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da Vinci Xi system (Model IS4000)

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatic use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

da Vinci X system (Model IS4200)

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatic use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The subject IS4000/IS4200 Endoscope Plus is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging.

Similar to the predicate device, the subject IS4000/IS4200 Endoscope Plus is a reusable, sterilizable unit that includes two cameras (left and right eyes) and an integrated cable to connect the endoscope to the Endoscope Controller. The two cameras generate the stereo image of the surgical site. Both the subject and the predicate device endoscopes include light fibers that transmit light from the light source in the Endoscope Controller into the surgical field. Similar to the predicate device, the subject endoscope, can be used laparoscopically (hand-held) at the start of a surgery and then be installed on any Patient Cart Arm. Both the subject and the predicate endoscopes are available in two configurations, 0° and 30° tip angle. However, the subject device has a few design modifications as compared to the predicate device. Some of the design modifications include new image sensor, modified optical assembly, new PCA board, modified thermal management design, and modified cable design.

This 510(k) summary describes a new version of the da Vinci Xi/X Endoscope Plus, an endoscopic instrument for robotic-assisted surgery. It is a re-submission of a previous device (K171426) with several design modifications.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria with numerical targets and corresponding reported device performance values. Instead, it describes general categories of testing and confirms that the device meets those requirements.

2. Sample sized used for the test set and the data provenance

The document does not specify the sample sizes for any of the tests, nor does it explicitly mention the provenance (country of origin, retrospective/prospective) of any data beyond indicating "testing with an animal model was performed."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not describe the use of experts to establish ground truth for any test set. The validation appears to rely on engineering and animal model testing rather than human expert interpretation of results for performance metrics like sensitivity or specificity.

4. Adjudication method for the test set

Not applicable, as there's no mention of human-interpreted test sets requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an endoscope, a piece of hardware, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would typically be conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm, but a physical device. Performance testing was done on the device itself and its interaction with the da Vinci surgical system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance claims appears to be based on:

• Pre-defined design input requirements for physical, mechanical, electrical, user interface, and software specifications.
• The expected functional behavior of the device as demonstrated in an animal model.

8. The sample size for the training set

Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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