(182 days)
The Greiner Vacuette™ blood collection tube with clot activator and gel separator is an evacuated blood collection device containing a clot activator (silicondioxide) and an inert polymeric barrier material. The product is intended for use in holding and separating blood serum from the cellular components of blood.
The Greiner Vacuette™ blood collection tube with clot activator and gel separator is an evacuated blood collection device containing a clot activator (silicondioxide) and an inert polymeric barrier material.
This document is a 510(k) summary for a medical device, specifically a blood collection tube. It does not describe a study involving an AI/Machine Learning device or software. Therefore, most of the requested information regarding acceptance criteria, study design for AI devices, ground truth, expert involvement, and sample sizes for training/test sets for AI models is not applicable.
Here's an interpretation of the provided text in the context of the prompt, highlighting what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Becton Dickinson's Vacutainer® SST tubes (K921806) | Good correlation of assay results for 41 analytes (correlation coefficients ranging from 0.864 to 1.000) when compared to Becton Dickinson Vacutainer® tubes. |
| Equivalent intended use | Stated as having the "same intended use." |
| Equivalent components when applicable | Contains "same stopper material, clot activator and separator" as the predicate device. |
Note: The document doesn't explicitly state quantitative acceptance criteria targets (e.g., "correlation coefficient must be > 0.90"). Rather, it implies acceptance based on demonstrating "good correlation" for substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not explicitly stated. The document mentions "paired samples collected in Greiner Vacuette™ tubes and Becton Dickinson Vacutainer® tubes" for 41 analytes, but it doesn't specify the number of patients or samples.
- Data provenance: Not specified. It does not mention country of origin or whether the data was retrospective or prospective.
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)
- Not applicable. This is a medical device (blood collection tube), not an AI/ML device requiring expert ground truth for image interpretation or similar tasks. The "ground truth" here is the actual assay results from the paired samples.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This concept is for resolving discrepancies in expert interpretations, which is not relevant to a blood collection tube study comparing assay results.
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
- Not applicable. This is not an AI/ML device, and no MRMC study involving human readers and AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context is the assay results obtained from the blood samples. The comparison is between the assay results from the investigational device (Greiner Vacuette™) and the predicate device (Becton Dickinson Vacutainer®).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for an AI/ML device.
§ 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.