(244 days)
The Boehringer Laboratories Liver Retractor is indicated for use in laparoscopic surgical procedures to elevate the liver, improve access to surgical sites, and provide visualization of target anatomy.
The Boehringer Laboratories Liver Retractor is comprised of three components: a Suction Delivery Assembly, a Positioning Clip, and an Integral Suction Regulator. The suction delivery assembly is composed of a Flexible Tube with a proximal Suction Cup and a distal Grasping Suture.
The suction delivery assembly is introduced into the abdomen via a standard laparoscopic trocar. A standard suture passer is then used to grip the grasping suture and pull the upper portion of the flexible tube percutaneously through the abdominal wall. The now externalized tip of the flexible tube is cut off and the open end is connected to the integral suction regulator. The conformable suction cup can then be applied laparoscopically to the liver and the external portion of the flexible tube manipulated to adjust liver position. Once at the desired height, the positioning clip is placed around the external portion of the flexible tube and against the skin to lock the device in place. The suction cup can be efficiently repositioned via laparoscopic technique to accommodate the evolving requirements of a procedure. The device is inserted, manipulated, and removed by or under the direct supervision of a surgeon.
The provided FDA 510(k) clearance letter and summary for the Boehringer Laboratories Liver Retractor (K243399) does not describe an AI device. It's a physical medical device (a liver retractor) and the clearance is based on substantial equivalence to a predicate device, supported by non-clinical testing (bench testing, animal studies, biocompatibility, sterilization, packaging, shelf-life).
Therefore, the information requested in your prompt (AI-specific acceptance criteria, test sets, ground truth establishment, MRMC studies, etc.) is not applicable to this specific medical device clearance. The document does not contain any reference to AI, machine learning, or software performance studies that would require the details you've asked for.
To reiterate:
- No AI device: This is a physical liver retractor.
- No AI acceptance criteria: The device's performance is demonstrated through physical properties and functionality (retraction times, regulator functionality, integrity) and safety (biocompatibility, animal safety).
- No test sets, ground truth, or MRMC studies for AI: These concepts are relevant for AI/ML-driven medical devices, which this device is not.
If you have a document for an AI/ML-driven medical device, I would be happy to analyze it against your criteria.
§ 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.