(67 days)
The COBE® Angel Whole Blood Separation System is intended to be used at the patient's point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood. The plasma and concentrated platelets can be used for diagnostic tests.
The COBE® Angel Whole Blood Separation System consists of a blood centrifugation device and associated disposable processing set and whole blood access kit. The device is intended to be used at the patient's point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood. The Blood Access Kit contains syringes, needles, anticoagulant, and a site preparation kit for collecting the blood to be processed with the Angel System. The Processing Set utilizes a variable volume separation chamber that separates autologous whole blood cells, platelet poor plasma, and platelet rich plasma. The Processing Set is provided sterile with a non-pyrogenic fluid pathway, and is for single patient use only. The Processing Set consists of the pre-connected variable volume separation chamber, a tubing set with a platelet sensor/valve assembly, and a three-compartment reservoir bag to hold the blood products (whole blood, red blood cells, and platelet poor plasma). A syringe is provided to collect the platelet rich plasma. The primary features of the Angel System hardware are the centrifuge well and lid, roller pump, platelet sensor, valve assembly driver, touch screen user interface, and emergency stop switch. The platelet sensor detects the presence of the separated blood components as they exit the variable volume separation chamber, and switches the position of a rotating valve in the Processing Set to channel the individual blood components into their respective collection containers.
The provided text describes the COBE® Angel Whole Blood Separation System and its 510(k) submission, focusing on establishing substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria in the way envisioned by the prompt's request for performance metrics (e.g., sensitivity, specificity, accuracy).
The document is a regulatory submission for a medical device that processes blood, not an AI/algorithm-based diagnostic device where typical AI acceptance criteria would apply. Therefore, many of the requested items (like ground truth, expert opinions, MRMC studies, AI assistance) are not relevant to this type of device and are not present in the provided text.
Based on the available information:
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A table of acceptance criteria and the reported device performance:
The document states: "A comparison of device features and in-vitro test data demonstrate that the Angel Whole Blood Separation System is substantially equivalent to the currently marketed Medtronic Magellan Autologous Platelet Separator System."
However, specific quantitative acceptance criteria (e.g., minimum purity of plasma, recovery rate of platelets) and the exact reported performance values are not detailed in the provided text. The assessment for this type of device focuses on demonstrating "substantial equivalence" to a predicate device, which implies that its performance is comparable and safe/effective for its intended use, but doesn't typically involve the same kind of detailed performance metrics as a diagnostic algorithm. -
Sample size used for the test set and the data provenance:
The document mentions "in-vitro test data" but does not specify the sample size, the type of test set (e.g., number of blood samples), or data provenance. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided as the device is a blood separation system, not an AI diagnostic system requiring expert-established ground truth for image or diagnostic interpretation. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. -
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 and not provided as the device is a blood separation system, not an AI diagnostic system. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable and not provided. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The concept of "ground truth" as typically used for AI diagnostic devices (e.g., pathology for cancer detection) is not directly applicable here. For a blood separation system, "ground truth" would likely relate to objective measurements of the separated components (e.g., cell counts, protein concentrations) determined by laboratory techniques rather than expert consensus on diagnostic interpretation. The document does not detail these specific "ground truth" methods. -
The sample size for the training set:
The document does not mention a "training set" as this is not an AI/machine learning device. -
How the ground truth for the training set was established:
This information is not applicable and not provided.
In summary, the provided 510(k) summary focuses on demonstrating "substantial equivalence" through "comparison of device features and in-vitro test data" rather than providing a detailed breakdown of acceptance criteria and performance study results specific to AI/algorithm validation.
§ 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
(a)
Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.(b)
Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.