(62 days)
The ES-3840, Video Sigmoidoscope, is intended to provide visualization (via a video monitor) of, and therapeutic access to, the Lower Gastrointestinal Tract. The Lower Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems: Rectum and Sigmoid Colon. The instrument is introduced per rectally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.
The ES-3840, Video Sigmoidoscope, must be used with a Video Processor (a software controlled device). The endoscope has a flexible insertion tube, 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, Forward Water Jet, 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 an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and study aspects, and where information is not present:
Key Takeaway from the Provided Text:
The most crucial piece of information for your request is: "The submission for substantial equivalence was not based on an assessment of clinical performance data."
This statement directly indicates that the 510(k) submission for the Pentax ES-3840 Video Sigmoidoscope did not include a study or clinical trial demonstrating its performance against specific acceptance criteria. Instead, substantial equivalence was established through comparison to legally marketed predicate devices based on specifications, components, and accessories.
Therefore, many of the questions you've asked about acceptance criteria and study details cannot be answered from this specific document, as such a study was not part of this clearance.
Detailed Breakdown based on your Request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated or provided in this 510(k) summary. Since no clinical performance study was conducted, there are no reported acceptance criteria for clinical efficacy or diagnostic accuracy.
- Reported Device Performance: Not reported in terms of clinical outcomes, sensitivity, specificity, accuracy, or other performance metrics typically derived from a study. The "performance" discussed in the document is limited to its functional description (e.g., "The instrument contains a working channel," "collects image data").
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No "test set" from a clinical study was used for this 510(k) submission.
3. 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. No clinical study with a "test set" requiring ground truth establishment was conducted or submitted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical study with a "test set" requiring adjudication was conducted or submitted.
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. This is a medical device for visualization, not an AI or CAD system. An MRMC study or AI-assisted improvement study is entirely unrelated to this type of device and its 1996 clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a human-operated sigmoidoscope, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical study requiring ground truth was conducted or submitted.
8. The sample size for the training set
- Not applicable. No "training set" in the context of a performance study was used for this 510(k). Training sets are typically associated with machine learning or AI algorithm development, which is not relevant here.
9. How the ground truth for the training set was established
- Not applicable. (See #8)
§ 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.