(40 days)
evacuated blood collection devices intended for use in testing glucose and lactate levels in blood.
Greiner Vacuette® blood collection tube with EDTA and sodium fluoride; and (2) its Greiner Vacuette® blood collection tube with potassium oxalate and sodium fluoride. Both Greiner Vacuette® blood collection tubes are evacuated blood collection devices intended for use in testing glucose and lactate levels in blood.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies, formatted as requested.
The provided document is a 510(k) summary for a medical device (blood collection tubes) and, as such, does not typically contain the detailed "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the format one might expect for an AI algorithm or a diagnostic imaging device. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
However, based on the information provided, we can infer some "acceptance criteria" related to the performance of the new device compared to the predicate, and describe the study conducted to support this claim.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Good correlation of glucose assay results between Greiner tube and Becton Dickinson predicate tube (for both EDTA/NaF and K.Oxalate/NaF types). | "Good correlation was observed" for glucose assay results from paired samples for each tube type (Greiner vs. BD). |
Note: The document only states "good correlation was observed." It does not provide specific metrics or thresholds (e.g., Pearson correlation coefficient > 0.95, or bias within a certain range). This level of detail is usually found in the full 510(k) submission, not the summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided summary. The text mentions "paired samples," indicating that for each comparison (Greiner EDTA/NaF vs. BD EDTA/NaF, and Greiner K.Oxalate/NaF vs. BD K.Oxalate/NaF), a set of blood samples was collected from an unspecified number of subjects.
- Data Provenance: Not specified. It's likely a controlled laboratory study, but the country of origin, and whether it was retrospective or prospective, are not mentioned. Given the nature of a 510(k) submission for a new device, it would most likely be a prospective study.
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 question is not applicable to this type of device and study. The "ground truth" here is the actual glucose and lactate levels in the blood, measured by standard laboratory methods. There is no expert interpretation of images or other subjective data involved. The "truth" is established by the assay itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point #3. The study compares quantitative measurements, not subjective interpretations requiring 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
- Not applicable. This study is not evaluating an AI algorithm or human reader performance. It's comparing the performance of a blood collection tube.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This study is not evaluating an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the comparison is the glucose assay results obtained from the predicate device's tubes (Becton Dickinson Vacutainer®), assumed to represent the established standard. The study seeks to show that the new Greiner tubes yield results that are "good correlation" with these established standards. Essentially, the predicate device's performance acts as the reference or implicitly "ground truth" for what constitutes acceptable glucose and lactate levels.
8. The sample size for the training set
- Not applicable. This study does not involve machine learning or a training set.
9. How the ground truth for the training set was established
- Not applicable. This study does not involve machine learning or 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.