(189 days)
The PENTAX Medical EG-J10U 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 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 EG34-J10U, EG36-J10UR and EG38-J10UT Ultrasound Upper GI Video Scopes, are endoscopes used to provide visualization of, and therapeutic access to, the upper gastrointestinal tract. They are used with cleared Pentax Video Processors (a softwarecontrolled device) and cleared Hitachi Ultrasound Scanners (a software-controlled device). 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 natural rubber 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 provided text is a 510(k) premarket notification for the PENTAX Medical EG-J10U Endoscopic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.
Therefore, many of the requested details, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set information (which are typical for AI/ML device submissions), are not present in this document.
The document primarily addresses hardware, software, and reprocessing aspects of the endoscopic ultrasound system. The "performance data" mentioned refers to non-clinical testing for functionality, safety, human factors, reprocessing validation, sterilization, shelf life, software verification/validation, EMC, electrical safety, and optical testing, rather than clinical performance metrics for a diagnostic or AI/ML algorithm.
Here's an attempt to answer the questions based on the available information, noting significant gaps:
1. A table of acceptance criteria and the reported device performance:
The document describes performance testing in general terms rather than specific quantifiable acceptance criteria with corresponding results in a table format. It states that the system "has been successfully tested for its functions, performance and safety as per FDA recognized consensus standards." For optical testing, it notes "All results show that there are no differences between the subject device, and the predicate device."
| Acceptance Criteria (Inferred/General) | Reported Device Performance (Summary) |
|---|---|
| Functions, Performance & Safety | Successfully tested as per FDA recognized consensus standards. |
| Human Factors (Reprocessing) | Study conducted to assess reprocessing staff's ability to carry out rIFU. Device found safe and effective for intended patients, users, and use environments. |
| Reprocessing Validation | Simulated use testing, soil accumulation analysis, cleaning, and high-level disinfection validation studies conducted; confirmed effectiveness of reprocessing procedures for EG34-J10U, EG36-J10UR, and EG38-J10UT scopes. |
| Sterilization & Shelf Life | System 1E liquid chemical sterilization validated for EG-J10U scopes. Gamma Ray Sterilization validated for packaging and natural rubber latex balloons; 2-year shelf-life verified for balloons. (Devices not provided sterile.) Warning for natural rubber latex included in labeling. |
| Software Verification & Validation | Tests conducted; documentation provided as recommended by FDA guidance. Software classified as CLASS A (IEC 62304:2006) with "Moderate" level of concern (FDA Guidance). Cybersecurity risks assessed and mitigated according to FDA guidances (Oct 2014, Dec 2016). |
| EMC & Electrical Safety | Acceptable level confirmed by IEC 60601-1-2:2007, IEC 60601-1:2005+A1:2012, IEC 60601-2-18:2009, and IEC 60601-2-37:2007. |
| Optical Properties | Measured for EG34-J10U, EG36-J10UR, and EG38-J10UT with EPK-i5010 and EPK-i7010 video processors (including signal to noise ratio, spatial resolution (MTF), distortion, light distribution, color (IEEE), spectral distribution, and photobiological safety). All results showed no differences between the subject device and the predicate device. |
2. Sample sizes used for the test set and the data provenance:
- Sample Size: Not specified in the document for any of the non-clinical tests.
- Data Provenance: Not specified. The tests are described as being conducted "as a part of Design Verification and Validation" and for "support of the substantial equivalence determination," implying internal company testing rather than clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. This document describes a medical device, not an AI/ML algorithm that requires expert ground truth for diagnostic accuracy. The "human factors" study involved reprocessing staff, not clinical experts establishing ground truth for diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not specified. No adjudication method is mentioned as it's not a diagnostic AI/ML study.
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 not an AI-assisted device. The document does not describe any MRMC studies or human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm. The device is a physical endoscope with associated control software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for this device's performance testing would be engineering specifications, industry standards (e.g., IEC standards for electrical safety), and validated reprocessing protocols, rather than clinical ground truth for disease states.
8. The sample size for the training set:
- Not applicable. This document describes a medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML algorithm is described.
§ 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.