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The Stryker ConstaVac Blood Conservation System II (CBCII) is an autologous blood recovery system intended for the post-operative collection and filtration of blood from a surgical wound in order to transfuse the whole blood back to the patient.

The Stryker ConstaVac Blood Conservation System II (CBCII) Disposal Blood Bag is used with the previously cleared CBC II System to provide a disposal Blood Bag is used with the CBCII reservoir in the CBCII reservoir.

The Stryker CBCII System is a single patient use, sterile, disposable, autotransfusion apparatus. The system consists of a wound drain and evacuator tube, an 800cc blood collection reservoir, a means for providing a vacuum in which to drain the blood from the wound site, a means for transferring the blood to a reinfusion bag and a reinfusion The blood disposal bag provides a means for the user to dispose of wound baq. drainage collection once reinfusion has been discontinued.

No specific acceptance criteria or a study proving the device meets them are provided in the input text. The document is primarily a 510(k) clearance letter for the Stryker ConstaVac Blood Conservation System II, establishing its "substantial equivalence" to predicate devices.

From the text, we can glean the following information about the device and its regulatory clearance:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable. The provided text does not describe a clinical study with a "test set" in the context of device performance metrics or a comparison to ground truth. The clearance is based on substantial equivalence to predicate devices, supported by adherence to standards and biocompatibility.

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

• Not Applicable. As no specific "test set" and associated ground truth establishment are described, this information is not provided.

4. Adjudication Method for the Test Set:

• Not Applicable. As no specific "test set" and associated ground truth establishment are described, this information is not provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:

• No MRMC comparative effectiveness study is mentioned. The clearance is based on substantial equivalence and adherence to standards, not a direct comparison of human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

• Not Applicable. This device is a physical medical apparatus (Autotransfusion Apparatus), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. The Type of Ground Truth Used:

• Not Applicable / Implied Equivalence: The concept of "ground truth" as it applies to diagnostic or prognostic AI models is not directly relevant here. The "ground truth" for the clearance of this autotransfusion device is an assessment of its equivalence to already legally marketed devices in terms of intended use, power modality, and safety risks, along with compliance with established industry standards (ANSI/AAMI AT6-1981) and biocompatibility guidelines.

8. The Sample Size for the Training Set:

• Not Applicable. This device is a physical medical apparatus, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. As per point 8, there is no "training set" for this type of device.

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