(58 days)
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.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Performance (Safety and Effectiveness) equivalent to the predicate device (Immunicon CellTracks Analyzer II K050145) | "The conclusion drawn from these studies is that the CellTracks Analyzer II is as safe and effective as the predicate device. No new issues of safety or effectiveness have been raised." |
| All algorithms associated with image acquisition, analysis, cell selection, review, reporting, and archiving remain unchanged. | "What has not changed with the OS replacement are: All the algorithms associated with image acquisition, analysis, cell selection, review, reporting and archiving, the logic and interface to the PC remain the same." |
| Basic cell definition, count, or quality cannot be altered by the user via the new GUI. | The new GUI "does not allow [users] to alter the basic cell definition, count or quality." |
Study Information
Based on the provided text, here's a breakdown of the study attributes:
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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.
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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.
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Adjudication method for the test set:
- Not applicable/Not specified. As no ground truth establishment by experts is described, no adjudication method is mentioned.
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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.
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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.
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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.
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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.
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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.
§ 866.6020 Immunomagnetic circulating cancer cell selection and enumeration system.
(a)
Identification. An immunomagnetic circulating cancer cell selection and enumeration system is a device that consists of biological probes, fluorochromes, and other reagents; preservation and preparation devices; and a semiautomated analytical instrument to select and count circulating cancer cells in a prepared sample of whole blood. This device is intended for adjunctive use in monitoring or predicting cancer disease progression, response to therapy, and for the detection of recurrent disease.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System.” See § 866.1(e) for availability of this guidance document.