(63 days)
The Greiner Vacuette® ESR blood collection tube with citrate solution is an evacuated blood collection device intended for use in evaluations of blood sedimentation rate.
Indication for Use: To evaluate blood-sedimentation-rates.
The Greiner Vacuette® ESR blood collection tube with citrate solution is an evacuated blood collection device intended for use in evaluations of blood sedimentation rate.
The Greiner Vacuette® ESR blood collection tube with citrate solution is an evacuated blood collection device intended for use in evaluations of blood sedimentation rate. The device's performance was evaluated by comparing it to a legally marketed predicate device, Becton Dickinson's Vacutainer® brand citrate ESR tube.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalency of assay results for erythrocyte sedimentation rate (ESR) between the Greiner Vacuette® tube and the predicate device (Becton Dickinson Vacutainer® tube). | "Test results from paired samples for erythrocyte sedimentation rate were evaluated and good correlation was observed." (K971220, Section I) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided text. The text only mentions "paired samples."
- Data Provenance: The text does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the given text. The study focuses on comparing the assay results between two collection tubes, rather than subjective interpretation of results requiring expert consensus for ground truth.
4. Adjudication method for the test set:
- This information is not applicable and therefore not provided. The study compares quantitative assay results, not subjective interpretations that would require an adjudication method.
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:
- This information is not applicable and therefore not provided. This is a study for a blood collection tube, not an AI-assisted diagnostic device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is not applicable and therefore not provided. This is a study for a blood collection tube, not an algorithm or AI.
7. The type of ground truth used:
- The ground truth used was the ESR measurement obtained using the legally marketed predicate device (Becton Dickinson Vacutainer® brand citrate ESR tube). The study's objective was to demonstrate equivalence to this established method.
8. The sample size for the training set:
- This information is not applicable and therefore not provided. This study is not for an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established:
- This information is not applicable and therefore not provided, as there is no training set for this type of 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.