Search Results

PENTAX Medical Single Use Video Bronchoscope EB-S01 is sterile single use flexible endoscopes intended for use with PENTAX Medical mobile processor, therapeutic accessories, and other ancillary equipment for endoscopy and endo-therapeutic procedures within the airways and tracheobronchial tree.

PENTAX Medical Mobile Processor ONE-M is intended to be used with PENTAX Medical endoscopes and other peripheral devices for endoscopic diagnosis, treatment and video observation.

PENTAX Medical Mobile Processor Plug-in ONE-Dock is intended to be attached to the PENTAX Medical Mobile Processor to provide additional ports for hardware interface.

PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System is intended to provide the optical visualization of the airways and tracheobronchial tree for diagnostics and therapeutic applications. The PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System consist of the following three component devices:

• . PENTAX Medical Single Use Video Bronchoscope EB11-S01 / EB15-S01
• . PENTAX Medical Mobile Processor ONE-M
• . PENTAX Medical Mobile Processor Plug-in ONE-Dock

The EB11-S01 / EB15-S01 endoscopes are connected to the ONE-M and video images captured with the bronchoscope are displayed on the touch screen of the ONE-M. The ONE-M is also connected to the Plug-in ONE-Dock, which has several interfaces, such as an external monitor to display captured images by the bronchoscope and a connection with an external network.

Based on the provided text, the document is a 510(k) Premarket Notification for the PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving clinical effectiveness through extensive clinical trials for new indications or technologies. Therefore, the information provided focuses on demonstrating equivalence through non-clinical performance data and technological comparisons, rather than a clinical study with detailed acceptance criteria and a human-in-the-loop performance study as might typically be found for AI/ML device submissions.

The document does not describe a study that proves the device meets specific acceptance criteria related to an AI/ML algorithm's diagnostic performance, as it is a bronchoscope system, not an AI/ML diagnostic aid. It lists various non-clinical performance tests to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested fields regarding acceptance criteria, study design for AI/ML, human expert involvement, and ground truth establishment are not applicable or not detailed in this submission because it is not an AI/ML device submission for diagnostic accuracy.

However, I can extract the relevant information that is present and explain why other requested information is not available:

1. A table of acceptance criteria and the reported device performance:

The document describes general performance equivalency rather than specific quantitative acceptance criteria for image analysis or diagnostic performance of an AI system. The key "acceptance criteria" here relate to demonstrating equivalence to a predicate device and meeting recognized standards for safety and performance (e.g., electrical safety, biocompatibility).

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

• Test Set: Not applicable in the context of an AI/ML "test set" for diagnostic performance. Performance testing involved various engineering and animal studies. For the "Animal Image Capture Study," an animal model was used, but the specific number of animals is not provided. The data provenance is implied to be from internal testing by PENTAX Medical.
• Data Provenance: Implied to be from internal testing and validation studies conducted by PENTAX Medical (e.g., "PENTAX Medical coordinated with HA2 Medizintechnik GmbH (German company) to validate the use of EO sterilization"). The animal study location and specifics are not provided.

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

This information is not applicable and not provided. The ground truth for this device's performance does not involve human expert adjudication of images for diagnostic purposes in the way it would for an AI/ML algorithm. The performance evaluation focused on physical, electrical, and optical properties as well as safety and biocompatibility.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as this is not an AI/ML diagnostic device requiring expert adjudication of results.

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:

Not applicable. This device is a bronchoscope system, not an AI-assisted diagnostic tool for image interpretation. No MRMC study was conducted or required for this type of submission.

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

Not applicable, as this is a medical device for direct visualization and not an AI algorithm.

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

Not applicable in the AI/ML sense. The "ground truth" for this submission are the established performance specifications for medical devices, relevant ISO standards, and the performance of the predicate device, against which the subject device's non-clinical performance was compared (e.g., electrical safety standards, biocompatibility testing results, optical measurements, and visualization capabilities in an animal model).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Ask a specific question about this device

The PENTAX Medical Video Bronchoscopes EB-J10 Series have been designed to be used with a PENTAX Video Processor (including Light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopic surgery within the airways and tracheobronchial tree.

The EB-J10 series endoscopes are used to provide visualization of, and therapeutic access to, the airways and tracheobronchial tree. There are two models of EB-J10 series: EB15-J10 and EB19-J10. These models are identical in all parameters and only differ in French size: 15 and 19.

The bronchoscopes are used with cleared PENTAX Video Processors (a softwarecontrolled device). The endoscopes have a flexible insertion tube, a control body, and PVE connector. The PVE connector will be attached to the Video Processor and has connections for illumination, video signals, air/ water and suction.

The control body includes controls for up/ down angulation, air/ water delivery, and an accessory inlet port. The endoscope contains light carrying bundles (LCB) to illuminate the body cavity, and a charge coupled device (CCD) to collect endoscopic 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 instrument is immersible (with the use of supplied cleaning accessories) as described in the endoscope reprocessing instructions.

Here's a summary of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the clinical image capture study (test set) or its specific provenance (e.g., country of origin, retrospective/prospective). It only mentions that "A clinical image capture study was performed."

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

This information is not provided in the document. The document only mentions "visualization of vascularity and mucosal surface for each anatomical area" as the outcome of the clinical image capture study, implying expert assessment, but no details about the experts are given.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The clinical image capture study primarily aimed to compare the visualization capabilities of the subject device against the predicate, not to assess human reader performance with or without AI assistance.

6. Standalone Performance Study

A standalone performance study (algorithm only without human-in-the-loop) was not performed as the device is a bronchoscope, which is a physical instrument used by a clinician, not an AI algorithm. The performance tests focused on the physical and optical characteristics of the device itself.

7. Type of Ground Truth Used

For the clinical image capture study, the "ground truth" was likely based on expert assessment of the bronchoscope's ability to clearly visualize vascularity and mucosal surface. However, the document does not explicitly state the methodology for establishing this ground truth (e.g., expert consensus, pathology, etc.). The other tests (reprocessing, software, EMC, optical) used established engineering standards and measurements as their "ground truth".

8. Sample Size for the Training Set

This information is not applicable and not provided. The PENTAX Medical Video Bronchoscope EB-J10 Series is a medical device, specifically a bronchoscope, and not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of AI.

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

This information is not applicable as there is no "training set" for this device.

Ask a specific question about this device