(324 days)
Cyber BLADE is intended for use under endoscopic visualization and removal of dissected benign prostatic hyperplasia (BPH) tissue during endoscopic surgical procedures in urology.
Cyber Blade provides efficient and rapid morcellation under endoscopic visualization. The cutting action is driven by the motor in the handpiece. Cyber Blade comprises: a single use sterile blade fixed to a handpiece where controls are placed, a re-usable internal motor provided with integrated battery pack, an AC powered charger for the battery pack. Cyber blade is also supplied with aspiration tubing and canister for the collection of evacuated tissue.
I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document refers to the Cyber Blade, which is a medical device for morcellation and removal of BPH tissue, but it does not contain information about acceptance criteria or performance studies with human subjects or AI.
The text primarily details:
- The FDA's 510(k) clearance for the Cyber Blade, indicating substantial equivalence to predicate devices.
- Device description, technical specifications, and comparison to predicate devices.
- A list of recognized consensus standards and guidelines that the device complies with (e.g., related to electrical safety, biocompatibility, sterilization, packaging, risk management, and software).
- Additional types of testing performed (morcellation efficiency, suction test, dimensional verification, tensile strength, comparative testing with a specific morcellator, risk analysis on performance tests, and battery testing).
None of these sections provide:
- A table of acceptance criteria and reported device performance for a study.
- Sample sizes or data provenance for studies involving performance against acceptance criteria.
- Details about experts or ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies or human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size or ground truth establishment for a training set.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed clinical trial data or performance against specific, quantifiable acceptance criteria often seen for novel devices or software with complex performance claims (like AI). The "performance testing" mentioned refers to engineering tests against established standards and product specifications, not clinical outcomes or diagnostic accuracy studies.
§ 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.