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The FlowCARE PLG CD4 Reagent is for use on the Coulter® EPICS® XL ™/XL-MCL™ or equivalent flow cytometer. The reagent kit combines two fluorescent-labeled monoclonal antibodies in a single reagent formulation. It is intended "For In Vitro Diagnostic Use" for the enumeration of CD4 absolute cell count and CD4 lymphocyte percentage in combination with a White Blood Cell (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 PLG CD4 Reagent consists of a two-color antibody reagent composed of CD45-FITC and CD4-PE. The assay is performed on the EPICS XL, Cytomics FC 500, or equivalent Flow Cytometer using appropriate quality control reagents in combination with an optional absolute count reagent, Flow-Count™ Fluorospheres for determination CD4 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 document, K043215, "FlowCARE PLG CD4 Reagent," is a 510(k) summary for a medical device. It does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria in the typical format of a clinical trial or performance study report.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device. This is a common regulatory pathway for medical devices where the manufacturer shows that their new device is as safe and effective as a legally marketed device (the predicate device) that is already cleared by the FDA.

Therefore, the specific questions outlined in your request related to acceptance criteria, sample size, ground truth, experts, adjudication, MRMC studies, and standalone performance for proving device acceptance are not explicitly addressed or applicable in this type of regulatory submission. The document emphasizes comparison and similarities to an existing cleared device rather than presenting novel performance data against pre-defined acceptance criteria.

Here's why and what information can be extracted or inferred:

• Acceptance Criteria and Reported Device Performance: This document does not present a table of acceptance criteria for the FlowCARE PLG CD4 Reagent's performance. Instead, it highlights that the device "claims substantial equivalence" to the predicate device (tetraONE SYSTEM) for the enumeration of CD4 T-Lymphocytes. The "performance" is implicitly deemed acceptable because it is considered equivalent to a device already on the market.
• Study Data (Sample Size, Provenance): There is no mention of a specific "test set" sample size or data provenance (country, retrospective/prospective). The document discusses the device's components and intended use, comparing them to the predicate. Any underlying data supporting the "equivalence" would have been part of the manufacturer's internal validation, but it's not detailed in this public summary.
• Number of Experts, Qualifications, Adjudication: These details are not relevant for a 510(k) summary of substantial equivalence. No expert review of specific cases or adjudication process is described as the primary mechanism for demonstrating device performance.
• MRMC Comparative Effectiveness Study: No MRMC study is mentioned. The focus is on the device's characteristics and its equivalence to a predicate, not on how human readers' performance might improve with or without AI assistance (which is not applicable here as it's a reagent, not an AI system for interpretation).
• Standalone Performance: The document describes the reagent's function as an "algorithm only (without human-in-the-loop performance)" is not applicable. The FlowCARE PLG CD4 Reagent is a biological reagent kit used in conjunction with flow cytometers and other laboratory equipment for in vitro diagnostic testing. The performance is the output of the instrument-reagent system.
• Type of Ground Truth: The concept of "ground truth" (expert consensus, pathology, outcomes data) is not discussed in the context of validating this device's performance against a standard. The performance is compared to that obtained using a predicate device.
• Training Set Sample Size and Ground Truth Establishment: This information is also not included. The device is a diagnostic reagent, not a machine learning algorithm that requires a "training set" in the conventional sense.

In summary, while the request asks for specific details about acceptance criteria and performance studies, the provided document (a 510(k) summary for substantial equivalence) does not contain this information because its purpose is to demonstrate equivalence to an already cleared device, not to present new performance data against pre-defined acceptance criteria in a detailed study report.

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