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The VGF-7 Vascular Graft Flowmeter is device for measuring the flow of saline or other fluid through a graft when driven by a constant steady pressure or a controlled pulsatile pressure. It is indicated during coronary artery bypass surgery for assisting the surgeon in intra-operatively assessing the ability of a given vein graft preparation to support fluid flow.

The VGF-7 Vascular Graft Flowmeter is indicated during artery bypass and other blood vessel surgeries for assisting the surgeon in intra-operatively assessing the ability of a given graft preparation to support fluid flow.

The VGF-7 consists of an automatic syringe that injects blood or saline solution into proximal end of the vein graft at a controlled physiological pressure. The resulting flow rate is displayed on a digital readout.

The system consists of a servo mechanism controlled by a microprocessor. The microprocessor activates a controlled pressure loop to maintain a predetermined pressure of liquid in a syringe during injection. The liquid is injected from the syringe through a PVC tube and small graft cannula into the graft. The flowrate is the outcome of the liquid pressure and the graft flow resistance.

The provided text offers very limited information regarding the acceptance criteria and study details for the VGF-7 Vascular Graft Flowmeter. Here's a breakdown of what can be extracted and what is missing based on your request:

Acceptance Criteria and Reported Device Performance

The text states that non-clinical tests were conducted to "validate the accuracy of flow determinations over the specified range of flows." However, it does not explicitly define specific numerical acceptance criteria (e.g., a percentage accuracy, a maximum deviation) or report the device's performance against such criteria. Instead, it concludes with a general statement of equivalency.

Table 1: Acceptance Criteria and Reported Device Performance (Limited Information)

Study Details

Due to the nature of the 510(k) summary, specific detailed study information is largely absent.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document only mentions "Non-clinical tests were conducted."
• Data Provenance: Not specified, but given the manufacturer is based in Israel, it's possible the testing was conducted there. It is a non-clinical, in-vitro test, not involving human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable, as this was a non-clinical, in-vitro test for device accuracy, not requiring clinical expert evaluation for ground truth.
• Qualifications of Experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Adjudication Method: Not applicable for a non-clinical accuracy test. The "ground truth" would be established by the precise measurement tools used in the test setup.

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:

• MRMC Study: No, an MRMC study was not done. This device is a flowmeter, not an AI-powered diagnostic tool used by human readers for interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Yes, the accuracy testing described implicitly refers to the standalone performance of the device's flow measurement capability. The statement "Non-clinical tests were conducted to validate the accuracy of flow determinations" directly addresses the device's inherent performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: For the "accuracy of flow determinations," the ground truth would have been established using reference standard instrumentation or precisely calibrated flow systems designed to measure fluid flow with high precision. This is a technical ground truth, not a clinical one.

8. The sample size for the training set:

• Sample Size: Not applicable. This device does not appear to use machine learning or AI that would require a "training set" in the conventional sense. The "training" for such a device would be its engineering design, calibration, and manufacturing process.

9. How the ground truth for the training set was established:

• Ground Truth Establishment: Not applicable, as there is no mention of a training set for an algorithm.

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