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The Flared Cannuiae are intended to be used with the da Vinci Surgical System (da Vinci S (Model IS2000) or da Vinci Si (Model IS3000)) to serve as a port of entry during da Vinci procedures that do not require maintenance of insufflation.

Device Description

The Intuitive Surgical Flared Cannula consists of a tapered hollow tubular shaft with a flared distal tip and a bowl with an Integral receptacle. The hollow shaft serves as the port of entry, the bowl is used to attach the cannula to the da Vinci Surgical System and the receptacle allows for attachment of commercially available dispersive electrode grounding pad via a 2-Pin grounding connector

AI/ML Overview

The provided text describes the 510(k) summary for the Intuitive Surgical 5 mm and 8 mm Flared Cannulas (K101743). This document is for a medical device that serves as a port of entry during surgical procedures, not an AI/ML-driven device for diagnostic or predictive purposes. Therefore, most of the requested information regarding acceptance criteria for AI models, sample sizes for test/training sets, expert consensus, adjudication methods, and MRMC studies are not applicable.

However, I can extract information related to the device's performance claims and how they were substantiated for this specific medical device submission.

Here's the relevant information based on the provided text, acknowledging that most questions about AI model validation don't apply:

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

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Functional Equivalence	The device must demonstrate substantial equivalence to the predicate device (Intuitive Surgical, Inc. da Vinci Endoscopic Instrument Control System (Model IS1000) and Endoscopic Instruments K990144) in intended use, design, and technology.	The subject device is equivalent in Intended use, design, and technology as compared to the predicate device.
Safety and Efficacy	Performance testing must demonstrate that the device is substantially equivalent to the predicate device in terms of safety and efficacy and that the design output meets the design input requirements without raising any new issues of safety or efficacy.	"Performance tests (bench and animal lab tests) were conducted to demonstrate that the device Is substantially equivalent to the predicate device and that the design output meets the design input requirements. The results of the testing did not raise any new Issues of safety or efficacy."
"Based on the technical characteristics, Intended use and performance test data, the Intuitive Surgical 5mm and 8mm Flared Cannula have been determined to be equivalent in in safety, efficacy, and performance to the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated. The document mentions "bench and animal lab tests," but details on the number of tests performed or animals used are not provided.
Data Provenance: Not explicitly stated. Assuming tests were conducted by Intuitive Surgical, Inc., based in Sunnyvale, California, USA, the data likely originates from internal testing. It would be prospective testing as it relates to the development and validation of the new device.

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

This question is not applicable as the device is a physical surgical instrument, not an AI/ML model requiring expert-established ground truth for diagnostic accuracy. The validation is physical and functional, not clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as the device is a physical surgical instrument and does not involve clinical interpretation 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

This question is not applicable as the device is a physical surgical instrument, not an AI/ML system, and therefore does not involve human readers interpreting images with or without AI assistance.

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

This question is not applicable as the device is a physical surgical instrument, not an algorithm.

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

For this type of physical device, the "ground truth" would be established by engineering specifications, material standards, and surgical functional requirements. The tests ("bench and animal lab tests") would verify that the device performs according to these pre-defined physical and functional standards, ensuring it is safe and effective for its intended use (acting as a port of entry without maintaining insufflation). There is no "pathology" or "outcomes data" in the sense of diagnostic accuracy for this device.

8. The sample size for the training set

This question is not applicable as the device is a physical surgical instrument and does not involve AI/ML training.

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

This question is not applicable as the device is a physical surgical instrument and does not involve AI/ML training.

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