(90 days)
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.
§ 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.