(59 days)
The EG-3830UT, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization 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, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Endoscopy
The EG-3830UT, Ultrasound Video Gastroscope, must be used with a Pentax Video Processor (software controlled device) and must be used with Ultrasound Scanner (software controlled device). The endoscope has a Flexible Insertion Tube, a Control Body, PVE Umbilical Connector, and Scanner Umbilical Corvector. The PVE Connector connects to the Video Processor and has connections for illumination, video signals, air/water and suction. The Scanner Connected at the Ultrasound Scanner. The Control Body includes controls for up/ down/ left/ right angulation, air/water delivery, suction selection/ control, balloon insufflation, and an accessory inlet port. The device contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect image data, and a radial array ultrasound transducer to collect ultrasonic 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 lamp that provides white light that is filtered, via a Red, Green, and Blue color filter wheel, and is focused at the PVE Connector I.ightguide 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 image frame is compiled. Image data and other screen display information are formatted and presented to the video outputs of the Video Processor for display. The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and signals are passed to the Ultrasound Scanner for display. The instrument is immersable (with the use of supplied cleaning accessories) except for the Ultrasound Scanner Connector (as described in the Endoscope operator Manual cleaning instructions).
Please note: The provided document is a 510(k) summary for a medical device (EG-3830UT Ultrasound Video Gastroscope and EUB-525 Ultrasound Diagnostic Scanner). As such, it focuses on demonstrating substantial equivalence to a predicate device, rather than providing the detailed results of a study designed to meet specific acceptance criteria in the way one might find for a novel device or AI-powered solution.
Therefore, many of the requested details, particularly those related to acceptance criteria, specific performance metrics, sample sizes for training/test sets, expert ground truthing, and MRMC studies, are not available in this type of regulatory submission. The 510(k) process primarily relies on showing that the new device is as safe and effective as a legally marketed predicate device, often through technological comparison and established methods, rather than new clinical effectiveness studies with pre-defined acceptance criteria.
Based on the provided document, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not define specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) for the device's diagnostic capabilities. Instead, the "acceptance criteria" for a 510(k) revolve around demonstrating substantial equivalence to a predicate device in terms of intended use, technology, and safety/effectiveness.
The document states:
"The submission for substantial equivalence was not based on an assessment of clinical performance data." This explicitly indicates that a study with defined performance acceptance criteria for the device itself was not conducted or provided in this submission.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable and not provided. The submission states that it was "not based on an assessment of clinical performance data."
- Data provenance: Not applicable. No clinical data presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical data or ground truthing by experts was presented for a defined test set.
4. Adjudication method for the test set
- Not applicable. No clinical data or ground truthing process 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, an MRMC comparative effectiveness study was not done. This is explicitly stated by "The submission for substantial equivalence was not based on an assessment of clinical performance data." Furthermore, this device (from 2003) is an ultrasound video gastroscope and diagnostic scanner, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is hardware (ultrasound video gastroscope and scanner) and software, providing imaging. It's not an algorithm intended for standalone diagnostic interpretation in the way "AI" often implies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No clinical data or ground truth derived from expert consensus, pathology, or outcomes data was used for assessing the device's performance in this submission. The "ground truth" for this 510(k) was the existence and safety/effectiveness of the predicate devices.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for an AI/machine learning model.
Summary of what the document does provide regarding substantial equivalence:
The document establishes substantial equivalence by:
- Intended Use Comparison: Demonstrating that the EG-3830UT and EUB-525 have the same intended use (optical and ultrasonic visualization, therapeutic access to the Upper GI Tract for adult and pediatric patients) as the predicate devices.
- Technological Characteristics Comparison: Providing a description of the device's components and functions, including the flexible insertion tube, control body, CCD for image data, and radial array ultrasound transducer, and stating that "comparison tables were provided to illustrate the comparisons to the predicated devices in summary." While the tables themselves are not included in this excerpt, the submission explicitly states such comparisons were made.
- Safety and Effectiveness: Implied by the comparison to legally marketed predicate devices shown to be safe and effective. The absence of new clinical performance data means the safety and effectiveness are derived from the predicate.
Predicate Devices:
§ 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.