(14 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 organ; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced 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: Intra-luminal, Endoscopy.
The EG-3830UT, Ultrasound Video Gastroscope, must be used with a Pentax Video Processor (software controlled device) and must be used with an Ultrasound Diagnostic Scanner. The endoscope has a Flexible Insertion Tube, a Control Body, a PV Connector, and a Scanner Umbilical Connector. The PV Connector is connected at the Video Processor, and the Scanner Connector is 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 for illumination, video signals, air/water and suction. 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 endoscope contains a charge couple device (CCD) to collect image data. The CCD is focused at the body cavity and the CCD collects image data for each strobe. The Video Processor stores the CCD information until all three color strobes are completed and a full color image is computed. The endoscope light carrying bundles present the color white light that is filtered, via a Red, Green, and Blue Color Wheel, at the Lightguide Prong. The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are processed by the Ultrasound Scanner for display. The instrument is immersable (That the Endoscope operator Manual cleaning instructions).
The provided text is a 510(k) summary for the Pentax EG-3830UT Ultrasound Video Gastroscope. It describes the device, its intended use, and a comparison to predicate devices, but it does not include detailed acceptance criteria or a study proving the device meets specific performance criteria.
Instead, the submission for substantial equivalence explicitly states: "The submission for substantial equivalence was not based on an assessment of clinical performance data." This indicates that a clinical study with acceptance criteria was not performed as part of this 510(k) submission. The FDA clearance is based on its substantial equivalence to previously cleared devices (K023401, K032503, K013722), meaning its technological characteristics and intended use are similar enough that it does not raise new questions of safety or effectiveness.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert adjudication, as this information is not present in the provided document.
Here's a summary of what can be extracted from the document regarding the "study" context, and why most of your questions cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance
- Not applicable. The document explicitly states that the submission for substantial equivalence was not based on clinical performance data. Therefore, no acceptance criteria for performance and no reported performance against such criteria are provided.
2. Sample size used for the test set and the data provenance
- Not applicable. No test set or clinical study was conducted 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
- Not applicable. No ground truth was established from a test set as no clinical study was performed.
4. Adjudication method for the test set
- Not applicable. No test set or adjudication was performed.
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
- Not applicable. This device is an Ultrasound Video Gastroscope, not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device (gastroscope with ultrasound capabilities), not an algorithm.
7. The type of ground truth used
- Not applicable. No ground truth for performance assessment was established as no clinical performance study was conducted. The clearance is based on substantial equivalence to predicate devices, meaning their safety and effectiveness characteristics are considered similar enough.
8. The sample size for the training set
- Not applicable. This refers to machine learning models. The device is a medical instrument.
9. How the ground truth for the training set was established
- Not applicable. This refers to machine learning models. The device is a medical instrument.
Key takeaway from the document: The 510(k) clearance for the EG-3830UT Ultrasound Video Gastroscope was based on its substantial equivalence to previously cleared predicate devices, as opposed to de novo clinical performance data and acceptance criteria specifically generated for this submission.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.