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The Cytomics FC 500 MPL is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file.

The Cytomics FC 500 MPL Flow Cytometer (FC 500 MPL) is a bench top laboratory instrument designed for In Vitro Diagnostic Use in clinical laboratories. The FC 500 MPL provides qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single file. The instrument can simultaneously measure forward scatter, side scatter, and five fluorescent dyes using one or two lasers at 488 nm and either 635 nm (solid-state laser) or 633 nm (HeNe laser). Therefore, the instrument can perform correlated multiparameter analyses of individual cells.

The provided document is a 510(k) summary for the Cytomics FC 500 MPL Flow Cytometer, filed in 2007. It establishes substantial equivalence to a predicate device and describes the device's function, but it does not contain information about acceptance criteria or specific studies proving the device meets those criteria.

The document states:

• The FC 500 MPL is based on the FC 500 flow cytometer.
• Modifications include hardware, software, and labeling changes to support sample presentation/introduction from multi-well plates, and additional software/labeling for 21 CFR Part 11 compliance.
• The FDA reviewed the premarket notification and found the device substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill the request to provide acceptance criteria and a study that proves the device meets them based on the provided text. The document is a regulatory submission for substantial equivalence, not a detailed study report with performance metrics against acceptance criteria.

The 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness and that the data submitted demonstrate that the device is as safe and effective as the predicate device. It typically doesn't include detailed performance studies with acceptance criteria in the manner requested for AI/diagnostic devices that might involve multi-reader studies or ground truth establishment.

To answer your questions:

1. A table of acceptance criteria and the reported device performance: Not available in the provided document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in the provided document.
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/available in the provided document. This document does not describe a study involving expert-established ground truth for a diagnostic AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/available in the provided document.
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 device is an automated cell counter, not an AI-assisted diagnostic imaging device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "Cytomics FC 500 MPL Flow Cytometer" for automated cell counting, implying standalone processing for its function. However, specific standalone performance studies with quantitative metrics are not detailed in this 510(k) summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available/applicable in the context of this 510(k) summary. For flow cytometers, "ground truth" might refer to established reference methods or known cell populations, but typical validation studies are not described here.
8. The sample size for the training set: Not applicable/available. This device predates widespread AI/ML training set concepts in regulatory documents.
9. How the ground truth for the training set was established: Not applicable/available.

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