Search Results
Found 1 results
510(k) Data Aggregation
(179 days)
PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
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)
| Acceptance Criteria Category | Specific Criteria (as implied) | Reported Device Performance and Confirmation |
|---|---|---|
| Reprocessing Validation | - Effective soil accumulation prevention (for reusability) | - Soil Accumulation Study performed. "All acceptance criteria were satisfied." |
| - Effective cleaning efficacy | - Cleaning Efficacy Study performed. "All acceptance criteria were satisfied." | |
| - Effective rinsing | - Rinsing Validation performed. "All acceptance criteria were satisfied." | |
| - Effective sterilization (for reusability) | - Sterilization Validation performed. "All acceptance criteria were satisfied." | |
| Biocompatibility | - No cytotoxicity | - Tested for Cytotoxicity. "toxicity was either not detected or of negligible level." "test results satisfy the acceptance criteria specified." Acceptance criteria conform to ISO 10993-1, 5, and 10 and FDA Guidance Document for mucosal membranes, limited contact duration ( |
Ask a specific question about this device
Page 1 of 1