(258 days)
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.
| Acceptance Criteria Category | Specific Tests/Standards Met | Reported Device Performance |
|---|---|---|
| Functional & Performance | Reliability Testing, Vision and Video Subsystem and System Testing, Subsystem and System Software Verification and Validation Testing, Reusable Camera Testing, Ship Testing, Mechanical Requirements Testing, Safety Subsystem Testing, System Electrical and Board Requirements Testing. | Met performance specifications. |
| Software | Compliance with FDA guidance "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices May 11, 2005" for "moderate level of concern" software. Software verification and validation. | Software was verified and validated and documents prepared per FDA guidance. |
| Shipping | Per applicable ISTA standards. | Withstood anticipated shipping conditions. |
| Usability/ Human Factors | Testing in accordance with FDA Guidance Document "Applying Human Factors and Usability Engineering to Medical Devices" (February 3, 2016) and Wiklund's Usability Testing of Medical Devices. Assessed performance by representative end users (surgeons/nurses). | Design meets user requirements and facilitates safe/effective interactions with low risk of user errors. |
| Biocompatibility | Testing per ANSI/AAMI/ISO/EN 10993-1:2009 and FDA Guidance Document "Use of International Standard ISO 10993-1..." for "external communicating device," contact with "tissue/bone/dentin," and "limited exposure" (≤24 hours). | Patient-contacting portions are biocompatible and nontoxic. |
| Sterilization (Single Use) | Ethylene oxide (EtO) cycle validated to a sterility assurance level (SAL) of 10^-6, per ANSI/AAMI/ISO 11135-1:2007, ANSI/AAMI/ISO TIR 11135-2:2008, AAMI TIR 28:2009, ANSI/AAMI/ISO/EN 10993-7:2008. Functional testing for shelf life stability. | EtO cycle validated to SAL of 10^-6. Device is stable over labeled shelf life. |
| Cleaning & Sterilization (Reusable) | Validation of cleaning/sterilization instructions per AAMI TIR12:2010, AAMI TIR30:2011, EN ISO 17664:2004, ANSI/AAMI ST81:2004/(R)2010, ISO TS 15883-5:2005, ANSI/AAMI ST77:2013, ANSI/AAMI ST79:2010, ANSI/AAMI/ISO 14937:2009, ANSI/AAMI/ISO 17665-1:2006, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, ISO 17665-2:2009. Validation of cleaning/disinfection for other reusable components (Base, Cart, Stand, Console, Monitor). | Cleaning/sterilization instructions were validated. |
| Electrical Safety | Compliance with IEC 60601-1 Ed: 3.1, ANSI/AAMI ES60601-1:2005/(R)2012, IEC 60601-1-6: 2010, IEC 62366: 2007, IEC 60601-1-4: 2000. | Demonstrated electrical safety and compliance. |
| Electromagnetic Compatibility (EMC) | Compliance with EN 60601-1-2:2007/AC:2010, IEC 60601-1-2 Ed. 3.0, IEC 60601-1-2:2014 (4th Ed.) Table 9 (for cell phones, Wi-Fi, Bluetooth, RFID), ad hoc testing for 125kHz and 13.56MHz RFID, and ESU immunity testing per IEC 60601-2-27:2011. | Device is in compliance with EMC standards. |
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.
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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.
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Cadaver Study:
- Sample Size: Six human cadaveric specimens.
- Data Provenance: Human cadaveric specimens.
- Retrospective/Prospective: This was a prospective study using cadavers.
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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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.