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The Venous Softbag Reservoirs are indicated for use in extracorporeal circuits during cardiopulmonary bypass procedures in the field of open-heart-surgery. The utilization period of this device is restricted to six hours. Blood contact longer than 6 hours is not recommended. Application and use of the softbag reservoir is in the sole responsibility of the respective physician.

The Venous Softbag Reservoir is used in extracorporeal circuits during cardiopulmonary bypass surgery and serves as container for a certain blood volume. It consists of plastic foils which are welded together and between which tubes of different diameters and a polyester mesh are sandwiched. The polyester mesh serves for an improved air removal. Application duration: The utilization period of this device is restricted to six hours. The softbag reservoir is delivered sterile and is determined for single use only.

The group of Venous Softbag Reservoirs consists of a variety of models which differ in size (filling volume) and in the port sizes. The filling volumes of the reservoirs range from 650 ml to 1900 ml depending on the model and the ports are either 3/8" or ½" in size.

The provided document is a 510(k) summary for a medical device (Venous Softbag Reservoirs with Softline Coating) seeking market clearance from the FDA. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through extensive clinical studies as one might find for novel or high-risk devices.

Therefore, the document does not contain the detailed information requested about acceptance criteria, specific study designs (like multi-reader multi-case studies), sample sizes for test sets or training sets, expert qualifications for ground truth establishment, or effect sizes for human readers with AI assistance. This is because the regulatory pathway for this specific device (a Class II device demonstrating substantial equivalence) relies more on bench testing, biocompatibility, and sterility data to show it performs as intended and is as safe and effective as a legally marketed predicate device.

However, I can extract the information that is present:

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

The document describes the areas tested and evaluated to demonstrate substantial equivalence, implying these areas represent the "acceptance criteria" for the device to be considered equivalent to the predicate. The "reported device performance" is essentially that the device was found to be substantially equivalent based on these evaluations.

Notes on Acceptance Criteria and Performance:

• Specific quantitative values are not provided in this summary. For example, it doesn't state "integrity passed if burst pressure > X psi." The "performance" assessment refers to the device functioning as intended for its specified use in extracorporeal circuits, likely validated through bench testing, but the specifics are not detailed.
• The overall "reported device performance" is the conclusion that "The data given demonstrate that the Venous Softbag Reservoirs with Softline Coating are substantially equivalent to the named predicate devices."

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

• Sample Size for Test Set: This information is not provided in the document. The submission implies bench testing for integrity, performance, biocompatibility, and sterility, but does not specify the number of units tested for each.
• Data Provenance: This information is not provided. Given the manufacturer is based in Germany, the testing may have occurred there, but this is not explicitly stated. The nature of these tests (integrity, performance, biocompatibility, sterility) typically involves laboratory or bench testing rather than clinical data, so the concepts of retrospective/prospective human data provenance are not directly applicable here.

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 applicable/not provided. The assessment of this device for substantial equivalence primarily relies on technical specifications, material properties, and bench testing, not expert interpretation of diagnostic images or clinical outcomes that would require ground truth establishment by medical experts in the way requested.

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

• This information is not applicable/not provided. Adjudication methods are typically used in clinical studies or evaluations involving human interpretation where disagreements need to be resolved. This document pertains to a 510(k) submission for a device component, where such methods are not relevant.

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 provided. An MRMC study is relevant for diagnostic imaging devices often involving AI algorithms that assist human readers. This device is a passive component in a cardiopulmonary bypass circuit and does not involve AI or human "readers" in that context.

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

• This information is not applicable/not provided. This device is not an algorithm and does not perform a standalone diagnostic function.

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

• Type of Ground Truth: The "ground truth" for this device's evaluation would be based on predefined engineering specifications, material standards, and biological compatibility requirements rather than expert consensus on clinical cases, pathology, or outcomes data. For example, "integrity" might be assessed against a standard burst pressure, "biocompatibility" against ISO 10993 standards, and "sterility" against standard sterilization assurance levels. The specific metrics are not detailed in this summary.

8. The sample size for the training set:

• This information is not applicable/not provided. This device is not an AI/ML algorithm that requires a training set.

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

• This information is not applicable/not provided. As above, this device is not an AI/ML algorithm that requires a training set or ground truth established in that manner.

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