(70 days)
The Vacutainer™ PLUS SST™ Tube is a plastic evacuated blood collection tube with silica clot activator and gel that provides a means of collecting, transporting, separating, and processing blood in a closed tube. Blood collected in a Vacutainer™ PLUS SST™ Tube is primarily used for clinical laboratory testing in chemistry using patient serum, but may be used for other assays requiring serum specimens as determined by the laboratory. In addition, the Vacutainer™ PLUS SST™ Tube is compatible with many commonly used therapeutic drugs therefore suitable for therapeutic drug monitoring (TDM). Blood can be collected, processed and stored in a Vacutainer™ PLUS SST™ tube for at least 24 hours for therapeutic drug monitoring without large losses in recovery.
The Vacutainer™ PLUS SST™ Tubes are sterile, plastic, evacuated blood collection tubes. The Vacutainer™ PLUS SST™ Tube consists of: (1) a closure assembly, (2) an inert polyester gel barrier, (3) silica clot activator, and (4) a silicone surfactant coated plastic tube. The specimen is centrifuged and the barrier material forms at the serum/blood clot interface, mechanically separating the serum from cells. The serum portion is used for clinical laboratory assays involving the use of patient serum.
The provided text describes a 510(k) summary for the BD Vacutainer™ PLUS SST™ Tube. This device is a blood collection tube, and the acceptance criteria and study detailed are related to its performance in therapeutic drug monitoring (TDM).
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The core claim and thus the primary acceptance criterion is related to the stability of therapeutic drugs in blood samples stored in the device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Blood can be collected, processed, and stored in a Vacutainer™ PLUS SST™ tube for at least 24 hours for therapeutic drug monitoring without large losses in recovery. | Clinical evaluations demonstrated that blood can be collected, processed and stored in a Vacutainer™ PLUS SST™ tube for at least 24 hours for therapeutic drug monitoring without large losses in recovery. |
| Storage conditions and time until analysis should be considered when collecting blood for TDM to ensure specimen integrity is maintained. | Clinical evaluations demonstrated that the storage conditions and time until analysis should be considered when collecting blood in Vacutainer™ PLUS SST™ tubes for TDM to ensure specimen integrity is maintained. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the sample size (number of patients or blood samples) used for the clinical evaluations.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It simply states "Clinical evaluations were performed."
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. The device is a blood collection tube, and its performance is assessed through laboratory assays, not typically by expert interpretation of images or clinical findings that require "ground truth" established by experts in the sense of, for example, radiologists. The "ground truth" here would be the actual concentration of therapeutic drugs in the blood samples, determined by standard laboratory methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., medical imaging) where there might be disagreement among reviewers. For a device like a blood collection tube, performance is measured by objective laboratory assays, which do not typically involve this type of 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
This information is not applicable and therefore not provided. MRMC studies and the concept of "human readers improving with AI assistance" relate to diagnostic or interpretative AI devices. The BD Vacutainer™ PLUS SST™ Tube is a blood collection device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and therefore not provided. This question is relevant for AI algorithms. The described device is a physical medical device (blood collection tube).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this type of device would be the measured concentration of therapeutic drugs in the collected blood samples using established and validated analytical methods (e.g., mass spectrometry, immunoassay). The document does not explicitly state the specific analytical methods used, but "clinical laboratory testing in chemistry" is mentioned.
8. The sample size for the training set
This information is not provided and is likely not relevant in the context of this type of device submission. Training sets are typically associated with machine learning or AI models. This device's performance is demonstrated through clinical evaluations, which are essentially validation studies, not training studies.
9. How the ground truth for the training set was established
This information is not applicable as there is no mention of a training set for an AI model. For the clinical evaluations (which serve as the validation study for the device's claims), the "ground truth" would be established by the analytical results of the therapeutic drug monitoring assays performed on the blood samples.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.