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The COLONOVIDEOSCOPE OLYMPUS CF-EZ1500DL & CF-EZ1500DI are intended to be used with a video system center, endoscope position detecting unit, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

The COLONOVIDEOSCOPE OLYMPUS CF-EZ1500DL/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-EZ1500 is intended to be used with a video system center, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-EZ1500 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

The endoscope consists of three parts: the control section, the insertion section, and the connector section.

1. Control section: The UP/DOWN angulation control knob and the RIGHT/LEFT angulation control knob on the control section are connected to the tip of the bending section by a series of wires. By operating the angulation control knobs, the bending section at the distal end bends vertically or parallel to guide the distal end for insertion and observation. The observation mode can be selected by focus switching function, "near focus mode" featuring innovative resolving power for close observation or "normal focus mode" for normal observation. To realize the dual focus mechanism, Voice Coil Motor (VCM) is incorporated as an actuator. The endoscope contains a cylinder to attach a suction valve for suction and air/water valve. Depressing the suction valve will allow the physician to use the endoscope to suction any fluids which are obscuring a good view of the tissue. Therapeutic instruments can be passed through the instrument channel for performing endoscopic biopsy and other therapies. Depressing the air/water valve will allow the doctor to feed water through the endoscope for lens washing. It also can be operated to feed air for removing any fluids or debris adhering to the objective lens.

2. Insertion section: The insertion section has main parts including the image guide, light guides that bring light from the video system center through the endoscope, and instrument channel where therapeutic tools can be pushed in and out (also the suction channel).

3. Connector section: The connector section connects the endoscope with the video system center (CV-1500) through the universal cord.

It appears crucial information regarding the AI or software components' acceptance criteria and the specific study proving the device meets these criteria is missing from the provided FDA 510(k) clearance letter for the Olympus Endoscopes (K250432).

The document details the substantial equivalence of the new endoscopes (CF-EZ1500DL/DI and GIF-EZ1500) to their predicates based on physical characteristics, intended use, and general performance. It mentions extensive non-clinical testing, including:

• Reprocessing validation
• Biocompatibility testing
• Software verification and validation (mentioning FDA guidance for software in medical devices, but not detailing specific performance criteria or tests related to AI/image analysis capabilities)
• Electrical safety and EMC
• Bench testing (performance characteristics like DOF/FOV, Resolution, Noise, etc.)
• Animal study to confirm WLI, NBI, RDI, and TXI performance.
• Risk management

However, the prompt asks for specifics related to an AI/Software component's acceptance criteria and its performance study. The provided text focuses on the endoscope hardware itself and its basic image capture and display functionalities. There is no mention of any AI-driven image analysis, diagnostic augmentation, or automated detection capabilities that would require the kind of clinical performance study details (e.g., sample size, ground truth, expert adjudication, MRMC studies) outlined in the prompt.

The "Indications for Use" for these endoscopes clearly state their purpose is for "endoscopy and endoscopic surgery" for visualization. They are tools for observation and facilitating therapeutic accessories. They are not described as having an AI component for automated analysis or diagnosis.

Therefore, since the provided document does not indicate the presence of an AI or advanced software feature requiring a separate performance study with associated acceptance criteria, I cannot fulfill most of the requested points.

Here's what can be inferred or stated based on the provided document and the information that is explicitly NOT present:

Based on the provided document, there is no evidence of an AI-driven or advanced image analysis software component in the Olympus Endoscopes (CF-EZ1500DL/DI and GIF-EZ1500) that would necessitate the type of acceptance criteria and performance study described in the prompt.

The 510(k) clearance focuses on demonstrating substantial equivalence to predicate endoscopes by comparing physical and operational characteristics, and through general performance testing of the device hardware and its fundamental image capture capabilities.

However, if we were to hypothetically assume there was an AI/Software component (e.g., for polyp detection), and based on common FDA expectations for such devices, here's how the answer would look, highlighting what's missing:

Acceptance Criteria and Study Proving Device Performance (Hypothetical AI Component)

Note: The provided FDA 510(k) clearance letter for K250432 does not detail any specific AI or advanced image analysis software functionality, nor does it contain the performance study metrics for such a component. The following table and points are constructed under the assumption of such a component existing, to illustrate what an ideal response would contain if the information were available in the document.

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical AI Component)

Since no AI/software component is described in the provided document, this table cannot be filled with actual data. Below is a hypothetical example of what such a table would contain if an AI component for, e.g., polyp detection, were present.

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set: Not specified (as no AI performance study is detailed). Typical AI/CADe clearances involve hundreds to thousands of cases.
• Data Provenance: Not specified. For AI devices, this would typically include details like:
  • Country of Origin (e.g., multi-center, US, Europe, Asia)
  • Retrospective or Prospective collection
  • Diversity of patient demographics, disease prevalence, equipment used, etc.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified. For AI/CADe devices, often 3 or more independent experts are used.
• Qualifications of Experts: Not specified. Typically, this would involve board-certified gastroenterologists or colorectal surgeons with significant experience (e.g., 5-10+ years) in endoscopic procedures, potentially sub-specialized in screening/surveillance or interventional endoscopy.

4. Adjudication Method for Test Set

• Adjudication Method: Not specified. Common methods for AI medical device clearances include:
  • Majority Rule: E.g., 2 out of 3, or 3 out of 5 experts agree.
  • Consensus Reading: Experts review and discuss cases to reach a unanimous decision.
  • 2+1 or 3+1: Initial reads by 2 or 3 experts, with a senior adjudicator resolving discrepancies.
  • Pathology Correlation: Where possible, biopsy/histology results serve as the definitive ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Conducted?: No mention of an MRMC study. The document states "No clinical study was performed to demonstrate substantial equivalence." This implies that any human-in-the-loop performance evaluation of an AI component was not required or not conducted for this 510(k).
• Effect Size of Human Improvement (if applicable): Not applicable as no MRMC study is mentioned. If performed, this would report metrics like the change in reader sensitivity, specificity, or reading time with AI assistance compared to without.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Conducted?: No explicit mention of a standalone algorithm performance study with specific metrics (e.g., AUC, sensitivity, specificity on a defined dataset). The "Software verification and validation" generally refers to software engineering and quality assurance, not necessarily clinical performance of an AI algorithm itself.

7. Type of Ground Truth Used

• Type of Ground Truth: Not specified. If an AI component were present for lesion detection, ground truth would typically be established by:
  • Expert Consensus: As described in point 3.
  • Pathology/Histology: Biopsy results confirming the presence or absence of lesions. This is often considered the gold standard for many gastrointestinal applications.
  • Clinical Outcomes Data: Long-term follow-up to confirm diagnoses, though less common for initial device clearance.

8. Sample Size for Training Set

• Sample Size for Training Set: Not specified. This information is typically not included in FDA clearance letters unless directly relevant to a novel AI claim. Training set sizes for medical AI can range from thousands to hundreds of thousands of images/cases.

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set: Not specified. It would generally be established through similar methods as the test set (e.g., expert annotations, pathological confirmation), often with additional data augmentation or curation processes.

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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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