Search Results

The EB-1970UK, Ultrasound Video Bronchoscope, 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 EB-1970UK, Ultrasound Video Bronchoscope, must be used with a Pentax Video Processor (a software controlled device) and must be used with an Ultrasound Scanner (a software controlled device). The endoscope has a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE connector will be attached to the Video Processor and has connections for illumination and video signals. The ultrasound umbilical connector will be attached to the ultrasound scanner unit.

The control body includes controls for up/down anqulation, suction control, video processor remote control buttons, and ports for manual balloon insufflation/ evacuation and accessory inlet. A sterile, single use disposable latex balloon is fitted over the convex array ultrasound transducer prior to the procedure. It is designed to be inflated with a specific volume of water during the procedure so that the effective transport of ultrasonic pulses from the ultrasound transducer to the target anatomical site and back to the ultrasound transducer can take place.

The endoscope contains light carrying bundles to illuminate the body cavity, a charge couple 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).

The provided text describes the PENTAX Ultrasound Video Bronchoscope EB-1970UK and its regulatory submission. However, it does not contain information about a study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity with a test set, expert readers, or ground truth data.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized non-clinical standards.

Here's an analysis based on the information provided and what is missing:

Acceptance Criteria and Study Details

The document details the device's conformance to various non-clinical standards and protocols, which serve as the "acceptance criteria" for safety and fundamental performance. However, there is no mention of a clinical or performance study with a test set of data, human readers, or a specific ground truth for diagnostic accuracy metrics.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not applicable for a clinical performance test. The testing focused on compliance with engineering, safety, and sterilization standards through in-house and external lab protocols. There isn't a defined "test set" of patient data in the context of diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No clinical performance study involving expert assessment of diagnostic accuracy is described.

4. Adjudication method for the test set:

• Not applicable. No clinical performance study involving expert adjudication is described.

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 device is an Ultrasound Video Bronchoscope, not an AI-powered diagnostic system. No MRMC study or AI assistance is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No. This device is an instrument used by a clinician, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. For the non-clinical tests conducted, the "ground truth" was typically defined by the specified requirements and methodologies of the referenced standards (e.g., specific chemical levels for biocompatibility, sterility for reprocessing, electrical thresholds for safety).

8. The sample size for the training set:

• Not applicable. No training set for a diagnostic algorithm is mentioned.

9. How the ground truth for the training set was established:

• Not applicable. No training set for a diagnostic algorithm is mentioned.

Summary of what the document does provide regarding acceptance criteria and performance:

The document primarily focuses on demonstrating that the PENTAX Ultrasound Video Bronchoscope EB-1970UK meets the acceptance criteria for safety and basic functional performance by complying with a comprehensive list of FDA-recognized consensus standards and in-house test protocols for:

• Electrical safety
• Electromagnetic compatibility
• Biocompatibility of materials
• Reprocessing and sterilization effectiveness
• Usability
• Software life cycle processes
• Risk management
• Quality management systems
• Specific optical and mechanical characteristics relevant to endoscopes.

The "study" in this context refers to the comprehensive series of non-clinical design verification and validation tests performed according to these standards, with the reported device performance being that "All the study results satisfy the acceptance criteria specified by the above applicable standards." The ultimate conclusion is that the device is "as safe and effective and substantially equivalent" to its predicate device based on these non-clinical evaluations.

Ask a specific question about this device