Search Results

The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, recturn and distal colon. The Flex Robotic System is intended for use in adults (≥22 years of age).

The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (≥22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.

The Medrobotics Flex Robotic System is an operator controlled flexible scope that include the benefits of both a rigid scope and a computer assisted controller. This allows for the Flex Colorectal Drive to be introduced via an operator controlled user interface, easily providing transanal access to the anus, rectum and distal colon. Visualization is provided by a user selectable 2D or 3D HD camera incorporated in distal end of the scope. The Flex Robotic System's scope also provides accessory channels for the use of varied flexible surgical instruments.

This document is a 510(k) summary for the Medrobotics Flex Robotic System. It details the device, its intended use, and substantial equivalence to a predicate device, but does not contain specific acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy. Instead, it focuses on general performance, safety, and regulatory compliance.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment cannot be extracted from this document as they are not present.

Based solely on the provided text, here is what can be extracted:

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

The document mentions that the device "has been successfully tested for function, performance, and safety as per FDA recognized Standards" and "met acceptance criteria." However, it does not provide a table of specific acceptance criteria or the numerical performance results against those criteria. It lists only the categories of testing performed.

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

This information is not provided in the document. The document refers to engineering and biocompatibility testing, not clinical performance studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. This type of information would be relevant for studies evaluating diagnostic accuracy or clinical outcomes, which are not detailed here.

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

This information is not provided in the document.

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 information is not provided in the document. The device is a robot-assisted surgical system, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable in this context and is not mentioned.

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

This information is not provided in the document. As a robot-assisted system, it inherently involves human operators, so a standalone algorithm performance without human-in-the-loop would not be applicable in the sense of a diagnostic algorithm.

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

For the mechanical, electrical, and materials testing mentioned, the "ground truth" would be established by reference to engineering specifications, validated test methods, and regulatory standards (e.g., IEC 60601-1, ISO 10993-1). The document doesn't detail what specific performance metrics were used as "ground truth" but implies compliance with these standards. For sterility, the ground truth is a Sterility Assurance Level (SAL) of 10-6.

8. The sample size for the training set

This information is not provided in the document. "Training set" is typically relevant for machine learning or AI models, which is not the focus of the testing described here.

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

This information is not provided in the document.

Ask a specific question about this device