(32 days)
The Quantix OR + Vessel Stabilizer device is intended for intraoperative examinations of blood flow measurements.
The Quantix OR + Vessel Stabilizer accessory is a dual-beam, angle-independent, pulsewave Doppler ultrasound system used for intraoperative blood flow volume. In addition to the conventional Doppler (blood flow velocity) measurements, the Quantix OR + Vessel Stabilizer technology utilizes special applications of 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 and 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-section area of the blood vessel.
This document is a 510(k) premarket notification for the Quantix OR + Vessel Stabilizer device, a blood flowmeter. It establishes substantial equivalence to a predicate device but does not contain detailed performance studies or specific acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.
Here's an analysis of what can and cannot be provided:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided: This document identifies the device and its intended use but does not present specific acceptance criteria (e.g., minimum accuracy, precision, or sensitivity/specificity targets) for its performance. It also does not include the results of any performance studies against such criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided: The document does not describe any specific test set or clinical study data.
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)
- Cannot be provided: No test set or ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided: No adjudication method is mentioned as no test set evaluation is detailed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable / Cannot be provided: This device is a blood flowmeter, not an AI-assisted diagnostic imaging device that involves human readers interpreting cases. Therefore, an MRMC study as described would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Cannot be provided: This document does not describe any standalone performance studies. The device itself is a blood flowmeter for intraoperative use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided: No specific ground truth methodology is mentioned as no performance study is detailed.
8. The sample size for the training set
- Cannot be provided: This document does not describe a training set, as it is a 510(k) for a medical device (blood flowmeter), not an AI/machine learning algorithm that typically requires a training set.
9. How the ground truth for the training set was established
- Cannot be provided: As there's no mention of a training set, there's no information on how its ground truth might have been established.
Summary regarding the provided text:
The provided document is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a predicate device. It defines the device, its intended use, and its technological characteristics. It does not include the detailed technical performance studies, acceptance criteria, or clinical trial data that would contain the information requested in the prompt. Such detailed performance data is typically found in accompanying technical documentation, internal reports, or other sections of a more comprehensive regulatory submission, but not in this summary form.
§ 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).