Search Results

The water container MAJ-901 has been designed to be used with endoscopes to allow gas insufflation and water feeding from the endoscope.

Do not use this instrument for any purpose other than its intended use.

The water container MAJ-902 has been designed to be used with endoscopes to allow gas insufflation and water feeding from the endoscope.

Do not use this instrument for any purpose other than its intended use.

The MAJ-901 and MAJ-902 have been designed to be used with Olympus light sources and endoscopes to allow gas insufflation and water feeding from the endoscope.
MAJ-901 and MAJ-902 are both comprised of a Lid, Container, O-ring, and Container Protector. Other than Lid, the devices are the same.
MAJ-902 also includes a "gas tube connector" in the lid for carbon dioxide gas delivery. Additionally, MAJ-902 includes a Caution tag that the MAJ-901 does not.

This is a 510(k) summary for a medical device (Water Container MAJ-901 and MAJ-902), which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a new therapeutic might.

Based on the provided document, here's what can be extracted regarding acceptance criteria and the "study" (non-clinical testing) that proves the device meets them:

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

The document mentions that all subject devices met design specifications and performed as intended in the non-clinical tests. However, it does not provide a table with specific quantitative acceptance criteria or the numerical performance results of these tests. Instead, it offers a high-level summary of the types of tests conducted:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on the sample sizes used for each of the non-clinical tests (e.g., how many water containers were tested for flow rate, durability, etc.). Similarly, it does not specify the country of origin of the data or whether the tests were retrospective or prospective. It is implied these were prospective bench tests conducted by the manufacturer.

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)

This is not applicable to this type of 510(k) submission. The "ground truth" for non-clinical bench testing often refers to established engineering standards or internal design specifications, verified through objective measurements, rather than expert consensus on medical images or clinical outcomes.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters where there's a need to resolve discrepancies in expert opinions. This document describes bench testing where performance against technical specifications is directly measured.

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 is a medical device for water and gas feeding in endoscopes, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a water container, not an algorithm.

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

For the non-clinical tests mentioned, the "ground truth" would be the engineering design specifications and recognized industry standards for flow rate, durability, biocompatibility, and reprocessing effectiveness. Performance was measured against these predefined technical parameters.

8. The sample size for the training set

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

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device

The PENTAX Medical EPK-i7010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.

The PENTAX Medical EPK-i7010 includes a digital post-processing imaging enhancement technology (PENTAX i-Scan™) and an 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 EPK-i5010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.

The PENTAX EPK-i5010 includes PENTAX i-Scan™, a digital post-processing imaging enhancement technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan is compatible with PENTAX k-series and i-series gastrointestinal videoscopes and colonovideoscopes.

The PENTAX Medical EPK-i7010 Video Processor and PENTAX EPK-i5010 Video Processor each consist of a video system, integrated light source, monitor, and ancillary equipment. These processors are intended for gastrointestinal endoscopic diagnostic, treatment and video observation.

The PENTAX Medical EPK-i7010 Video Processor contains two types of contrast enhancement techniques: PENTAX i-Scan technology, and optical enhancement (OE) technology. The PENTAX EPK-i5010 Video Processor contains only PENTAX i-Scan. The PENTAX i-Scan technology is a digital post-processing image enhancement technique with three modes, i-Scan 1, 2 and 3.

The provided text is a 510(k) summary for the PENTAX Medical EPK-i7010 and EPK-i5010 Video Processors, with a focus on a minor design change related to the Water Bottle Assembly OS-H5. It is NOT a study proving the device meets acceptance criteria for an AI/imaging diagnostic device.

The document discusses performance testing in a general sense, but this testing relates to the physical and functional characteristics of the water bottle accessory and its reprocessing, not to the diagnostic accuracy or clinical performance of the imaging enhancement technologies (i-Scan and OE) with human readers.

Therefore, many of the requested criteria for describing an AI/imaging diagnostic study (e.g., sample size for test set, number of experts for ground truth, MRMC study, effect size) cannot be found in this document because the document does not describe such a study.

The closest relevant information relates to the performance of the Water Bottle Assembly OS-H5.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:

Acceptance Criteria and Study for PENTAX Medical EPK-i7010/EPK-i5010 (Water Bottle Assembly OS-H5)

The provided document (510(k) summary) does not describe a study related to the diagnostic performance of the PENTAX i-Scan or Optical Enhancement (OE) technologies, especially in conjunction with human readers or AI algorithms. Instead, it focuses on demonstrating the substantial equivalence of the PENTAX Medical EPK-i7010 and EPK-i5010 Video Processors, specifically addressing a minor design change: the replacement of a disposable water bottle system with the reusable PENTAX Water Bottle Assembly OS-H5.

The "acceptance criteria" and "study" described pertain to the safety and functional performance of the reusable water bottle accessory and its reprocessing methods, not the diagnostic utility of the imaging processors themselves or any associated AI.

1. Table of Acceptance Criteria and Reported Device Performance (Specific to Water Bottle Assembly OS-H5)

Ask a specific question about this device