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The Endophys Pressure Sensing Sheath Kit (Endophys Pressure Sensing Sheath and vessel dilator) 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 (PSAS™).

The Endophys Pressure Sensing Sheath Kit is comprised of the Endophys Pressure Sensing Sheath and vessel dilator. 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 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.

This FDA 510(k) summary for the Endophys Pressure Sensing Sheath Kit (K190098) primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study proving performance against specific acceptance criteria in the manner you've described.

The document emphasizes a comparison of technological characteristics and non-clinical performance data to show that the new device is as safe and effective as the predicate. It does not describe a multi-reader multi-case (MRMC) study, an algorithm-only standalone study, or specific clinical performance metrics with detailed acceptance criteria for a new AI/medical device.

Therefore, many of your specific questions cannot be answered from the provided text because the regulatory pathway chosen (510(k) Substantial Equivalence) does not typically require the level of detailed clinical efficacy testing or AI-specific validation you've outlined.

However, I can extract information related to the device's performance as presented in this 510(k) submission:

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

The document lists "Sensor Accuracy" as a performance data item. While it doesn't provide specific numerical acceptance criteria (e.g., "accuracy > X%"), it states that the device "met all specified criteria." This implies internal design specifications were met.

Important Note: These are primarily non-clinical, engineering, and biocompatibility tests, not clinical performance metrics on patient data.

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

• Sample Size: Not specified in the document. The tests performed are primarily benchtop and material-based, not clinical trials on patient populations.
• Data Provenance: Not specified, but given the non-clinical nature of the tests, it would be laboratory data.

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

• Not applicable/Not specified. This type of information is relevant for studies involving human interpretation (e.g., radiologists reading images), which is not detailed here. The "ground truth" for the listed tests would be established by validated measurement techniques and scientific standards for material and mechanical properties.

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

• Not applicable/Not specified. Adjudication methods are typically used in clinical studies where expert consensus on subjective findings is required.

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 device is a physical medical device (sheath with a pressure sensor), not an AI algorithm for interpreting medical images or data. Therefore, an MRMC study is not relevant to this submission.

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

• No. This is a physical device, and its primary function is to facilitate access and measure blood pressure continuously. It does not appear to employ a standalone AI algorithm that provides diagnostic outputs without human interaction. The pressure sensor's output is displayed on a monitor for human clinicians to use.

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

• For the non-clinical tests listed:
  • Sensor Accuracy: Likely established against a highly accurate reference pressure measurement system.
  • Dimensional, Flexibility, Force, Pouch Peel tests: Established against engineering specifications and industry standards for physical properties.
  • Biocompatibility (L929, Rabbit Pyrogen, Hemolysis): Established against ISO and ASTM standards for material safety and biological response.
• No "expert consensus," "pathology," or "outcomes data" are mentioned as ground truth for these specific performance tests.

8. The sample size for the training set

• Not applicable. This document is for a physical medical device, not an AI/machine learning model, so there is no "training set."

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

• Not applicable for the reason above.

Summary of Device and Study Context:

The Endophys Pressure Sensing Sheath Kit is an introducer sheath with an integrated fiber optic pressure transducer. It is intended to facilitate device introduction into the vasculature and continuously measure blood pressure. This 510(k) submission demonstrates substantial equivalence to a previously cleared predicate device (K173399). The performance data cited are primarily non-clinical benchtop, engineering, and biocompatibility tests, which confirmed that the modified device met its specified design criteria and is as safe and effective as the predicate. This is a common approach for device modifications under the 510(k) pathway, where extensive new clinical studies are often not required if substantial equivalence can be demonstrated through comparative data.

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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.

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The Endophys Blood Pressure Monitor Model 651 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 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 standalone 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 Endophys Blood Pressure Monitor Model 651 is powered by a standard AC power adapter. The Endophys Blood Pressure Monitor Model 651 is used outside of the sterile environment and has standard alerts and alarms.

The Endophys Blood Pressure Monitor Model 651 has an operating pressure range of 0-300 mmHg with an accuracy of ±2mmHg or ±4% of the reading, whichever is greater.

The provided document is a 510(k) premarket notification letter and summary for a Blood Pressure Monitor. It outlines the device's indications for use, technological characteristics, and performance data provided to support substantial equivalence to a predicate device.

However, the request asks for information related to a study proving a device (presumably an AI/imaging device, given the context of "human readers" and "ground truth" derived from experts) meets acceptance criteria, specifically for applications like those that might involve image analysis or disease detection.

The provided document describes a Blood Pressure Monitor, which is a physiological measurement device, not an AI-assisted diagnostic imaging device. Therefore, many of the requested criteria (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone algorithm performance, training set details) are not applicable to the type of device described in the input text.

The acceptance criteria and performance data for a blood pressure monitor would typically involve accuracy against a reference standard, electrical safety, electromagnetic compatibility, and functional testing, as mentioned in the document. It does not involve AI model performance metrics like sensitivity, specificity, or AUC, nor does it involve human expert ground truth establishment for image interpretation.

Given this fundamental mismatch, I can only provide information relevant to the blood pressure monitor based on the provided text, recognizing that it addresses very different types of acceptance criteria and study methodologies than those implied by the prompt's structured questions.

Based on the provided document (K160945 for the Endophys Blood Pressure Monitor, Model 651), the following is applicable:

The device is a Blood Pressure Monitor, not an AI/imaging device requiring multi-reader studies or complex ground truth establishment by experts for diagnostic interpretation. Its acceptance criteria and performance studies are focused on its accuracy in measuring blood pressure and its electrical and safety compliance.

Acceptance Criteria and Reported Device Performance (for a Blood Pressure Monitor)

Study that Proves the Device Meets Acceptance Criteria:

The document states that "The following performance data were provided in support of the substantial equivalence:"

• Functional Testing
• Electrical Safety (IEC 60601-1)
• Electromagnetic compatibility (IEC 60601-1-2)
• Safety and Essential Performance for Invasive blood pressure monitoring equipment (IEC 60601-2-34)

The conclusion states: "The modified Endophys Blood Pressure Monitor Model 651 met all specified criteria and did not raise new safety or performance questions. Based on the design verification performance the modified Endophys Blood Pressure Monitor was found to have a safety and effectiveness profile that is similar to the predicate device."

Addressing the prompt's specific questions with respect to the provided document (and highlighting non-applicability):

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

   • See table above. The document primarily focuses on technical and safety standards compliance and intrinsic accuracy, not clinical diagnostic performance metrics.

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

   • Not specified in the document for the performance testing. These are typically design verification/validation tests for electro-mechanical devices, often conducted in-house to demonstrate compliance with standards and specifications. The document does not indicate a clinical study with a patient test set size or data provenance details in the way an AI diagnostic device submission would.

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

   • Not applicable. This device measures blood pressure. "Ground truth" would be established by a primary reference standard source for blood pressure measurement, not by human experts interpreting data.

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

   • Not applicable. This pertains to expert consensus for complex diagnostic interpretation, which is not relevant to a blood pressure monitor.

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 a standalone physiological measurement device, not an AI-assisted diagnostic tool involving human readers.

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

   • Partially applicable/Re-interpretation: The performance outlined (accuracy, electrical safety, etc.) is the "standalone" performance of the blood pressure monitor device itself. It operates as an algorithm (converting optical transducer data to electrical signals and displaying blood pressure) without human interpretive input beyond observing the displayed values. There's no separate "human-in-the-loop" aspect to its fundamental function for evaluation.

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

   • Based on standard practices for such devices: The ground truth for blood pressure measurement accuracy would typically be established by comparison to a highly accurate reference blood pressure measurement device (e.g., a manometer calibrated to a known standard, or another validated invasive blood pressure measurement system). It would not be expert consensus, pathology, or outcomes data in this context. The document does not explicitly state the reference method used.

8. The sample size for the training set

   • Not applicable. This is not a machine learning/AI device that requires a "training set" in the common understanding of the term for AI model development.

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

   • Not applicable. See point 8.

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