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Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes are designed for the collection, transportation and processing of capillary blood (collected via lancet stick) whenever a small amount of blood is preferred.

Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA) are used to obtain whole blood for testing parameters in hematology.

Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with K2EDTA are non-evacuated, non-sterile, low sample volume tubes made from virtually unbreakable, highly transparent polypropylene. The tube measures 11 x 40 mm and there is a predefined nominal fill volume of 0.5 mL for achieving correct additive concentrations.

The provided 510(k) summary for K063357 (Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA)) mentions a study conducted to demonstrate substantial equivalence, but it does not provide specific acceptance criteria or detailed results in the format requested.

The summary states: "A study was conducted to demonstrate substantial equivalence of the Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with K2EDTA with the Greiner Bio-One VACUETTE® Blood Collection Tube with K2EDTA (K014104) and the Becton Dickinson Microtainer® Tube with K2EDTA (K940905) when samples from these tubes are used in hematology assays."

And the conclusion: "The conclusion from the study is that the hematology results from samples collected in the Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA) are substantially equivalent to those collected in the predicate tubes."

This indicates that the study aimed to show that key hematology parameters measured from blood collected in the new device were comparable to those from predicate devices. However, the exact metrics for "substantial equivalence" (e.g., specific ranges for acceptable differences in cell counts, hemoglobin, etc.) are not detailed in this document.

Therefore, much of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be answered based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Note: The document states that the conclusion of the study was substantial equivalence. It does not provide the specific numerical acceptance criteria (e.g., "difference in WBC count must be within +/- X%") or the actual numerical results obtained for each hematological parameter for a direct comparison.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The study was "conducted," implying it was likely prospective, but this is not explicitly stated.

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

• Not applicable. This study is a performance comparison of blood collection tubes for hematology assays, not an AI device requiring expert ground truth for interpretation. The "ground truth" would be the measurements obtained from the predicate devices.

4. Adjudication Method for the Test Set:

• Not applicable. This study is a performance comparison of blood collection tubes for hematology assays, not an AI device requiring expert adjudication.

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

• No. This is not an MRMC study. It is a study comparing the performance of a medical device (blood collection tube) against predicate devices for analytical performance in hematology assays.

6. Standalone Performance Study (Algorithm Only):

• Not applicable. This is a physical medical device (blood collection tube), not an algorithm.

7. Type of Ground Truth Used:

• The "ground truth" for this study would be the hematology assay results obtained from samples collected in the predicate devices. The new device's performance is compared against these established results.

8. Sample Size for the Training Set:

• Not applicable. This is a performance study for a physical device, not an AI/machine learning model that requires a training set.

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

• Not applicable. As above, no training set for an AI model.

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