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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.

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.

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The Endophys Blood Pressure Monitor is intended for use in a catheterization laboratory to continuously provide systolic, diastolic and mean blood pressure based on the output of the Endophys Pressure Sensing Sheath in patients undergoing therapeutic and/or diagnostic procedures involving percutaneous vascular access.

The Endophys Blood Pressure Monitor ("BPM") Model 651 is a blood pressure computer that computes and continuously displays systolic, diastolic, and mean blood pressure values. The BPM obtains an optical signal from the Endophys Pressure Sensing Sheath, which is a stand-alone catheterization sheath that is inserted percutaneously during intravascular diagnostic or interventional procedures. The BPM converts the optical transducer data to electrical signals and displays blood pressure measurements.

The provided text describes a 510(k) premarket notification for the "Endophys Blood Pressure Monitor" (K141615). However, it does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/ML device evaluations (e.g., sensitivity, specificity, accuracy against a recognized standard). This document is a regulatory approval letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study against specific acceptance metrics.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified. The document mentions "design verification testing" and "performance testing" but does not provide details on sample sizes for any test sets that would typically assess clinical performance.
• Data provenance: Not specified.

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

• Not applicable/Not specified. The document focuses on performance relative to predicate devices and general safety/effectiveness, not on a ground truth established by experts for a specific diagnostic task.

4. Adjudication method for the test set

• Not applicable/Not specified.

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 blood pressure monitor, not an AI/ML diagnostic aid for human readers.

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

• Not explicitly detailed as a distinct 'standalone' study for an algorithm in the AI/ML sense. However, the device itself "computes and continuously displays systolic, diastolic, and mean blood pressure values" based on an optical signal. The "design verification testing" and "performance testing" would assess this standalone measurement capability. No specific metrics are provided.

7. The type of ground truth used

• The document states the device "continuously provide[s] systolic, diastolic and mean blood pressure based on the output of the Endophys Pressure Sensing Sheath." The "ground truth" would implicitly be the established accuracy of pressure measurements against a recognized standard (e.g., an invasive catheter-based pressure measurement device or laboratory-calibrated pressure sensors), but this is not explicitly detailed with specific metrics or methodologies in the provided summary.

8. The sample size for the training set

• Not applicable/Not specified. This is not an AI/ML device in the modern sense that involves a separate training phase with a distinct dataset.

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

• Not applicable. No training set is mentioned 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.

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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