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The Medrobotics Flex® Robotic System is intended to provide robot-assisted control of the Flex® Transabdominal Drive.

The Flex® Transabdominal Drive is intended to be used with ancillary equipment for endoscopic surgery. The Flex® Transabdominal Drive is indicated to provide robot-assisted visualization within the thoracic and abdominal cavities including female reproductive organs.

This instrument must not be used for observation of the heart and must not contact the heart or any area near the heart. This instrument must not contact with any device or therapeutic accessory that contacts the heart or any area near the heart.

The Flex® Robotic System and Flex® Transabdominal Drive make up the Flex Robotic Transabdominal System. The system includes three (3) major components: Flex Console; Flex Cart/Base; and Flex Transabdominal Drive with camera. The Flex console is the primary user interface for controlling functionality of the Flex Transabdominal System. The Flex Cart/Base positions and manipulates the Flex Transabdominal Drive. The Flex Camera is a sterile, reusable component that is attached to the Flex Transabdominal Drive. The Flex Transabdominal Drive is attached to the Flex Base and is introduced to the patient through a commercially available trocar. The physician provides input to manipulate the Flex Transabdominal Drive via the Physician Controller located on the Flex Console. The input from the Physician Controller generates the desired motion in the Flex Base resulting in driving and articulation of the endoscope inside the patient's anatomy. Manipulation of available camera controls allows the physician to achieve appropriate visualization of the target site. The Flex® Robotic Transabdominal System is an operatorcontrolled flexible endoscope that provides the benefits of both a rigid endoscope and a computer-assisted controller. The Flex® Robotic Transabdominal System is a software-controlled device. The Flex® Robotic Transabdominal System allows for the endoscope to be introduced via an operator-controlled user interface easily providing visualization of structures in the thoracic and abdominal cavities, including female reproductive organs. Visualization is provided by a 3D camera attached at the distal end of the endoscope. The Flex® Robotic Transabdominal System is intended for professional use only in a hospital setting. The Flex® Robotic System is provided non-sterile and reusable. The Flex® Transabdominal Drive is provided sterile through EtO sterilization and is intended for single patient use. The patient-contacting components of the proposed system are all composed of biocompatible materials.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medrobotics Flex® Robotic System and Flex® Transabdominal Drive, guided by your requested information points.

Important Note: The provided document is a 510(k) summary for a medical device. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a novel device's effectiveness through large-scale clinical trials in the same way a drug or a Class III device might. Therefore, many of your requested points (like MRMC studies, training set details for AI, and explicit "acceptance criteria" presented as targets for the device's performance vs. reported performance) are not typically included in this type of submission. The "acceptance criteria" for a 510(k) device are generally that it performs comparably or better than the predicate device in relevant non-clinical tests.

Description of Acceptance Criteria and Study:

The Medrobotics Flex® Robotic System and Flex® Transabdominal Drive (collectively, the Flex® Robotic Transabdominal System) demonstrated substantial equivalence to its predicate device, the Olympus LTF-190-10-3D, Endoeye Flex 3D Deflectable Videoscope [K123365], through a series of non-clinical performance tests. The acceptance criteria are implicitly met by demonstrating that the device performs equivalently or acceptably within established medical device standards and compared to the predicate.

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

As explained, a 510(k) emphasizes substantial equivalence through comparison to a predicate device and adherence to recognized standards. The following table extracts relevant performance characteristics and reported values. Explicit "acceptance criteria" are not given as numerical targets in this document, but rather a demonstration of performance consistent with the predicate and relevant standards.

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The Medrobotics Flex® System is a device that is intended for robot-assisted visualization and surgical site access to the oropharynx, hypopharynx, and larynx in adults (≥ 22 years of age). The Flex System also provides accessory channels for compatible flexible instruments used in surgery.

The Flex® Robotic System is an operator-controlled flexible scope that provides the benefits of both a rigid endoscope and a computer assisted controller. The Flex® Robotic System allows for the scope to be introduced via an operator-controlled user interface easily providing visualization and access of structures within the oropharynx and hypopharynx and larynx. Visualization is provided by a HD 2D/3D digital camera attached at the distal end of the scope. The Flex Robotic System's scope also provides two accessory channels for use of varied flexible instruments.

The provided document does not describe a study proving the device meets specific acceptance criteria in terms of diagnostic performance or clinical outcomes. Instead, it details the verification and validation (V&V) testing performed to demonstrate that the Medrobotics Flex® Robotic System (K170453), a modified version of a previously cleared predicate device, maintains its functional, performance, and safety specifications. The device is a surgical robotic system for visualization and access, not a diagnostic AI.

Therefore, many of the requested categories, such as "reported device performance," "sample size for test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set sample size," and "how ground truth for training set was established," are not applicable to the regulatory submission described. The acceptance criteria relate to engineering and safety standards, rather than diagnostic accuracy or clinical effectiveness in the way an AI model for diagnosis would be evaluated.

Here's an overview of the information that is present in relation to acceptance criteria and "studies" (which are primarily engineering and usability tests):

1. Table of Acceptance Criteria and Reported Device Performance

As noted, this device is a surgical robotic system, and its "performance" is assessed against engineering, safety, and functionality standards. There are no performance metrics directly comparable to those for a diagnostic AI (e.g., sensitivity, specificity). The "acceptance criteria" are compliance with established standards, and the "reported device performance" is that it successfully met these standards.

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: Not applicable. The "tests" described are engineering, safety, and functionality validations, not evaluations of diagnostic accuracy on a case dataset.
• Data Provenance: Not applicable. The tests are bench tests, usability studies (likely in a simulated environment with human participants, but not using clinical patient data in the typical sense of AI model evaluation), and compliance testing against international standards for medical devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: The usability/human factors testing involved "representative end users (i.e., surgeons and nurses/technicians)" (p. 5). The exact number is not specified in this summary.
• Qualifications of Experts: "Surgeons and nurses/technicians" are mentioned as representative end-users for usability testing. Further specific qualifications (e.g., years of experience, subspecialty) are not provided in this document.
• Ground Truth: For usability, the "ground truth" would be safe and effective interaction and meeting user needs, based on observation and feedback from these representative users.

4. Adjudication Method for the Test Set

• Not applicable in the context of diagnostic performance. For usability testing, adjudication methods would typically involve observers and analysis of user performance against predefined tasks and error rates, but specific details are not provided beyond the general statement that testing "demonstrated that the Flex® Robotic System design meets the intended user requirements and facilitates safe and effective user interactions."

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

• No, an MRMC comparative effectiveness study was not done. This device is a surgical robotic system for visualization and access, not an AI for image interpretation or diagnosis. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• No, standalone performance testing (in the sense of an AI algorithm performing a diagnostic task independently) was not done. The primary function of this device is to assist a human surgeon in performing a procedure.

7. The Type of Ground Truth Used

• For biocompatibility: Compliance with ISO 10993 standards and a rationale for not testing for specific components.
• For sterilization: Validation to a Sterility Assurance Level (SAL) of 10-6 and compliance with relevant ISO/AAMI standards.
• For electrical safety and EMC: Compliance with IEC standards.
• For usability: Safe and effective user interaction as observed and assessed by human factors experts (not detailed).
• For functional and performance testing: Meeting internal design specifications and comparing favorably to the predicate device.
• No clinical ground truth (e.g., pathology, outcomes data) was used in the context of diagnostic accuracy, as this is not a diagnostic device.

8. The Sample Size for the Training Set

• Not applicable. This document describes a robotic surgical system, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for the system refers to its design and engineering iterations, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no "training set" for an AI model in this context.

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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.

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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 Flex® Robotic System and Flex® Colorectal Drive make up the Flex Robotic Colorectal System. The Flex Robotic Colorectal System is an operator-controlled flexible endoscope that provides the benefits of both a rigid endoscope and a computer assisted controller. The Flex Robotic Colorectal System is a software-controlled device. The Flex® Robotic Colorectal System allows for the endoscope to be introduced via an operator-controlled user interface easily providing visualization and access of structures in the anus, rectum, and distal colon. Visualization is provided by a digital camera attached at the distal end of the endoscope. The Flex Robotic Colorectal System's endoscope also provides two accessory channels for use of varied flexible instruments. The Flex Robotic Colorectal System is intended for professional use only in a hospital setting. The Flex Robotic System is provided non-sterile and reusable. The Flex Robotic Colorectal Drive is provided sterile through EtO sterilization and is intended for single patient use. The patient contacting components of the proposed system are all composed of biocompatible materials.

The provided text describes the Medrobotics Flex Robotic System and Flex Colorectal Drive, focusing on its substantial equivalence to predicate devices. It details various performance tests rather than acceptance criteria for a specific outcome like diagnostic accuracy, as this is a surgical access and visualization device, not a diagnostic one.

However, I can extract and describe the types of studies performed to demonstrate the device's safety and effectiveness, which implicitly satisfy the "acceptance criteria" of being safe and effective for its intended use, as determined by the FDA for 510(k) clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Since this device is for surgical access and visualization rather than providing a diagnostic output, the acceptance criteria are not in the form of sensitivity/specificity or similar metrics. Instead, "acceptance criteria" are demonstrated via various engineering, safety, and functional tests. The reported device performance is that it met these criteria.

2. Sample Sizes Used for the Test Set and Data Provenance

Due to the nature of the device (surgical instrument, not diagnostic AI), traditional "test sets" with labeled data are not explicitly mentioned in the context of diagnostic performance. However, human cadaveric specimens were used to test surgical performance.

• Animal Studies:

  • Sample Size: Not explicitly stated as an "N" number for each study. One study compared the Flex Colorectal Drive to a colonoscope control in a porcine model. Two other studies involved "live (porcine) rectal tissue."
  • Data Provenance: Porcine (animal) models.
  • Retrospective/Prospective: These were prospective animal studies.

• Cadaver Study:

  • Sample Size: Six human cadaveric specimens.
  • Data Provenance: Human cadaveric specimens.
  • Retrospective/Prospective: This was a prospective study using cadavers.

• Usability/Human Factors Testing:

  • Sample Size: "Representative end users (i.e., surgeons and nurses/technicians)." A specific number is not provided.
  • Data Provenance: Not specified (presumably from a clinical or simulated environment).
  • Retrospective/Prospective: Prospective testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

For the animal and cadaver studies, the "ground truth" related to surgical performance (e.g., successful access, visualization, ability to perform procedures, absence of increased abrasion) was established by the observers/surgeons conducting the study.

• Animal and Cadaver Studies: The studies state they were conducted by "the surgeon." While the number of surgeons/experts is not explicitly given (e.g., "three surgeons"), the implication is that qualified surgical personnel were involved in evaluating these outcomes.
• Qualifications: "Surgeon" is mentioned, implying relevant medical qualifications. Animal studies were conducted in accordance with Good Laboratory Practice (GLP).

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for the animal and cadaver studies. The assessments of performance and outcomes were likely made by the participating surgeons/observers during the studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is described for this device, as it is a surgical access/visualization system and not a diagnostic AI. There is no mention of human readers improving with AI assistance, as the "AI" (robotics) is the primary method of use, not an assistant to human interpretation of images.

6. Standalone Performance Study (Algorithm Only)

The device is a "robot-assisted control" system requiring an operator. Therefore, a standalone (algorithm only without human-in-the-loop performance) study is not applicable or described. The software components underwent verification and validation, but this refers to the software's functionality within the human-operated robotic system, not a standalone diagnostic output.

7. Type of Ground Truth Used

• Animal and Cadaver Studies:
  • Performance-based Outcomes: Evaluation of successful visualization, surgical access, ability to perform surgical procedures (excision, suturing, bleeding control), maintenance of insufflation, and assessment of tissue abrasion. This could be considered expert assessment/observation of surgical outcomes on models.

8. Sample Size for the Training Set

This document describes a medical device (robot-assisted surgical system) rather than a machine learning or AI model that would typically have a distinct "training set." Therefore, no specific sample size for a training set in the context of an AI model is provided. The development and refinement of the device would be based on engineering principles and iterative testing.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" in the context of an AI model for diagnostic purposes mentioned, this question is not directly applicable. The device's development and validation relied on engineering standards, bench testing, usability testing, and animal/cadaver studies, with "ground truth" for those tests established by direct observation, measurement against specifications, and expert surgical assessment of the device's functionality and safety.

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The Medrobotics Flex® System is a device that is intended for robot-assisted visualization and surgical site access to the oropharynx, hypopharynx, and larynx in adults (≥ 22 years of age). The Flex System also provides accessory channels for compatible flexible instruments used in surgery.

The Flex System is an operator-controlled flexible endoscope that provides the benefits of both a rigid endoscope and a computer assisted controller. The Flex System allows for the endoscope to be introduced via an operator-controlled user interface, providing visualization and surgical site access to structures within the oropharynx, and larynx. Like some other video endoscopes, visualization is provided by a digital camera incorporated in the distal end of the endoscope. The Flex System's endoscope also provides two accessory channels for use of varied flexible instruments.

The Medrobotics Flex System acceptance criteria and performance are as follows:

1. Table of Acceptance Criteria & Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Clinical Study: 45 subjects.
• Data Provenance: European post-market clinical follow-up study (prospective, originating from Europe).

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

• The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the clinical study. It mentions that "investigator visualized and accessed" the anatomical locations, implying the assessment was made by the medical professionals conducting the study.

4. Adjudication method for the test set:

• The document does not specify an adjudication method like 2+1 or 3+1 for the clinical study results. The reported percentages (e.g., "45 (100%)" or "44 (98%)") suggest direct observation and recording by the study investigators.

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:

• No MRMC comparative effectiveness study was done to compare human readers with and without AI assistance described in this document. The Flex System is a robot-assisted visualization and surgical access device, not an AI-assisted diagnostic tool for human readers.

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

• The Flex System is an "operator-controlled flexible endoscope" and "robot-assisted visualization and surgical site access" device, explicitly designed for human-in-the-loop operation. Therefore, a standalone algorithm-only performance study would not be applicable or conducted for this type of device.

7. The type of ground truth used:

• Clinical Study: The ground truth was based on direct observation and assessment by the study investigators (medical professionals) during the "Five-Point Visualization & Access Procedure" and "Surgical Procedures." This is best described as expert consensus/direct observation by medical professionals.
• Bench, Animal, Electrical Safety, EMC, Biocompatibility, Sterilization, Packaging, Cleaning, Software Testing: Ground truth established through compliance with recognized standards, specifications, and validated test methodologies.

8. The sample size for the training set:

• The document does not provide details about a "training set" in the context of machine learning, as the device primarily involves robotic assistance and control rather than a learning algorithm. The software was verified and validated, but no specific training set size is mentioned.

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

• This question is not applicable as there is no mention or indication of a machine learning "training set" or corresponding ground truth establishment process for the Flex System in the provided text. The software validation refers to standard engineering verification and validation processes against requirements and specifications.

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