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The Pathfinder® CR System is an accessory to the Pathfinder Endoscope Overtube, intended to be used with an endoscope to facilitate evacuation of retained blood, free-floating blood clots, and fluid from the stomach in adult patients (22 years of age or older).

It is for use only by medically licensed and trained gastroenterologists located in hospitals, clinics and doctors' offices.

The Pathfinder® CR System is a disposable endoscopy fluid management system for the 14mm ID Pathfinder®Endoscope Overtube. It is designed to evacuate retained blood, free-floating blood clots, and fluid from the stomach in adult patients (22 years of age or older). It also provides access for endoscopic device passage and exchange. The suction adapter is attached to the Overtube and connected to a foot pedal to control suction on/off functionality. The foot pedal is connected to a suction source with vacuum regulator that provides a range between 200 to 375 mmHg (26.7 to 50.0 kPa). It is for use only by medically licensed and trained gastroenterologists located in hospitals, clinics, and doctor offices. The Pathfinder® CR System consists of the following main components: Suction Adapter (CR, Adapter), Foot Pedal (Suction Controller), Suction Tubing (Tubing).

The provided FDA 510(k) summary for the Neptune Medical Pathfinder® CR System primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, biocompatibility, and non-clinical functional and performance testing. It explicitly states that "No clinical testing was applicable to this submission" and "No animal testing was applicable to this submission." Therefore, the document does not contain information about a study with acceptance criteria of the type requested, which would typically involve human-in-the-loop performance or standalone algorithm performance.

However, based on the provided text, I can infer the "acceptance criteria" are related to successful functional and performance testing and biocompatibility, rather than a clinical performance study with metrics like sensitivity, specificity, or AUC.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The document describes several non-clinical functional and performance tests. While specific quantitative acceptance criteria are not explicitly listed in a table format with corresponding reported performance values, the overall conclusion states that the device "successfully demonstrated that the device correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness."

To provide a table as requested, I'll interpret the successful completion of each test as meeting an implicit acceptance criterion.

Regarding the specific questions about evaluation studies:

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

• Not applicable / Information not provided. This document details non-clinical (bench) testing, not a clinical study involving a test set of patient data.

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

• Not applicable. No expert review of a "test set" to establish ground truth is described, as there was no clinical study.

4. Adjudication method for the test set:

• Not applicable. No clinical test set or adjudication method 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. The document explicitly states, "No clinical testing was applicable to this submission." This device is a mechanical system, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance would not be relevant.

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

• Not applicable. This device is a mechanical system, not an algorithm. The testing described is functional performance testing of the device itself.

7. The type of ground truth used:

• Bench Test Specifications / Engineering Requirements. For the functional tests, the "ground truth" would be the engineering specifications and design requirements against which the device's performance was measured. For biocompatibility, it's compliance with ISO 10993 standards.

8. The sample size for the training set:

• Not applicable. This pertains to algorithm development. This device is a mechanical system.

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

• Not applicable. This pertains to algorithm development. This device is a mechanical system.

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The Pathfinder Endoscope Overtube with Balloon is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).

The Pathfinder Endoscope Overtube with Balloon device consists of a hollow tube with a balloon at the distal end for use over a flexible gastrointestinal endoscope. The purpose of the balloon is to contact the lumen walls to provide stabilization to the distal end of the overtube within the GI tract. The endoscope is inserted through the proximal end of the device and comes out the distal end. The free space between the overtube and the endoscope is lubricated with water through the irrigation line by connecting to the irrigation/water Luer (female Luer lock fitting) and injecting water. The vacuum line is connected to free space within the device and is completely contained. A source of vacuum must be connected to the barb fitting per the diagram below for the overtube to transition between the flexible and rigid conditions. The balloon line is connected to an extrusion within the device that creates an air pathway from handle to the balloon. An inflation device must be connected to the Luer (male Luer lock fitting) to inflate and/or deflate the balloon. The handle rotator has two positions. The first position connects the device to atmosphere (vent) to stay in the flexible condition. The second position connects the device to a source of vacuum to transition to the rigid condition. When transitioned to the rigid condition, the device maintains its shape at the time of rigidization, allowing the endoscope to advance or withdraw relative to the overtube with minimal disturbance to surrounding anatomy. Balloon inflation and deflation are actuated and controlled by an existing balloon controller unit within the endoscopy suite. The device must be connected to the balloon controller to transition into the inflated and deflated condition.

The provided text does not contain information about a study that proves a device meets acceptance criteria related to AI/algorithm performance.

The document is a 510(k) Premarket Notification from the FDA to Neptune Medical, Inc. for their "Pathfinder Endoscope Overtube with Balloon Device." It describes the device, its intended use, comparison to predicate devices, and summaries of functional and performance bench testing, and biocompatibility testing. It explicitly states:

• "No clinical testing was applicable to this submission."
• The entire submission focuses on a physical medical device, not an AI or algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study for an AI-powered device's performance, as the provided text pertains to a traditional medical device not involving AI.

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The Pathfinder Endoscope Overtube is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).

The Pathfinder Endoscope Overtube (Pathfinder) device consists of a flexible overtube that may be connected to vacuum for rigidization. It is used with an endoscope for procedures in the gastrointestinal tract. The handle includes a vacuum line which is connected to free space within the device that is completely contained, forming the vacuumable volume. The handle rotator has two positions: the first connects the vacuumable volume within the device to atmosphere (vent) to stay in the flexible position, and the second position connects the vacuumable volume to a source of vacuum to transition to the rigid condition. When transitioned to the rigid condition, the device maintains its shape at the time of rigidization, allowing the endoscope to advance or withdraw relative to the overtube with minimal disturbance to the surrounding anatomy. When transitioned to the flexible condition, the device is able to move relative to the patient anatomy and endoscope for navigation through the GI tract. The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations.

The provided document describes a Special 510(k) submission for modifications to the Pathfinder Endoscope Overtube, specifically the addition of new sizes and a change in material durometer for the vacuum and irrigation line. This is NOT a typical AI/ML medical device submission, and therefore, many of the requested fields related to AI/ML performance, ground truth, and expert evaluation are not applicable.

Here's the breakdown of the information that can be extracted from the provided text, and where it indicates non-applicability for AI/ML specific criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a device modification submission for physical characteristics (sizes, material), the "acceptance criteria" are related to the functional and performance testing of the physical properties of the device, rather than a quantifiable performance metric like sensitivity or specificity for an AI algorithm. The document states that the "line extension was the subject of extensive testing under applicable design control requirements."

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

The document mentions "extensive testing" but does not provide specific sample sizes for each type of functional and performance testing (e.g., how many devices were tested for lubricity, how many cycles for rigidization).

• Sample Size (Test Set): Not specified in the provided summary.
• Data Provenance: The testing appears to be bench testing (laboratory-based) as stated in section 1.10: "the modified Pathfinder Endoscope Overtube has been shown to be safe through bench testing." This is not retrospective or prospective clinical data.

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

This question is not applicable as this submission is for a physical medical device (endoscope overtube) and not an AI/ML device that requires human interpretation for ground truth.

4. Adjudication method for the test set

This question is not applicable for the same reason as point 3.

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

This question is not applicable as this is not an AI-assisted device requiring human interpretation of results. No MRMC study was conducted.

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

This question is not applicable as this is not an AI algorithm.

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

This question is not applicable as there is no "ground truth" in the context of an AI algorithm's performance. The "truth" for this device modification is adherence to design specifications and successful functional performance as measured by engineering tests.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device, and therefore, there is no "training set."

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

This question is not applicable as there is no "training set" and no "ground truth" in the AI/ML context.

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The Pathfinder Endoscope Cap is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.

The Pathfinder Endoscope Cap is single-use distal attachment for endoscopes. It is an aid to endoscopic visualization and treatment in the gastrointestinal (GI) tract. The Pathfinder Endoscope Cap consists of a single piece of Pebax® in a symmetrical, tapering shape for placement on the distal tip of an endoscope. It is a short, transparent tube with an attaching portion used to connect the cap to an applicable endoscope, a distal portion that tapers into a narrower diameter opening, and a side hole for drainage to prevent fluids lodging on the surface of the endoscope. The device is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection in the GI tract.

The Pathfinder Endoscope Cap has the following physical and performance characteristics:

• Sterilized by ethylene oxide
• For single use
• Tapering distal tip
• Soft stop (tactile indicator of correct depth position)
• Compatible with endoscopes with 11.7 mm outer diameter distal ends, such as the Olympus PCF-H180A and PCF-H190
• Compatible with the Pathfinder Endoscope Overtube, which is intended for use with the same size endoscopes.

The provided text describes the 510(k) premarket notification for the "Pathfinder Endoscope Cap" and its substantial equivalence comparison to a predicate device. However, it does not include the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning performance metrics like sensitivity, specificity, or reader improvement with AI.

The document focuses on the Pathfinder Endoscope Cap's physical characteristics, materials, and a comparison with a predicate device based on general technological and performance criteria. It also mentions mechanical testing and biocompatibility testing.

Here's a breakdown of what is and is not in the provided text, structured as requested:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the text. The document states that the device underwent "mechanical testing" and "biocompatibility evaluation," but it does not list specific acceptance criteria (e.g., minimum tensile strength, maximum tracking force) or the quantitative results from these tests. It only lists the types of tests performed.

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

This information is not provided in the text. The document mentions "mechanical testing" and "biocompatibility evaluation" but gives no details about the sample sizes used for these tests or the origin of any data.

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

This information is not provided in the text. The device is a physical endoscope cap, not an AI or diagnostic tool that would typically involve expert ground truth for performance evaluation in the context of medical image analysis.

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

This information is not provided in the text. Similar to point 3, this type of method is relevant for expert-based evaluation of diagnostic or AI performance, which is not described for this physical device.

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:

This information is not provided in the text. The device is a physical endoscope cap, not an AI system. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable and not mentioned.

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

This information is not provided in the text. As noted, this is a physical device, not an algorithm.

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

This information is not provided in the text. Given the device is a physical cap, typical "ground truth" as applied to diagnostic or AI performance evaluation (e.g., pathology, expert consensus) would not be relevant. The "ground truth" for its performance would likely be engineering specifications and functional testing results (e.g., does it fit correctly, does it maintain integrity during use), but these specific details are not elaborated.

8. The sample size for the training set:

This information is not provided in the text. Since this is not an AI device, there is no "training set."

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

This information is not provided in the text. As above, this is not an AI device, so this concept is not applicable.

Summary of available information regarding the "study" for the Pathfinder Endoscope Cap:

The document describes the following types of testing that were performed:

• Mechanical Testing:
  • Dimensional and visual testing
  • Cap tracking force (through compatible overtube)
  • Cap tensile strength with tape
• Biocompatibility Testing: Conducted in accordance with ISO 10993-1 and relevant standards.
  • Cytotoxicity
  • Sensitization
  • Irritation
  • Systemic Toxicity

The stated conclusion (Section 1.10) is: "The enclosed biocompatibility and performance testing results demonstrate that the subject device is safe and effective for its intended use and substantially equivalent to the predicate."

However, the specific quantitative results of these tests and the acceptance criteria that those results met are not detailed in the provided FDA letters and summary. This document primarily serves as a notification of a 510(k) clearance and outlines the general characteristics and comparison to a predicate device, rather than a detailed study report.

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The Pathfinder™ Endoscope Overtube is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).

The Pathfinder™ Endoscope Overtube (Pathfinder™) device consists of a flexible overtube that may be connected to vacuum for rigidization via an attached stopcock and is used with an endoscope for procedures in the gastrointestinal tract. The stopcock is connected to the vacuum line which is connected to free space within the device and is completely contained, forming the vacuumable volume. The stopcock has two positions: the first position connects the vacuumable volume within the device to atmosphere (vent) to stay in the flexible condition, and the second position connects the device to a source of vacuum to the rigid condition. When transitioned to the rigid condition, the device maintains its shape at the time of rigidization, allowing the endoscope to advance or withdraw relative to the overtube with minimal disturbance to surrounding anatomy. When transitioned to the flexible condition, the device is able to move relative to the patient anatomy and endoscope for navigation through the GI tract. The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations.

This document is a 510(k) premarket notification for a medical device called the Pathfinder™ Endoscope Overtube. It does not describe a study involving an AI-based medical device, nor does it include information on acceptance criteria for such a device.

The document focuses on demonstrating substantial equivalence to a predicate device (KMS Medical EndoGuide) primarily through:

• Comparison of technological characteristics: This involves comparing the design, materials, intended use, and other features of the new device to the predicate.
• Non-clinical performance data: This typically includes biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity) and mechanical testing (simulated use, lubricity, insufflation, insertion/removal, steering, navigation, rigidization/de-rigidization, endoscope compatibility).

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria for an AI-based device and the study proving it meets them. The document does not contain any of the following:

• Table of acceptance criteria and reported device performance for an AI device.
• Sample size used for an AI test set or data provenance.
• Number of experts or their qualifications for establishing ground truth for an AI test set.
• Adjudication method for an AI test set.
• MRMC comparative effectiveness study or human reader improvement with AI assistance.
• Standalone algorithm performance.
• Type of ground truth used for an AI algorithm.
• Sample size for an AI training set.
• How ground truth for an AI training set was established.

The provided text is solely for a traditional medical device (an endoscope overtube) and its regulatory clearance process, not for an AI/ML-based diagnostic or therapeutic device.

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