for changes to Reprocessing Instructions for all reusable da Vinci Si and Xi Single-Site Instruments and Accessories.

The da Vinci Single-Site Instruments include instruments to perform grasping, cautery, cutting, clip ligation, suturing, and suction/irrigation functions. They are intended to be used with the IS3000 da Vinci Si Surgical System.

da Vinci Si Single-Site Accessories consist of fixed Shape Curved Cannulas (250mm and 300mm length), accessory cannulae for insertion of manual laparoscopic instruments, and semi-rigid blunt obturators (250mm and 300mm length).

The da Vinci Xi Single-Site Instruments enables single incision laparoscopic cholecystectomy, benign hysterectomy, and salpingo oophorectomy using the da Vinci Xi (IS4000) Surgical System.

The da Vinci Xi Single-Site Accessories include: 5mm Curved Cannulae, 5mm and 10mm straight cannulae, 8mm endoscope cannula, and flexible and rigid blunt obturators that enable single incision laparoscopic cholecystectomy, benign hysterectomy, and salpingo oophorectomy using the da Vinci Xi (IS4000) Surgical System.

The provided text describes a 510(k) premarket notification for "Da Vinci Si Single-Site Instruments and Accessories" and "Da Vinci Xi Single-Site Instruments and Accessories" by Intuitive Surgical, Inc. The submission concerns changes to the reprocessing instructions for these reusable instruments and accessories.

The document does not describe an AI medical device or a study proving its performance. Instead, it focuses on the validation of reprocessing instructions for surgical instruments. Therefore, most of the requested information regarding AI device acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment (which are typical for AI/ML device submissions) cannot be extracted from this document.

However, I can provide information on the acceptance criteria and proof of reprocessing instruction efficacy as described in the document.

Here's a breakdown of what can be extracted related to the reprocessing instructions, and what cannot be extracted because it's not an AI/ML device submission:

Information available from the document (related to Reprocessing Instructions):

• Acceptance Criteria for Reprocessing Instructions:

  • Cleaning Validation: Efficacy of the cleaning process demonstrated by qualitative visual inspection and quantitative endpoints, in accordance with specific standards (FDA Guidance, AAMI TIR 12:2010, AAMI TIR 30:2011). The cleaning process must effectively clean devices representing the greatest challenge.
  • Thermal Disinfection Validation: Efficacy of the disinfection process demonstrated by a quantitative endpoint of 6-log10 reduction of typical vegetative organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Klebsiella-Enterobacter group), in accordance with FDA Guidance (March 17, 2015) and FDA Guidance (February 7, 2002). This was performed on devices representing significant challenges to disinfection.
  • Human Factors Testing: Usability, effectiveness, and use safety of the Reprocessing Instructions were assessed through a rigorous process including preliminary evaluation, Usability Risk Analysis (URA), design team participation, formative testing, and validation testing with representative end users.

• Study Proving Device Meets Acceptance Criteria (focused on Reprocessing Instructions):

  • Cleaning Validation: Conducted using devices within the product family that represent the greatest challenge for the cleaning process. Evaluated cleaning efficacy using qualitative visual inspection and quantitative endpoints.
  • Thermal Disinfection Validation: Conducted using devices within the product family that represent significant challenges to the disinfection step. Evaluated efficacy using a quantitative endpoint (6-log10 reduction of specified vegetative organisms).
  • Human Factors Testing: A validation study was completed with representative end users to assess the usability, effectiveness, and use safety of the Reprocessing Instructions.

Information NOT available from the document (as it's not an AI/ML device submission):

• Table of Acceptance Criteria and Reported Device Performance for an AI device. (The document describes performance for reprocessing, not for an AI algorithm).
• Sample size used for the test set and data provenance for an AI device.
• Number of experts used to establish the ground truth for an AI device test set and their qualifications.
• Adjudication method for an AI device test set.
• If a multi reader multi case (MRMC) comparative effectiveness study was done for an AI device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done for an AI device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI device.
• The sample size for the training set for an AI device.
• How the ground truth for the training set was established for an AI device.

Summary regarding the provided text:

The document is a 510(k) submission for changes to reprocessing instructions for surgical instruments, not an AI/ML device. Therefore, the detailed questions about AI model performance, training, and validation cannot be answered from this source. The performance data presented refers to the validation of the cleaning, disinfection, and usability of the reprocessing instructions for the physical instruments.

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