(77 days)
The CellSearch™ Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+ and cytokeratin 8 & 18+, and/or cytokeratin 19+) in whole blood in conjunction with the CellTracks® AutoPrep System, the CellSpotter® Analyzer or CellTracks® Analyzer II, and the CellSearch™ Circulating Tumor Cell Control Kit.
The presence of CTC in the peripheral blood, as detected by the CellSearch™ Circulating Tumor Cell Kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast cancer. A CTC count of 5 or more per 7.5 mL of blood generally is predictive of shorter progression free survival and shorter overall survival.
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This document is a 510(k) clearance letter for the CellSearch™ Circulating Tumor Cell Kit, not a study report. Therefore, it does not contain the detailed acceptance criteria and study results in the format requested. The letter confirms that the FDA has found the device to be substantially equivalent to legally marketed predicate devices.
However, I can extract what is present related to device function and some context of a study that would have been submitted to the FDA for this clearance.
Missing Information: Most of the requested information regarding detailed acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC study details are not available within this document. This information would typically be found in the 510(k) submission itself, which is a much larger technical dossier.
Here's what can be gathered, with the understanding that key details are absent:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document. The clearance letter only states that the device is "substantially equivalent" to predicate devices for its intended use. This implies the device met certain performance criteria compared to the predicate, but these criteria are not itemized here.
- Reported Device Performance: The document provides the intended use and clinical significance of the device's measurements, rather than raw performance metrics.
| Acceptance Criteria (Implied) | Reported Device Performance (Clinical Significance) |
|---|---|
| (Not explicitly stated in this document, typically comparative to predicate device performance in accuracy, precision, reproducibility, etc.) | "The presence of CTC in the peripheral blood, as detected by the CellSearch™ Circulating Tumor Cell Kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast cancer." |
| "A CTC count of 5 or more per 7.5 mL of blood generally is predictive of shorter progression free survival and shorter overall survival." |
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: Not available in this document.
- Data Provenance: Not available in this 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 available in this document. Since this is an assay for enumerating circulating tumor cells using technology like immunomagnetic separation and image analysis, the "ground truth" would likely involve methods beyond just human expert review, potentially including independent staining and manual counting by trained laboratory personnel.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not available in this 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
- This device is for automated enumeration of circulating tumor cells using an analyzer (CellSpotter® Analyzer or CellTracks® Analyzer II). While there's a human element in initiating the test and interpreting the clinical significance, it's primarily an automated system. An "MRMC study" in the traditional sense (improving human reader performance with AI) is unlikely to be directly applicable as the primary claim is the enumeration by the device. The "AI" would be embedded in the CellSpotter® Analyzer's image analysis algorithms. The document does not provide details on such a study or effect sizes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the core claim is for the "CellSearch™ Circulating Tumor Cell Kit" used in conjunction with the "CellTracks® AutoPrep System, the CellSpotter® Analyzer or CellTracks® Analyzer II". This implies a standalone performance component of the automated system in enumerating CTCs. However, the exact performance metrics of this standalone component are not provided in this clearance letter. The indications for use describe the kit's function with the automated analyzers.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "Indications for Use" mentions the device "is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast cancer." This suggests that clinical outcomes data (progression-free survival and overall survival) were used to establish the clinical utility and significance of the CTC counts provided by the device. The "ground truth" for enumerating CTCs would typically involve orthogonal methods like manual microscopy counts by trained cytotechnologists or other validated cell counting methods, though this is not explicitly stated.
8. The sample size for the training set
- Not available in this document.
9. How the ground truth for the training set was established
- Not available in this document.
§ 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.