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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.

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The Quantix/OR device is intended for intra-operative examinations of blood flow measurements.

Intended Use: Diagnostic blood flow measurements

Additional Comments: Intra-operative (Specify): For direct application to exposed blood vessel (miniature, sterilizable transducer)

The Quantix/OR is a dual-beam, angle-independent, pulse-wave Doppler ultrasound system used for intra-operative volume blood flow measurements, including blood flow velocity and volume blood flow. In addition to the conventional Doppler (blood flow velocity) measurements, the Quantix/OR technology utilizes special applications of ultrasound Doppler methods to obtain real-time measurements according to the definition of volume blood flow in 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.

Since there is no study included in the provided text, I am unable to provide criteria from an efficacy study.

This document (K030357) is a 510(k) premarket notification for a medical device called Quantix/OR, a cardiovascular blood flowmeter. The purpose of a 510(k) is to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This process does not typically involve extensive clinical efficacy studies in the same way a Premarket Approval (PMA) would.

Therefore, the acceptance criteria are based on substantial equivalence to the predicate device, not on specific performance metrics established through an efficacy study. The "study" proving the device meets acceptance criteria is the 510(k) submission itself, which argues for substantial equivalence.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for substantial equivalence, the "acceptance criteria" are not reported as specific performance thresholds, but rather as alignment with the predicate device. The "reported device performance" is implicitly that it functions similarly to the predicate.

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

The provided 510(k) document does not describe an independent test set with a specific sample size for evaluating clinical performance. The substantial equivalence claim is based on comparing the new device's technological characteristics and intended use to a predicate device. This process generally relies on engineering and design comparisons, potentially bench testing, and comparisons of specifications, rather than a clinical "test set" in the traditional sense of an efficacy study.

Data Provenance: Not applicable in the context of this 510(k) submission, as it doesn't detail a clinical study with patient data.

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

Not applicable. This 510(k) focuses on substantial equivalence to a predicate device, not on establishing ground truth for a novel claim via a clinical study with expert adjudication.

4. Adjudication Method for the Test Set

Not applicable. There is no described test set requiring expert adjudication in this 510(k) submission.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this 510(k) submission. The document focuses on demonstrating substantial equivalence to a predicate device, not on comparing performance with and without AI assistance or human readers.

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

The Quantix/OR is described as a "dual-beam, angle-independent, pulse-wave Doppler ultrasound system used for intra-operative volume blood flow measurements." This implies it's a diagnostic device operated by a human, not an AI algorithm performing without human intervention. Therefore, a standalone algorithm-only performance study is not applicable and not described.

7. The Type of Ground Truth Used

Not applicable. The 510(k) primarily relies on the predicate device (FlowGuard, K013803) as the "standard" against which the new device's characteristics and performance are judged for substantial equivalence. There is no mention of pathology, outcomes data, or expert consensus being used as ground truth for a clinical performance evaluation in this document.

8. The Sample Size for the Training Set

Not applicable. The Quantix/OR is a Doppler ultrasound system, not an AI/machine learning algorithm that requires a "training set" in the computational sense.

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

Not applicable. As the device is not an AI/machine learning algorithm, there is no training set mentioned or described.

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The Quantix/ND device is intended for non-invasive, peripheral vessel examinations of blood flow measurements
Diagnostic Blood Flow Measurements

The Quantix/ND is a dual-beam, angle-independent, pulse-wave Doppler ultrasound system used for non-invasive (peripheral vessel) volume blood flow measurements, including blood flow velocity and volume blood flow. In addition to the conventional Doppler (blood flow velocity) measurements, the Quantix/ND technology utilizes special applications of ultrasound Doppler methods to obtain real-time measurements according to the definition of volume blood flow in 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.

It is impossible to provide the requested information based on the input text. The provided text is a 510(k) premarket notification for the Quantix/ND Device, which focuses on demonstrating substantial equivalence to a predicate device.

The document does not contain:

• Any specific acceptance criteria or performance metrics for the Quantix/ND device.
• Details of a study proving the device meets acceptance criteria.
• Information on sample sizes, data provenance, ground truth establishment, or expert qualifications for testing.
• Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.

The document primarily describes the device, its intended use, and its technological characteristics in comparison to a predicate device (FlowGuard, K013803) to assert substantial equivalence, which is the basis for 510(k) clearance. Clinical performance data or detailed validation studies with defined acceptance criteria are not typically part of the summary provided in a 510(k) notification unless specifically requested or if substantial equivalence cannot be established through other means.

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