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The Endophys Pressure Sensing Sheath Kit (Endophys Pressure Sensing Sheath, vessel dilator and guidewire) is intended to facilitate the introduction of diagnostic and interventional devices into the vasculature and to continuously measure blood pressure during the procedure when used with the Endophys Blood Pressure Monitor.

Together, the Pressure Sensing Sheath and the Blood Pressure Monitor comprise the Endophys Pressure Sensing Access System (PSASTM).

The Endophys Pressure Sensing Sheath Kit is comprised of the Endophys Pressure Sensing Sheath, vessel dilator and guidewire. The Endophys Pressure Sensing Sheath and accessories are provided sterile (EO).

The Pressure Sensing Sheath ("PSS") is an introducer sheath with an integrated fiber optic pressure transducer. The PSS is provided with a dilator and a guidewire, which together make up the Endophys Pressure Sensing Sheath Kit ("PSS Kit"). The PSS Kit is intended to be used only with the Endophys Blood Pressure Monitor ("BPM"), which connects to the PSS and displays the blood pressure measurements. Together with the BPM, the PSS is used to continuously monitor patient blood pressure during procedures requiring vascular access.

The PSS introducer sheath is used to assist vascular access in the same manner as do standard catheter introducers. The PSS introducer sheath has an integrated pressure sensor that provides high resolution, continuous and instantaneous pulse wave hemodynamics to monitor blood pressure. Together, the Pressure Sensing Sheath and the Blood Pressure Monitor comprise the Endophys Pressure Sensing Access System (PSASTM).

The vessel dilator is used to facilitate insertion of the PSS, and is packaged with the Endophys PSS Kit. Once the PSS has been properly positioned in the vessel, the dilator is removed.

The guidewire is J tipped, 50cm (length), 0.89mm (diameter), and is used to assist in the placement of the dilator/PSS Introducer Sheath through the skin and into the vasculature. Once the dilator and introducer are positioned over the guidewire, the guidewire is removed through the dilator.

Here's an analysis based on the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in a quantitative format for each test. Instead, it states that the device "met all specified criteria." Therefore, the table below will broadly indicate "Met all specified criteria" where specific numerical targets are not provided.

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

The document does not specify the sample sizes used for each of the performance tests. It also does not explicitly state the provenance of the data (e.g., country of origin) or whether it was retrospective or prospective. Given the nature of these tests (design verification and biocompatibility), they are typically conducted in a controlled, prospective manner, often in laboratory settings.

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

This information is not provided in the document. The tests performed are primarily engineering and biocompatibility tests, which do not typically involve human "experts" establishing ground truth in the same way clinical studies do (e.g., for image interpretation). Instead, ground truth is based on established engineering standards and biological assay results.

4. Adjudication Method for the Test Set

This information is not applicable and is not provided in the document. Adjudication methods like 2+1 or 3+1 are relevant for clinical studies involving multiple human readers, not for the types of engineering and biocompatibility tests described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. This type of study is typically associated with AI-driven diagnostic devices where human readers' performance is compared with and without AI assistance. The Endophys Pressure Sensing Sheath Kit is a medical device for facilitating vascular access and measuring blood pressure, not a diagnostic imaging device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone study (in the context of AI algorithms) was done. The device itself performs the pressure sensing; it's not an AI algorithm that generates a diagnosis or interpretation without human interaction. The studies performed focused on the physical and biological performance of the device components.

7. Type of Ground Truth Used

The ground truth used for the performance tests appears to be based on:

• Established engineering specifications and design requirements: For dimensional analysis, flexibility, kink resistance, liquid leak, and separation forces.
• Standard biological assay results and established biocompatibility guidelines: For the biocompatibility tests (acute systemic injection, intracutaneous injection, sensitization, MEM elution, pyrogenicity, hemolysis). These tests have predefined pass/fail criteria based on accepted scientific and regulatory standards.

8. Sample Size for the Training Set

This information is not applicable and is not provided. The Endophys Pressure Sensing Sheath Kit is not an AI/machine learning device that requires a "training set" in the conventional sense. Its function is based on physical and optical principles.

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

This information is not applicable and is not provided, as there is no "training set" for this type of device.

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The Endophys Pressure Sensing Sheath Kit (Endophys Pressure Sensing Sheath, vessel dilator and guidewire) is intended to facilitate the introduction of diagnostic and interventional devices into the vasculature and to continuously measure blood pressure during the procedure when used with the Endophys Blood Pressure Monitor.

Together, the Pressure Sensing Sheath and the Blood Pressure Monitor comprise the Endophys Pressure Sensing Access System (PSASTM).

The Endophys Pressure Sensing Sheath Kit is comprised of the Endophys Pressure Sensing Sheath, vessel dilator and guidewire. The Endophys Pressure Sensing Sheath and accessories are provided sterile (EO).

The Pressure Sensing Sheath ("PSS") is an introducer sheath with an integrated fiber optic pressure transducer. The PSS is provided with a dilator and a guidewire, which together make up the Endophys Pressure Sensing Sheath Kit ("PSS Kit"). The PSS Kit is intended to be used only with the Endophys Blood Pressure Monitor ("BPM"), which connects to the PSS and displays the blood pressure measurements. Together with the BPM, the PSS is used to continuously monitor patient blood pressure during procedures requiring vascular access.

The PSS introducer sheath is used to assist vascular access in the same manner as do standard catheter introducers. The PSS introducer sheath has an integrated pressure sensor that provides high resolution, continuous and instantaneous pulse wave hemodynamics to monitor blood pressure. Together, the Pressure Sensing Sheath and the Blood Pressure Monitor comprise the Endophys Pressure Sensing Access System (PSASTM).

The vessel dilator is used to facilitate insertion of the PSS, and is packaged with the Endophys PSS Kit. Once the PSS has been properly positioned in the vessel, the dilator is removed.

The guidewire is J tipped, 50cm (length), 0.89mm (diameter), and is used to assist in the placement of the dilator/PSS Introducer Sheath through the skin and into the vasculature. Once the dilator and introducer are positioned over the guidewire, the guidewire is removed through the dilator.

This document, a 510(k) Summary for the Endophys Pressure Sensing Sheath Kit, primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria with performance metrics. While it lists various performance data that were provided, it does not explicitly define acceptance criteria or present a study report with measured performance against those criteria.

Therefore, many of the requested details (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC study details) are not available in this document.

Here's a summary of what information can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The modified Endophys Pressure Sensing Sheath met all specified criteria and based on the design verification performance, the conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device."

However, the specific "specified criteria" and the quantitative "reported device performance" are not detailed in this summary. The summary lists types of tests performed. Without the actual test reports, the acceptance criteria and performance data cannot be presented in a table.

Here's an example of the types of performance data mentioned, but without acceptance criteria or reported values:

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample sizes used for each test listed. It also does not provide details on the data provenance (e.g., country of origin, retrospective or prospective nature). The tests appear to be bench and laboratory-based, as well as biocompatibility studies.

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

Since the listed tests are primarily physical, mechanical, and biological (biocompatibility), establishing "ground truth" in the traditional sense of clinical diagnosis by experts is not applicable. For tests like "Sensor Accuracy," the ground truth would likely be a highly accurate reference instrument or method. The document does not specify who performed these technical evaluations or their qualifications.

4. Adjudication Method

This concept is not applicable to the types of tests listed. Adjudication methods are typically relevant in studies where human interpretation of data (e.g., medical images) is being compared or requires consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not mentioned or indicated in this document. The device is a physical medical device (introducer sheath with a pressure sensor), not an AI or diagnostic imaging device that would typically undergo MRMC studies comparing human readers with and without AI assistance.

6. Standalone Performance Study

The document describes various performance tests of the device itself (e.g., Sensor Accuracy, Dimensional Analysis, Biocompatibility). These would constitute standalone performance studies for the product's physical and functional properties. However, the details of these studies are not provided.

7. Type of Ground Truth Used

For the listed performance tests, the "ground truth" would be established by:

• Engineering specifications and standards: For dimensional analysis, luer fittings, flexibility, kink resistance, etc.
• Laboratory-validated reference methods/instruments: For sensor accuracy, pressure measurements, etc.
• Established biological and chemical testing protocols: For biocompatibility tests (e.g., ISO 10993 standards).

The document does not explicitly state these ground truth sources but implies their use by mentioning adherence to "specified criteria."

8. Sample Size for the Training Set

This device does not appear to be an AI/machine learning device that would have a "training set" in the conventional sense. The "training set" concept is not applicable here.

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

As there is no indication of a training set for an AI/machine learning component, this question is not applicable.

Ask a specific question about this device

The Endophys Pressure Sensing Sheath Kit (Endophys Pressure Sensing Sheath, vessel dilator and guidewire) is intended to facilitate the introduction of diagnostic and interventional devices into the vasculature and to continuously measure blood pressure during the procedure when used with the Endophys Blood Pressure Monitor.

The Endophys Pressure Sensing Sheath Kit is comprised of the Endophys Pressure Sensing Sheath, vessel dilator and guidewire. The Endophys Pressure Sensing Sheath and accessories are provided sterile (EO). The Pressure Sensing Sheath ("PSS") is an introducer sheath with an integrated fiber optic pressure transducer. The PSS is provided with a dilator and a guidewire, which together make up the Endophys Pressure Sensing Sheath Kit ("PSS Kit"). The PSS Kit is intended to be used with the Endophys Blood Pressure Monitor ("BPM"), which connects to the PSS and displays the blood pressure measurements. Together with the BPM, the PSS is used to continuously monitor patient blood pressure during procedures requiring vascular access. The PSS introducer sheath is used to assist vascular access in the same manner as do standard catheter introducers. The PSS introducer sheath has an integrated pressure sensor that provides high resolution, continuous, and instantaneous pulse wave hemodynamics to monitor blood pressure. The PSS introducer sheath is intened only for connectin with the Endophys Blood Pressure Monitor. The 6F Vessel Dilator is used to facilitate insertion of the PSS, and is packaged with the Endophys PSS Kit. Once the PSS has been properly positioned in the vessel, the Dilator is removed. The guidewire is J tipped, 50cm (length), 0.89mm (diameter), and is used to assist in the placement of the Dilator/PSS Introducer Sheath through the skin and into the vasculature. Once the Dilator and Introducer are positioned over the Guidewire, the Guidewire is removed through the Dilator.

The provided text is a 510(k) summary for the Endophys Pressure Sensing Sheath Kit. It outlines the device, its intended use, and a comparison to a predicate device, along with a list of performance tests conducted.

However, the document does not describe the acceptance criteria for these tests, nor does it provide a detailed study that proves the device meets specific acceptance criteria. It only states that the modified device "met all specified criteria" and "did not raise new safety or performance questions" based on the design verification performance.

Therefore, many of the requested items cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated based on the text:

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

The document lists performance tests but does not provide specific acceptance criteria or quantitative performance results. It only states that the device "met all specified criteria."

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.

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 provided in the document. The studies mentioned are performance tests on the device itself, not studies on diagnostic accuracy requiring expert ground truth.

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

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an introducer sheath with an integrated pressure sensor, not an AI diagnostic tool.

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

This is not applicable as the device is a physical medical instrument, not an algorithm. The "Sensor functionality" test would assess the standalone performance of the pressure sensor.

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

The ground truth for the performance tests would be based on engineering specifications and direct measurements against established standards for medical device functionality (e.g., pressure calibration against a known standard, dimensional accuracy against design drawings). The document does not specify the exact ground truth methodologies but implies standard engineering and laboratory testing.

8. The sample size for the training set

This is not applicable as the device is a physical medical instrument, not a learning algorithm that requires a training set.

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

This is not applicable.

Ask a specific question about this device

The Endophys Pressure Sensing Sheath Kit (Endophys Pressure Sensing Sheath, vessel dilator and guidewire) is intended to facilitate the introduction of diagnostic and interventional devices into the vasculature and to continuously measure blood pressure during the procedure when used with the Endophys Blood Pressure Monitor.

The Pressure Sensing Sheath ("PSS") is an introducer sheath with an integrated fiber optic pressure transducer. The PSS is provided with a dilator and a guidewire, which together make up the Endophys Pressure Sensing Sheath Kit ("PSS Kit"). The PSS Kit is intended to be used with the Endophys Blood Pressure Monitor ("BPM"), which connects to the PSS and displays the blood pressure measurements. Together with the BPM, the PSS is used to continuously monitor patient blood pressure during procedures requiring vascular access.

I am sorry, but the provided text does not contain the detailed information required to answer your request about acceptance criteria and the study that proves the device meets them. The text primarily consists of an FDA 510(k) clearance letter and a summary of the device, its indications for use, and a general statement about testing to support substantial equivalence.

Specifically, the text does not include:

• A table of acceptance criteria and reported device performance.
• Details on the sample size for the test set or data provenance (country, retrospective/prospective).
• Number or qualifications of experts used for ground truth.
• Adjudication method.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Information on a standalone algorithm performance study.
• Specifics on the type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The text generally states that "All necessary testing was conducted on the PSS Kit to support a determination of substantial equivalence" and lists types of testing like "Design verification testing," "Sterilization validation," "Biocompatibility testing," "Shelf life and packaging testing," and "In vivo testing." However, it does not provide any specific results, acceptance criteria, or methodological details for these studies.

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