(198 days)
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.
| Acceptance Criteria (Implied from 510(k) Process) | Reported Device Performance (Implied from Substantial Equivalence Claim) |
|---|---|
| Intended Use is the same as the predicate device | Intended for intra-operative examinations of blood flow measurements. |
| Technological Characteristics are substantially equivalent to the predicate device | Overall design, materials, mechanism of action, mode of operation, and performance characteristics are substantially equivalent to the predicate device (FlowGuard, K013803). |
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.
§ 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).