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The FlowGuard device is intended for non-invasive, peripheral vessel examinations and intraoperative examinations of blood flow measurements
Intended Use: Diagnostic blood flow measurements

The FlowGuard is a dual-beam, angle-independent, pulse-wave Doppler ultrasound system used for non-invasive (peripheral vessel) and 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 FlowGuard 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.

Here's an analysis of the provided text regarding the FlowGuard device:

Based on the provided text, the FlowGuard device cleared the 510(k) pathway by demonstrating substantial equivalence to predicate devices, rather than through a study proving it met specific performance acceptance criteria. The document is an FDA clearance letter and summary, which focuses on regulatory equivalence.

Therefore, much of the requested information about concrete acceptance criteria, study data, sample sizes, ground truth, and expert involvement for a performance study is not available in the provided text.

Here's a breakdown of what can be extracted and what is explicitly not present:

Acceptance Criteria and Device Performance

There are no explicit, quantitative acceptance criteria or performance values reported for the FlowGuard device in this document. The clearance is based on substantial equivalence.

Study Details (Not explicitly present for a performance study)

1. Sample size used for the test set and the data provenance: Not provided. The document does not describe a performance study with a test set. It mentions "non-invasive (peripheral vessel) and intra-operative volume blood flow measurements."
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided, as no dedicated performance study is detailed where ground truth would be established.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
4. 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. This device is a blood flowmeter, not an AI-assisted diagnostic tool for human readers.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an algorithm. This is a medical device for measurement. Its performance would be assessed intrinsically, but no such study is described here beyond "substantial equivalence."
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
7. The sample size for the training set: Not applicable, as this is not an AI/machine learning device with a training set in the conventional sense.
8. How the ground truth for the training set was established: Not applicable.

Key Information from the Document:

• Device Name: FlowGuard device: Blood Flowmeter
• Intended Use: Non-invasive, peripheral vessel examinations and intraoperative examinations of blood flow measurements. Specifically, diagnostic blood flow measurements. For direct application to exposed blood vessel (miniature, sterilizable transducer).
• Classification Name: Cardiovascular Blood Flowmeter, Class II, 870.2100.
• Predicate Devices:
  • Blood Flow Meter Model HD-4200 (Koven Technology, Inc., K892707)
  • EchoFlow BVM-1 (EchoCath Inc., K990642)
  • Dynemo 3000 (Sometec Inc., K972798)
• Technological Characteristics: Dual-beam, angle-independent, pulse-wave Doppler ultrasound system. Measures blood flow velocity and volume blood flow. Calculates volume blood flow by deriving flow velocity from Doppler shift frequency and multiplying by the cross-sectional area of the blood vessel.
• Basis for Clearance: Substantial equivalence to predicate devices in overall design, materials, mechanism of action, mode of operation, performance characteristics, and intended use.
• Post-Clearance Requirement: The manufacturer is required to submit a "postclearance special report" containing complete information, including acoustic output measurements based on production line devices, as requested in Appendix G of the FDA's "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." This is a post-market requirement, not a pre-market performance study detail.

In summary, this document is a regulatory clearance letter focused on demonstrating substantial equivalence, not a detailed report of a performance study with specific acceptance criteria that the device met.

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