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Disposable Distal Cap is used with the endoscope and installed to the distal end of endoscope to keep appropriate endoscopic field of view.

Disposable Distal Cap is used with the endoscope and installed to the distal end of endoscope to keep appropriate endoscopic field of view. Disposable Distal Cap is a single structural product, a total of 3 types, and each type is divided into different specifications according to different inner diameter and the diameter of attaching endoscopic distal end. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10⁻⁶ and placed in a sterility maintenance package to ensure a shelf life of one year.

The provided FDA 510(k) clearance letter and summary for the "Disposable Distal Cap" does not describe an AI medical device. Therefore, the requested information regarding acceptance criteria, study details, human reader performance, AI-specific ground truth, and training set information is not applicable and cannot be extracted from the given document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K984358) based on intended use, technological characteristics, and various performance and biocompatibility tests typical for a physical medical accessory. These tests ensure the device's physical and biological safety and performance, not the performance of an AI algorithm.

Below is a breakdown of what can be extracted or inferred from the provided text, but it will not fulfill the requirements for an AI device as those details are absent.

Acceptance Criteria and Device Performance (Non-AI Device)

Since this is not an AI device, there are no AI-specific performance metrics like sensitivity, specificity, AUC, etc. The acceptance criteria revolve around physical and biological attributes. The document states that the proposed device, "Disposable Distal Cap," is substantially equivalent to the predicate device, "Disposable Distal Attachment (K984358)". This substantial equivalence forms the primary "acceptance criterion" for clearance.

Table of Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence and Performance Data provided for a Non-AI Device):

Information NOT Applicable/Present for an AI Device:

1. Sample size used for the test set and the data provenance: Not an AI device, so no "test set" in the context of AI algorithm evaluation. The testing involved physical device samples.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI device. No ground truth established by experts for algorithmic performance.
3. Adjudication method: Not an AI device. No adjudication method for algorithmic output.
4. 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 an AI device. This type of study is irrelevant.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI device.
6. The type of ground truth used: Not an AI device. "Ground truth" for this device refers to meeting established engineering and biological safety standards (e.g., passing a cytotoxicity test, maintaining a certain connection force).
7. The sample size for the training set: Not an AI device. No training set.
8. How the ground truth for the training set was established: Not an AI device. No training set.

In summary, the provided document details the regulatory clearance for a physical medical accessory, not an AI medical device. Therefore, the questions specifically related to AI device performance and study design cannot be answered from this text.

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The EvoEndo Model LE Gastroscope is intended for the visualization of the upper digestive tract in adults and pediatric patients, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The gastroscope is a sterile single‐use device and can be inserted orally or transnasally.

The EvoEndo Controller is intended for use with an EvoEndo Endoscope for endoscopic diagnosis, treatment, and video observation.

The EvoEndo Endoscopy System is comprised of two regulated components:

• EvoEndo Model LE Single‐Use Gastroscope (hereafter referred to as the EvoEndo Endoscope)
• EvoEndo Controller (hereafter referred to as the Controller)

The EvoEndo Endoscope is a sterile, single‐use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult and pediatric patients. The EvoEndo Endoscope is ethylene oxide (EO) sterilized and is comprised of:

• Handle
• Umbilical Bundle that includes air, water, and suction lines, as well as the video connector
• Endoscope shaft with HD Camera

The Controller of the EvoEndo Endoscopy System translates the images or video captured by the camera at the distal end of the EvoEndo Endoscope to a monitor via an HDMI cable.

The provided FDA 510(k) clearance letter and summary for the EvoEndo Single-Use Endoscopy System (K250900) do not describe a study involving acceptance criteria for device performance in the context of an AI/human reader study. Instead, this submission focuses on extending the indicated age range for an existing medical device (an endoscope system) and increasing its shelf life.

The "performance testing summary" sections (1.7, 1.8, 1.9, 1.10) refer to:

• Non-clinical functional and performance testing (e.g., visual, dimensional, tip deflection, air/water/suction flow rates, optical performance, electrical safety, EMC). These tests have specific acceptance criteria typical for medical device engineering, but they are not related to AI performance, clinical accuracy, or human reader performance.
• Biocompatibility testing
• Human factors/usability engineering testing
• Literature review to support the age extension. This is a scientific review, not a performance study with acceptance criteria of the type requested in the prompt.

Therefore, I cannot fulfill most of the requested information regarding acceptance criteria and studies typical for AI-enabled medical devices or comparative effectiveness studies with human readers. The document does not contain information about:

• A table of acceptance criteria and reported device performance (in the context of clinical accuracy or AI performance).
• Sample sizes used for a test set (clinical images) or the data provenance.
• Number of experts or their qualifications to establish ground truth for a test set.
• Adjudication methods for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study or related effect sizes.
• Standalone (algorithm only) performance.
• Type of ground truth used for clinical validation.
• Sample size for a training set or how its ground truth was established.

The prompt's requirements are designed for AI/imaging analysis devices, which this clearance document does not pertain to. This document is for a physical endoscopy system.

However, I can extract information related to the device and its predicate, as well as the justification for the Indication for Use extension:

Device: EvoEndo Single-Use Endoscopy System
Submission: K250900 (for indication extension and shelf-life extension)
Predicate Device: EvoEndo Single-Use Endoscopy System (K213606)

Summary of Device and Changes:

• Subject Device: EvoEndo Single-Use Endoscopy System (K250900)
  • Components: EvoEndo Model LE Single-Use Gastroscope & EvoEndo Controller
  • Intended Use: Visualization of the upper digestive tract (esophagus, stomach, duodenal bulb) for observation, diagnosis, and endoscopic treatment in adult and pediatric patients (extended from "patients over the age of five years" in predicate). Sterile, single-use, oral or transnasal insertion.
  • Key Differences from Predicate (K213606):
    1. Indicated Age: Removal of "in patients over the age of five years."
    2. Shelf Life: Extended from 6 months to 14 months.
• Predicate Device: EvoEndo Single-Use Endoscopy System (K213606)
  • Intended Use: Same as above, but "in patients over the age of five years."
  • Shelf Life: 6 months.

Acceptance Criteria and "Study" for Indication Extension:

Since this is not an AI-enabled device or a diagnostic device relying on accuracy metrics, the "acceptance criteria" here relate to demonstrating equivalence and safety for the extended indications and shelf life.

Regarding the specific questions in the prompt, based solely on the provided document:

1. A table of acceptance criteria and the reported device performance: As explained above, the "acceptance criteria" for this specific submission relate to the justification for the extended Indication for Use and shelf life, not typical AI/diagnostic performance. The table above attempts to capture this contextually.
2. Sample size used for the test set and the data provenance: Not applicable. No "test set" of clinical images or data was used for a performance validation in this submission type. The justification for age extension was a literature review.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data (like diagnostic accuracy) was not established or presented in this 510(k) for an endoscope.
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: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the current submission, the "ground truth" for the expanded age indication was supported by a clinical literature review and anatomical considerations, along with a risk/benefit evaluation. This is not "ground truth" in the sense of a definitive diagnostic label for performance evaluation.
8. The sample size for the training set: Not applicable. There is no AI training set mentioned.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA document is for the clearance of an endoscope and its extended indications, not an AI-enabled diagnostic device. Therefore, the detailed requirements for AI/diagnostic performance studies cannot be addressed from this document.

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FUJIFILM Endoscope Models EG-840T and EG-840TP is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

FUJIFILM Endoscope Model EG-840N is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. This product can be inserted orally or nasally.

Never use this product for any other purposes.

The insertion portion of the device has a mechanism (hereinafter "the bending portion") which bends the tip from right to left and up and down, and a flexible tube (hereinafter "the flexible portion") consists of the bending portion and operating portion with a knob which controls the bending portion. The forceps channel which runs through the operating portion to the tip is arranged inside the insertion portion for inserting the surgical instrument. The insertion portion of the endoscopes comes into contact with the mucosal membrane.

The tip of the insertion portion is called the "Distal end" which contains the Imaging section, Distal cap, Objective lens, Air/water nozzle, Water jet nozzle (Except EG-840N), Instrument channel outlet, and Light guide. The bending portion is controlled by knobs on the control portion/operation section to angulate the distal end to certain angles.

The Flexible portion refers to the long insertion area between the Bending portion and the Control portion (a part of Non-insertion portion). This portion contains light guides (glass fiber bundles), air/water channels, a forceps/suction channel, a CrOS image sensor, and cabling. The glass fiber bundles allow light to travel through the endoscope to illuminate the body cavity, thereby providing enough light to the CMOS image sensor to capture an image and display the image on a monitor. The forceps channel is used to introduce biopsy forceps and other endoscopic accessories, as well as providing suction.

The control portion/operating section provides a grip to grasp the endoscopes and contains mechanical parts to operate the endoscopes. This section includes a Forceps inlet, which allows endoscope accessories to be introduced. The Scope connector connects the endoscopes to the light source.

The provided FDA 510(k) clearance letter pertains to endoscopes, which are hardware devices, not AI/ML software. Therefore, the information requested regarding acceptance criteria, study details, and data provenance for an AI/ML device is not explicitly present in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device through various non-clinical tests (electrical safety, biocompatibility, endoscope-specific testing, software validation, and reprocessing validation) rather than a clinical effectiveness study involving human readers or AI performance metrics.

However, I can extract information about the device's performance specifications that were tested to prove its general functionality and safety, which can be interpreted as fulfilling certain "acceptance criteria" for a physical medical device.

Here's a breakdown of the available information based on your request, with the caveat that it does not directly address AI/ML performance:

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

The document lists various performance specifications that the device met. It does not provide specific numerical acceptance criteria alongside reported performance values in a table format. Instead, it states that "The subject device met performance specifications in the following additional testing." This implies that the device did meet predefined internal thresholds for these parameters.

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

• Sample Size: Not specified for any of the tests. The document mentions "testing" or "validation activities" without detailing the number of devices or trials involved.
• Data Provenance: Not specified. As this is a 510(k) for a physical medical device (endoscope), the testing would typically be conducted in a laboratory setting by the manufacturer, rather than involving patient data in the context of imaging performance.

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

Not applicable. The tests performed are engineering and safety validations. There is no mention of human expert involvement for establishing "ground truth" in the context of image interpretation or diagnosis, as this is not an AI/ML diagnostic tool.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a concept typically used in clinical studies involving interpretation by multiple readers, which is not described here.

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 is not an AI-assisted device. The document describes a traditional endoscope.

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

Not applicable. The device itself is an endoscope, not an algorithm. Software validation was conducted (IEC 62304:2015), but this relates to the software controlling the endoscope's functions, not a standalone diagnostic AI.

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

For the listed performance specifications (field of view, resolution, etc.), the "ground truth" would be established by objective physical measurements using calibrated equipment and engineering standards. For biocompatibility, it's based on biological response to materials, and for reprocessing, it's based on sterility and decontamination efficacy. There is no "ground truth" in the diagnostic sense as there would be for an AI/ML algorithm.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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Endoscopic Distal Attachment is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.

The Endoscopic Distal Attachment is an additional device, made of TPU designed to attach to the distal end of the endoscope. The device is composed of three main portions: an attaching portion, a distal portion, and a drain portion. The attaching portion is a wider diameter opening which is used to connect the attachment to a compatible endoscope; the distal portion is the ending portion of the attachment which tapers into narrower diameter opening. The hole, which is only available for some models, forms drain portion which prevent the fluids lodging on the surface of the endoscope.

The Endoscopic Distal Attachment can be used in combination with compatible endoscopes to maintain an appropriate endoscopic field of view.

The Endoscopic Distal Attachment has six models, depending on different surface design (flat or incline), with or without hole and with scale or without scale. The models include models of flat face without hole, flat face with hole, inclined face without hole, inclined face with hole, flat face without hole with scale and flat face.

This document is a 510(k) clearance letter for a medical device called "Endoscopic Distal Attachment (AF-D series)". Based on the provided text, the device is not an AI/Software as a Medical Device (SaMD). It is a physical accessory made of TPU that attaches to endoscopes.

Therefore, many of the requested bullet points, such as "MRMC comparative effectiveness study," "standalone (i.e. algorithm only) performance," "sample size for training set," and "how ground truth for training set was established," are not applicable to this type of device and are not discussed in the clearance letter.

The clearance relies heavily on bench testing and biocompatibility data to demonstrate substantial equivalence to a predicate device, rather than clinical study data or AI performance metrics.

Here's an analysis of the provided text in relation to your questions:

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

The document does not present a formal table of acceptance criteria with quantified reported device performance in the precise way you've requested for an AI/SaMD. Instead, it lists the types of performance tests conducted and states that the device "met all design specifications" and "demonstrated safety and essential performance."

The acceptance criteria are implicitly defined by the standards and the comparison to the predicate device. The performance is summarized as meeting these criteria.

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

• Sample Size for Test Set: Not explicitly stated in terms of number of devices or number of tests conducted for each category. The document indicates "performance tests were implemented on both the subject device and the predicate device," implying sufficient samples were used to conduct the various bench tests. This is a physical device, so "test set" would refer to the number of physical devices and components tested.
• Data Provenance: The testing was conducted by Alton (Shanghai) Medical Instruments Co. Ltd. (China). The data origin is from their internal testing. The document implies these are prospective tests conducted specifically for this submission.

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

• N/A. This is a physical non-AI medical device. The "ground truth" for its performance is established through adherence to engineering specifications, material properties, and standardized testing protocols (e.g., ISO, ASTM standards), not through expert consensus on images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• N/A. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical imaging studies or pathology where human annotators are involved. For this physical device, performance is evaluated against objective, measurable criteria defined by engineering standards and specifications.

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. This is a physical device, not an AI/SaMD. MRMC studies are not applicable.

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

• N/A. This is a physical device, not an algorithm.

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

• For this physical device, the "ground truth" (or basis for verification) comes from engineering specifications, material science principles, and international consensus standards (e.g., ISO for biocompatibility and sterilization, ASTM for packaging and mechanical properties). The device's performance is compared against the established limits or requirements of these standards and against the performance of the predicate device.

8. The sample size for the training set

• N/A. This is a physical device, not an AI/SaMD. There is no "training set."

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

• N/A. This is a physical device, not an AI/SaMD. There is no "training set" or corresponding ground truth establishment process in the AI sense.

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The Disposable Distal Attachment D-201 Series have been designed to be attached to the distal end of the endoscope to keep the suitable depth of endoscope's view field within the gastrointestinal tract.

The Disposable Distal Attachment D-201 Series is comprised of seven (7), sterile, single-use, distal attachments of varying diameters. Each distal attachment is a short transparent plastic tube which is attached to the distal end of an endoscope to facilitate observation of tissues during endoscopic procedures. A subset of the models includes a drainage side hole that allows egress of water and blood during use. The Disposable Distal Attachment D-201 Series is to be used with compatible endoscopes.

The provided FDA 510(k) clearance letter and summary for the "Disposable Distal Attachment D-201 Series" does not describe a study involving an AI/Medical Imaging device that requires ground truth, human readers, or a test set as described in the prompt.

Instead, this document describes a traditional medical device (a physical accessory for an endoscope) and the performance testing conducted to demonstrate its substantial equivalence to a predicate device. The performance data focuses on biocompatibility, sterilization, packaging, shelf-life, mechanical testing, and human factors. There is no mention of an algorithm, image analysis, or clinical performance in terms of diagnostic accuracy or reader improvement.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided information, as the requested elements (ground truth, expert consensus, MRMC studies, training/test sets for an algorithm, etc.) are not applicable to this type of device and its clearance process.

The document states: "Clinical data is not required to demonstrate substantial equivalence." This further confirms that no studies involving analysis of images or AI performance were conducted or necessary for this device's clearance.

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PENTAX Medical Video Upper GI Scope EG27-i20c:
The PENTAX Medical Video Upper GI Scope EG27-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.

PENTAX Medical Video Colonoscope EC34-i20cL:
The PENTAX Medical Video Colonoscope EC34-i20cL 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 5kg of body weight.

PETNAX Medical Video Upper GI Scope EG27-i20c
The PENTAX Medical Video Upper GI Scope EG27-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.

PENTAX Medical Video Colonoscope EC34-i20cL
The PENTAX Medical Video Colonoscope EC34-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 provided document describes the clearance of two PENTAX Medical Video Scopes, the Upper GI Scope (EG27-i20c) and the Colonoscope (EC34-i20cL), and does not contain acceptance criteria for specific device performance metrics in the format of a table with reported performance. The document focuses on showing substantial equivalence to predicate devices through various non-clinical performance data categories.

Therefore, I cannot fulfill your request for "A table of acceptance criteria and the reported device performance".

However, I can extract information related to the studies conducted to support the substantial equivalence:

Non-Clinical Performance Data / Studies Conducted:

The document mentions several non-clinical performance tests but does not define specific acceptance criteria or report numerical performance results against those criteria. Instead, it generally states that "All acceptance criteria were satisfied" or that the devices demonstrated equivalence.

Here's a breakdown of the studies mentioned and related information:

• Sample size used for the test set and the data provenance: Not specified for any of the tests.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified for any of the tests. The document does not mention the use of experts to establish ground truth for testing.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned. The document primarily focuses on technical and safety equivalence.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The devices are endoscopes, which are human-in-the-loop devices. The document does not describe any standalone algorithm performance testing.
• The type of ground truth used: Not explicitly stated for any test. For the "Animal Image Capture Study," it compares "visualizations of vascularity and mucosal surfaces" to predicate devices, implying a qualitative assessment.
• The sample size for the training set: Not applicable, as these are hardware medical devices (endoscopes) and not AI/machine learning algorithms that require training sets in the typical sense.
• How the ground truth for the training set was established: Not applicable for the reasons mentioned above.

Detailed Information from the Document Regarding Studies:

1. Reprocessing Validation:

   • Study: Simulated use testing, cleaning, high-level disinfecting, and rinsing validation studies for EG27-i20c and EC34-i20cL.
   • Purpose: Confirmed effectiveness of reprocessing procedures.
   • Acceptance Criteria: Established in accordance with AAMI TIR 30:2011 for amount of residual soil accumulation and extraction efficiency.
   • Results: "All acceptance criteria were satisfied."

2. Sterilization and Shelf Life:

   • Study: Validation of System 1E liquid chemical sterilization with STERIS Corporation.
   • Purpose: Confirmed suitable sterilization method.
   • Results: Devices are not provided sterile, shelf-life not applicable.

3. Biocompatibility:

   • Study: Assessment of cytotoxicity, sensitization, and intracutaneous reactivity for direct and indirect contact materials.
   • Standard: In accordance with ISO 10993-1:2018.
   • Results: Risk levels of local toxicity determined as "Acceptable."

4. Software and Cybersecurity:

   • Study: Software verification and validation, including cybersecurity assessments.
   • Standards/Guidance: IEC 62304:2006 + A1:2015 and FDA Guidance for Industry and Staff.

5. Electrical Safety and EMC:

   • Study: Testing to confirm acceptable levels of electrical safety (ES) and electromagnetic compatibility (EMC).
   • Standards: IEC 60601-1-2:2014 + A1:2020; IEC 60601-1:2005 + A1:2012 + A2:2020; IEC 60601-1-6:2010 + A1:2013 +A2:2020; and IEC 60601-2-18:2009.

6. System Performance:

   • Results: "The system performance of the subject device demonstrated the equivalence to the predicate/reference devices."

7. Optical Performance:

   • Study: Measurement of optical properties of imaging and illumination performances.
   • Results: "All results show that the optical characteristics of the subject devices are equivalent to those of the predicate devices."

8. Animal Image Capture Study:

   • Study: Used as part of optical and color performance testing.
   • Purpose: To demonstrate visualization capabilities.
   • Results: "The findings demonstrate that the subject devices provide visualizations of vascularity and mucosal surfaces for each anatomical area comparable to those achieved by the predicate devices."

In summary, the document provides evidence of various non-clinical performance studies demonstrating that the new PENTAX Medical Video Scopes meet established safety and performance standards and are substantially equivalent to predicate devices. However, it does not present this information in the specific structured format requested for acceptance criteria and reported numerical performance values.

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This hood is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.

This hood is intended to be used in compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.

Principles of Operation: Align the objective lens of endoscope with the drain of the hood and attach the hood to the distal end of endoscope by pressing the hood until it stops. Securely attach the endoscope with sterile medical tape. Insert the endoscope equipped with the hood through the mouth. Perform the intended treatment. After completion of the examination, slowly withdraw the endoscope along with the attached hood. Peel the tape off the endoscope completely and remove the hood from the endoscope. Dispose of the hood and tape according to local laws and regulations.

The presented document is a 510(k) summary for the Hood (DH-083ST) by Fujifilm Corporation. It describes the device's intended use and performance testing conducted to demonstrate substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "performance testing was conducted, and the passed all test objectives."

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

This information is not provided in the document. The testing described focuses on physical dimensions and compatibility with endoscopes, rather than a clinical evaluation requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests (dimensional measurements and compatibility), an adjudication method as typically used in clinical studies with human interpretation is unlikely and not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable and therefore not provided. The device is a physical hood for an endoscope, not an AI-powered diagnostic tool.

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

This information is not applicable and therefore not provided. The device is a physical component (an endoscope hood), not an algorithm.

7. The Type of Ground Truth Used

For the described tests, the "ground truth" would be the engineering specifications and measurements of the device's dimensions and its fit with compatible endoscopes, along with compliance with the ISO 8600-1:2015 standard. There is no mention of expert consensus, pathology, or outcomes data as these types of ground truth are more relevant for diagnostic or therapeutic devices with clinical interpretation.

8. The Sample Size for the Training Set

This information is not provided and not applicable as this is not an AI/machine learning device that requires a training set.

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

This information is not provided and not applicable as this is not an AI/machine learning device.

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FUJIFILM Endoscope Models EG-840T and EG-840TP is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophaqus, stomach, and duodenum.

FUJIFILM Endoscope Model EG-840N is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. This product can be inserted orally or nasally. Never use this product for any other purposes.

The insertion portion of the device has a mechanism (hereinafter "the bending portion") which bends the tip from right to left and up and down, and a flexible tube (hereinafter "the flexible portion") consists of the bending portion with a knob which controls the bending portion. The forceps channel which runs through the the tip is arranged inside the insertion portion for inserting the surgical instrument. The insertion of the endoscopes comes into contact with the mucosal membrane.

The tip of the insertion portion is called the "Distal end" which contains the Imaging section, Distal cap, Objective lens, Air/water nozzle, Water jet nozzle (Except EG-840N), Instrument channel outlet, and Light guide. The bending portion is controlled by knobs on the control portion/operation section to angulate the distal end to certain angles.

The Flexible portion refers to the long insertion area between the Control portion (a part of Non-insertion portion). This portion contains light guides), air/water channels, a forceps/suction channel, a CMOS image sensor, and cabling. The class fiber bundles allow light to travel through the endoscope to illuminate the body cavity, thereby providing enough light to the CMOS image sensor to capture an image on a monitor. The forceps channel is used to introduce biopsy forceps and other endoscopic accessories, as well as providing suction.

The control portion/operating section provides a grip to grasp the endoscopes and contains mechanical parts to operate the endoscopes. This section includes a Forceps inlet, which allows endoscope accessories to be introduced. The Scope connector connects the endoscopes to the light source.

This is a 510(k) summary for medical devices (endoscopes), and it refers to "bench testing data" and "performance specifications" being met, rather than clinical study results against acceptance criteria in the manner of an AI/algorithm-driven device.

From the provided text, there is no information about acceptance criteria or a study proving that an AI-driven device meets those criteria for the following reasons:

• Device Type: The devices described (FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP) are physical endoscopes for visualization, diagnosis, and treatment. They are not described as AI or software-as-a-medical-device (SaMD) products designed to process or interpret images/data using algorithms.
• Study Types Mentioned: The document refers to:
  • Electrical safety evaluations (standards: ANSI/AAMI ES 60601-1-2012, IEC 60601-1-6:2020, IEC 60601-2-18:2009)
  • Biocompatibility testing (standards: ISO 10993-5:2009, ISO 10993-10:2010, FDA guidance)
  • Endoscope-specific testing (standards: ISO 8600-3:1997, ISO 8600-4:2014)
  • Software-specific testing (standard: IEC 62304:2015, FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) - This refers to software within the device, not a standalone AI algorithm for medical image analysis.
  • Cleaning and disinfection validation (FDA guidance)
  • Additional testing for physical parameters like Field of view, Bending capability, Rate of suction, Working length, Diameter of forceps channel, Resolution, LG output, Uneven illumination, Viewing direction, Color reproducibility.

The phrase "Resolution" is listed twice, implying a focus on the optical performance of the endoscope itself.

Therefore, the information required for your request (acceptance criteria, study details for an AI-driven device) cannot be extracted from this document because it pertains to the clearance of a traditional medical device (an endoscope) and not an AI/algorithm-based diagnostic or treatment tool.

If this were an AI device, the document would typically contain sections explicitly detailing:

• The AI algorithm's intended use and function (e.g., detecting polyps, classifying lesions).
• Specific performance metrics (e.g., sensitivity, specificity, AUC) for the AI.
• The clinical study design, comparator (e.g., human experts), and statistical analysis.
• Details about the dataset used (test set, training set, ground truth derivation).

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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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Ambu® aScope™ Gastro Large:
The endoscope is a sterile, single-use, flexible gastroscope intended to be used for endoscopic access to and examination of the upper gastrointestinal anatomy.
The endoscope is intended to provide visualization via a compatible Ambu displaying unit and to be used with endotherapy accessories and other ancillary equipment.
The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ Gastro Large Endoscopy System is a system used for endoscopic procedures in the upper gastrointestinal anatomy. It consists of a sterile, single-use, flexible endoscope, the Ambu® aScope™ Gastro Large, and a displaying unit, the Ambu® aBox™ 2.

The provided text does NOT describe an AI/ML-driven device or study. It is a 510(k) summary for a medical device called the Ambu® aScope™ Gastro Large Endoscopy System. This system is an endoscope and a display unit used for examining the upper gastrointestinal anatomy.

The document discusses various performance tests relevant to a physical medical device (e.g., geometrical characteristics, functional performance of insufflation/suction, optical performance, biocompatibility, sterilization, electrical safety, etc.). It explicitly states that the device has "similar technological characteristics and principles of operation" to its predicate devices, with only "minor technological differences" that "raise no new concerns regarding safety or effectiveness."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria from an AI/ML perspective, as the provided text pertains to a traditional, non-AI medical device. The information you requested (sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are specific to the evaluation of AI/ML algorithms, which are not mentioned or implied in this document.

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