(182 days)
The Greiner Vacuette™ blood collection tube with lithium heparin and gel separator is an evacuated blood collection device containing lithium heparin, an anticoagulant additive, and an inert polymeric barrier material. The product is intended for use in holding and separating blood plasma from the cellular components of blood.
The Greiner Vacuette™ blood collection tube with lithium heparin and gel separator is an evacuated blood collection device containing lithium heparin, an anticoagulant additive, and an inert polymeric barrier material.
Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the supporting study.
It's important to note that this 510(k) predates many of the more rigorous statistical and AI-specific reporting standards now common, so some of the requested information may not be explicitly present or detailed.
Acceptance Criteria and Study Details for Greiner Vacuette™ Blood Collection Tube
Given the nature of the device (blood collection tube) and the era of the submission (1996), the "acceptance criteria" here refer to demonstrating substantial equivalence to a predicate device, primarily through performance in clinical assays. The criteria are implicitly tied to "Good correlation" of assay results.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Equivalency of Assay Results | Good correlation of assay results between paired samples collected in the Greiner Vacuette™ tubes and the Becton Dickinson Vacutainer® tubes. (Implicitly, correlation coefficients reflecting strong agreement) | Correlation coefficients ranging from 0.768 to 0.990 across 23 analytes and 3 hormones. |
Note: The specific numerical thresholds for "good correlation" (e.g., minimum r-value) are not explicitly stated in this summary, but the reported range implies the criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The summary mentions "paired samples." While the number of analytes tested is 23 (plus 3 hormones), the number of patient samples or specimens used for this testing is not explicitly stated. It's common in such studies for a certain number of patient blood draws to be split between the two tube types. Without this detail, we cannot confirm the exact sample size for the test set.
- Data Provenance: This information is not specified in the summary. We do not know the country of origin of the data, nor whether the study was retrospective or prospective. Given it's a 510(k) from 1996, it's highly likely to have been a prospective comparison study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable / Not specified. For a device like a blood collection tube, "ground truth" for assay results is typically established by the analytical method itself (e.g., a chemistry analyzer, immunoassay platform) run in a clinical laboratory setting, not by human expert consensus or adjudication on diagnostic interpretation. The "truth" is the measured value from the predicate device tube. There is no indication of human experts establishing a "ground truth" in the way it's done for imaging or diagnostic algorithms.
4. Adjudication Method for the Test Set
- Not applicable. As noted above, the study compared quantitative assay results. There was no need for human adjudication of qualitative interpretations.
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
- No, an MRMC study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks, especially with AI assistance. The Greiner device is a blood collection tube; therefore, an MRMC study is not applicable to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device (blood collection tube), not an algorithm or AI system. Therefore, standalone algorithm performance is not a concept that applies here.
7. The Type of Ground Truth Used
- The "ground truth" was established by the assay results obtained from the predicate device (Becton Dickinson Vacutainer® tubes). The objective was to demonstrate that the Greiner tube yielded comparable results. In essence, the predicate device's performance served as the reference standard.
8. The Sample Size for the Training Set
- Not applicable. This study is a direct comparison study for a physical medical device, not an AI/ML development. There is no concept of a "training set" for this type of submission.
9. How the Ground Truth for the Training Set was Established
- Not applicable. See point 8.
§ 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.