(52 days)
The BD Vacutainer™ SST™ II PLUS Tube is a plastic evacuated blood collection tube with silica clot activator and gel barrier material that provides a means of collecting, transporting, separating, and processing blood in a closed tube. Blood collected in a BD Vacutainer™ SST™ II PLUS Tube is primarily used for clinical laboratory testing - chemistry assays using patient serum but may be used for other assays requiring serum specimens as determined by the laboratory. In addition, the BD Vacutainer™ SST™ II PLUS Tube is compatible with many commonly used therapeutic drugs and is therefore suitable for therapeutic drug monitoring (TDM).
The BD Vacutainer™ SST™ II PLUS Tubes are sterile, plastic, evacuated blood collection tubes. The BD Vacutainer™ SST™ II PLUS Tube consists of: (1) a closure assembly, (2) an acrylic gel barrier, (3) silica clot activator, (4) a silicone surfactant coating, and (5) a 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 and TDM involving the use of patient serum.
This 510(k) premarket notification describes the BD Vacutainer™ SST™ II PLUS Tube. However, the provided document does not contain the specific acceptance criteria or detailed study results, such as accuracy metrics or statistical analyses, that would typically be presented to prove the device meets said criteria.
The document primarily focuses on establishing "substantial equivalence" of the new device to existing predicate devices based on device features, materials, and intended use. While it mentions "clinical evaluations were performed to determine the efficacy," it does not elaborate on the methodology, results, or how these results demonstrate fulfillment of pre-defined acceptance criteria.
Therefore, many of the requested sections regarding acceptance criteria and study details cannot be fulfilled from the provided text.
Here's an attempt to answer the questions based on the available information, noting where information is absent:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria (e.g., specific thresholds for analytical performance, such as bias, recovery, or precision relative to predicate devices) are provided in the document. The document primarily focuses on a claim of "equivalent clinical performance" and "better compatibility" with predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not specified in document | - Equivalent clinical performance to predicate PLUS SST tubes and Glass Serum Tubes for clinical laboratory testing - chemistry assays using patient serum. |
| Not specified in document | - Equivalent clinical performance to predicate Glass Serum tubes for many commonly used therapeutic drugs (suitable for TDM). |
| Not specified in document | - Better compatibility than predicate PLUS SST tubes with many commonly used therapeutic drugs. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. It only states that "Clinical evaluations were performed."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The study involves blood collection and chemistry assays, where "ground truth" would likely be established by validated laboratory instruments and recognized reference methods, rather than expert consensus on images or clinical assessments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically relevant for subjective assessments or complex clinical endpoints, which do not appear to be the primary focus of this device's evaluation (which concerns analytical performance of blood tubes).
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
A MRMC comparative effectiveness study is not applicable and not mentioned. This type of study is typically used for diagnostic imaging devices involving human interpretation (readers) and AI assistance. The BD Vacutainer™ SST™ II PLUS Tube is a blood collection device, not an imaging or AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study is not applicable and not mentioned. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document implicitly suggests that the ground truth for the "clinical evaluations" would be based on analytical results from clinical laboratory assays. For chemistry assays and Therapeutic Drug Monitoring (TDM), this would involve quantitative measurements from established laboratory instruments and methodologies, often compared against reference intervals or medically relevant thresholds. The specific "type of ground truth" (e.g., a specific reference standard method) for each analyte is not explicitly detailed.
8. The sample size for the training set
Not applicable and not provided. As this is a blood collection tube and not an AI/ML-based device, there is no "training set."
9. How the ground truth for the training set was established
Not applicable and not provided. As this is a blood collection tube and not an AI/ML-based device, there is no "training set" or ground truth establishment method for a training set.
§ 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.