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The Gas/Water Feeding Valve OE-B14 is intended to be attached in place of Air/Water Feeding Valve (OE-B12) to PENTAX Medical GI endoscopes and used to feed the gas/water to the body (via the air/water channel).

The Gas/Water Feeding Valve OE-B14 is intended to be attached in place of Air/Water Feeding Valve (OE-B12) to PENTAX Medical GI endoscopes and used to feed the gas/water to the body (via the air/water channel).

The OE-B14 is attached onto the air/water feeding cylinder of the control body of PENTAX Medical endoscope. The endoscope is linked to non-flammable gas cylinder and the water bottle assembly via air/water feeding circuit.

The device descriptions for the PENTAX Medical EPK-i8020c Video Imaging System remain unchanged from K231249. They include the PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, and PENTAX Medical Video Colonoscope EC38-i20cL.

The provided text describes the regulatory clearance of the PENTAX Medical Gas/Water Feeding Valve OE-B14, an accessory for GI endoscopes. The device's clearance is based on its substantial equivalence to a predicate device. The information provided focuses on non-clinical performance data rather than a clinical study evaluating diagnostic or therapeutic efficacy with human subjects.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is an accessory device and the review focuses on substantial equivalence based on non-clinical performance, the "acceptance criteria" here refer to meeting standards for reprocessing, sterilization, biocompatibility, and system/mechanical performance. There are no specific quantifiable clinical performance metrics like sensitivity/specificity for a diagnostic device.

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

The document describes non-clinical bench testing and validation studies, not a clinical trial with human subjects. Therefore, the concept of a "test set" in the context of clinical data or patient samples, sample size, or data provenance (country of origin, retrospective/prospective) is not applicable here as it would be for a diagnostic or therapeutic device. The "test set" would refer to the physical devices subjected to the various non-clinical tests (reprocessing, mechanical, etc.), for which specific numerical sample sizes are not provided in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable. The device underwent non-clinical performance testing and validation against recognized standards and internal criteria. There was no "ground truth" derived from expert clinical opinion on patient data as would be for an AI/diagnostic device.

4. Adjudication Method for the Test Set

This information is not applicable. There was no clinical test set requiring expert adjudication for ground truth.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The device is an accessory that feeds gas/water, not a diagnostic or AI-assisted tool that would involve human readers interpreting cases.

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

No, a standalone performance study in the context of an algorithm or AI was not done. The device is a physical accessory.

7. The Type of Ground Truth Used

For this device, the "ground truth" for proving its safety and effectiveness was established through:

• Compliance with recognized consensus standards: (e.g., AAMI TIR 30: 2011/(R)2016 for reprocessing, ISO 10993-1: 2018 for biocompatibility).
• Achievement of pre-defined acceptance criteria for bench testing of functions, performance, and safety (e.g., residual soil levels, successful steam sterilization, acceptable toxicity levels, sufficient gas/water feeding performance, verified mechanical performance).
• Comparison to a legally marketed predicate device (PENTAX Gas/Water Feeding Valve OF-B194) to demonstrate substantial equivalence, particularly regarding intended use and technological characteristics.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical accessory, not an AI or machine learning algorithm that requires a training set.

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

This information is not applicable as there was no training set for an AI/ML algorithm.

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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.

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EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I
This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor. EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

The EVIS EXERA III COLONOVIDEOSCOPE PCF-H190TL/I is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190L/I
This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

The EVIS EXERA III COLONOVIDEOSCOPE PCF-HO190L/I is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

The EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I are intended to be used with an Olympus video system center, light source, endoscope position detecting unit (for PCF-HQ190L/I only), documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The PCF-H190TL/I and PCF-HQ190L/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

The EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I consist of three parts: the control section, the insertion section, and the connector section. The basic principle including user interface and operation for the procedure of the PCF-H190TL/I and PCF-HQ190L/I are identical to that of the predicate devices.

Available imaging modes are listed below:
WLI
NBI

This document pertains to the clearance of the EVIS EXERA III Colonovideoscope, specifically the PCF-H190TL/I and PCF-HQ190L/I models. It is a 510(k) premarket notification, which demonstrates substantial equivalence to previously cleared devices rather than requiring a full demonstration of safety and effectiveness as in a PMA. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are not in the context of an AI/ML device evaluating specific metrics like sensitivity/specificity for a diagnostic claim, but rather demonstrating that the new colonoscopies are as safe and effective as existing ones, with the added adjunctive feature of Narrow Band Imaging (NBI).

The clinical performance section largely focuses on the NBI feature. Here's a breakdown of the information provided, specifically addressing the points related to performance data:

The document does not detail specific acceptance criteria for a "device performance" metric in the typical sense of a diagnostic algorithm (e.g., a specific sensitivity or specificity target). Instead, the performance testing is focused on demonstrating that the new device models perform as intended and meet design specifications, and that the NBI feature is an acceptable adjunctive tool. The "acceptance criteria" can be inferred as successful completion of the listed tests in accordance with relevant standards and guidance documents.

Device Performance Summary:

The document does not present a table of acceptance criteria and reported device performance with specific quantitative metrics directly comparable to an AI/ML algorithm's diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, the performance data provided are primarily non-clinical and relate to the safety and functionality of the physical endoscope, along with clinical evidence for the adjunctive NBI feature.

The "acceptance" in this context is the FDA's determination of substantial equivalence (SE) based on these tests, which implies the device's acceptable performance for its intended use.

Inferred "Acceptance Criteria" for Substantial Equivalence:

• Reprocessing Validation: Compliance with guidance for reprocessing medical devices.
• Biocompatibility: Compliance with ISO 10993-1 and FDA guidance.
• Software Verification and Validation: Compliance with FDA guidance for software in medical devices and cybersecurity.
• Electrical Safety & EMC: Compliance with ANSVAAMI ES 60601-1, IEC 60601-2-18, and IEC 60601-1-2.
• Bench Testing: Device performs as intended and meets design specifications for thermal safety, composite durability, photobiological safety, and retroflexed withdrawal/detection of hidden polyps.
• Clinical Performance (for NBI): Real-time predictions of diminutive polyp histology using NBI provide "reasonable certainty" of neoplastic vs. non-neoplastic identity, and the NICE classification helps achieve similar performance. This is presented as an adjunctive tool, not a standalone diagnostic.

Reported Device Performance (from the document):

• Reprocessing Validation: Conducted and documentation provided as recommended. (Meets inferred criteria)
• Biocompatibility Testing: Conducted in accordance with guidance, including Cytotoxicity, Intracutaneous, and Guinea Pig Maximization Sensitization Tests. (Meets inferred criteria)
• Software V&V: Conducted and documentation provided as recommended. (Meets inferred criteria)
• Electrical Safety & EMC: System complies with relevant standards. (Meets inferred criteria)
• Bench Testing: Conducted to ensure the device performs as intended and meets design specifications. (Meets inferred criteria)
• Clinical Performance (Meta-analysis for NBI): Pooled data from NBI-experienced and inexperienced endoscopists making high-confidence predictions of diminutive polyp histology in real-time show "reasonable certainty" of neoplastic vs. non-neoplastic identity. The NICE classification helps achieve similar performance.

1. Table of Acceptance Criteria and Reported Device Performance

As explained above, specific quantitative acceptance criteria and reported performance metrics (like sensitivity/specificity targets) for a diagnostic AI are not provided in this 510(k) for a colonoscope. The "acceptance criteria" are implied by compliance with various testing standards and guidance, and the "reported performance" is that these tests were conducted and the device complied.

For the NBI feature, which is the closest to an "AI-assisted" clinical claim, the performance is described qualitatively:

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

The document specifies the clinical performance data for the NBI feature came from a meta-analysis of independent studies, with the exception of two Olympus-sponsored studies. It does not provide a specific sample size for a "test set" in the context of an algorithm evaluation, nor does it specify the country of origin of the data or whether the studies were retrospective or prospective. A meta-analysis implies aggregation of various study data.

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

Not applicable in the typical sense for this submission. The clinical data reviewed is a meta-analysis on NBI, where the "ground truth" for polyps (neoplastic vs. non-neoplastic) would typically be established by histopathology, which is the gold standard, not by expert consensus on imaging. The document states: "This application does not seek to show superiority or non-inferiority of NBI to the gold standard histopathology." This confirms histopathology as the ground truth.

The meta-analysis included "NBI-experienced and inexperienced endoscopists," but their role was in making the predictions themselves, not establishing the ground truth from pathology.

4. Adjudication method for the test set

Not applicable in the typical sense for a meta-analysis focused on a medical device. The "ground truth" for the NBI feature's performance in differentiating polyps is histopathology, which does not require an adjudication method among experts on test set images.

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

An MRMC study was not explicitly described in the document as a primary method for this 510(k) submission. The clinical performance data relies on a meta-analysis of existing clinical literature regarding NBI. The description of the meta-analysis does not focus on an "AI vs. without AI assistance" paradigm, but rather on the predictive accuracy of endoscopists utilizing NBI. NBI itself is an imaging mode, not an AI, though it aids human interpretation. The application is for NBI as an "adjunctive tool," suggesting human-in-the-loop performance is inherently assumed. No specific effect size of improvement is quantified in the provided text.

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

No standalone performance data was provided because NBI is an imaging mode used by an endoscopist, not an autonomous AI algorithm. The device itself (the colonovideoscope) is a medical instrument requiring human operation.

7. The type of ground truth used

For the clinical meta-analysis on NBI, the type of ground truth used for polyp differentiation was histopathology. This is explicitly stated: "This application does not seek to show superiority or non-inferiority of NBI to the gold standard histopathology."

8. The sample size for the training set

This information is not applicable as this is not an AI/ML algorithm that undergoes a "training" phase. The clinical data comes from independent studies and Olympus-sponsored studies for a meta-analysis of the NBI feature.

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

This information is not applicable as there is no "training set" in the context of an AI/ML algorithm being cleared via this 510(k) notification. The ground truth for the meta-analysis of NBI's clinical performance was histopathology.

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