(26 days)
The Quantix/OR Blood Flow Monitor is intended for invasive and noninvasive diagnostic blood flow measurements.
The Quantix/OR™ Blood Flow Monitor with Flexible Probe and Vessel Stabilizer is a dualbeam, angle independent, pulse-wave Doppler ultrasound system for the invasive and noninvasive blood vessel flow measurements. In addition to the conventional Doppler (blood flow velocity) measurements, the Quantix/ORTM Flexible Probe technology utilizes ultrasound Doppler methods to obtain real-time measurements according to the definition of blood flow volume to target blood vessels. By definition, blood flow is the product of velocity cross-sectional area. In other words, the volume blood flow is calculated by deriving flow velocity from the Doppler shift frequency using the basic standard formula and then multiplying the velocity by the cross-sectional area of the blood vessel.
This device is a Quantitative Flow Monitor, not an AI/ML device. Therefore, the requested information pertaining to AI/ML device studies (such as sample size for test/training sets, experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable or cannot be extracted from the provided text.
The provided text describes a 510(k) premarket notification for the Quantix/OR™ Blood Flow Monitor, a medical device for measuring blood flow. The submission focuses on demonstrating substantial equivalence to predicate devices, which is the standard for 510(k) clearances. This type of submission typically relies on comparing technological characteristics and intended use, rather than detailed performance studies with acceptance criteria in the way an AI/ML device would.
Here's an analysis based on the information available in the text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format typically used for AI/ML device evaluation (e.g., sensitivity, specificity, AUC). The submission's core argument is substantial equivalence to predicate devices rather than meeting specific performance thresholds in a clinical study for a novel algorithm.
The "performance" is implicitly deemed equivalent to the predicate devices due to similar technological characteristics and intended use.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable as this is not an AI/ML device and no such test set is described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable as this is not an AI/ML device.
4. Adjudication Method for the Test Set:
Not applicable as this is not an AI/ML device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable as this is not an AI/ML device.
7. The type of ground truth used:
Not applicable in the context of an AI/ML device's ground truth. However, for a traditional medical device, ground truth for performance claims (if any were made beyond equivalence) would typically be established through recognized measurement standards or validated clinical methods. The document does not describe such studies for this device.
8. The sample size for the training set:
Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable as this is not an AI/ML device.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).