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510(k) Data Aggregation
(28 days)
BD VACUTAINER PLUS PST II TUBE
The BD Vacutainer™ PLUS PST II™ Tube is a lithium heparin coated plastic evacuated blood collection tube that provides a means of collecting, transporting and processing blood in a closed tube. Blood collected in a Vacutainer™ PLUS PST II™ Tube is used for clinical laboratory assays involving the use of patient plasma.
The Vacutainer™ PLUS PST II™ Tubes are sterile, plastic, evacuated blood collection tubes. The Vacutainer™ PLUS PST II™ Tube consists of: (1) a closure assembly. (2) an inert acrylic gel mechanical barrier, and (3) a lithium heparin coated plastic tube. The specimen is centrifuged and the barrier material forms at the plasma interface, mechanically separating the plasma from cells. The plasma portion is used for clinical laboratory assays involving the use of patient plasma. The benefits of a plastic tube decrease the occurrence of accidental breakage increases the safety of laboratory personnel and reduces the necessity of repeat specimens.
The provided text describes the BD Vacutainer™ PLUS PST II™ Tube and its 510(k) summary, primarily focusing on its substantial equivalence to a predicate device. It includes information about the device's description, intended use, and claims. However, it does not provide a detailed study report with specific acceptance criteria, sample sizes for test and training sets, information on expert ground truth establishment, or details about comparative effectiveness studies (like MRMC studies) as requested in the prompt.
Therefore, much of the requested information cannot be extracted directly from the given text.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Claim | Reported Device Performance |
|---|---|
| Improved plasma quality vs. BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube | Provides improved plasma quality vs. the BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube (Claim) |
| Selected analyte stability up to twenty-four hours after centrifugation | Provides selected analyte stability up to twenty-four hours after centrifugation (Claim) |
| Stability for up to two hours after centrifugation for cardiac analytes (troponin I, CKMB, myoglobin) | Provides stability for up to two hours after centrifugation for the following cardiac analytes: troponin I, creatine kinase MB fraction (CKMB), and myoglobin (Claim) |
| Clinically equivalent chemistry analyte results when compared to the BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube | Clinical evaluations demonstrated the BD Vacutainer™ PLUS PST II™ Tube provides clinically equivalent chemistry analyte results when compared to the BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube (Finding) |
Missing information for this table due to lack of detail in the source text:
- Specific quantitative acceptance thresholds for "improved plasma quality," "analyte stability," or "clinically equivalent chemistry analyte results." The document only states these claims were met or demonstrated without providing the actual metrics or statistical targets.
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified. The document states "Clinical evaluations were performed," but does not provide the number of samples or patients involved.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set:
- Not specified.
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:
- MRMC Study: No, this device is a blood collection tube, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers improving with AI is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No, this device is a blood collection tube, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable and not mentioned. The clinical evaluations compared the tube's performance to another tube.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance claims (plasma quality, analyte stability, equivalent chemistry results) would have been established through laboratory analytical testing that compares the results obtained from blood processed in the new tube versus the predicate tube, likely against established analytical standards or reference methods. The document states "Clinical evaluations were performed to determine the safety and efficacy" and "demonstrated that the BD Vacutainer™ PLUS PST II™ Tube provides clinically equivalent chemistry analyte results." This implies a direct comparison of analytical outputs, rather than expert consensus on images or pathology.
8. The sample size for the training set:
- Not applicable/Not specified. As this is a physical medical device (blood collection tube) and not an AI/ML algorithm, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" for this type of device.
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