Search Results

The BD Vacutainer® Citrate Blood Collection Tube (0.109M buffered sodium citrate) is a sterile, single use tube used for the collection, containment, transport, and centrifugation of venous blood specimens to obtain plasma for in vitro diagnostic testing. It is used in settings where a venous blood sample is collected by a trained healthcare worker. The BD Vacutainer® Citrate Blood Collection Tube is used for clinical laboratory testing in coagulation.

BD Vacutainer® Citrate Blood Collection Tubes (BD Citrate Tubes) are available in plastic configurations and contain a liquid additive. Tubes include a color-coded BD Hemogard™ Closure and are comprised of an inner and outer tube to maintain the draw volume and liquid additive. Refer to Table 1 for unique product configurations. Tube stoppers are lubricated with silicone to facilitate stopper insertion. The buffered sodium citrate solution provides an anticoagulated specimen when used in accordance with the instructions for use. The tubes are compatible with the BD Vacutainer® Blood Collection Needles, Blood Collection Sets, Transfer Devices. Holders and Adaptors.

The information provided in the document describes the substantial equivalence of the "BD Vacutainer Citrate Blood Collection Tubes" to a predicate device, focusing on physical and chemical characteristics, rather than the performance of an AI or software device. As such, many of the requested categories for AI/software device evaluation (e.g., sample size of test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, how ground truth for training set was established) are not applicable to this submission.

However, I can extract information related to the device's performance testing and acceptance criteria as described for the medical device itself.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Non-Clinical Performance Testing Results" in Table 3, which can be interpreted as demonstrating the device's adherence to its design specifications or performance criteria. The acceptance criteria themselves are not explicitly detailed in the provided text (e.g., what constitutes a "Pass" for "Draw Volume" or "Resistance to Breakage"). However, the results consistently report "Pass."

Clinical Performance Studies and Acceptance Criteria (as described):

The clinical studies aimed to demonstrate "Clinical Equivalence" and evaluated specific parameters. The acceptance criteria for these (e.g., non-inferiority margins) are not explicitly stated but are implied by the "demonstrated clinical equivalence" and "passed non-inferiority criterion" statements.

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

The document does not explicitly state the sample sizes for the clinical test sets. It mentions "whole blood collected," but the number of subjects or samples is not specified.

Data Provenance: "Clinical testing was conducted on whole blood collected in the subject device, BD Citrate Tubes, and a similar comparator tube." This implies the data were collected from human subjects, likely in a clinical setting. The country of origin is not specified, and it's a prospective collection for these studies as they were performed to demonstrate equivalence.

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

This information is not applicable. The device is a blood collection tube, not an AI diagnostic system requiring expert interpretation of primary data (like medical images). The "ground truth" for clinical performance likely refers to the analytical results obtained from the blood samples, which are objectively measured by laboratory instruments.

4. Adjudication Method for the Test Set

This information is not applicable for a device of this nature. Adjudication methods are typically relevant for subjective interpretations (e.g., by human readers in medical imaging studies).

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

This is not applicable as the device is a blood collection tube, not an AI or software device that assists human readers.

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

This is not applicable as the device is a blood collection tube, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the clinical studies, the "ground truth" refers to the analytical measurements of coagulation parameters (Prothrombin Time [PT], Activated Partial Thromboplastin Time [aPTT], International Normalized Ratio [INR], D-Dimer, Anti-Factor Xa) obtained from the blood plasma after collection and processing. These are objective laboratory measurements, not expert consensus, pathology, or outcomes data in the typical sense for AI devices.

8. The Sample Size for the Training Set

This is not applicable as the device is not an AI/machine learning device that requires a training set.

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

This is not applicable as the device is not an AI/machine learning device that requires a training set.

Ask a specific question about this device