(240 days)
The Pancreaticobiliary Video System consists of PB Digital Controller and Single-use Video Pancreaticobiliary Scope.
The Single-use Video Pancreaticobiliary Scope is used in combination with the PB digital controller, which is designed to provide imaging for the diagnosis and treatment application of endoscopic surgery process of pancreatic biliary system, and provide working channel for other diagnosis and treatment accessories.
The PB Digital Controller can be used together with the Single-use Video Pancreaticobiliary Scope of Micro-Tech to process the image collected by the scope and transmit it to the display.
Pancreaticobiliary Video System consists of:
Single-Use Video Pancreaticobiliary Scope:
- CDS11001
- CDS11002
- CDS11003
- CDS11004
- CDS11005
- CDS22001 ●
- CDS22002
- CDS22003
- CDS22004
- CDS22005
PB Digital Controller:
- BS-W-100
The Single-Use Video Pancreaticobiliary Scope is a sterile single use flexible scope and PB Digital Controller is a reusable device.
The Single-Use Video Pancreaticobiliary Scope has the following physical and performance characteristics:
- Maneuverable tip controlled by the user
- Insertion port
- Suction port
- Camera at the distal tip and LED light source in the handle of the pancreaticobiliary scope
The light emitted by the cold light source located in the handle is transmitted to the distal end of the pancreaticobiliary scope through the glass fiber, and irradiates the human tissue from the distal end. CMOS and glass fiber are located at the same position at the distal end. CMOS transmits the collected image information to the PB Digital Controller through cable, and the PB Digital Controller displays the image on the display after processing.
CMOS and optical components are identical for all specifications of products.
- Working channel port
- Lever which can lock the control
The Single-Use Video Pancreaticobiliary Scope have different size as follows:
- Maximum insertion portion width
- Effective working length
- Minimum accessories channel width
The PB Digital Controller has the following physical and performance characteristics:
- Displays the image from The Single-Use Video Pancreaticobiliary Scope on the screen
- Can record screenshots or video of image from the Single-Use Video Pancreaticobiliary Scope
- Can connect to an external monitor
- Reusable device
The provided text describes a 510(k) summary for the Micro-Tech (Nanjing) Co., Ltd.'s Single-use Video Pancreaticobiliary Scope and PB Digital Controller. This is a premarket notification for a medical device seeking substantial equivalence to existing devices, not a study proving an AI device meets acceptance criteria.
The document discusses bench testing to demonstrate the performance of the proposed device against a predicate, but it does not involve an AI device or a study structured to prove an AI's performance against specific acceptance criteria, including human expert evaluation.
Therefore, I cannot extract the information required by your prompt, such as acceptance criteria for an AI device, sample sizes for AI test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, or training set details.
The relevant sections of the document explicitly state:
- "No animal study is included in this submission."
- "No clinical study is included in this submission."
This indicates that clinical (human) performance data, which would be crucial for evaluating an AI device's effectiveness, was not part of this submission for market clearance. The "Performance Data" section (page 10-11) lists a series of bench tests for physical and electrical characteristics of the scope and controller, not for an AI algorithm.
§ 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.