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The PENTAX Medical Endoscopic Ultrasound System is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but 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 procedure are pediatric patient populations.

The PENTAX Medical Endoscopic Ultrasound System is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract including but 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 procedure are observed in adult and pediatric patient populations.

The PENTAX Medical Ultrasound Video Gastroscopes used to provide visualization of, and therapeutic access to, the upper gastrointestinal tract. These endoscopes are used with cleared Pentax Video processors (a software-controlled device) and cleared Hitachi Ultrasound Scanner (a software-controlled device) to comprise the PENTAX Medical Endoscopic Ultrasound System. The endoscopes have a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE umbilical connector will be attached to the Video Processor and has connections for illumination, video signals, air/ water/ and suction.

The ultrasound scanner umbilical connector will be attached to the ultrasound scanner unit. A sterile, single use disposable latex balloon is fitted over the convex array ultrasound transducer prior to the procedure. During an ultrasound endoscopy procedure, the latex balloon is inflated with water. The water that is contained within the balloon creates a water field that covers the transducer. The water field enables more effectively transport of ultrasonic pulses from the ultrasound transducer to the target anatomical site and back to the ultrasound transducer.

The control body includes controls for up/ down/ left/ right angulation, air/ water delivery, and an accessory inlet port. The endoscope contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect endoscopic image data, and a linear or 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 video processor contains a lamp that provides white light and is focused at the PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic 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 the signals are passed to the uitrasound scanner for processing and display. The instrument is immersible (with the use of supplied cleaning accessories) except for the ultrasound scanner connector (as described in the endoscope operator manual cleaning instructions)

This FDA 510(k) summary describes the PENTAX Medical Endoscopic Ultrasound System. However, it does not contain the specific details required to fully address your request about acceptance criteria and study results. The document primarily focuses on demonstrating substantial equivalence to a predicate device and discusses minor design changes and compatibility with different processors and scanners.

Here's a breakdown of what can and cannot be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document

• does not explicitly list quantitative acceptance criteria
• and does not provide numerical reported device performance metrics tied to such criteria.

It states: "The PENTAX Medical Endoscopic Ultrasound System has been successfully tested for its functions, performance and safety as per FDA recognized consensus standards." This is a general statement of compliance, not a presentation of specific performance data against defined thresholds.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify

• the sample size used for performance testing (test set)
• nor the data provenance (country of origin, retrospective/prospective).

It mentions "performance testing," but no details about the test set are provided.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

The document does not

• mention the use of experts to establish ground truth
• or their qualifications.

Given the nature of the device (endoscopic ultrasound system), ground truth for image quality and functionality would likely be assessed through objective measurements and potentially expert review of image outputs, but this is not detailed.

4. Adjudication Method for the Test Set:

Not applicable, as no information regarding human review or adjudication of data is provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention

• an MRMC comparative effectiveness study
• or any effect size for human readers with and without AI assistance.

The device described is an imaging system, not an AI-assisted diagnostic tool in the sense of providing automated interpretations to readers.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is a medical imaging system, not a standalone algorithm. Its performance is intrinsically linked to its hardware and software components working together to present visual and ultrasonic data to a human operator.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for any testing. For an endoscopic ultrasound system, ground truth might involve:

• Physical phantoms: For evaluating imaging capabilities.
• Clinical observations/pathology: For accuracy of visualization in a clinical setting (though no clinical study data is provided in this summary).
• Developer-defined functional criteria: For verifying the various functions of the system (e.g., image clarity, angulation, accessory channel functionality).

8. Sample Size for the Training Set:

Not applicable, as the document describes an imaging device, not a machine learning model that would require a distinct training set in the typical sense. The software mentioned is for control and processing, not for AI-based interpretation.

9. How Ground Truth for the Training Set Was Established:

Not applicable, for the same reason as point 8.

Summary of what is present:

The document confirms that:

• Software verification and validation testing were conducted as per FDA guidance.
• The software is classified as Class A (IEC 62304:2006) with a "Moderate" level of concern.
• Cybersecurity risks were assessed and mitigated according to FDA guidances.
• EMC and Electrical Safety were confirmed by relevant IEC standards (IEC 60601-1-2:2007; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+AM 1:2012; and IEC 60601-2-37:2007).

However, these are tests of compliance with standards and safety, not performance against specific clinical or quantitative acceptance criteria for image quality or diagnostic accuracy. The substantial equivalence argument relies on the device having "no effect on the performance, function or general intended use" in comparison to the predicate, and that "The PENTAX Medical Endoscopic Ultrasound System is functionally equivalent to its predicate device."

To obtain the detailed information you requested about acceptance criteria and specific study results, one would typically need to review the full 510(k) submission, not just the publicly available summary.

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