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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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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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