(62 days)
The COULTER® CellPrep is an automated system that processes human blood for preparation of leukocyte suspensions for quantitative immunofluorescence analysis by optical flow cytometers.
The use of data generated by this instrument depends on the regulatory status of the reagents you use. If the reagent is labeled by the manufacturer "For Research Use Only. Not for use in diagnostic procedures," federal law prohibits the use of the data for diagnosis.
This product is intended "For In Vitro Diagnostic Use" when using the "IVDImmunophenotype" protocol and processing whole blood samples with COULTER reagents and antibodies labeled for In Vitro Diagnostic Use.
The COULTER® CellPrep is a compact, fully automated sample processing workstation which can be programmed to perform a variety of cell wash, dilution, and concentration operations.
The provided text presents a 510(k) summary for the COULTER® CellPrep device. However, it does not contain the specific details required to answer all the questions about acceptance criteria and the study proving the device meets them. The document primarily focuses on establishing substantial equivalence to a predicate device and describing its intended use.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or provide a table of reported device performance metrics against such criteria. It only states: "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided text.
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 information is not present in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided text.
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 present in the provided text. The COULTER® CellPrep is an automated system for processing blood, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is described as a "fully automated sample processing workstation." The entire device is designed to operate in a standalone manner for sample preparation. However, the document does not provide performance metrics for this standalone operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present in the provided text.
8. The sample size for the training set
This information is not present in the provided text.
9. How the ground truth for the training set was established
This information is not present in the provided text.
In summary, the provided document is a 510(k) premarket notification summary, which primarily aims to demonstrate substantial equivalence to a predicate device based on its intended use and general performance. It does not delve into the detailed study methodology, acceptance criteria, or performance metrics in the way a more comprehensive clinical study report would.
§ 864.5240 Automated blood cell diluting apparatus.
(a)
Identification. An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further testing.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.