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The CELLTRACKS ANALYZER II® is a semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immunomagnetically selected and aligned. This product is for in vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device.

The CELLTRACKS ANALYZER II® is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS® software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation, which consists of a dedicated computer with CELLTRACKS® software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II® is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS® AUTOPREP® System, which automates and standardizes the sample preparation with specific reagent kits. The optional Remote Review Workstation provides the capability to review images and report results remotely.

The provided text does not contain detailed acceptance criteria or a specific study that demonstrates the device meets these criteria in the format requested. The document is a 510(k) summary for the CELLTRACKS ANALYZER II® System, focusing on establishing substantial equivalence to a predicate device.

However, based on the information provided, here's a breakdown of what can be inferred or explicitly stated, and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The submission states "The information presented in the premarket notification demonstrates that the performance of the CELLTRACKS ANALYZER II® System (modified) is substantially equivalent to the predicate device." but does not list specific performance metrics or their acceptable ranges.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not explicitly provided in the document. The document mentions "Non-clinical testing for the CELLTRACKS ANALYZER II® System included: Unit/Integration/System Verification, System Level Validation, Stress Testing, Regression Testing, Control Cell/Sample Performance Validation Testing." but does not specify the sample sizes, data origin (country), or whether the data was retrospective or prospective for these tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

This information is not provided in the document. The device is for "enumerating fluorescently labeled cells that are immunomagnetically selected and aligned," so human interpretation/adjudication might not be the primary ground truth establishment method. However, if any human review was involved in validation, it's not detailed.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not provided in the document. Given the description of the device as a "semi-automated fluorescence microscope used to enumerate fluorescently labeled cells," it's unlikely a traditional MRMC study as commonly understood for image-based diagnostic interpretations was performed or would be relevant in the same way. The focus seems to be on the accuracy and consistency of the enumeration function itself.

6. Standalone (Algorithm Only) Performance:

The device is described as "semi-automated" and includes "CELLTRACKS® software." The primary study mentioned is "non-clinical functional testing" to demonstrate substantial equivalence. The document doesn't explicitly refer to "algorithm only" performance as a distinct study. However, the system's core function is automated cell enumeration, suggesting that its performance is essentially standalone in terms of the enumeration task. The "semi-automated" aspect likely refers to the overall workflow involving sample preparation and then the device's automated analysis.

7. Type of Ground Truth Used:

This information is not explicitly provided in the document. For a cell enumeration system, the ground truth would typically be established by a highly accurate (manual or another validated automated) counting method, or potentially by using spiked samples with a known number of cells. The document mentions "Control Cell/Sample Performance Validation Testing," which implies the use of samples with known characteristics, but the method for establishing that "known" is not detailed.

8. Sample Size for the Training Set:

This information is not provided in the document. The document refers to software modifications (version 2.6.0) but does not detail any machine learning algorithms or training processes that would require a separate training set. The term "algorithm" is not used in the context of learned models. It appears to be a rule-based or image processing system rather than a deep learning model.

9. How the Ground Truth for the Training Set was Established:

This information is not provided and is likely not relevant as no machine learning training set is mentioned.

Summary of what is present:

• Device Name: CELLTRACKS ANALYZER II® System
• Predicate Device: CELLTRACKS ANALYZER II® (K113181)
• Modifications: Software update (version 2.6.0) and addition of an optional Remote Review Workstation.
• Basis for Equivalence: Non-clinical functional testing demonstrating performance is "substantially equivalent" to the predicate device.
• Testing Types Mentioned: Unit/Integration/System Verification, System Level Validation, Stress Testing, Regression Testing, Control Cell/Sample Performance Validation Testing.
• Intended Use/Indications: Enumerating fluorescently labeled cells that are immunomagnetically selected and aligned, for in vitro diagnostic use.

It's important to note that a 510(k) summary often provides a high-level overview. The detailed performance data, acceptance criteria, and study methodologies would be contained within the full 510(k) submission, which is not publicly available in this format.

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The Immunicon CellTracks Analyzer II is a semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immuno-magnetically selected and aligned. The system is for in-vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device.

The CellTracks® Analyzer II is a semi-automated fluorescence microscope. The product consists of the CellTracks® Analyzer II, a dedicated computer loaded with CellTracks® software, monitor, keybord and mouse.

The Cell Tracks Analyzer II is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CellTracks® AutoPrep System, which automates, standading wild optimizes the sample preparation with specific reagent kits.

The CellTracks Analyzer II is used in conjunction with the CellTracks AutoPrep System and in vitro diagnostic reagent kits that contain a ferrofluid-based capture reagent and immunofluonescent my one of or the detection and characterization of the captured cells. The ferrofluid reagent consists of naro-partigles with a magnetic core surrounded by a polymeric layer coated with antibodies targeting the cells of partiers. After Immunomagnetic capture and enrichment, fluorescent reagents are added for identification and enumeration of the target cells.

The processed reagent/sample mixture is dispensed by the CellTracks AutoPrep System into a cartridge that is inserted into a MagNest® cell presentation device. The strong magnetic field of the MagNest causes the magnetically-labeled target cells to move to the surface of the CallTracks Analyzer II sans the entire surface of the cartridge with a series of fluorescence filters that are defined for the assay. Cellimages from the filter are compiled and presented in a gallery format for final cell classification busths user.

What follows is an analysis of the provided text, outlining the acceptance criteria and study details based on the information given.

Acceptance Criteria and Device Performance

The provided text focuses on a 510(k) submission for the Immunicon CellTracks® Analyzer II, where the key modification is the change in the operating system from Microsoft Windows XP to Mandrake Linux and a new Graphical User Interface (GUI). The submission asserts that "These modifications of the CellTracks Analyzer II do not raise any new issues of safety or effectiveness. The intended use of the device is the same." The conclusion drawn is "that the CellTracks Analyzer II is as safe and effective as the predicate device."

This implies that the primary acceptance criterion is equivalence in safety and effectiveness to the predicate device (Immunicon CellTracks Analyzer II K050145). However, specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision for cell enumeration) for either the predicate or the modified device are not provided in the given document.

Therefore, the table below reflects the stated acceptance criterion based on the 510(k) summary, rather than explicit numerical targets.

Study Information

Based on the provided text, here's a breakdown of the study attributes:

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document does not explicitly state the sample size (number of cases/samples) used for testing. It describes the software testing methodology but does not quantify the test data.
   • Data Provenance: Not specified. The document describes software testing against requirements and design documents, but doesn't mention if biological samples or patient data were used for performance evaluation of the new software/OS. Given that the underlying algorithms remained unchanged, the focus seems to be on software functionality and integrity rather than re-validating the biological performance with new samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not specified. The document describes software validation focused on requirements, design, and fault testing of the OS and GUI changes. It does not mention any expert review or ground truth establishment for a test set in the context of the device's diagnostic performance. The device is a "semi-automated fluorescence microscope" where "Cell images from the filter are compiled and presented in a gallery format for final cell classification by the user." This indicates the user is responsible for final classification, implying the algorithm provides candidates, but the document doesn't detail how the accuracy of these candidates was validated post-OS change using expert-derived ground truth.

3. Adjudication method for the test set:

   • Not applicable/Not specified. As no ground truth establishment by experts is described, no adjudication method is mentioned.

4. 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:

   • No. The document describes software-centric testing related to changes in the operating system and graphical user interface. It does not mention any MRMC studies or human reader performance with or without AI assistance. The device is described as semi-automated, with the user performing final cell classification.

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

   • The document implies the core algorithms for image acquisition, analysis, and cell selection remain unchanged from the predicate device. The testing described primarily validates the new operating system and GUI, ensuring they do not negatively impact the existing algorithms' function or the system's overall operation. It does not detail a standalone performance study of the algorithm itself, likely because the algorithm itself was not modified in this submission.

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

   • For the software changes, the "ground truth" was defined by the software requirements specification (SRS) and design documents (software and database). Tests were developed to ensure the software met these specifications. There is no mention of biological or clinical ground truth (e.g., pathology, outcomes data, expert consensus on cell enumeration) being used for the validation of these specific changes.

7. The sample size for the training set:

   • Not applicable/Not specified. The document does not describe the development or training of new algorithms. It focuses on changes to the operating system and GUI of an existing device, where the "algorithms associated with image acquisition, analysis, cell selection, review, reporting and archiving" remain the same as the predicate device.

8. How the ground truth for the training set was established:

   • Not applicable/Not specified, as no new training set or algorithm training is mentioned in this submission. The ground truth for the original algorithms of the predicate device would have been established during its development, but this information is not provided here.

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