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The Stöckert Gas Blenders (2L, 5L, and 10L) are intended to enable qualified personnel to set monitor and control gas flows of medical grade gases (air/02/CO2) during cardiopulmonary bypass. The Stockert Gas Blenders are used as components of or optional accessories to the Stöckert S5 System (or any compatible Sorin system using the S5 firmware versions of 3.0 or greater) for periods of six hours or less.

The Stöckert Gas Blender Base Unit is 200 mm wide, 185 mm high, and 270 mm deep and it weighs 2.5 kg. It can be used either from a suitable horizontal surface such as a table or cart or it can be mounted on one of the masts (using the mast holder). It is attached to HLM console with the supplied 24V/CAN connector. This connection provides both power and communication between the Stöckert Gas Blender and the System Display Panel of the HLM. The Stöckert Gas Blenders are designed to provide a maximum mixed gas flow rate of 2L/min, 5L/min or 10 L/min depending on the model used to allow the perfusionist to purge the oxygenator with gas during the priming process. The front panel is the user interface and includes the on/off key, displays and controls. The rear panel houses the three inlet gas connections, the gas mix outlet, and the 24V/CAN connector. Gas line connectors are fast release connectors, consisting of a male connector (installed on the tubing) and a coupler socket (on the housing of the Gas Blender). Both sets (male and female) of connectors are labeled with the respective gas for which they are intended to be used. The Stöckert Gas Blenders enable the qualified perfusionists who are managing the cardiopulmonary bypass circuit using a Stöckert S5 or Sorin C5 System to precisely set, monitor and control the gas flows required for the oxygenation of the patient's blood during extracorporeal circulation. The supply sources for air, O2 and CO2 are connected to the rear inlets of the Stöckert Gas Blender and the gas mixture outlet is connected to the oxygenator (not supplied). The Stöckert Gas Blenders are optional accessories to and designed to be operated with the Stöckert S5 System/Sorin C5 System. They cannot be operated independently from the heart lung machine console. The values for total gas flow (air + O2), FiO2 and CO2 can be adjusted independently without affecting the remaining two values. Gas flow is displayed at both the Stöckert Gas Blender base unit and the remote display module situated in the Stöckert S5 System/Sorin C5 System "control desk" or "System Panel." Set values and actual values are continuously monitored and any discrepancy between them causes both optical and acoustic alarms. If desired, the perfusionist may set alarm limits at the remote display module to monitor the blood flow/gas flow ratio for the arterial pump.

The provided text describes the Stöckert Gas Blender and its FDA 510(k) submission. However, it does not include detailed information about acceptance criteria or a study that specifically proves the device meets those criteria in the format requested.

The document is a 510(k) summary for a medical device (Stöckert Gas Blender). For this type of submission, substantial equivalence to a predicate device is the key, not necessarily a detailed clinical study demonstrating specific performance metrics against pre-defined acceptance criteria in the way a new drug or a novel AI diagnostic might.

Based only on the provided text, here's what can be extracted and what is missing:

1. Table of acceptance criteria and reported device performance:

This information is not provided in the document. The document states that "Design verification and validation testing presented in the 510(k) included electrical/safety testing (IEC60601-1), EMI/EMC testing (IEC60601-1-2), and Functional Acceptance testing, and design validation testing (internal and external)." However, it does not list the specific acceptance criteria for these tests (e.g., accuracy of gas flow, precision of mixture) or the numerical performance results of the device against those criteria.

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

This information is not provided. The document mentions general "testing" but no specific test sets or their characteristics.

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

This information is not applicable/not provided. This device is a gas blender for heart-lung machines, not an AI diagnostic that requires expert interpretation for ground truth. Its performance would be validated through engineering and functional testing.

4. Adjudication method for the test set:

This information is not applicable/not provided. (See point 3).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. The document explicitly states: "No formal clinical testing was provided as the basis for substantial equivalence or is required." Therefore, no MRMC study was conducted or reported here.

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

This concept is not applicable to this device. The Stöckert Gas Blender is a physical medical device that blends gases, not an algorithm. Its "standalone performance" would be its functional performance, which is generally verified through engineering tests, but specific details are not provided in this summary.

7. The type of ground truth used:

This information is not explicitly stated or applicable in the traditional sense of clinical ground truth (e.g., pathology). For a physical device like a gas blender, "ground truth" would be established by reference standards, calibrated measurement equipment, and compliance with engineering specifications. The document mentions "prospectively defined design and performance specifications," which would form this basis.

8. The sample size for the training set:

This information is not applicable/not provided. As this is a physical device and not an AI/machine learning algorithm, there is no "training set."

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

This information is not applicable/not provided (see point 8).

In summary:

The provided document is a 510(k) summary for a medical device focused on demonstrating substantial equivalence to a predicate device. It confirms that engineering, safety, and functional testing were performed but does not delve into the specific acceptance criteria or the detailed results of those tests, nor does it involve clinical studies or AI-related performance metrics.

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