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FUJIFILM Endoscope Model EC-760S-A/L

This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. Never use this product for any other purposes.

Endoscopy Support Program EW10-VM01

This software provides image information to assist the user in estimating the size of an object displayed in the endoscopic field of view. This software provides no therapeutic or diagnostic function.

FUJIFILM Endoscope Model EC-760S-A/L is comprised of three general sections; a control portion, an insertion portion and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains glass fiber bundles, several channels and a complementary metal-oxide-semiconductor (CMOS) image sensor, and laser emitting window in its distal end. The insertion portion assist in delivering air/suction as well as endoscope accessories. such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The endoscope is used in combination with the Company's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart.

Endoscopy Support Program EW10-VM01 is a software-only device that detects the laser spot position of the dedicated endoscope in the image obtained via the video processor and displays a superimposed scale ("Virtual Scale") in the endoscopic image (e.g., displayed in a monitor). The Virtual Scale images can be either linear or circular. The virtual scale shows the graduated markings at 5mm, 10mm, and 20mm. EW10-VM01 must be installed on a personal computer (PC) that meets the mandatory system requirements for it to function. When the PC with EW10-VM01 connects to the video processor and the Virtual Scale function is turned ON. EW10-VM01 automatically retrieves the calibration data from the EC-760S-A/L. EW10-VM01 uses the data from the calibration table and detects the relative position of the red laser beam in the endoscopic image. EW10-VM01 superimposes the virtual scale images in the endoscopic image in real-time. The virtual scale acts as the virtual reference for the users to estimate sizes.

Here's a breakdown of the acceptance criteria and study information for the Endoscopy Support Program EW10-VM01, based on the provided document.

Acceptance Criteria and Reported Device Performance

The document states that the "Accuracy of Virtual Scale images with Endoscopy Support Program EW10-VM01 has been evaluated." However, it does not explicitly list quantitative acceptance criteria for accuracy (e.g., a specific percentage error or range of deviation) nor does it provide the reported device performance against any such criteria. It only confirms that the evaluation was performed.

Study Details for Endoscopy Support Program EW10-VM01

Given the information in the provided text, many details about the specific study proving the device meets acceptance criteria are not explicitly provided. The document focuses on general compliance with standards and the fact that evaluations were performed, rather than furnishing detailed study methodologies or results for the EW10-VM01 software.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The document generally discusses testing of the Endoscope Model EC-760S-A/L and the EW10-VM01 software.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated.

3. Adjudication method for the test set: Not explicitly stated.

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:

   • MRMC Study: Not explicitly stated.
   • Effect Size: Not explicitly stated. The software "provides image information to assist the user in estimating the size of an object," implying an assistive role. However, the document does not compare human performance with and without the assistance.

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

   • The document implies a standalone evaluation of the software's accuracy: "Accuracy of Virtual Scale images with Endoscopy Support Program EW10-VM01 has been evaluated." It also states, "The software does not have a measuring function—the software only calibrates the virtual scale (e.g., by the object recognition), and does not estimate the measurement by itself." This suggests the calibration and display of the virtual scale is the standalone function evaluated, rather than the software performing a measurement autonomously.

6. The type of ground truth used: Not explicitly stated. Given that it relates to the "Accuracy of Virtual Scale images," the ground truth would likely be precise, independently measured physical dimensions of objects in the endoscopic field of view.

7. The sample size for the training set: Not explicitly stated.

8. How the ground truth for the training set was established: Not explicitly stated.

Summary of available information:

The document confirms that the Endoscopy Support Program EW10-VM01 software was evaluated for "Accuracy of Virtual Scale images" and "in-vivo performance testing of visualization of laser spot". It also states that the software was evaluated using IEC 62304:2015 and in accordance with FDA's guidance for software in medical devices. However, it does not provide specific quantitative results, sample sizes, expert details, or ground truth methodologies for these evaluations. The focus of this 510(k) summary is to demonstrate substantial equivalence through compliance with recognized standards and general performance evaluations, rather than to present detailed efficacy study results.

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The AccuMeasure™ System is intended to be used as an accessory in conjunction with an endoscope to measure observable anatomy and pathology in the gastrointestinal tract. The AccuMeasure™ System provides no therapeutic or diagnostic function.

The device is used in conjunction with an endoscope to measure objects on the mucosal surface of the gastrointestinal (GI) tract. The device consists of two components (1) the measuring device and (2) a processing unit. The measuring device consists of a through the scope probe that is connected to a handheld laser source. The processing unit includes a video grabber and a touch screen PC. The medical-grade PC comes with dedicated software for conducting measurements during an endoscopic procedure.

Here's a breakdown of the acceptance criteria and the study information for the AccuMeasure™ System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This table focuses on the "Accuracy Validation" from the Performance Testing - Bench section, as it's the primary quantitative performance claim for the device's main function.

Note: The clinical study did not assess the accuracy of the device due to limitations in determining the true length of structures in vivo. Its primary endpoints were safety and usability.

Study Details

Here's a breakdown of the specific information requested:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size (for accuracy): The accuracy validation was conducted via bench testing using "phantoms" (simulated round and flat polyps between 5-15 mm in diameter). The exact number of simulated polyps or measurements is not specified, but the text states "for all sizes."
• Test Set Sample Size (for clinical study, usability/safety): The clinical study involved [redacted] patients from a healthcare facility in Israel.
  • [redacted] patients were excluded for poor preparation.
  • 100 patients had no polyps.
  • [redacted] patients were excluded due to an endoscope issue.
  • The remaining [redacted] patients had one or more polyps.
  • A total of [redacted] polyps were attempted to be measured.
  • [redacted] polyps could not be measured.
  • Of the remaining, physicians measured [redacted] polyps.
• Data Provenance:
  • Accuracy Test (Bench): Not explicitly stated, but implies internal testing by the manufacturer.
  • Clinical Study (Usability/Safety): Prospective; conducted at a healthcare facility in Israel.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Accuracy Test (Bench): For the bench testing, ground truth was the known, precise dimensions of the simulated polyps in the phantoms. No human experts were required to establish this ground truth, as it was inherent to the phantom design.
• Clinical Study (Usability/Safety): The clinical study focused on physician subjective assessments of usability and safety, not on establishing a ground truth for measurement accuracy. The measurements obtained in the clinical study were not used to assess the accuracy of the device against a "true" measurement. [redacted] physicians participated in the study; their qualifications are not specified beyond being "physicians."

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

• Accuracy Test (Bench): Not applicable. The ground truth was objective (known dimensions of phantoms).
• Clinical Study (Usability/Safety): The clinical study involved subjective user assessments. No adjudication method for ground truth determination was applicable, as ground truth for accuracy was not assessed in vivo. For adverse events, standard clinical monitoring was performed, but no formal adjudication of disagreements is described.

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 comparative effectiveness study was done. The clinical study was solely for safety and usability, not comparative effectiveness with human readers or other measurement methods.
• The text does state that the device "demonstrated greater accuracy than other methods of assessing length during endoscopy procedures (e.g., visual estimation, biopsy forceps, and snares)" based on bench testing compared to previously published estimates of error ranges for visual estimation and biopsy forceps. This is not an MRMC study with human readers using the AI vs. without AI assistance.

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

• Standalone Performance (Accuracy): Yes, the "Performance Testing - Bench" section describes testing where the device (AccuMeasure™ System software) acquired images and made measurements of simulated polyps in phantoms. This was evaluating the algorithm's performance in a controlled, non-human-in-the-loop setting for its core function of measurement accuracy.
• Standalone Performance (Clinical): No. While the algorithm performs the calculation, it is used "in conjunction with an endoscope" and requires physician interaction to acquire images, position the laser, and
  drag target markers. It is not intended to be a standalone diagnostic device.

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

• Accuracy Test (Bench): Objective, precisely known physical dimensions of simulated polyps within custom-built phantoms.
• Clinical Study (Usability/Safety): The "ground truth" for the clinical study was physician subjective assessments via questionnaires for usability and observation for adverse events for safety. There was no ground truth for measurement accuracy in this study.

8. The sample size for the training set

• The provided text does not mention a specific training set sample size. The software is pre-calibrated for each endoscope model, but details about dataset size or how frequently "training" occurs are not given. This product description focuses on verification and validation, not development.

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

• Given that the text does not mention a specific training set or process (beyond "pre-calibrated for each endoscope model to find its camera parameters and distortion coefficients"), the method for establishing ground truth for any potential training data is not described. It's possible that proprietary internal calibration procedures provided the necessary reference data without a formal "ground truth establishment" process in the context of an AI/ML training paradigm.

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The Dornier MINNOW Ureteral catheter is indicated for access and catheterization of the urinary tract, including the following applications: Delivery of contrast media Drainage of fluids from the urinary tract Delivery of irrigation fluids to the urinary tract Navigation of a tortuous ureter Access, advancement, or exchange of wire quides

The target population is for adults only (at least 22 years old).

The MINNOW Ureteral Catheter is a sterile single lumen medical grade thermoplastic elastomer (Pebax®) catheter. It is designed to assist in access to the upper urinary tract using standard endoscopic technique for drainage and delivery of gels or fluids. The device is offered without side holes and is available in 5 and 6 Fr. Sizes, which are common to the industry. The catheter is indicated for use by physicians for facilitating access to the urinary tract through a retrograde route and may be used in conjunction with a quidewire or for the injection of gels or fluids into the urinary tract. The catheter tip is radiused and has a .041" ID that allows for a smooth transition and passage when placed over a guidewire of up to 0.038" inches in diameter that is pre-positioned through the urological tract. The MINNOW Ureteral Catheters are packaged with a standard Touhy-Borst adapter that allows for injection or aspiration of fluids, but removable to allow for scope exchange without having to remove the catheter. The MINNOW Ureteral Catheters are available in 5 and 6 French (Fr) diameter, with a catheter length of 70 centimeters (cm).

This document describes a 510(k) submission for the Dornier MINNOW Ureteral Catheter, aiming to demonstrate its substantial equivalence to a predicate device. The information provided outlines the performance testing conducted to support this claim, rather than a clinical study evaluating the device's diagnostic performance or effectiveness in a "with AI vs without AI" scenario.

Therefore, many of the requested categories regarding acceptance criteria, study details, human reader performance, ground truth, and training sets are not applicable to this type of regulatory submission, as it focuses on demonstrating equivalence through engineering and biocompatibility testing for a physical medical device, not a diagnostic AI system.

Here's an analysis based on the provided text, addressing the applicable points and indicating when information is not relevant to this type of device and submission:

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

The document does not explicitly provide a table of acceptance criteria with specific numerical targets and matching reported performance values. Instead, it lists the types of tests performed and states that "All testing was found to be acceptable and substantially equivalent to those of the predicate device."

Note: Specific numerical acceptance criteria and performance values are not detailed in this summary. The "acceptable" status implies compliance with relevant standards and/or equivalence to the predicate device's performance within acceptable ranges.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described (sterility, biocompatibility, mechanical properties) would typically involve specific sample sizes for each test according to established standards. Data provenance (country, retrospective/prospective) is not applicable, as this is laboratory testing of a manufactured physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. For this type of physical medical device (catheter), "ground truth" as it pertains to expert consensus on diagnostic images or clinical outcomes is not relevant. The "ground truth" for the performance tests would be defined by the specifications and standards for each physical or chemical property being measured. Expert involvement for physical/chemical testing is usually in the form of qualified laboratory personnel conducting the tests and engineers/scientists reviewing the results against specifications.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments, often for diagnostic devices. The testing described here involves objective physical and chemical property measurements.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices where human performance with and without AI assistance is being evaluated. The Dornier MINNOW Ureteral Catheter is a physical medical device (catheter) for access and fluid management in the urinary tract, not a diagnostic AI system.

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

This information is not applicable. The device is a physical ureteral catheter, not an algorithm or AI system.

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

For the physical and material integrity tests conducted (Sterility, Packaging, Biocompatibility, Radiopacity, Effective Working Length, Catheter Shaft ID, Catheter Tensile Strength, Catheter Stiffness), the "ground truth" is defined by established engineering specifications, material standards (e.g., USP Class VI for biocompatibility), and relevant ISO/ASTM testing standards. There is no "expert consensus," "pathology," or "outcomes data" in the traditional sense for these types of tests in this context. The aim is to meet predefined technical requirements and demonstrate equivalence to the predicate device's performance.

8. The sample size for the training set

This information is not applicable. The Dornier MINNOW Ureteral Catheter is a physical medical device, not an AI model or software algorithm that requires a training set.

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

This information is not applicable. As stated above, this device does not involve a training set.

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