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510(k) Data Aggregation
(179 days)
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 (< 24 hours). |
| - No sensitization | - Tested for Sensitization. "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 (< 24 hours). | |
| - No intracutaneous reactivity | - Tested for Intracutaneous Reactivity. "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 (< 24 hours). | |
| Functional Performance (Water Bottle) | - Prevention of backflow of contaminants | - Tested for backflow prevention. "The results concluded that acceptance criteria were met, and no backflow occurred in OS-H5 under the worst-case test conditions." |
| - Equivalent or greater flow rate and air delivery compared to predicate (Endo Smart Cap) | - Flow rate and air delivery testing conducted. "The results of the testing confirmed that the performance of OS-H5 is equivalent to or greater than that of the predicate Endo Smart Cap." This demonstrates substantial equivalence for this specific characteristic. |
2. Sample Size Used for the Test Set and Data Provenance:
- This information is not provided in the document for any diagnostic performance study, as such a study is not described.
- For the water bottle assembly tests (reprocessing, biocompatibility, functional performance), specific sample sizes for units tested are not detailed, but standard validation practices would imply a sufficient number of samples were used to meet test specifications. Data provenance is implied to be from internal lab testing conducted for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable/Not provided. This pertained to the water bottle accessory's physical and functional properties, not diagnostic ground truth.
4. Adjudication Method for the Test Set:
- Not applicable/Not provided.
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. An MRMC study was not described. The document pertains to the video processor and its water bottle accessory, not an AI or human-assisted diagnostic system. The "i-Scan" and "OE" are described as "imaging enhancement technologies" and "digital post-processing" or "optical," which are image processing features, not explicitly deep-learning AI algorithms in the context of this submission.
- No effect size is discussed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This document does not describe a standalone algorithm performance study.
7. The Type of Ground Truth Used:
- Not applicable for diagnostic ground truth. For the water bottle evaluation, the "ground truth" was laboratory measurements and validation results conforming to established engineering, cleaning/sterilization, and biocompatibility standards.
8. The Sample Size for the Training Set:
- Not applicable. No training set for an AI algorithm is mentioned in this submission.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. No training set or associated ground truth establishment is mentioned.
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