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The B-Cares is intended for use as a component part of or optional accessory to the Stöckert S5 system (or any compatible system using the S5 firmware versions of 3.0 or greater), during cardiopulmonary bypass for procedures up to six hours. The B-Cares is used exclusively for determining oxygen saturation, hematocrit value and temperature in the venous blood circuit.

The Sorin B-Cares described in this 510(k) Premarket Notification is identical to the device that was cleared under K092463 and uses the same in-line sensors cleared under K001388. When switched on, the Sorin B-Cares progresses from warm-through initialization . self test while resting on the holder. When self test is successful, Sat- (venous saturation) and Hct- (hematocrit) values are displayed. The sensor is then mounted on the disposable connector in the extra-corporal circuit. The B-Cares alerts (alarms or warns) the user if laboratory reference values have not been stored for venous O2 saturation and hematocrit. The Sorin B-Cares monitors blood values via the sensor head with two LED sources and a receiver in contact with the optical window integrated into the venous connectors. Temperatures are monitored using thermistors in the venous probes. The technology of the Sorin B-Cares is based on the technology of the Dideco Data Master (Sorin Group Italia is the parent company of Sorin Group Deutschland GmbH and was formerly known as Dideco). The B-Cares is used for determining oxygen saturation, hematocrit, and temperature in the venous blood circuit.

Here's a breakdown of the acceptance criteria and study information for the Sorin B-Cares device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not provide a direct table of specific, quantitative acceptance criteria for parameters like accuracy or resolution of oxygen saturation, hematocrit, and temperature. Instead, it refers to the device meeting "prospectively defined performance criteria" and being "within clinically relevant ranges."

However, it does compare some specifications to the predicate device (Dideco Data Master). While not explicit acceptance criteria, these comparisons highlight the device's performance characteristics.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a numerical sample size for the "test set." It refers to "Testing of the Sorin B-Cares (hardware, firmware, and performance)" as having demonstrated that the system "fulfills prospectively defined performance criteria."
• Data Provenance: The testing was "non-clinical" and appears to be internal performance testing conducted by the manufacturer. No details are provided regarding the country of origin of the data or whether it was retrospective or prospective, other than the mention of a "formal prospectively defined functional acceptance test."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. The study was non-clinical performance testing, not a clinical study involving experts establishing ground truth on patient data.

4. Adjudication Method for the Test Set

This information is not provided. As it was non-clinical performance testing, an adjudication method for ground truth would not typically be applicable in the same way as a clinical study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Formal clinical testing of the Sorin B-Cares has not been performed. Therefore, this section does not apply."

6. If a Standalone (Algorithm only without human-in-the-loop performance) was done

Yes, the testing described appears to be standalone performance testing of the device itself (hardware, firmware, and its ability to monitor blood values). The device's function is to display data digitally and alert the user, which is a standalone function, though it is used by a human in a clinical setting. The "non-clinical performance testing" focuses on the device's technical specifications and functionality independent of human interpretation or assistance for its core measurements.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance testing would be the actual, measured values from calibrated laboratory equipment or reference standards against which the device's readings (oxygen saturation, hematocrit, temperature) were compared. The text mentions that "Venous saturation and hematocrit values are calibrated to reference (laboratory) values," indicating that laboratory reference values serve as the ground truth.

8. The Sample Size for the Training Set

This information is not provided. The document describes a medical device for monitoring, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The device's technology is based on the Dideco Data Master, and its performance relies on physical principles (LED sources, receivers, thermistors) and firmware, not a learned model from a data training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the device does not employ a "training set" in the context of machine learning or AI that would require establishing ground truth in that manner. The device's core functionality is based on established scientific principles for measuring blood gases and hematocrit. Its calibration would involve comparison to laboratory reference measurements.

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