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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 GASTROINTESTINAL VIDEOSCOPE GIF-1TH190 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

The GIF-1TH190 consists 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 GIF-1TH190 is identical to that of the primary predicate device (K112680) and reference device (K131902).

This document describes the EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 and its substantial equivalence to a predicate device. It appears to be part of a 510(k) submission to the FDA. The information provided heavily focuses on bench testing and comparison to predicate devices rather than clinical studies with defined acceptance criteria for diagnostic performance metrics like sensitivity or specificity.

Here's an analysis based on the provided text, addressing your specific points:

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

The document does not present a single table of "acceptance criteria" alongside specific reported "device performance" in the way one might expect for a diagnostic AI device (e.g., statistical thresholds for sensitivity/specificity). Instead, the "performance data" section details various engineering and safety tests. The acceptance criteria for these tests are generally implied to be meeting design specifications and regulatory standards.

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

The document explicitly states:

• "No animal study was performed to demonstrate substantial equivalence."
• "No clinical study was performed to demonstrate substantial equivalence."

This indicates that there was no formal test set in the sense of patient data or clinical samples used to evaluate diagnostic performance. The "tests" mentioned are primarily engineering bench tests on the device itself or material and reprocessing validation studies. Therefore, sample size and data provenance are not applicable in the context of clinical/diagnostic performance testing.

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

Since no clinical or diagnostic performance study was conducted on patient data, there was no "ground truth" to be established by experts in this context. The evaluation relies on technical comparisons and non-clinical validations.

4. Adjudication method for the test set

Not applicable, as no clinical or diagnostic performance test set was used that would require adjudication.

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 device is a gastrointestinal videoscope, not an AI-powered diagnostic system or an assistance tool for human readers. It's a hardware device designed for direct human operation for visualization.

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

Not applicable. This is a hardware device for direct visualization by a human, not an algorithm.

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

Not applicable. No "ground truth" for diagnostic purposes was established as no clinical or diagnostic performance study was conducted. The "ground truth" for the various engineering tests would be the established industry standards, regulatory requirements, and internal design specifications.

8. The sample size for the training set

Not applicable, as this is a hardware device and not an AI/machine learning algorithm.

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

Not applicable, as this is a hardware device and not an AI/machine learning algorithm.

Summary Conclusion from the Document:

The document focuses on demonstrating substantial equivalence of the EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 to a legally marketed predicate device (EVIS EXERA III GIF-H190 and referenced PENTAX Video Upper G.I. Scopes EG-3490K) primarily through:

• Comparison of technological characteristics: Highlighting similarities and justifying differences through non-clinical testing.
• Non-clinical performance testing: Including reprocessing validation, biocompatibility, electrical safety/EMC, and various bench performance tests (e.g., optical properties, mechanical durability).
• Risk management: Assurance that potential risks have been identified and mitigated.

The submission did not involve clinical studies, animal studies, or expert evaluations of diagnostic performance, as is typical for traditional hardware medical devices demonstrating substantial equivalence to a well-established predicate. The acceptance criteria are therefore tied to meeting established engineering specifications, regulatory standards, and demonstrating that any differences from the predicate device do not raise new questions of safety or effectiveness.

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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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