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The FlowCARE TLG Reagent kit combines four fluorescent labeled monoclonal antibodics in a single reagent formulation. It is intended "For In Vitro Diagnostic Use" for the enumeration of CD3+, CD3+CD4+ and CD3+CD8+ absolute cell count and CD3+, CD3+CD4+ and CD3+CD8+ lymphocyte percentage in combination with a White Blood Ccll (WBC) Count from a hematology instrument as a dual platform measurement, or independently when used in combination with Flow-Count™ Fluorospheres as a single platform measurement.

The FlowCARE™ TLG Reagent consists of a four-color antibody reagent composed of CD45-FITC, CD4-PE, CD8-ECD, and CD3-PC5. The assay is performed on the EPICS XL or suitably equipped flow cytometer using appropriate quality control reagents in combination with an optional absolute count reagent, Flow-Count™ Fluorospheres, for determination of CD3+, CD3+CD4+, and CD3+CD8+ absolute counts as a single platform measurement, or in combination with a White Blood Cell Count from a hematology analyzer as a dual platform measurement.

The provided text is a 510(k) summary for the FlowCARE™ TLG Reagent. It outlines the device's intended use, comparison to a predicate device, and a brief statement about performance data. However, it does not contain detailed information about specific acceptance criteria or the study data that proves the device meets those criteria.

The document states: "Accuracy, precision, and linearity studies were conducted and demonstrated acceptable performance per the manufacturer specifications. The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution." This is a general statement and lacks the specific details required to complete your request.

Therefore, I cannot fill in the table or provide detailed answers to most of your questions based only on the provided text.

Here's an analysis of what information can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in the provided text. The document only mentions "acceptable performance per the manufacturer specifications."
• Reported Device Performance: Not explicitly stated in the provided text.

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 mentioned.
• Data Provenance: Not mentioned (country of origin, retrospective/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 as this seems to be an in vitro diagnostic reagent for automated cell counting, not an imaging device requiring expert interpretation for ground truth. The ground truth would typically be established by established laboratory methods or reference standards. The document does not specify how ground truth was established for the performance studies mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/mentioned.

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 an in vitro diagnostic reagent, not an AI-assisted diagnostic tool requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The device is a reagent for flow cytometry, which is an automated process. The "analysis software" difference highlighted (predicate uses automated software, subject device uses "Manual analysis using customer created protocols according to package insert") suggests that the interpretation might involve manual steps, but the primary function is reagent-based cell counting. The performance studies would be for the reagent's analytical accuracy, precision, and linearity, which are inherently "standalone" in terms of the reagent's performance on the instrument. However, the details of these studies are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not specified. For this type of device (cell counting reagent), ground truth would typically come from a well-established reference method, potentially manual microscopy counts, or a predicate device.

8. The sample size for the training set

• Not applicable/mentioned. This is not an AI/machine learning device that typically involves a training set in the conventional sense. The "training" here would be related to establishing the assay protocol parameters.

9. How the ground truth for the training set was established

• Not applicable/mentioned.

Summary of what can be extracted from the text:

• Device Name: FlowCARE™ TLG Reagent
• Intended Use: Enumeration of CD3+, CD3+CD4+, and CD3+CD8+ absolute cell count and lymphocyte percentage, either as a dual platform measurement (with a hematology instrument's WBC count) or a single platform measurement (with Flow-Count™ Fluorospheres).
• Studies Conducted (mentioned, but no details): Accuracy, precision, and linearity studies.
• Conclusion of Studies (general statement): "demonstrated acceptable performance per the manufacturer specifications."
• Predicate Device: tetraONE™ SYSTEM for EPICS XL Flow Cytometry SYSTEM with CYTO-STAT© tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent (Beckman Coulter, Inc., K990172)

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