(77 days)
The EG-2940, Video Gastroscope, is intended to provide visualization (via a video monitor) of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Small Bowel. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.
The EG-2940, Video Gastroscope, must be used with a Video Processor (a software controlled device). The endoscope has a flexible insertion tube. a control body, and umbilicus. The umbilicus provides connection to the video processor. The control body includes controls for up/ down/ left/ right angulation, air/water delivery, suction, and an accessory inlet port. The device contains light carrying bundles, to illuminate the body cavity, and a charge couple device (CCD) to collect image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced (the instrument is supplied with two biopsy forceps). The Video Processor contains a 300 watt xenon lamp which provides white light that is filtered, via a Red, Green, Blue color wheel, and is focused at the connected video endoscope lightguide prong. The endoscope light carrying bundles present the color strobes to the body cavity and the CCD collects image data for each strobe of color. The video processor stores the CCD information until all three color strobes are completed and a full color frame is compiled. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.
Here's the analysis of the provided text regarding acceptance criteria and study details:
Unfortunately, the provided text does not contain any information about acceptance criteria or a study designed to prove the device meets those criteria.
The document is a 510(k) summary for the Pentax EG-2940 Video Gastroscope. A 510(k) summary primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a performance study with detailed acceptance criteria.
The key statement confirming this is:
"The submission for substantial equivalence was not based on an assessment of clinical performance data."
Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a performance study, as this information is explicitly stated as not being part of this submission's basis.
Here's how I would present the information based on your request, highlighting the absence of the requested data:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample size used for the test set and the data provenance
No test set or performance study data is described in this 510(k) summary. The submission for substantial equivalence was not based on an assessment of clinical performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No performance study or test set described.
4. Adjudication method for the test set
Not applicable. No performance study or test set described.
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
No MRMC study was done. The device described is a video gastroscope, not an AI-powered diagnostic tool. The submission was not based on clinical performance data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device described is a physical medical instrument (gastroscope) requiring human operation, not a standalone algorithm. The submission was not based on clinical performance data.
7. The type of ground truth used
Not applicable. No performance study data is described.
8. The sample size for the training set
Not applicable. No machine learning model or training set is described.
9. How the ground truth for the training set was established
Not applicable. No machine learning model or training set is described.
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JUL 9 1988
Image /page/0/Picture/1 description: The image shows the characters "K961564" in a handwritten style. The characters are arranged diagonally from the bottom left to the upper right. The text is in black and the background is white.
510(K) SUMMARY EG-2940, VIDEO GASTROSCOPF DEVICE: -PREPARED BY: PAUL SILVA DATE SUMMARY PREPARED: 06-28-96
1. SUBMITTER INFORMATION: Pentax Precision Instrument Corporation 30 Ramland Road Orangeburg, NY, 10962 TEL: (914)-365-0700
2. NAME OF DEVICE:
EG-2940. Video Gastroscone Trade Name: Classification Name: Gastroscope, Gastro- Urology (FDS), 876.1500
3. PREDICATED DEVICE(S) INFORMATION:
| 1. EC-3800L, Video Colonoscope | Pentax | K951574 |
|---|---|---|
| 2. FG-23H, Fiber Gastroscope | Pentax | K850020 |
| 3. EPM-330, Video Processor | Pentax | K934918 |
DEVICE DESCRIPTION: 4.
The EG-2940, Video Gastroscope, must be used with a Video Processor (a software controlled device). The endoscope has a flexible insertion tube. a control body, and umbilicus. The umbilicus provides connection to the video processor. The control body includes controls for up/ down/ left/ right angulation, air/water delivery, suction, and an accessory inlet port. The device contains light carrying bundles, to illuminate the body cavity, and a charge couple device (CCD) to collect image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced (the instrument is supplied with two biopsy forceps). The Video Processor contains a 300 watt xenon lamp which provides white light that is filtered, via a Red, Green, Blue color wheel, and is focused at the connected video endoscope lightguide prong. The endoscope light carrying bundles present the color strobes to the body cavity and the CCD collects image data for each strobe of color. The video processor stores the CCD information until all three color strobes are completed and a full color frame is compiled. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.
న. INTENDED USE:
The EG-2940, Video Gastroscope, is intended to provide visualization (via a video monitor) of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Small Bowel. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.
6. COMPARISON TO PREDICATED DEVICE(S):
The submission for substantial equivalence included EG-2940 literature including specifications, the identification of standard set components, and identification of optional accessories, comparision tables were provided to illustrate the comparisons to the predicated devices. The submission for substantial equivalence was not based on an assessment of clinical performance data.
§ 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.