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The Magellan™ Autologous Platelet Separator System is designed to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of blood. The plasma and concentrated platelets produced can be used for diagnostic tests.

Magellan Autologous Platelet Separator system consists of a microprocessor controlled table-top centrifuge and processing disposables designed to allow for safe and rapid automatic separation of plasma and platelets. The centrifuge spins at a maximum speed of 3800 rpms at the maximum g-force of approximately 1300g.

The Magellan™ Autologous Platelet Separator System is a general-purpose centrifuge for clinical use, designed for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small blood sample for diagnostic tests.

Here's an analysis of the provided information, addressing your questions:

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list numerical acceptance criteria or detailed device performance metrics (e.g., platelet yield, purity, processing time) in a table format. It states that "Performance data that supports the safety and effectiveness of the use of Magellan Autologous Platelet Separator System is included in this 510(k) premarket notification." However, this data itself is not presented in the provided text excerpts.

The conclusion states: "Magellan Autologous Platelet Separator System is substantially equivalent to the noted predicate device based on the similarities of technological characteristics, the identical indications for use and the results of performance comparative testing." This implies that the device's performance was compared to the predicate SmartPREPTM Centrifuge System (K991430) and found to be substantially equivalent, meaning it meets the performance expectations set by the predicate device for its intended use.

Therefore, for this specific submission, the "acceptance criteria" appear to be meeting or demonstrating equivalence to the predicate device's performance as established in its prior clearance. Without access to the full 510(k) submission, specific quantitative acceptance criteria cannot be provided.

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply mentions "performance comparative testing" was conducted.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the device is a centrifuge for separating blood components, not an AI or diagnostic device that requires expert ground truth for interpretation of images or patient data. Its performance is assessed through laboratory metrics of separation efficiency and product quality.

4. Adjudication Method

This information is not applicable for the reasons stated above (not an AI/diagnostic device requiring expert interpretation).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. The device is a medical instrument (centrifuge) for preparing blood components, not a medical imaging or diagnostic AI tool that would typically involve human readers for interpretation.

6. Standalone Performance Study

Yes, a standalone performance assessment was conducted for the device. The summary states: "Performance data that supports the safety and effectiveness of the use of Magellan Autologous Platelet Separator System is included in this 510(k) premarket notification." The conclusion further confirms that the device was deemed substantially equivalent based on "results of performance comparative testing." This indicates that the device's ability to separate plasma and platelets was evaluated independently. However, the details of this study (e.g., specific metrics, experimental design) are not provided in the given text.

7. Type of Ground Truth Used

The "ground truth" for this type of device would typically involve established laboratory methods for:

• Platelet count: To determine platelet yield in the concentrate and platelet removal in the plasma.
• White Blood Cell (WBC) count: To assess the purity of the platelet concentrate (i.e., minimal WBC contamination).
• Red Blood Cell (RBC) count/hematocrit: To assess red cell contamination in the plasma and platelet concentrate.
• Volume measurements: To determine recovery efficiency.

These would be measured using standard clinical laboratory analyzers and techniques. The goal is to demonstrate that the device effectively separates blood components into platelet-rich plasma and platelet-poor plasma, meeting predefined biological and physical parameters.

8. Sample Size for the Training Set

This information is not applicable. The Magellan Autologous Platelet Separator System is a physical device (centrifuge) with automated processing, not an AI/machine learning algorithm that requires a "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above.

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