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The PENTAX Medical ED-3490TK Video Duodenoscope is intended to provide optical visualization (via a video monitor) of, and therapeutic access to the Biliary Tract via the Upper GI Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Common Bile, Hepatic, and Cystic Ducts. This instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric populations.

The PENTAX Medical ED-3490TK Video Duodenoscope is used with a PENTAX compatible Video Processor (software controlled device). The duodenoscope has a flexible insertion tube, a control body and umbilicus The umbilicus provides connection to the video processor. The control body includes controls for up/down/left/right angulation, air/water delivery, suction and an accessory inlet port. The devices contain light carrying bundles to illuminate the body cavity and a charge couple device (CCD) to collect image data. The instruments contain a working channel through which biopsy devices or other devices may be introduced.

This appears to be an FDA 510(k) clearance letter and summary for a medical device, specifically a duodenoscope. The core of this submission is not about an AI/ML-driven device's performance in terms of diagnostic accuracy or effect on human readers, but rather about an updated version of an existing device, primarily focusing on revisions to its reprocessing instructions for use (RIFU) based on human factors testing.

Therefore, many of the standard questions regarding AI/ML device performance (like MRMC studies, standalone algorithm performance, training set details, ground truth establishment for diagnostic tasks) are not applicable to this document. The "device performance" here refers to the device's physical and functional characteristics, and the "study" is a human factors study on the RIFU, not a clinical trial assessing medical outcomes or AI diagnostic accuracy.

Given the document provided, here's an attempt to address the relevant points and explain why others are not applicable:

Acceptance Criteria and Study for PENTAX Medical ED-3490TK Video Duodenoscope (K192280)

This 510(k) submission primarily focuses on improved "Reprocessing Instructions for Use (RIFU)" for the PENTAX Medical ED-3490TK Video Duodenoscope, not on the diagnostic/imaging performance of an AI/ML component. The "study" mentioned is a human factors study to ensure the RIFU are clear and lead to proper reprocessing, thereby enhancing safety and effectiveness in that aspect.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific submission, the "performance" is related to the usability and clarity of the Reprocessing Instructions for Use (RIFU), assessed through human factors testing.

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

The document states a "Human Factors study" was conducted to revise the RIFU.

• Sample Size: The specific sample size for the human factors test set is not provided in this 510(k) summary. Human factors studies typically involve a defined number of representative users.
• Data Provenance: The data provenance (e.g., country of origin, retrospective/prospective) is not specified in this summary. Human factors studies are inherently prospective, as they involve users interacting with the instructions and device in a controlled setting.

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

This question is not applicable in the traditional sense of diagnostic ground truth for an AI model.

The "ground truth" here would be the correct/intended reprocessing steps. The human factors study evaluates whether users can correctly follow those steps based on the RIFU. This involves observing user performance. The "experts" would be the designers of the RIFU and the human factors specialists who designed and analyzed the study, not annotators for image data. The document does not specify the number or qualifications of these internal experts.

4. Adjudication Method for the Test Set

This question is not applicable as there is no diagnostic "ground truth" being adjudicated between multiple human readers or an AI. The human factors study involved evaluating user performance based on whether they correctly followed the revised RIFU. The evaluation method would be specified in the human factors study protocol but is not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size of AI vs. Without AI Assistance

Not applicable. This submission is for a physical medical device (duodenoscope) and revised instructions for its reprocessing, not for an Artificial Intelligence (AI) or Machine Learning (ML) driven diagnostic or assistive device. Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Not applicable. See point 5. There is no standalone algorithm being evaluated.

7. The Type of Ground Truth Used

The "ground truth" in the context of this human factors study is the correct and complete set of reprocessing steps as defined by the manufacturer and relevant standards. The study sought to confirm that the revised RIFU enabled users to achieve this "ground truth" through their actions. It is not an expert consensus, pathology, or outcomes data in the medical diagnostic sense.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device where a "training set" of data is used to train an algorithm. The "training" here refers to the user's ability to learn and follow the instructions, which is what the human factors study assesses.

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

Not applicable. See point 8.

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The ED-3490TK, Video Duodenoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to the Biliary Tract via the Upper GI Tract. This anatomy includes, but is not restricted to, the organs; tissues: and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic, and Cystic Ducts. This instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric populations.

The PENTAX Duodenoscope ED34-i10T is intended to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs: tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts. These instruments are introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.

These Video Duodenoscopes must be used with a PENTAX compatible Video Processor (software controlled device). The endoscopes have a flexible insertion tube, a control body and umbilicus. The umbilicus provides connection to the video processor. The control body includes controls for up/down/left/right angulation, air/water delivery, suction and an accessory inlet port. The devices contain light carrying bundles to illuminate the body cavity and a charge couple device (CCD) to collect image data. The instruments contain a working channel through which biopsy devices or other devices may be introduced.

There is no information in the provided document about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.

The document is a 510(k) premarket notification letter from the FDA to PENTAX of America, Inc., regarding PENTAX Medical ED3490TK Video Duodenoscope and PENTAX Medical ED34-i10T Video Duodenoscope.

The focus of the document is on establishing substantial equivalence to a predicate device (PENTAX ED-3490TK Video Duodenoscope, K161222), primarily based on intended use, technological characteristics, and safety/effectiveness considerations, rather than detailed performance study results of the type requested.

Specifically, the document states:

• Performance Data: "No performance standards or special controls applicable to these devices have been adopted under Section 513 or 514 of the Federal Food, Drug, and Cosmetic Act."
• Technological Characteristics: The differences between the subject devices and the predicate device are listed as "O-ring Thickness" and "Elevator Link Concentricity." The proposed design change to the O-ring was to demonstrate a "minimum of 10% Compression Ratio," and it is stated that "Through analysis, the modification has demonstrated a Compression Ratio that met the pre-determined acceptance criterion." This is the only mention of an acceptance criterion and its fulfillment by analysis, not by a detailed clinical or performance study with the metrics you've requested.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document describes a regulatory clearance based on substantial equivalence, with a focus on design changes and their impact on safety and effectiveness, rather than a detailed performance study with clinical or AI-related metrics.

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The ED-3490TK, Video Duodenoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to the Biliary Tract via the Upper GI Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic, and Cystic Ducts. This instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric populations.

The ED-3490TK Video Duodenoscope must be used with a PENTAX compatible Video Processor (software controlled device). The endoscope has a flexible insertion tube, a control body and umbilicus. The umbilicus provides connection to the video processor. The control body includes controls for up/down/left/right angulation, air/water delivery, suction and an accessory inlet port. The device contains lightcarrying bundles to illuminate the body cavity and a charge couple device (CCD) to collectimage data. The instrumentcontains a working channel through which biopsy devices or other devices may be introduced. The Video Processor contains a 300 watt short Arc Xenon lamp which provides white light that is focused at the connected video endoscope lightguide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.

This document is a 510(k) premarket notification for the PENTAX Medical ED-3490TK, Video Duodenoscope. The document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a study to prove the device meets specific acceptance criteria for a novel AI or diagnostic performance claim.

Therefore, many of the requested sections regarding AI/algorithm performance studies, such as specific acceptance criteria for diagnostic metrics, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable to this submission. This is a medical device clearance for an endoscope, not an AI-powered diagnostic tool.

The document highlights changes to the device (distal end design, reprocessing procedures) and discusses non-clinical tests conducted to support safety and effectiveness.

Here's a breakdown based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) that would be relevant for an AI-driven diagnostic device. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device and showing that design changes do not raise new questions of safety or effectiveness.
• Reported Device Performance:
  • Safety and Performance Data (Non-clinical tests): "PENTAX Medical has conducted performance testing and design analysis to demonstrate the safety and effectiveness of the elevator wire channel seal, as well as the distal end cap seal strength and integrity."
  • Biocompatibility: "Biocompatibility of the ED-3490TK was evaluated in accordance with ISO 10993-1."
  • Software: "Software changes were made to enhance functionality and do not raise new or different questions of safety and effectiveness. Changes were validated in accordance with FDA's 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'."
  • Reprocessing Validation: "Validation of the cleaning, disinfection, and sterilization instructions was performed in accordance with FDA's guidance, 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'. The following Technical Information Reports (TIRs) were referenced: AAMI TIR 12:2010, AAMI TIR30:2011."
  • EMC and Electrical Safety: "No changes have been made to the EMC or electrical safety as compared to prior submission (K092710)."

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

• Not applicable for diagnostic performance. The document mentions "performance testing and design analysis" for mechanical and reprocessing aspects, but does not specify sample sizes in the context of a "test set" for a diagnostic algorithm because one is not being evaluated.
• The studies conducted are internal engineering and validation tests, not clinical studies with patient data for diagnostic evaluation.

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

• Not applicable. This information is relevant for AI/diagnostic performance studies where ground truth is established by medical experts for image interpretation. This document pertains to an endoscope's mechanical and sterilization properties.

4. Adjudication Method for the Test Set:

• Not applicable. This applies to clinical diagnostic studies, not device engineering or reprocessing validation.

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 done. This device is an endoscope, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• No, a standalone algorithm performance study was NOT done. This device is an endoscope, not an AI algorithm.

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" would be established through engineering specifications, direct measurements, and established industry standards (e.g., ISO 10993-1 for biocompatibility, AAMI TIRs for reprocessing). It's not clinical "ground truth" like pathology or outcomes data.

8. The Sample Size for the Training Set:

• Not applicable. There is no AI algorithm being trained for this device notification.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. There is no AI algorithm being trained for this device notification.

In summary, this 510(k) submission for the PENTAX Medical ED-3490TK Video Duodenoscope focuses on non-clinical testing (biocompatibility, reprocessing, mechanical integrity, software validation for functionality, EMC/electrical safety) to demonstrate substantial equivalence to a predicate device. It does not involve AI or diagnostic performance studies, and therefore, most of the requested fields regarding acceptance criteria and studies for AI performance are not relevant to this document.

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