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The BD Vacutainer® Rapid Serum Tube Plus Blood Collection Tube (BD RST) is a single use tube used to collect, separate, transport and process venous blood specimens to obtain serum for chemistry determinations for in vitro diagnostic use. It is used in settings where a venous blood sample is collected by a trained healthcare worker.

The BD RST is not recommended for patients on heparin therapy, direct thrombin inhibitor therapy or with Factor I deficiency.

BD Vacutainer® Tubes are sterile, single-use, evacuated plastic blood collection tubes with rubber stoppers that provide a means of collecting, transporting, separating, and processing blood in a closed tube. The BD Vacutainer® Rapid Serum Tube Plus Blood Collection Tube (BD RST) clots blood specimens much faster than other additives (5 minutes), and therefore is desirable when a fast turn-around-time is necessary.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission claims "substantially equivalent performance" to the predicate device, the BD Vacutainer® SST™ Plus Blood Collection tube (BD SST™). This implies that the acceptance criteria for individual analytes were likely defined as meeting pre-determined equivalence bounds (e.g., within a certain percentage difference, or within clinical significance ranges). However, the specific quantitative acceptance criteria for each analyte are not explicitly stated in this document. The reported performance is that the device met these unstated equivalence criteria.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "clinical testing was performed on blood collected in both the evaluation and predicate tubes" but does not give a specific number of samples or subjects.
• Data Provenance: Not explicitly stated. There is no mention of the country of origin of the data or whether it was retrospective or prospective.

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

This type of information is not applicable here. The study assesses the performance of a blood collection tube for clinical chemistry measurements, not the interpretation of medical images or diagnostic results that would typically require expert ground truth establishment. The ground truth for this type of test is the objective measurement of analytes by laboratory instrumentation.

4. Adjudication Method for the Test Set

This information is not applicable as the study design focuses on objective laboratory measurements rather than expert interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. This is a study evaluating a blood collection device, not an AI-assisted diagnostic tool involving human readers.

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

This information is not applicable. This is a study of a medical device (blood collection tube) with laboratory performance assessments, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used in this study would be the objective laboratory measurements/values of the various chemistry, serology, and immunology analytes obtained from the blood samples. This is determined by validated laboratory instruments and methodologies, not by expert consensus, pathology, or outcomes data in the usual sense.

8. The Sample Size for the Training Set

This information is not applicable. This study does not involve a machine learning algorithm that requires a training set.

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

This information is not applicable as there is no training set for a machine learning algorithm in this study.

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