(262 days)
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.
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows.
Clinical Application: Endoscopy
Mode of Operation: B, M, PWD, Color Doppler, Amplitude Doppler
The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U 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, suction control, and ports for manual balloon insufflation/evacuation and accessory inlet.
The endoscope contains light carrying bundles to illuminate the body cavity, a change couple device 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 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 instrument is immersible (with the use of supplied cleaning accessories).
The provided text is a 510(k) Summary for the PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U. It details the device's technical specifications, intended use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices. However, it does not contain any information about a study proving that the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, accuracy, or reader performance with or without AI assistance.
The document focuses on non-clinical testing to demonstrate that the device is equivalent to a legally marketed predicate device, especially regarding safety and effectiveness from a design and manufacturing perspective. It mentions "Performance Testing - Bench" for "System compatibility" and "Optical characteristics," but does not provide specific acceptance criteria or quantitative results for these tests.
Therefore, I cannot fully answer your request for acceptance criteria and a study that proves the device meets them, as the provided text does not include the necessary information regarding a clinical performance study involving AI, human readers, or specific diagnostic performance metrics.
Here's an breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document lists various types of non-clinical testing (Sterilization, Reprocessing, Biocompatibility, Software, EMC + Electrical Safety, System Compatibility, Optical Characteristics), and states that "Testing results confirm the subject device is safe and effective as the predicate device, and performs as intended." However, it does not provide specific quantitative acceptance criteria or detailed numerical results for these tests. For example, it says "The subject device demonstrates equivalent or better optical characteristics than the predicate device," but gives no numerical value for either.
2. Sample size used for the test set and the data provenance:
- Cannot be provided definitively for a performance study. The document outlines non-clinical bench testing. These tests typically don't involve "samples" in the same way clinical studies do (e.g., patient data). The data provenance (country of origin, retrospective/prospective) is not applicable or mentioned for the types of tests described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This information is relevant for studies establishing diagnostic ground truth, often used for AI/clinical performance evaluations. The document describes engineering and safety testing, not clinical diagnostic performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used in clinical studies to resolve discrepancies in expert interpretations for ground truth establishment. This document doesn't describe such a 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, such a study was not done according to this document. This device is a bronchoscope, which is a physical instrument for visualization and access, not an AI software intended to assist human readers in image interpretation. The document does not mention any AI component or any MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not an AI algorithm. This is a hardware device (bronchoscope) with associated software for its operation. Therefore, a standalone algorithm performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of diagnostic performance. The "ground truth" for the tests described relates to engineering specifications and safety standards (e.g., whether the device sterilizes correctly, whether electrical current is within safe limits, whether optical clarity meets design specs).
8. The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this is not an AI device being trained.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
In summary, the provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of a medical device (a bronchoscope) through non-clinical testing of its physical, electrical, and reprocessing characteristics. It does not involve AI or diagnostic performance studies that would require the types of acceptance criteria and study details you requested for AI-driven devices.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.