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B-Capta is indicated for supplementary, in-line monitoring of the extracorporeal arterial oxygen partial pressure, venous oxygen saturation, venous hematocrit/hemoglobin, and arterial and venous temperature during cardiopulmonary bypass procedures up to six hours.

B-Capta is intended to be used for in-line continuous monitoring of patient's blood parameters during procedures requiring extracorporeal circulation.

B-Capta is designed to work with a Stöckert S5 System (K071318) heart-lung machine.

Provided in-line measured parameters of B-Capta are: In the Venous line:

• Haematocrit / Haemoglobin (Hct/Hb)
• Venous blood oxygen saturation (sO2)
• Venous blood temperature (venT)

In the Arterial line:

• Arterial blood oxygen partial pressure (pO2)
• Arterial blood temperature (artT)

The duration of application is limited to 6 hours of continuous use.

B-Capta consist of the following components / disposables:

• B-Capta Venous and Arterial Sensors
• B-Capta Sensor Module
• B-Capta Venous and Arterial Reference Element Holders
• B-Capta disposable Venous and Arterial Cuvettes

B-Capta is a microprocessor based device. The venous sensor is an optical sensor which measures, when connected to its dedicated disposable cuvette, hematocrit/hemoglobin and oxygen saturation using an optical reflectance technology. Moreover, an infrared technology is used to measure the temperature of the venous blood.

The arterial sensor is an optical sensor which measures, when connected to its dedicated disposable cuvette, partial pressure of oxygen using an optical fluorescence technology. Moreover, an infrared technology is used to measure the temperature of the arterial blood.

Both sensors are functionally connected to the compatible heart-lung machine via a cable plugged in the sensor module and communicate with B-Capta firmware via a RS232 interface according to a dedicated communication protocol. Data are displayed on the graphical user interface of the heart-lung machine.

The provided text describes a 510(k) premarket notification for the B-Capta device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical study data to establish acceptance criteria and prove device performance against them.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert qualifications for ground truth are not present in this regulatory document. The document primarily highlights non-clinical testing performed to support substantial equivalence.

Here's a breakdown based on the information available:

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

This information is not explicitly available in the provided text. The document states "Design functionality testing confirms that the product meets its product requirements," but it does not specify what those requirements (acceptance criteria) are or provide quantitative performance results against them.

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

This information is not available. The document mentions "Design Verification and Validation Testing" and "Software verification and validation testing," but it does not provide details on sample sizes, data provenance, or the nature of these "test sets" for performance evaluation in a clinical or simulated clinical context.

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)

This information is not available. Given that no clinical testing was required or submitted, there's no mention of experts establishing a ground truth for a test set.

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

This information is not available. No adjudication method is mentioned as there's no reported test set requiring expert adjudication.

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

This information is not applicable/not available. The B-Capta is an on-line blood gas monitor, not an AI-assisted diagnostic imaging device that would involve human readers or MRMC studies.

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

The B-Capta device itself is a standalone measurement device, intended for in-line continuous monitoring. Its performance is evaluated on its ability to accurately measure blood parameters. While "standalone performance" was implicitly assessed through design verification and validation, the document does not present this as a separate study with specific metrics (e.g., sensitivity, specificity) against a reference standard in the way an AI algorithm's standalone performance might be described. It focuses on functional compliance and safety.

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

For the performance of measuring blood parameters, the ground truth would typically be established by:

• Reference laboratory methods: For blood gas parameters, this usually involves validated laboratory blood gas analyzers.
• Traceable standards: For temperature measurements, calibrated temperature probes.

The document does not explicitly state the specific "ground truth" methods used during its design verification and validation, but these would be the standard approaches for such a device.

8. The sample size for the training set

This information is not available. The B-Capta is described as a "microprocessor based device" with optical and infrared sensors. It's not explicitly framed as a machine learning/AI device requiring a "training set" in the typical sense of deep learning or predictive models. Its functionality is based on established physical principles for sensing.

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

This information is not available and likely not applicable, as explained in point 8.

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