Search Results

The Immunicon CellPrep™ Sample Preparation System is a general-purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks™ Analyzer, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for in vitro diagnostic use.

The CellPrep System is a semi-automated sample-handling instrument that starts with a tube of anticoagulated whole blood and delivers an enriched, processed sample that is ready to analyze by flow-cytometry, fluorescent microscopy or by the CellTracks™ Analyzer. The CellPrep™ System performs several steps, including red cell detection, plasma aspiration and filling of a sample chamber or test tube. The user is prompted to perform various operations such as reagent addition and mixing. The principal of operation relates to the addition of a ferrofluid, which has been conjugated with monoclonal antibodies that act with the system to magnetically separate the cells of interest and in subsequent steps, within the system, to add fluorescence-labeled monoclonals to further differentiate the captured cells. The first reagent added is ferrofluid, which consists of a magnetic core surrounded by a protein layer coated with antibodies for attachment to cells. Ferrofluid particles are colloidal and when mixed with a sample containing the target cells, they interact and attach to the target cells. The ferrofluid/sample mixture is placed in a strong magnetic field, which causes the labeled target cells to move to the side of the tube. The blood is aspirated, the magnetic field is removed and the cells are resuspended in a small volume of buffer and fluorescent reagents are added for the identification and enumeration of the target cells. Another magnetic separation step and resuspension is performed and the sample is now ready for analysis.

The provided text describes the Immunicon CellPrep™ Sample Preparation System and summarizes the testing performed to demonstrate its safety and effectiveness. However, it does not explicitly present a table of acceptance criteria or a detailed, structured study report in the format requested. Instead, it provides a narrative summary of performance findings.

Based on the provided text, here's an attempt to extract and infer the requested information:

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

The document does not explicitly state "acceptance criteria" as a separate, defined list. However, we can infer the performance targets/criteria from the reported results.

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 for Test Set: The text states, "Clinical testing was performed at five clinical sites." It mentions the device was "capable of removing small numbers of cells (~950) from a 7.5 ml volume of blood" and that the CV range was for "duplicate samples." However, it does not explicitly state the total number of patient samples, runs, or analyses conducted within the clinical trial. It only refers to "small numbers of cells (~950)". For non-clinical testing, it mentions "very low levels of approximately 10 cells" and "range of 50 to 200 cells" in a 7.5ml sample, but again, no specific sample size (i.e., number of spiked samples or replicates) is provided.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: "Clinical testing was performed at five clinical sites" implies a prospective study, where samples were processed and analyzed as part of the trial. The term "nonclinical testing" typically refers to laboratory-based, controlled studies, which are also generally prospective in nature.

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 document. The text states, "Clinical testing was performed at five clinical sites by Medical technicians or degreed biologists." While these individuals performed the testing, the method and number of experts establishing the ground truth (e.g., the true cell count before processing, or an independent verification of captured cells) are not detailed.

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

This information is not provided in the document. The text does not describe any adjudication process for the results obtained.

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

The Immunicon CellPrep™ Sample Preparation System is described as a "semi-automated sample-handling instrument" designed to prepare samples for analysis by "flow cytometers or microscopes." It processes blood and delivers an enriched sample. It is not an AI-powered diagnostic tool for image interpretation or diagnosis that would typically be evaluated in an MRMC study involving human readers with and without AI assistance. Therefore, an MRMC study as described, and its effect size, are not applicable and were not performed for this device type based on the provided text.

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

The device is a "semi-automated sample-handling instrument." It performs physical steps to prepare blood samples. While it has automated components, it is not an "algorithm only" device in the sense of an AI model. The performance metrics (recovery, precision, sensitivity, linearity) are for the device's ability to process samples, which is inherently a "standalone" performance evaluation of the instrument itself in its intended function.

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

The document implies that the ground truth for cell recovery and linearity studies would have been established by:

• Known input concentrations: For nonclinical sensitivity and linearity testing, cells are typically spiked into samples at known concentrations.
• Baseline measurements or reference methods: For clinical recovery, it would involve knowing the initial cell count in the 7.5 ml blood volume before the CellPrep device processes it. This might be done using a highly accurate reference method or manual counting.
  The document does not explicitly state the exact method used, but for "recovery" and "sensitivity" of a sample preparation system, the ground truth is generally a quantified, validated initial cell count or concentration.

8. The sample size for the training set

The device is a sample preparation instrument. It does not use machine learning or AI models that require a "training set" in the typical sense of AI/ML software development. Therefore, this concept is not applicable to the Immunicon CellPrep™ Sample Preparation System as described.

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

As explained in point 8, the concept of a "training set" for an AI/ML model does not apply to this device.

Ask a specific question about this device