Search Results

The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.

The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes.

The PENTAX Medical Video Upper Gl Scope EG29-i20c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes the organs; tissues; and subsystems: esophagus, stomach, and duodenum.

This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in patient populations with greater than 20 kg of body weight.

The PENTAX Medical Video Colonoscope EC38-120cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel.

This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 20 kg of body weight.

The PENTAX Medical Video Processor EPK-i8020c is intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. The video processor consists of a video system, integrated light source, monitor, and ancillary equipment.

The EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX Medical i-scan™) and an optical imaging enhancement technology (OE). These post-imaging functions are not intended to replace histopathological sampling.

The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is supposed to be found in the instructions for use (IFU) and/or in the commercial materials such as brochures.

The PENTAX Medical Video Upper GI Scope EG29-i20c is designed to be used with a PENTAX Medical Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the upper gastrointestinal tract.

The PENTAX Medical Video Colonoscope EC38-i20cL is designed to be used with a PENTAX Medical Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the lower digestive tract. The device is equipped with stiffness setting mechanism for the insertion tube. This feature enables the physician to choose the stiffness of the insertion tube, depending on the preferred level.

The document provides information on the PENTAX Medical EPK-i8020c Video Imaging System, including its components (Video Processor EPK-i8020c, Video Upper GI Scope EG29-i20c, and Video Colonoscope EC38-i20cL) and their intended uses. It also details the non-clinical performance data used to support the substantial equivalence determination to predicate devices.

However, the document does not contain the specific details required to answer all parts of your request, particularly regarding detailed acceptance criteria, reported device performance metrics in a table, an AI component, and the specifics of a study proving the device meets acceptance criteria in the way you've outlined.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices through various technical and performance tests, rather than setting and meeting a specific set of quantitative acceptance criteria for a new clinical performance claim or an AI algorithm.

Here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance Study (Based on provided document)

The document describes various non-clinical performance tests to demonstrate substantial equivalence, rather than a single study with specific acceptance criteria for a novel AI feature. The "acceptance criteria" here are generally compliance with recognized standards or demonstration of equivalence to predicate devices.

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

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

The document does not specify a "test set" in the context of clinical images or patient data for an algorithm. The non-clinical tests mentioned rely on physical devices, simulated use, and animal models.

• For Reprocessing Validation: Simulated use testing. Sample size not specified.
• For Biocompatibility: Materials assessed in accordance with ISO standards. Sample size not specified.
• For Animal Image Capture Study: Animal model used. Sample size not specified.

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

Not applicable as there is no mention of a human-expert-annotated "test set" for an AI algorithm or clinical performance study. The ground truth for the non-clinical tests is based on objective measurements, standards, or comparison to established predicate devices/methods.

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

Not applicable.

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 or AI assistance claim is described in the provided document. The device includes "digital post-processing imaging enhancement technology (PENTAX i-Scan™)" and "optical imaging enhancement technology (OE)", but this is described as an "optional adjunct following traditional white light endoscopy" and "not intended to replace histopathological sampling." It is not presented as an AI-assisted diagnostic tool that would typically undergo an MRMC study to compare human performance with and without AI.

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

This document does not describe the performance of a standalone algorithm for diagnostic purposes. The imaging enhancements (i-Scan, OE) are adjuncts for visual inspection by a clinician.

7. The type of ground truth used

For the non-clinical performance tests:

• Reprocessing Validation: AAMI TIR 30:2011 for residual soil accumulation and extraction efficiency.
• Biocompatibility: ISO 10993-1:2018 (toxicity, sensitization, intracutaneous reactivity).
• Electrical Safety and EMC: IEC and ISO standards.
• Optical Performance/Animal Image Capture Study: Comparison against predicate and reference devices' images and visualization capabilities.

No histological pathology or specific clinical outcomes data are mentioned as ground truth for a diagnostic performance study.

8. The sample size for the training set

Not applicable. There is no mention of an AI algorithm requiring a training set in this submission. The imaging enhancement technologies are likely rule-based image processing or optical filtering techniques rather than deep learning AI.

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

Not applicable.

Ask a specific question about this device

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