(269 days)
The OpClear® System consists of a reusable control unit and a range of disposable sterile single-use accessories intended to remove visual obstructions such as condensation, blood and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintaining a clear image of the surgical site.
OpClear® System is a laparoscopic lens cleaning device which is intended to be used during any laparoscopic surgical procedure where there is a potential for contamination of the distal lens. Consisting of a reusable control unit and a range of sterile, invasive, single use disposables, it is intended to maintain surgical vision by removing contaminants such as condensation, blood, peritoneal fluid, smoke, fat and tissue smears that have contaminated the distal lens of the laparoscope during surgical procedures.
OpClear® System is composed of a control unit and a range of disposable accessories as shown below.
This document describes the OpClear® System, a laparoscopic lens cleaning device, and its FDA 510(k) submission (K171637). The information provided focuses on device description, indications for use, operating principles, and a summary of non-clinical testing. It does not contain a detailed study with specific acceptance criteria, reported device performance metrics, or information on sample sizes, expert ground truth, adjudication methods, or MRMC studies.
Therefore, many of the requested elements cannot be extracted from the provided text.
Based on the available text:
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A table of acceptance criteria and the reported device performance
The document mentions that "Performance validation has been performed following improvement in the operating parameters for the Device" but does not provide a table of acceptance criteria or specific reported device performance metrics. -
Sample sizes 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 provided. The document refers to "a simulated human abdominal cavity environment" for testing.
- Data Provenance: The testing described is "non-clinical testing" conducted in a "simulated human abdominal cavity environment" in a "laboratory." This implies the data is prospective from an in vitro or benchtop study, not human subject data. The submitter is UK-based (Cipher Surgical Limited, Coventry, UK), suggesting the laboratory testing was likely conducted in the UK.
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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)
Not applicable/Not provided. The ground truth for the non-clinical testing appears to be based on the validated "simulated human abdominal cavity environment" and optimizing device parameters, not expert consensus on diagnostic images. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided, as the testing was non-clinical and did not involve human interpretation or diagnostic adjudication. -
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
Not applicable. The OpClear® System is a physical medical device (laparoscopic lens cleaning device), not an AI-powered diagnostic or assistive tool. Its function is to maintain clear vision during surgery, reducing the need for human readers (surgeons) to interrupt their work for cleaning. The document does not describe any MRMC study or AI components. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical device, not an algorithm. Its performance is inherent to its mechanical and fluid delivery functions as operated by a surgeon. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the "Performance validation" in the non-clinical testing was based on the "suitability" of the "simulated human abdominal cavity environment...as a simulation of the operating environment for the device." This implies an engineered definition of cleanliness or obstruction removal within the simulated environment. -
The sample size for the training set
Not applicable. The OpClear® System is a physical device, not a machine learning algorithm that requires a "training set." -
How the ground truth for the training set was established
Not applicable, as there is no training set for this physical device.
§ 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.