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The Bio-Probe blood flow monitoring system is to be used with an appropriate model Bio-Console extracorporeal blood pumping console to measure directly the blood flow in the extracorporeal perfusion circuit.

The Bio-Probe 10 Blood Flow Monitoring System consists of a flow transducer and a sterile, single-use insert. The flow transducer consists of a flow-meter, cable and connector. The TX50 (adult) and TX50P (pediatric) transducer models are reusable. The Bio-Probe blood flow monitoring system can be used to measure the patient blood flow during the extracorporeal procedure.

The provided document is a 510(k) summary for the Bio-Probe Blood Flow Transducer. This particular submission concerns the addition of a contraindication statement to the device.

Therefore, the document explicitly states that "Testing was not required for addition of a contraindication statement. Addition of the contraindication statement does not change the indications for use, technology and performance specifications of this device." This means there is no study described in this document proving the device meets acceptance criteria, as the submission is not about performance.

Here's the breakdown based on your request, highlighting the lack of relevant information for a performance study in this specific submission:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not applicable/Provided.
• Reported Device Performance: Not applicable/Provided.

Explanation: This 510(k) is solely for adding a contraindication statement, not for demonstrating new performance or design changes.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not applicable.
• Data Provenance: Not applicable.

Explanation: No testing was performed for this submission.

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)

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

Explanation: No ground truth establishment was needed as no performance testing was conducted.

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

• Adjudication Method: Not applicable.

Explanation: No adjudication was needed as no performance testing was conducted.

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.
• Effect Size: Not applicable.

Explanation: This device is a blood flow transducer, not an AI-assisted diagnostic or interpretation device that would involve human readers.

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

• Standalone Performance: Not applicable.

Explanation: This device is a physical transducer for measuring blood flow, not an algorithm.

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

• Type of Ground Truth: Not applicable.

Explanation: No ground truth was established as no performance testing was conducted.

8. The sample size for the training set

• Training Set Sample Size: Not applicable.

Explanation: This submission does not involve an algorithm or machine learning that would require a training set.

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

• Ground Truth Establishment (Training Set): Not applicable.

Explanation: No training set or ground truth for it was established.

In summary, this 510(k) submission is a regulatory update for an existing device (Bio-Probe Blood Flow Transducer, predicate device K070286) to add a contraindication statement. It explicitly states that no testing was required or performed because the change does not impact the device's indications for use, technology, or performance specifications. Therefore, information regarding acceptance criteria and performance study details is not present in this document.

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