(68 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 PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), 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 EG-J10U Endoscopic Ultrasound System (Proposed) includes three endoscope models EG34-J10U. EG36-J10UR, and EG38-J10UT Ultrasound Upper GI Video Scopes, and is used to provide visualization of, and therapeutic access to, the upper gastrointestinal tract. They are used with FDA cleared PENTAX Medical Video Processors (a software-controlled device) and FDA cleared Hitachi Ultrasound Scanners (a softwarecontrolled 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 effective 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 coupled 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. 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 ultrasound scanner for processing and display. EG34-J10U, EG36-J10UR, and EG38-J10UT Ultrasound Upper GI Video Scopes are connected to the ultrasound scanner ARIETTA 70 and the ALOKA ARIETTA 850 via the scanning unit connector of the endoscope directly to the probe connector of the scanning unit. In order to connect to the Preirus scanning unit, junction box PUN-JBP1 is required to connect the scanning unit connector to the probe connector. The instrument is immersible (with the use of supplied cleaning accessories) except for the ultrasound scanner connector (as described in the endoscope Operators Manual cleaning instructions).
The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (Proposed) connects with a video processor and an ultrasound scanner, both of which are software-controlled devices. The endoscope has a flexible insertion tube, a control body, PVE connector, and scanning unit connector. The PVE connector attaches to the video processor and has connections for illumination and video signals. The ultrasound umbilical connector attaches to the ultrasound scanner unit. The control body includes remote buttons for functions assigned from the video processor. It also includes controls for up/down angulation or neutral position control, and ports for manual balloon insufflation/evacuation, and an accessory inlet. The endoscope contains light carrying bundles to illuminate the body cavity, a charge coupled device (CCD) to collect endoscopic image data, and a convex 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 focused at the endoscope PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. 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 ultrasound scanner for processing and display. The instrument is immersible (with the use of supplied cleaning accessories). EB19-J10U is connected to the ultrasound scanners ARIETTA 70, ALOKA ARIETTA 850, and Noblus via the scanning unit connector of the endoscope directly to the probe connector of the scanning unit. In order to connect to the Preirus scanning unit, junction box PUN-JBP1 is required to connect the scanning unit connector to the probe connector.
The provided text appears to be a 510(k) summary for medical devices, specifically endoscopic ultrasound systems and a video bronchoscope, from PENTAX of America, Inc. It describes the devices, their indications for use, and a comparison to predicate devices, focusing on the addition of compatibility with a new diagnostic ultrasound system (ALOKA ARIETTA 850).
However, the document does not contain specific acceptance criteria or a study design in the way one might expect for a clinical performance study measuring diagnostic accuracy (e.g., sensitivity, specificity, AUC) or human reader improvement with AI assistance. Instead, it focuses on engineering and performance testing to demonstrate substantial equivalence to predicate devices after a minor modification (compatibility with a new ultrasound scanner).
Therefore, a table of acceptance criteria and reported device performance as typically understood for diagnostic accuracy would be largely inapplicable here. The "performance data" section details verification/validation methods used to mitigate identified risks, which serve as the acceptance criteria for these specific engineering tests.
Here's an attempt to answer your questions based on the provided text, acknowledging the nature of the submission:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the "acceptance criteria" are the satisfaction of relevant international standards and the reported "performance" is that the devices passed these checks.
| Acceptance Criteria (Verification / Validation Methods) | Reported Device Performance |
|---|---|
| Measure distal end temperature (according to IEC 60601-2-37: 2007 +A1: 2015) | Confirmed ultrasound output properly adjusted; temperature does not create thermal injuries. |
| Measure leak current (according to IEC 60601-2-37: 2007 +A1: 2015) | Confirmed ultrasound output properly adjusted; leakage current satisfies the standard. |
| Measure electromagnetic irradiation (according to IEC 60601-1-2: 2014) | Confirmed electromagnetic irradiation from the connection part satisfied the standard. |
| Measure acoustic output of new combinations (accordance with FDA guidance) | Test results passed criteria; new combinations are acceptable. |
| Measure doppler sensitivity of new combinations (by methods used for ARIETTA 70) | Test results passed criteria; new combinations are acceptable. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text describes engineering, electrical safety, and acoustic output testing. It does not involve a "test set" of patient data or clinical images. The testing was conducted on the devices themselves or their interaction with the new ultrasound scanner. Therefore, typical patient-data related sample size and provenance information are not applicable.
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. The ground truth for this type of engineering and performance testing is established by compliance with international standards and technical specifications, not by expert clinical consensus on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring adjudication. The verification and validation activities were based on standardized measurements and testing protocols.
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 MRMC study was done. This submission is for an endoscopic ultrasound system and video bronchoscope with a minor modification (compatibility with a new diagnostic ultrasound system), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The devices are visualization tools for human operators, not standalone algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the compliance with established international standards and FDA guidance for medical device safety and performance. This includes:
- IEC 60601-2-37: 2007 +A1: 2015 (Electrical safety standard for ultrasonic medical diagnostic and monitoring equipment)
- IEC 60601-1-2: 2014 (EMD standard for medical electrical equipment)
- FDA guidance, "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound systems and Transducers"
8. The sample size for the training set
Not applicable. This submission is for hardware devices (endoscopes) and their compatibility, not for an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there was no training set for an AI algorithm.
§ 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.