(29 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 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.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Function | Successfully tested |
| Performance | Successfully tested |
| Safety | Successfully tested |
| Biocompatibility and Toxicity | Met acceptance criteria to ISO 10993-1 |
| Labeled Shelf Life | Met acceptance criteria per FDA recognized standards |
| Shipping | Met acceptance criteria per FDA recognized standards |
| Sterility (ETO and Steam) | Validated to a SAL of 10-6 |
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.
§ 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.