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QUANTIEN Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.

QUANTIEN Measurement System is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

QUANTIEN Measurement System is a diagnostic computer designed to record, compute, display and store data from PressureWire™ guidewire (K113584, K080813, K062769) and other external transducers. The information is displayed as graphs as well as numerical values on the screen. Data includes: systolic, diastolic and mean blood pressure, heart rate, and Fractional Flow Reserve (FFR) and data from ECG.

Information on screen can also be transferred to an external hemodynamic recording system or to an external video monitor. Recorded procedures can be viewed on a PC for review and analysis with application specific viewing software installed, such as RadiView™ software.

Additional functions allow for import of a patient work list from the hospital DICOM system, export recorded measurement data to DICOM or to an external server location or save it to a USB memory stick.

The provided text describes the QUANTIEN™ Measurement System and its 510(k) submission, focusing primarily on its intended use, technical characteristics, and substantial equivalence to a predicate device. However, it does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample size or data provenance for a test set.
• Details on experts used for ground truth establishment.
• Adjudication methods.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• The type of ground truth used (beyond implying physiological parameters).
• Sample size for the training set.
• How ground truth for the training set was established.

The document focuses on explaining that the QUANTIEN™ Measurement System "meets the design inputs and raises no new safety or efficacy concerns" and is "substantially equivalent to the marketed predicate device, RadiAnalyzer Xpress (K092105)." This implies that the acceptance criteria are met by demonstrating equivalence and adherence to design specifications, but the specific criteria and performance figures are not detailed.

Given the limitations of the provided text, I can only provide information based on what is available.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided 510(k) summary for the QUANTIEN™ Measurement System emphasizes that the device meets its design inputs and is substantially equivalent to its predicate device, the RadiAnalyzer® Xpress (K092105). This implies that the acceptance criteria for the QUANTIEN™ system are largely based on demonstrating that it performs comparably to the predicate device in its intended function of recording, computing, displaying, and storing physiological data, including Fractional Flow Reserve (FFR), without introducing new safety or efficacy concerns.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not include a specific table of acceptance criteria or reported device performance metrics for the QUANTIEN™ Measurement System. The core claim is that it "meets the design inputs" and is substantially equivalent to the predicate device.

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

The document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical performance study. The 510(k) submission primarily relies on technical characteristics, intended use, operational characteristics, and fundamental design similarities to the predicate device for demonstrating substantial equivalence.

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

This information is not provided in the document.

4. Adjudication method 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

The document does not describe an MRMC comparative effectiveness study nor does it mention AI assistance. The QUANTIEN™ Measurement System is described as a diagnostic computer for physiological measurements, not an AI-assisted diagnostic tool.

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

The document does not describe a standalone algorithm performance study. The device is intended to "compute and display various physiological parameters based on the output from one or more electrodes, transducers or measuring devices," implying human interaction in its use and interpretation.

7. The type of ground truth used

While not explicitly stated as "ground truth," the device's function is to "compute and display various physiological parameters." The implication is that the accuracy of these computed physiological parameters against established physiological measurement methods would serve as the ground truth for its performance. The document mentions "output from one or more electrodes, transducers or measuring devices" as the input, which suggests the ground truth would be against the direct measurements from these established sensors.

8. The sample size for the training set

The document does not specify a training set sample size.

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

The document does not provide information on how ground truth for a training set was established.

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RadiAnalyzer® Xpress is indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters with Pressure Wire®.

RadiAnalyzer® Xpress is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological and blood flow parameters based on the output from one or more electrodes, transducers or measuring devices.

RadiAnalyzer® Xpress is a diagnostic computer designed to compute, record and display information from Pressure Wire® and other external transducers. The information is displayed as graphs as well as numerical values on the integrated screen and may also be transferred to a cardiac monitor, RadiAnalyzer® Printer and/or PC with external viewing software installed, such as RadiView® or PhysioMon™. Data includes: systolic, diastolic and mean blood pressure, heart rate, and Fractional Flow Reserve (FFR). RadiAnalyzer® Xpress can be upgraded with additional software, such as Thermo Option software to enable assessments of invasive temperature, Coronary Flow Reserve (CFR) or other physiological parameters such as first time derivative of pressure (dP/dt).

RadiAnalyzer® Xpress comes with one remote control, two monitor cables, one adapter cable, and one mains cable (standard configuration).

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for the RadiAnalyzer® Xpress, primarily focusing on showing its substantial equivalence to a predicate device. It discusses:

• Device Description: What the RadiAnalyzer® Xpress does and its components.
• Intended Use/Indications for Use: The medical purpose of the device.
• Technical Characteristics: Mentions additions to the device (algorithm for dP/dt and IMR calculation in accessory RadiView®) compared to the predicate.
• Functional/Safety testing: A general statement that "software verification/validation conducted indicate that RadiAnalyzer® Xpress and its accessories PhysioMon™ and RadiView® satisfy safety and performance requirements of the device specifications and do not raise additional safety issues." This is a blanket statement and not a detailed description of acceptance criteria or a specific study.
• Conclusion: Declares substantial equivalence to predicate devices.
• FDA Correspondence: Official letter from the FDA regarding the 510(k) submission.

Therefore, I cannot populate the requested table or answer the specific questions about the study, sample sizes, ground truth, or MRMC results. This type of detailed performance criteria and study summary is typically found in the full 510(k) submission, not usually in the publicly available 510(k) summary document itself, which often focuses on the regulatory aspects and equivalence demonstration.

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PressureWire® 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 vessel.

PressureWire® is a .014" guidewire with an integrated pressure and temperature sensor. together with a detachable cable or transmitter/receiver for connection to a diagnostic computer or a cathlab hemodynamic recording system.

The provided 510(k) summary for the PressureWire® Aeris and PressureWire® Receiver describes its technical characteristics and claims substantial equivalence to predicate devices. However, the document does not describe the acceptance criteria and a study proving the device meets those criteria, as typically understood for sophisticated diagnostic or AI-powered devices.

Instead, this submission focuses on functional/safety testing to demonstrate that the new device (which incorporates wireless technology) is as safe and performs as well as previous wired versions. It does not present a clinical performance study with specific acceptance criteria in terms of diagnostic accuracy or effect size.

Here's an analysis based on the information provided, highlighting the absence of what was requested:

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

Explanation: The 510(k) summary does not define explicit, quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy for a particular diagnostic task). The "performance testing" mentioned is likely related to the device's functional integrity as a pressure guidewire, rather than its diagnostic efficacy in a clinical setting against a gold standard. The primary focus of this 510(k) is the change from a wired to a wireless signal transfer mechanism.

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 applicable. The document does not describe a clinical performance study involving a test set of patient data.
• Data provenance: Not applicable.

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)

• Number of experts: Not applicable.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable.

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

• MRMC study: No, this device is a medical instrument (pressure guidewire) for measuring physiological parameters, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
• Effect size: Not applicable.

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

• Standalone performance: Not applicable. The device itself is the "standalone" instrument. It measures physiological parameters for clinicians to interpret. There is no "algorithm only" performance to evaluate in the context of interpretation, as this is not an AI-driven image analysis or diagnostic software.

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

• Type of ground truth: Not explicitly stated or applicable as no clinical performance study against a diagnostic ground truth is described. The "performance requirements" would likely be engineering specifications for pressure and temperature measurement accuracy and reliability, validated against calibrated standards or in-vitro models rather than clinical ground truth for diagnostic interpretation.

8. The sample size for the training set

• Sample size for training set: Not applicable. This is not an AI/ML device that requires a training set.

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

• Ground truth for training set: Not applicable.

Summary of Device and 510(k) Filing:

The K080813 submission for the PressureWire® Aeris focuses on the technical modifications of an existing device (PressureWire®) by introducing a wireless signal transfer mechanism. The key argument for substantial equivalence is that the new wireless version performs its intended function (directing a catheter and measuring physiological parameters) and meets safety standards just like its predicate wired versions. The 510(k) summary explicitly states: "The guidewire part of subject device is identical to the predicate device (K062769)." The "Functional/Safety Testing" mentioned refers to electrical, EMC, radio, sterilization, and general performance testing to ensure the new wireless components do not introduce new safety concerns or functional degradation compared to the wired predicate. This is a common approach for 510(k) submissions where the changes are primarily technological rather than a new diagnostic claim or a new type of device.

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FemoStop® Femoral Compression System is indicated for use in the compression for the femoral artery or vein after vessel cannulation, and in ultrasounded-guided compression repair of a femoral artery pseudoaneurysm .

This combination of FemoStop®Femoral Compression System consists of an arch with a sterile pneumatic pressure dome, an integrated pump with a digital manometer, a belt and a hemostatic dressing and is called FemoStop®Gold Femoral Compression System. The pressure dome is placed over the vessel puncture site in the groin. The belt is placed around the patient. The dome applies mechanical pressure over the vessel puncture site to induce hemostasis. The pressure of the dome is controlled by the integrated pump and the manometer. The arch and belt provide counter pressure for the dome. The sterile hemostatic dressing is placed on the skin incision site as a bacterial barrier and for topical control of bleeding,

I am sorry, but the provided text does not contain information about acceptance criteria, device performance tables, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document is a 510(k) summary and FDA clearance letter for a medical device called the FemoStop® Femoral Compression System. It describes the device, its intended use, and its substantial equivalence to a predicate device, but it does not include details of a study with the specific criteria you've requested.

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PressureWire® is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.

Pressure Wire® is a .014" guidewire with an integrated pressure and temperature sensor, together with a detachable cable for connection to a diagnostic computer.

The provided text describes a 510(k) submission for the PressureWire® device, focusing on its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed performance metrics, or information about a study designed to prove the device meets acceptance criteria in the way typically expected for a medical imaging AI device or diagnostic tool.

Instead, the document states:

• "Biocompatibility and performance testing indicate that PressureWire® satisfies safety and performance requirements of the device specifications and do not raise additional safety issues."
• "On the basis of the testing conducted, it may be concluded that PressureWire® satisfies specified safety and performance requirements."
• "PressureWire® is substantially equivalent to the predicate device."

This indicates that general performance and safety testing was performed, leading to the conclusion of substantial equivalence. The "performance data" mentioned is described broadly without specific quantitative metrics or a study design to meet defined acceptance criteria.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's an attempt to answer based on the absence of the requested information, and what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified. It's likely pre-clinical (bench/in-vitro) and possibly animal testing given the nature of a guidewire, but no details are provided. This is a medical device, not an AI model, so "country of origin of data" in the typical sense for AI data is not relevant here.

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

• Number of Experts: Not applicable/not specified. This is a medical device for physical measurement and guidance, not an imaging diagnostic device requiring expert interpretation for ground truth. Ground truth would likely be established by physical measurements against known standards.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not specified. As above, ground truth is likely established by physical measurements, not human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC study was not done, as this is a medical device, not a diagnostic AI intended to assist human readers in interpreting cases.

6. If a Standalone Study Was Done (Algorithm Only Without Human-in-the-Loop Performance)

• Standalone Study: Not applicable in the context of an "algorithm only" study. Performance tests would have been conducted on the device itself (standalone in a physical testing sense) to assess its functional characteristics (e.g., pressure measurement accuracy, steerability, biocompatibility). The document states "Biocompatibility and performance testing indicate..." which implies standalone testing of the device's physical properties.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated but would likely involve:
  • Known Physical Standards: For pressure and temperature measurements (e.g., comparison against calibrated sensors).
  • Material Science Standards: For biocompatibility and mechanical properties.
  • Engineering Specifications: For design, construction, and mechanical performance.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This is a physical medical device, not an AI algorithm that undergoes data-driven training. Device design and validation are based on engineering principles, materials science, and physical testing.

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

• Ground Truth Establishment: Not applicable. As it's not an AI model, there isn't a "training set" in the machine learning sense. The "ground truth" for its development would be established through engineering specifications, material properties, and iterative design and testing.

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RadiAnalyzer® is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.
RadiAnalyzer® is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

RADIAnalyzer® is a diagnostic computer designed to compute, record and display information, based on the input from PressureWire® Sensor and an Aortic Pressure Transducer (AO). The information is displayed as graphs as well as numerical values on the integrated screen and may also be transferred to a cardiac monitor, RADIAnalyzer® Printer and/or PC with external vicwing software installed such as RADIView® Software. Data includes: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), Coronary Flow Reserve (CFR) and temperature.

This K042628 510(k) submission for the RADIAnalyzer® Xpress does not contain the details of a study with acceptance criteria and reported device performance.

The document is a 510(k) summary and the FDA's clearance letter, which focus on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for the new device.

Therefore, I cannot provide the requested information from the provided text. The submission primarily addresses:

• Device identification: Proprietary name, common name, classification, and predicate device.
• Description of the device: How it functions and what it measures (systolic, diastolic, mean blood pressure, heart rate, FFR, CFR, temperature).
• Intended Use: Diagnosis and treatment of coronary or peripheral artery disease, and its use in catheterization labs.
• Technical Characteristics: Stating it's a smaller/lighter version of the predicate, with equivalent electrical and signal properties.
• FDA Clearance Letter: Confirming substantial equivalence to the predicate device.

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TopSeal™ Hemostatic Dressing is indicated for control of minor bleeding from wounds and lacerations or minor bleeding from skin incisions or punctures following percutaneous medical procedures.

TopSeal™ Hemostatic Dressing is a sterile dressing impregnated with the hemostatic agent m.docTM (calcium/sodium salt of micro-dispersed oxidized cellulose). The active hemostatic agent promotes the topical control of bleeding. The dressing comes as a pad which is impermeable to water and acts as a bacterial barrier.

The provided text describes a 510(k) submission for the TopSeal™ Hemostatic Dressing and its substantial equivalence determination by the FDA. However, the text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

The document is a regulatory letter and a 510(k) summary, which focuses on:

• The administrative change regarding the product code.
• The determination of substantial equivalence to predicate devices.
• The description and intended use of the device.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details because it is not present in the provided text.

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The PressureWire Sensor is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.

The PressureWire™ Sensor is a 0.014" diameter, 183 or 300 cm long guidewire with a pressure sensor mounted three cm from the distal end and a detachable cable for connection to a programmable diagnostic computer manufactured by the submitter.

The provided document is a 510(k) summary for the PressureWire™ Sensor, a medical device. It does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document focuses on regulatory compliance, specifically demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used.
• The sample size for the training set or how its ground truth was established.

This 510(k) summary primarily addresses the regulatory approval process based on similarity to an already approved device (predicate device), rather than presenting a detailed performance study with acceptance criteria.

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FemoStop® Femoral Compression System is indicated for use in the compression for the femoral artery or vein after vessel cannulation, and in ultrasounded-guided compression repair of a femoral artery pseudoaneurysm

The FemoStop®Femoral Compression System consists of an arch with a sterile pneumatic pressure dome attached to an arch, a belt, and a reusable pump with manometer. With this application a sterile hemostatic dressing, HD, is added to the system. The dressing has an active agent made of calcium/sodium salt of micro dispersed oxidized cellulose for topical control of bleeding.

This is a 510(k) summary for the FemoStop® Femoral Compression System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the provided text does not contain any information regarding specific acceptance criteria, study details, or performance data beyond stating substantial equivalence. Therefore, a complete answer as requested cannot be generated from the given input.

The document primarily focuses on establishing substantial equivalence based on technical characteristics and intended use, comparing the new device (with an added hemostatic dressing) to existing FemoStop models and other relevant products.

Based on the provided text, the following information is missing or cannot be extracted:

• A table of acceptance criteria and the reported device performance: This information is not present. The document claims technical characteristics are "identical" or "substantially equivalent" to predicate devices, but no performance metrics or specific acceptance criteria are listed.
• Sample size used for the test set and the data provenance: No test set or data provenance is mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment is described.
• Adjudication method: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, this is a medical device, not an AI algorithm.
• The type of ground truth used: Not applicable, as no ground truth is established for performance evaluation.
• The sample size for the training set: Not applicable, as this is a medical device, not a machine learning algorithm.
• How the ground truth for the training set was established: Not applicable.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and study details based on the provided text. The document is strictly a 510(k) summary aiming for substantial equivalence.

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RADIAnalyzer™ is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease. RADIAnalyzer™ is intended for use in catheterization and related cardiovascular specially laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers or measuring devices.

RADIAnalyzer™ is a diagnostic computer designed to compute, record and display information, based on the input from PressureWire™ Sensor and other External Pressure Transducer. The information is displayed as graphs as well as numerical values on the integrated screen and may also be transferred to a cardiac monitor, RADIAnalyzer™ Printer and/or PC with RADIView™ installed. Data includes: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), Coronary Flow Reserve (CFR) and temperature.

The provided text describes the regulatory clearance for the RADIAnalyzer™ device and details its function and intended use. However, it does not contain any information regarding specific acceptance criteria, a study that proves the device meets those criteria, sample sizes, data provenance, expert qualifications, or ground truth methods.

The document states that the RADIAnalyzer™ complies with voluntary standards and that quality assurance measures were applied, including:

• Requirements specification review
• Code inspection
• Software and hardware testing
• Safety testing
• Environmental testing
• Final validation

It concludes that "The results of these measures demonstrate that the RADIAnalyzer™ is as safe, as effective, and performs as well as the predicate devices." This implies that the device was compared to predicate devices for safety and effectiveness, but no details of such a comparison (e.g., performance metrics, statistical analysis) are provided.

Therefore, I cannot populate the table or answer the specific questions you've posed based on the given input. The information required (acceptance criteria, study details, sample sizes, ground truth methodology, etc.) is not present in the provided 510(k) summary.

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