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The Blood Cell Separator is intended for the use as a sample preparation aid to in vitro Lithium colorimetric diagnostic testing systems where a precise, micro-volume sample of serum or plasma is required to be collected from a whole blood specimen. The liguid produced by the device is dependent upon the sample collected; whole blood collected with an anti-coagulant will produce plasma, and whole blood collected without an anticoagulant will produce serum.

The Blood Cell Separator is intended for use as a sample preparation aid in in vitro lithium colorimetric diagnostic testing systems where a precise, micro-volume sample of serum or plasma is required to be collected from a whole blood specimen.

The Blood Cell Separator consists of two components packaged in a single separator device: the membrane system and a capillary tube. The device is based upon a multiple layer membrane system designed to separate blood cells and serum/plasma. This is achieved through the attraction and capture of blood cells from a whole blood specimen applied to the surface of the membrane system. The residual liquid continues to flow laterally to the tip of the membrane at which time the capillary tube fills vertically to the pipette's fixed, controlled volume and is ready to use.

The Akers Laboratories, Inc. Blood Cell Separator is intended as a sample preparation aid for in vitro lithium colorimetric diagnostic testing. The device separates blood cells from whole blood to produce a precise, micro-volume sample of serum or plasma without the need for centrifugation. The acceptance criteria and performance were assessed through non-clinical studies comparing the device to predicate devices (BD Vacutainer® Brand Tubes).

1. Table of Acceptance Criteria and Reported Device Performance:

• Serum: Control at ~1.5 mEq/L lithium had a 6.4% CV over 50 runs/5 days.
• EDTA Plasma: Control at ~0.8 mEq/L lithium had a 6.7% CV over 30 runs/3 days.
• Daily SD for low value sample: 0.01 to 0.04 mEq/L (compared to BD Vacutainer 0.03 to 0.08 mEq/L).
• Daily SD for high value sample: 0.03 to 0.07 mEq/L (compared to BD Vacutainer 0.03 to 0.08 mEq/L).
• Composite %CV over 50 samples/5 days:
  • Low value: 8.4% (compared to BD Vacutainer 9.5%).
  • High value: 5.7% (compared to BD Vacutainer 6.1%).

Recovery Correlation: R value of 0.993, Re value of 0.9866 (between Akers and BD Vacutainer methods).

Assay Sensitivity: 0.03 mEq/L (equivalent to BD Vacutainer Tube EDTA Plasma Separation). |
| Efficient Cell Separation: The resultant liquid sample should be free of blood cells. | Cell Count: Liquid sample contained "no blood cells" based on comparison to a routine cell separating technique (results listed as total cells per High Powered Field (HPF)). |
| Functional Equivalence: Ability to provide a sample suitable for lithium colorimetric analysis. | Yes, the device provides a liquid fraction (serum or plasma) used in lithium colorimetric analysis. |

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

• Sample Size:
  • Precision Study (Serum): 50 runs over 5 days (10 runs per day) for a control at ~1.5 mEq/L lithium.
  • Precision Study (EDTA Plasma): 30 runs over 3 days (10 runs per day) for a control at ~0.8 mEq/L lithium.
  • Overall Precision Study: 50 samples over 5 days for both low and high value lithium samples (implicitly comparing to predicate).
  • Cell Separation Comparison: Number of samples not explicitly stated beyond "summary data."
  • Assay Sensitivity: Not explicitly stated, but implies comparison data.
  • Recovery Correlation: Not explicitly stated.
• Data Provenance: The studies were non-clinical, performed "via bench by independent laboratory and/or internally." The document does not specify the country of origin but implies laboratory-controlled experiments. The studies were prospective in nature, designed to test the device's performance attributes.

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

This information is not provided in the document. Given that the studies were non-clinical (bench testing), there were likely no "experts" in the clinical sense establishing ground truth. The ground truth for lithium concentration was established by the analytical reference methods or control values used in the testing.

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

This information is not applicable as the studies were non-clinical, analytical performance evaluations, not clinical studies involving human observers or subjective assessments that would require adjudication.

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:

No, an MRMC comparative effectiveness study was not done. This device is a sample preparation aid, not an AI-powered diagnostic imaging tool that would involve human readers or AI assistance in interpretation. The studies focused on the analytical performance of the device itself.

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

Yes, the studies conducted were standalone performance evaluations of the device. The device itself is an automated sample preparation tool, and its performance was assessed directly through analytical measurements of the prepared samples. There is no "human-in-the-loop" component in the device's function or in the evaluation mentioned.

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

The ground truth for the performance studies was based on:

• Reference Standard Values: For lithium concentration, established control values or reference methods were used to determine precision and accuracy (implied by comparison studies).
• Analytical Measurement: Quantitative measurements of lithium concentration and cell counts (e.g., cells per HPF) served as the objective ground truth against which the device's performance was measured.

8. The sample size for the training set:

The concept of a "training set" is not applicable to this device. It is a physical medical device for sample preparation, not an AI/machine learning algorithm requiring a training dataset.

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

As the concept of a training set is not applicable, this question is not relevant to the provided information.

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