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The Better-Bladder™ is a device that isolates from blood contact when measurements of blood pressure in extracorporeal circuits are made during term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures.

The Better-Bladder™ (BB) is a length of standard perfusion tubing, a portion of which has been processed to form a sausage shaped balloon with a thin wall that is then sealed within a clear, rigid housing. This device can be used as an inline blood reservoir during extracorporeal circulation. It can also be used to monitor the blood pressure noninvasively: because the pressure of blood flowing inside the tubing is transmitted across the thin wall to the housing chamber, this pressure can be monitored via a pressure monitoring line to a pressure sensor. The BB thereby serves as a pressure transducer protector, isolating the blood from the pressure sensor and allowing noninvasive pressure measurements, which in turn can be used as input signals to control the pump speed.

This 510(k) notification describes a medical device, the Better-Bladder™ BB14-72, and its substantial equivalence to a predicate device, focusing on its physical characteristics and performance in a mock circulatory system. The document does not describe the acceptance criteria and study design elements typically associated with AI/ML-based medical devices or diagnostics. Therefore, many of the requested fields cannot be directly answered from the provided text.

Here's an analysis based on the provided text, addressing the points where information is available and noting when it is not:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the BB14-72 appears to be its ability to mitigate negative pressure spikes due to venous line obstruction, performing "as well or better than the predicate device," and providing "more time for a pump flow controller to respond than the predicate device."

Study Details

The provided document describes a performance study to demonstrate the BB14-72 device's mechanical characteristics, not a clinical study involving human patients or complex AI/ML algorithms.

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

   • Sample Size: Not explicitly stated as a numerical sample size. The testing involved comparing the BB14-72 against the predicate device (BB14) and a 1/4" standard perfusion tubing in a "mock extracorporeal circuit." The graphs show results for three devices/configurations.
   • Data Provenance: The study was conducted in a "mock extracorporeal circuit," which implies a laboratory setting. There is no mention of country of origin of data or whether it was retrospective or prospective. It's a prospective engineering performance test.

2. 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):

   • Not applicable. This was a physical device performance test using a mock circuit, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" was mechanical measurements (pressure and time).

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

   • Not applicable. See point 2.

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 is not an AI/ML device, and no MRMC study was performed.

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

   • Not applicable. This is not an AI/ML algorithm; it is a physical medical device. The "standalone" performance shown is purely mechanical, not algorithmic.

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

   • The "ground truth" was direct physiological measurements (pressure and time) obtained from a simulated environment (mock extracorporeal circuit) under controlled conditions.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, and therefore no training set was used.

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

   • Not applicable. See point 7.

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