Search Results

The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures.

The proposed OptoMonitor 3 includes the display of ARi/TIARi adjunctive hemodynamic indicators when compared to the approved OptoMonitor 3 with a fully integrated TAVI software update cleared via K213854.

The provided text is a 510(k) summary for the OptoMonitor 3 device. It describes a comparative analysis to a predicate device, focusing on the addition of ARi/TIARi adjunctive hemodynamic indicators. Unfortunately, the document does NOT contain a table of acceptance criteria and reported device performance directly tied to a specific study meeting those criteria. Instead, it describes general claims of meeting acceptance criteria for risk and functionality, and then details two analyses: a retrospective analysis of ARi/TIARi calculations and a clinical annotation study.

Based on the provided text, here's a description of the acceptance criteria (inferred from the studies described) and the study that proves the device meets the acceptance criteria, as much as can be extracted:

Overview of Device Performance and Acceptance Criteria (Inferred)

The document primarily focuses on demonstrating the substantial equivalence of the new OptoMonitor 3 (with ARi/TIARi) to a previously cleared OptoMonitor 3 (predicate). The acceptance criteria are therefore implicitly related to showing that the new features (ARi/TIARi calculation) are accurate and that the device's original functions (pressure measurement) remain robust after the software update.

Inferred Acceptance Criteria & Reported Device Performance

Study Information

The document describes two key analyses: a Retrospective Analysis for ARi/TIARi calculation, and an Annotation Study for pressure measurement accuracy.

1. Retrospective Analysis (for ARi/TIARi Calculation)

• Sample size: 30 pressure recordings from 10 unique patients, for a total of 150 beats.
• Data Provenance: Clinically derived data recorded with the OptoMonitor from "existing pre and post market data sources." (Country of origin not specified, retrospective).
• Number of experts used to establish ground truth: Not applicable – ground truth was established by "mathematical expressions given in the literature by Sinning et al. and Bugan and Kumar et al." and manual calculation (Microsoft Excel). No human experts were involved in establishing this specific ground truth.
• Qualifications of experts (for ground truth): Not applicable.
• Adjudication method for the test set: Not applicable, as ground truth was mathematical.
• MRMC Comparative Effectiveness Study: No, this was an algorithmic comparison to mathematical ground truth.
• Standalone Performance: Yes (algorithm's calculation vs. mathematical formula).
• Type of Ground Truth: Mathematical expressions from published literature and manual calculation.
• Sample size for training set: Not specified, implicitly zero for this specific evaluation as it's testing the implementation of known mathematical formulas. The device is a "currently marketed device" and only software changes are discussed, implying any core training would have occurred previously.
• How the ground truth for training set was established: Not applicable for this specific evaluation.

2. Clinical Annotation Study (for Pressure Measurement and Waveform Interpretation)

• Sample size used for the test set: 420 waveforms in 29 patients.
• Data Provenance: Retrospectively conducted annotation study. (Country of origin not specified, retrospective).
• Number of experts used to establish the ground truth for the test set: "Experts panel" (number not specified, but plural implies more than one).
• Qualifications of those experts: "Expert clinicians." Specific qualifications (e.g., years of experience, specialty) are not provided.
• Adjudication method for the test set: Not explicitly stated, but "experts panel annotated" implies a consensus or independent annotation approach. No formal 2+1 or 3+1 method is mentioned.
• MRMC Comparative Effectiveness Study: No, this was a comparison of the device's output to expert annotations, not an MRMC study comparing human readers with and without AI assistance.
• Standalone Performance: Yes (algorithm's interpretation of tracings vs. expert annotation).
• Type of Ground Truth: Expert consensus/annotations. The experts annotated "the systolic Ao, diastolic LV, diastolic Ao, and LVEDP pressures on the pressure tracings."
• Sample size for the training set: Not specified. As with the first study, the device is marketed, suggesting prior development.
• How the ground truth for the training set was established: Not specified.

Additional Considerations from the Document:

• Risk-Based Approach: The document states that the Risk Management File for the predicate device was reviewed, and one new risk ("indices measured under suboptimal conditions") was identified, evaluated as tolerable, and benefits outweigh risks. This implies internal acceptance criteria for risk management were met.
• Verification and Validation Activities: It's stated that "All acceptance criteria were met regarding risks and device functionality" and that "No new questions of safety and effectiveness were identified during review of Risk Management documentation or execution of Verification and Validation activities." While the specific criteria aren't listed, this indicates a broader V&V process was conducted.

Ask a specific question about this device

The ACIST RXi System is indicated for obtaining intravascular pressurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus II MicroCatheter is intended for use with the ACIST RXi System.

The current RXi system obtains intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The RXi measures intravascular pressure in a hyperemic state following administration of adenosine as fractional flow reserve (FFR). The proposed software update for the RXi system adds a diastolic pressure ratio (dPR), which measures intravascular pressure in a non-hyperemic (resting) state. Both current and proposed ACIST RXi Systems are used in conjunction with the Navvus Catheter.

The proposed RXi System console containing embedded software that provides the main user interface. The system is used with the Navvus catheter which contains a pressure sensor for acquisition of pressure distal (Pd) to a lesion. The proximal aortic pressure (Pa) is acquired via an interface to a third-party hemodynamic system. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR) using hyperemic agents and/or nonhyperemic indices of diastolic pressure ratio (dPR) and PdPa for physiological assessment of ischemic stenotic lesions.

Measurement of FFR requires simultaneously monitoring the blood pressures proximal and distal to a lesion while inducing hyperemia. dPR is a measure of the diastolic portion of the hemodynamic waveform and can be used by the physician to perform a physiologic assessment without inducing hyperemia in the patient.

The provided text describes the ACIST RXi System and Navvus II MicroCatheter, with a focus on a software update to include a diastolic pressure ratio (dPR) modality. The information primarily relates to the substantial equivalence determination for this medical device, rather than a clinical study evaluating an AI device's performance against human readers. Therefore, many of the requested points, particularly those pertaining to AI device performance evaluation criteria (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details), are not present in the provided document.

However, I can extract information related to the device's performance and the study that demonstrated its substantial equivalence.

Here's a summary of the available information based on the provided text, addressing your points where possible and noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the dPR functionality were primarily based on demonstrating agreement with an FDA-cleared reference device (Volcano iFR Modality) when compared to FFR measurements.

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

• Sample Size: The document mentions "a dataset collected in a prospective clinical study." The exact number of patients or waveforms in this dataset is not specified.
• Data Provenance: The dataset was collected in the "prospective CONTRAST clinical study," suggesting real-world clinical data. The country of origin is not specified.
• Retrospective or Prospective: The study is explicitly stated as prospective.

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

This information is not applicable/not available as the study did not involve human experts establishing ground truth for an AI device. The ground truth was established by another medical device (FFR measurements).

4. Adjudication Method for the Test Set

This information is not applicable/not available as the study did not involve human experts requiring adjudication.

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

An MRMC study was not done. This study demonstrates the performance of a new device modality (dPR calculation) against an existing device/modality (iFR) and a reference standard (FFR), not an AI algorithm assisting human readers.

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

Yes, the diagnostic performance evaluation was essentially a standalone assessment of the dPR algorithm's output compared to iFR and FFR. It states: "Resting and hyperemic pressure readings from each recorded waveform were measured using the ACIST RXi System and Navvus Catheter, and in parallel, the Philips Verrata PLUS wire and Philips (Volcano) CORE Mobile system." This describes an evaluation of the device's output (dPR) against other device outputs (iFR, FFR).

7. The Type of Ground Truth Used

The ground truth used for demonstrating substantial equivalence was Fractional Flow Reserve (FFR) measurements using a cutpoint of 0.80.

8. The Sample Size for the Training Set

This information is not applicable/not available. The dPR algorithm is a new calculation modality added to existing software, not a deep learning AI model that requires a separate training set. The calculations are based on known physiological principles.

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

This information is not applicable/not available for the same reason as point 8. The dPR calculation is based on established hemodynamic principles, not learned from a labeled training set.

Ask a specific question about this device

The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

The TruWave Disposable Pressure Transducer is a sterile, single-use device that is used to monitor intravascular, intracranial, and intrauterine pressures. The pressure transducer has a straight, flow-through design across the pressure sensor, and is available with or without the integral flush device. The pressure sensor is a pressure sensitive silicon chip with two electrodes for excitation voltage and two electrodes for signal output. A transparent fluid path with an integral stopcock at one end and an integral flush device (either 3mL or 30mL) at the other end encloses the sensor. The enclosure of the TruWave Disposable Pressure Transducer has a pathway for air to enter the housing and acts as a vent. A disposable cable (available in 10-inch/25 cm and 48-inch/120 cm lengths) attached to the pressure transducer housing interfaces with an Edwards Lifesciences reusable cable that is specifically wired for the monitor being used. The TruWave Disposable Pressure Transducer can be mounted on the patient's arm using an arm strap or it may be mounted on an IV pole in a holder. The TruWave Disposable Pressure Transducer may be a component in various pressure monitoring kits or systems.

The provided text describes a 510(k) premarket notification for a medical device, the TruWave Disposable Pressure Transducer. The information primarily focuses on demonstrating substantial equivalence to a predicate device through various non-clinical tests.

However, the question asks for details related to acceptance criteria, device performance, and study information that would typically be found in a clinical study report or a more detailed performance study. The provided document does not contain a table of acceptance criteria with reported device performance metrics in a quantitative sense, nor does it detail a clinical study with human patients, ground truth establishment by experts, or MRMC studies.

Instead, the document states: "All device acceptance criteria were met. Results of non-clinical testing show that the subject device TruWave Disposable Pressure Transducer meets its intended use and demonstrate that the device is as safe, as effective, and performs as well as the predicate device." It then lists types of non-clinical testing performed.

Therefore,Based on the provided text, the following information can be extracted regarding acceptance criteria and the study:

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

The document states "All device acceptance criteria were met" and that the non-clinical testing demonstrated the device "meets its intended use and demonstrate that the device is as safe, as effective, and performs as well as the predicate device." However, a specific table outlining quantitative acceptance criteria and their corresponding reported device performance values is not provided in the excerpt. The text mentions several types of testing performed to demonstrate equivalence and safety/effectiveness.

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

The document refers to "non-clinical testing" and does not specify sample sizes in terms of number of devices or data points for each test category. No information on data provenance (e.g., country of origin, retrospective or prospective) is provided, as these are non-clinical (laboratory/bench) tests.

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

This information is not applicable and not provided. The testing described is non-clinical performance and safety testing against established standards, not a clinical study requiring expert consensus for ground truth. The "usability/human factors" evaluation was performed by "healthcare provider users," but without details on the number or specific qualifications.

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

This information is not applicable and not provided, as it pertains to clinical studies with expert reviewers and not the non-clinical testing 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:

This information is not applicable and not provided. The device is a physical pressure transducer, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided, as the device is a physical pressure transducer, not an algorithm.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" relates to compliance with established international and national standards (e.g., ISO 10993-1, IEC 60601 series, ANSI/AAMI BP22, ASTM F2503) and the manufacturer's internal design requirements. This is based on standardized measurement and testing protocols, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set:

This information is not applicable and not provided. The described tests are for device verification and validation, not for training a model or algorithm.

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

This information is not applicable and not provided, as there is no "training set" in the context of the reported non-clinical device testing.

Ask a specific question about this device

To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/ or any interventional procedures.

Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel desease.

The proposed OptoMonitor 3 and its components are considered accessories to Opsens OptoWire™ pressure guidewires and are intended for use with legally marketed pressure guidewires.

The proposed OptoMonitor 3 includes an Optical Unit (OU), a Display Unit (DU), a Handle Unit (HU) and accessories (cables, power supply, etc).

The device is a non-sterile, non-patient contact device.

The provided text describes the 510(k) submission for the OptoMonitor 3 device, which is a pressure monitor used with OptoWire™ pressure guidewires to measure pressure in blood vessels. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (OptoMonitor 3 cleared via K193620).

Crucially, this document does not describe a study involving an AI/Machine Learning algorithm for diagnostic purposes, nor does it present acceptance criteria and performance data in the context of an AI-based system. Instead, it concerns a medical device that measures physiological pressure. The "performance data" section specifically refers to electrical safety, electromagnetic compatibility (EMC), and wireless coexistence testing, not diagnostic accuracy or efficacy.

Therefore, many of the requested points related to AI/ML (e.g., ground truth, expert consensus, MRMC study, training data) are not applicable to the content of this document.

However, I can extract the relevant information regarding acceptance criteria and performance testing for this specific device.

Device Type: Medical Device - Catheter Tip Pressure Transducer (OptoMonitor 3)
Intended Use: To measure pressure in blood vessels (coronary and peripheral) during diagnostic angiography and/or interventional procedures, providing hemodynamic information such as fractional flow reserve for diagnosis and treatment of blood vessel disease.

Here's an attempt to answer the prompt based only on the provided text, recognizing that it's for a traditional medical device, not an AI product:

Acceptance Criteria and Device Performance Study for OptoMonitor 3

The OptoMonitor 3 is a pressure monitoring device, and the provided document is a 510(k) submission seeking substantial equivalence to a predicate device. The "study" described here is primarily a series of verification and validation (V&V) tests to confirm that changes in the new device version do not introduce new questions of safety and effectiveness, and that its performance remains comparable to the predicate. It is not a clinical study assessing diagnostic accuracy in the way an AI algorithm would be evaluated.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal "acceptance criteria" table with numerical targets in the same format as for an AI/ML diagnostic. Instead, it focuses on demonstrating that the performance characteristics of the new OptoMonitor 3 are "essentially the same" or "equivalent" to the predicate OptoMonitor 3 (K193620). The changes are primarily related to communication methods (Bluetooth) and display unit options, along with minor software updates. The "performance data" section details compliance with various electrical safety, EMC, and wireless coexistence standards.

The table below summarizes the key performance characteristics compared to the predicate, implying that the acceptance criterion is "same" or "equivalent performance" to the legally marketed and cleared predicate device.

Performance Data provided to support substantial equivalence (Verification & Validation (V&V))

• Electrical safety and electromagnetic compatibility (EMC) testing:
  • Compliance with IEC 60601-1:2012 (Consolidated text - edition 3.1)
  • Compliance with IEC60601-1-2:2007 (third edition)
  • Compliance with IEC60601-1-2:2014 (fourth edition)
• Wireless coexistence testing:
  • Successfully tested per ANSI/IEEE C63.27:2017 in accordance with the FDA guidance (2013) Radio Frequency Wireless Technology in Medical Devices.
• Risk Management Process: Evaluated changes, and "no new questions of safety and effectiveness were identified."
• Verification and Validation activities: "No new questions of safety and effectiveness were identified during the execution of Verification and Validation activities."
• Software Validation: Changes are validated in accordance with Opsens QMS, including code review, unit testing, system testing, and regression testing.

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

• Sample Size: Not applicable in the context of clinical data for diagnostic accuracy. The testing described is primarily laboratory-based V&V testing (e.g., electrical safety, EMC, wireless coexistence), not a patient-based test set size.
• Data Provenance: Not applicable. The "study" is a technical V&V assessment of the device hardware and software, not a collection of patient data.
• Retrospective/Prospective: Not applicable.

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

• Not applicable. This is not a study requiring expert-established ground truth for diagnostic purposes. The "ground truth" for the V&V tests are the established standards for electrical safety, EMC, and wireless communication, and the specifications of the predicate device.

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

• Not applicable. This is not a study requiring adjudication of expert interpretations.

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 is not an AI-assisted device, therefore an MRMC study is not relevant.

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

• Not applicable. This is not an AI algorithm. Its performance is inherent in its measurement capabilities.

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

• Not applicable in the AI/clinical ground truth sense. The "ground truth" for this device's performance relies on:
  • Engineering specifications and standards: Compliance with IEC 60601-1, IEC 60601-1-2, ANSI/IEEE C63.27, etc., which define acceptable performance for medical electrical equipment.
  • Predicate device performance: The previously cleared OptoMonitor 3 (K193620) serves as the benchmark for "equivalent" performance characteristics.

8. The sample size for the training set:

• Not applicable. The device is not an AI/ML algorithm that requires a training set.

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

• Not applicable.

Ask a specific question about this device

To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/ or any interventional procedures.

Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel desease.

The proposed OptoMonitor 3 is a new version of the OptoMonitor System. This device and its components are considered accessories to Opsens OptoWire™ pressure guidewires and are intended for use with legally marketed pressure guidewires.

The proposed OptoMonitor 3 includes an Optical Unit (OU), a Display Unit (DU), a Handle Unit (HU) and accessories (cables, power supply, etc). These hardware components and device functionalities are equivalent to that of the previous generation OptoMonitor (K192340 (cleared on 12/12/2019).

The device is a non-sterile, non-patient contact device.

The provided text describes a 510(k) premarket notification for the OptoMonitor 3 device, which is an updated version of the OptoMonitor System. The submission aims to establish substantial equivalence to a predicate device (K192340).

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison table between the proposed OptoMonitor 3 and its predicate device, OptoMonitor (K192340), rather than explicitly listing acceptance criteria with reported performance for a new study. However, the "Technological Characteristics" section of the table effectively serves as a list of performance parameters with implied acceptance criteria being "Same" as the predicate device.

2. Sample Size for Test Set and Data Provenance

The document states: "No animal studies or clinical investigations are included with this submission." and "Results from these tests mentioned above demonstrate that the technological and performance characteristics of the proposed OptoMonitor 3 is comparable to the predicate device". This implies that the substantial equivalence determination for performance was primarily based on bench testing and verification/validation activities of the device's hardware and software changes, rather than a clinical trial with a "test set" of patients.

Therefore:

• Sample Size for Test Set: Not applicable in the context of a clinical test set. Performance was evaluated through technical testing.
• Data Provenance: Not applicable for clinical data. The data provenance would be internal laboratory testing.

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

Since no clinical studies or human-in-the-loop evaluations were performed as part of this submission, there were no experts used to establish ground truth for a clinical test set. The validation focused on engineering and software verification.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring adjudication.

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

No MRMC study was performed or cited in this submission. The device is a pressure monitoring system, not an imaging interpretation or diagnostic aid that typically requires such studies.

6. Standalone (Algorithm Only) Performance Study

The document focuses on the entire OptoMonitor 3 system. While it mentions that "algorithms used for the FFR calculation remained unchanged from the predicate OptoMonitor," it does not detail a standalone performance study solely on the FFR algorithm. The performance data presented (pressure range, accuracy, etc.) relates to the entire device's ability to measure pressure.

7. Type of Ground Truth Used

For the engineering and software verification/validation, the ground truth would be established by:

• Reference standards and calibrated instruments: For pressure measurements, the device's output would be compared against known, highly accurate reference pressure sources.
• Pre-defined specifications and requirements: The software and hardware performance were validated against their design specifications.

8. Sample Size for the Training Set

Not applicable. This device is a measurement instrument, not an AI/ML model that undergoes a training phase with a "training set" of data in the typical sense.

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

Not applicable, as there was no training set for an AI/ML model.

Summary of Device Changes and Performance Rationale:

The OptoMonitor 3 is an updated version of the predicate OptoMonitor. The key changes are related to:

• Optical Unit: New casing, CPU, PCBs, validated software (algorithms for FFR calculation unchanged), addition of capability to receive aortic pressure signal from Cathlab Hemodynamic system, addition of low-level signal input, redesigned handle unit.
• Display Unit: Use of commercially available all-in-one PC, new software to support additional hardware options, addition of possibility to connect to hospital DICOM system.
• Aortic Input: Change from High Level (100 mmHg/V) to Low Level (5μV/V/mmHg) for the aortic input.
• AUX Input: Addition of a High Level (100 mmHg/V) AUX input, which was not present on the predicate.

The manufacturer argues substantial equivalence because:

• Indications for Use are the same.
• Technological characteristics are "essentially the same."
• The "Substantial Equivalence Table" shows identical specifications for crucial performance parameters like pressure range, accuracy, thermal zero shift, and zero drift.
• Software verification and validation testing were conducted.
• Electrical safety and EMC testing confirmed compliance with relevant standards.
• Risk Management processes evaluated the changes, and "no new questions of safety and effectiveness were identified."
• The algorithms for FFR calculation remained unchanged.

Therefore, the study supporting the device's acceptance criteria primarily involved bench testing and verification/validation activities against established engineering specifications and comparison to the predicate device's performance characteristics, without the need for animal or clinical studies.

Ask a specific question about this device

The Comet II Pressure Guidewire is indicated to direct a catheter through a blood vessel and measure physiological parameters in the coronary and peripheral blood vessels.

Comet™ II is a coronary and peripheral quidewire with a pressure sensor mounted approximately 3 cm proximally to the distal end of the straight tip. The optical pressure sensor is integrated within the distal region of a 0.014" quidewire to measure blood pressure gradient changes across coronary and peripheral lesions during endovascular procedures. The tip is radiopaque to help with guidewire placement and shapeable by the user. The guidewire is attached to an optical cable through a detachable connector. The optical cable has a connector on the proximal end for interface with an ancillary Boston Scientific signal processing module. When connected to the signal-processing module, a Boston Scientific iLab Polaris™ Multi-Modality Guidance System displays various physiological parameters including aortic pressure, distal pressure and a fractional flow reserve (FFR) value calculated from the ratio of distal pressure over aortic pressure. A torque device is preloaded onto the proximal end of the wire. The pressure guidewire, optical cable, and torque device are all connected in the single use sterilized packaging. The intended use of Comet II remains within the scope of the predicate intended use.

The provided text describes a 510(k) premarket notification for the Comet™ II Pressure Guidewire. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study report for a new device's performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of an AI/human-in-the-loop study, is not present in the provided text.

Specifically, the text states: "Performance testing from clinical studies is not required to demonstrate substantial equivalence of the Comet II." This indicates that a comprehensive clinical trial with human subjects to prove the device meets specific acceptance criteria typical of an AI-driven medical device (like those involving multi-reader multi-case studies, expert consensus on ground truth, or analysis of human reader improvement with AI assistance) was not performed or not required for this 510(k) clearance.

The study described is primarily non-clinical performance bench testing.

Here's a breakdown of the requested information based only on the provided text, with clear indications where the information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Performance criteria includes dimensional requirements, pressure gradient measurement (sensor) requirements, and interface with compatible devices." However, specific numerical acceptance criteria (e.g., accuracy +/- X mmHg) and the corresponding reported performance values from these bench tests are not detailed in the provided text.

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

• Sample Size for Test Set: Not specified. The document refers to "bench testing" which would involve a sample size of devices, but the number is not provided.
• Data Provenance: Not specified. As it's bench testing, country of origin related to patient data is not applicable. The data would be newly generated from the bench tests.

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)

• Not applicable. The ground truth for bench testing of a pressure guidewire would be established by calibrated instruments and established engineering standards, not by human experts interpreting clinical data.

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

• Not applicable. Ground truth for bench testing is objectively measured by instruments, not subject to human interpretation or adjudication methods.

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, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "Performance testing from clinical studies is not required to demonstrate substantial equivalence of the Comet II." This type of study would be relevant for devices involving AI assistance to human readers, which this guidewire is not.

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

• Not applicable in the context of an AI algorithm. This device is a physical pressure guidewire that measures physiological parameters. Its "performance" is its ability to accurately measure pressure and direct a catheter, relying on its internal sensor and physical properties, not a standalone AI algorithm. The text states it interfaces with a "Boston Scientific iLab Polaris™ Multi-Modality Guidance System" which "displays various physiological parameters including aortic pressure, distal pressure and a fractional flow reserve (FFR) value calculated from the ratio of distal pressure over aortic pressure." While this system performs calculations, it's not described as a standalone AI algorithm whose performance needs to be evaluated independently of the device's physical function.

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

• For "pressure gradient measurement (sensor) requirements," the ground truth would typically be established by reference standard measurements from highly accurate and calibrated pressure transducers used in a controlled laboratory setting (bench testing).

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the context of machine learning or AI models. Its performance is based on its physical design, manufacturing, and calibration, not learned from data.

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

• Not applicable, as there is no "training set" for this device.

Ask a specific question about this device

To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and or any interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessels.

The proposed OptoMonitor is a software upgrade that includes software modifications allowing for the calculation of dPR index, and revised labeling relevant to this change. This device and its components are considered accessories to catheter pressure transducers and are intended for use with leqally marketed catheters. The OptoMonitor with the new dPR calculation is an upgraded version of the software embedded in the previously cleared OptoMonitor's Display Unit. The OptoMonitor comprises the exact same hardware as cleared version with most of the software remaining unchanged, except for the display unit software which in addition to the current calculation of Fractional Flow Reserve (FFR), the upgraded version will also calculate the diastolic pressure ratio (dPR). dPR is a resting index which consists in calculating the ratio of Pd and Pa over the diastolic portion of the heart beat cycle. dPR is a resting index for the diagnostic of the severity of stenosis equivalent to iFR (instantaneous wave-Free Ratio). IFR calculates the ratio of Pd and Pa over 75% of the diastolic portion. The OptoMonitor is composed of 3 parts: The Hybrid Cable Unit (HCU), the Signal Conditioner Unit (SCU) and the Display Unit (DU). There are no changes to the device hardware (HCU and SCU) from device system cleared under K142598. The device is a non-sterile, non-patient contact device.

Here's a breakdown of the acceptance criteria and study information for the OptoMonitor with dPR software upgrade, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for the dPR software update itself. Instead, it compares the dPR's diagnostic performance against iFR (the reference standard and reference device) and FFR. The "reported device performance" are the accuracy, specificity, and sensitivity of dPR.

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

• Test Set Sample Size: Not explicitly stated. The performance metrics (accuracy, specificity, sensitivity) were "calculated from both CONTRAST² and VERIFY ²² studies." The exact number of patients or cases from these studies used for the dPR analysis is not provided.
• The document implies that the data is retrospective, as it is based on re-analysis of existing study data (CONTRAST and VERIFY). The country of origin for these studies is not specified in this document.

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

This information is not provided in the document. The ground truth for the dPR analysis appears to be the iFR itself (as a "reference standard") and FFR. The qualifications of the original investigators/experts who conducted the CONTRAST and VERIFY studies and established FFR/iFR values are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document. The analysis appears to be a direct comparison of calculated dPR values against iFR and FFR values from existing studies, rather than a new adjudication process involving human reviewers.

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

• Was a MRMC study done? No. The document explicitly states: "No animal studies or clinical investigations are included with this submission."
• Effect Size of Human Readers with/without AI assistance: Not applicable, as no human reader study was conducted.

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

Yes, a standalone study was performed. The reported accuracy, specificity, and sensitivity for dPR (97.1%, 95.9%, and 98.4% respectively) are results of the algorithm's performance in calculating dPR and comparing it to iFR from existing studies. The dPR calculation is an automated software function on the OptoMonitor.

7. Type of Ground Truth Used

The ground truth used for evaluating dPR's performance was:

• Instantaneous wave-Free Ratio (iFR): Explicitly stated as the "reference standard."
• Fractional Flow Reserve (FFR): Used as a comparative measure to assess the diagnostic performance of dPR vs FFR and iFR vs FFR.

8. Sample Size for the Training Set

This information is not provided in the document. The document describes a "software upgrade" to calculate dPR, indicating that the algorithm was likely developed and validated on internal datasets, but the size of any training data is not mentioned.

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

This information is not provided in the document. Given that the dPR calculation is a derivation from existing physiological measurements (Pd and Pa pressures), the "training" might involve tuning the algorithm to accurately replicate known iFR values or align with FFR correlations from existing clinical data. The exact method of establishing ground truth for any potential training set is not detailed.

Ask a specific question about this device

Zurich Pressure Guidewire System is indicated to measure physiological parameters in the coronary and peripheral blood vessels and in the heart. Zurich Pressure Guidewire System is also indicated to direct a catheter through a blood vessel.

The Zurich Pressure Guidewire System Model 100™ ("Zurich Pressure Guidewire System") consists of a 0.014" (0.36 mm) diameter, 180 cm long Interventional Guidewire with a high fidelity sensor located immediately beyond the 3 cm shapeable radiopaque tip and a uniquely paired Portable Display. The signals from the sensor can be used to measure blood pressures and calculate Fractional Flow Reserve (FFR). The Guidewire is connected to the Portable Display via the Handle. The distal end has hydrophilic coating. The Portable Display also has an AO Cable that may be used to connect to the Zurich Medical Accessory Cable for AO pressure signal.

The provided document is a 510(k) premarket notification for the Zurich Pressure Guidewire System Model 100. Its purpose is to demonstrate substantial equivalence to existing predicate devices, not primarily to prove performance against specific acceptance criteria for a new clinical indication. Therefore, the document does not contain the detailed information requested regarding acceptance criteria for an AI/device performance study, such as specific metrics (e.g., sensitivity, specificity), sample sizes for test sets, expert adjudication methods, MRMC studies, or detailed ground truth establishment.

The document primarily focuses on:

• Device Description and Intended Use: The Zurich Pressure Guidewire System is indicated to measure physiological parameters in coronary and peripheral blood vessels and the heart, and to direct a catheter through a blood vessel.
• Comparison to Predicate Devices: It highlights similarities and minor differences in intended use, indications for use, technological characteristics, and physical properties compared to two predicate devices (PressureWire™ Certus™ guidewire and RadiAnalyzer™ Xpress portable display).
• Non-Clinical Testing: A summary of non-clinical (bench and animal) testing performed to demonstrate that the device meets its physical and performance specifications and is safe and effective. These tests are primarily related to general medical device safety and functionality (e.g., EMC, electrical safety, biocompatibility, sterility, software verification and validation).

Therefore, I cannot provide a table of acceptance criteria, reported performance, sample sizes for test sets, information on expert ground truth, or details of MRMC studies as these are not present in the provided text for this specific medical device submission.

The document does mention:

• Non-Clinical Testing (similar to a standalone performance evaluation in a broader sense):

  • The Zurich Pressure Guidewire System has undergone extensive non-clinical testing to meet its physical and performance specifications. This includes electromagnetic compatibility, electrical safety, biocompatibility, packaging validation, labeling compliance, sterilization, human factors, shelf life, animal studies (under GLP guidelines), and various Guidewire/Portable Display/System software and bench verification tests (e.g., diameter, tensile, kink, pushability, torque, flexibility, coating uniformity, corrosion, lubricity, fatigue, fracture, dimensional, particulate).
  • Study Proving Device Meets Acceptance Criteria: "The testing showed that the device meets specifications before and after aging, indicating that the device is as safe and effective as the predicate devices." (Page 6)
  • This implies that the "acceptance criteria" here refer to the specifications and requirements outlined by various standards (IEC, AAMI, ISO, ASTM) and FDA guidance for the type of device. The "study" proving it meets these is the sum of all the non-clinical tests mentioned.
  • Type of Ground Truth: For non-clinical tests, the "ground truth" is typically derived from physical measurements against established engineering specifications, animal study observations, and compliance with industry standards.

• Training Set Information:

  • There is no mention of a training set in the context of an AI/machine learning model. This submission is for a physical medical device (pressure guidewire system), not an AI algorithm.

In summary, the provided text does not contain the specific information requested under points 1-9 because the device and its submission type (510(k) for substantial equivalence of a physical device) do not typically involve the kind of AI/algorithm performance studies implied by your questions.

Ask a specific question about this device

The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

The Edwards Lifesciences Pressure Monitoring kit with TruWave disposable pressure transducer is a sterile, single-use kit that monitors intravascular blood pressure, intracranial pressure, and intrauterine pressure. The disposable sterile cable (available in 12-inch/30 cm and 48-inch/120 cm lengths) interfaces exclusively with an Edwards Lifesciences cable that is specifically wired for the patient monitor used to display the pressure data.

The TruWave disposable pressure transducer has a straight, flow through design, where the fluid is passed across the pressure sensor. The DPT is available either with or without an integral flush device.

The provided text is a 510(k) summary for a medical device, the TruWave Disposable Pressure Transducer. It describes the device, its intended use, and the regulatory determination of substantial equivalence.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device, which is what the prompt is asking for. The device described (a pressure transducer) is a physical medical device, not an AI/ML algorithm.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) from the provided document as it is not relevant to an AI/ML device study.

The document discusses:

• Device Name: TruWave Disposable Pressure Transducer
• Regulation Number: 21 CFR 870.2870 (Catheter Tip Pressure Transducer)
• Indications for Use: For patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
• Substantial Equivalence: To predicate devices K171996 and K142749.
• Testing: Mentions "successfully passed biocompatibility and functional testing," but no details on the specific performance metrics or acceptance criteria for these tests are provided, nor is there any mention of AI/ML performance metrics. The "functional testing" broadly refers to the device's physical operation, not an AI algorithm's performance.

To answer your prompt, I would need a document detailing the clinical validation or performance study of an AI/ML medical device, including its acceptance criteria and how it was proven to meet them.

Ask a specific question about this device

The PressureWire™ X guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. Physiological parameters include blood pressure. The PressureWire™ X guidewire can also measure blood temperature.

The PressureWire™ X guidewire has an integrated sensor element at the tip to enable measurements of physiological parameters. The wire is introduced into the patient's blood vessel. A torque device is used to steer the wire and sensor into the required position for pressure measurements according to standard clinical practice. PressureWire™ X guidewire is available in two different lengths. The guidewire is uniquely paired with a specific connection cable or with a specific transmitter. Both PressureWire™ X guidewire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system. The PressureWire™ guidewire is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a vessel. The signal output from the sensor is transmitted to associated equipment for analysis, calculations, and display of physiological parameters or indices based on pressure or temperature, e.g. Fractional Flow Reserve (FFR).

The provided text describes the PressureWire™ X guidewire, a medical device used to direct catheters and measure physiological parameters like blood pressure and temperature. The submission is a Special 510(k), indicating a minor design modification to an already cleared device (K161171). As such, a detailed comparative effectiveness study with human readers or extensive clinical trials are not typically required for this type of submission. The focus is on demonstrating that the modified device remains substantially equivalent to the predicate device and that the modification does not raise new safety or effectiveness concerns.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a Special 510(k) like this, the "acceptance criteria" are primarily based on demonstrating that the modified device performs comparably to the predicate device and meets established performance standards for its type. The reported device performance centers on various bench tests.

Note: The text states "Tests were conducted to evaluate the following: ... Additionally, simulated-use testing was completed as part of design validation to demonstrate the subject device met user needs and the intended use. The following test was performed: Signal Drift." It implies all these items were successfully met to demonstrate safety and effectiveness.

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

• Sample Size for Test Set: Not explicitly stated in terms of a specific number of units for each test. The text outlines categories of tests (e.g., Tensile Strength, Torque Strength) and generally states "Performance bench testing was completed as part of design verification" and "simulated-use testing was completed as part of design validation." Typically, for bench testing, a statistically relevant number of samples would be tested to ensure reliability. However, this specific number is not disclosed in the summary.
• Data Provenance: The testing was "Performance bench testing" and "simulated-use testing." This indicates the data was generated in a controlled laboratory environment, not from human or animal subjects. Thus, there's no "country of origin of the data" in the typical sense, nor is it retrospective or prospective clinical data. It's pre-market engineering and product verification/validation data.

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

• Number of Experts: Not applicable or mentioned. The "ground truth" for bench testing is defined by engineering specifications, validated test methods, and industry standards (e.g., for tensile strength, torque strength).
• Qualifications of Experts: Not applicable. The tests are designed to objectively measure physical and electrical properties according to predefined methods and pass/fail criteria.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Bench tests typically involve objective measurements and comparisons against predetermined specifications rather than subjective expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of human readers improve with AI vs without AI assistance

• MRMC Comparative Effectiveness Study: No. The device is a physical guidewire with measurement capabilities, not an AI-powered diagnostic imaging tool that assists human readers in interpreting medical cases. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or applicable here.

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

• Standalone Performance: Not applicable in the context of an "algorithm only" device. The PressureWire™ X is a hardware device with an integrated sensor. Its "standalone performance" is demonstrated through the various bench tests ensuring the physical and measurement properties meet specifications.

7. The type of ground truth used

• Type of Ground Truth: For the "test set" (bench and simulated-use testing), the ground truth is based on engineering specifications, established physical properties, and validated measurement techniques. For example, a tensile strength test would have a pre-defined acceptable range of force the wire must withstand, and the measured force is compared against that objective standard.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a physical hardware product. It does not employ machine learning or AI algorithms that require a "training set" of data in the conventional sense. The "training" for such devices involves design, prototyping, and iterative testing, not algorithmic data training.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no "training set" for an AI algorithm in this context. The "ground truth" during the device's development (design and iterative testing) would similarly be based on engineering principles, material science, and performance specifications derived from intended use and predicate device characteristics.

Ask a specific question about this device