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The CellSearch® Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood. 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, colorectal or prostate* cancer. The test is to be used as an aid in the monitoring of patients with metastatic breast, colorectal or prostate cancer. Serial testing for CTC should be used in conjunction with other clinical methods for monitoring metastatic breast, colorectal and prostate cancer. Evaluation of CTC at any time during the course of disease allows assessment of patient prognosis and is predictive of progression free survival and overall survival.

*Metastatic prostate cancer patients in this study were defined as having two consecutive increases in the serum marker PSA above a reference level, despite standard hormonal management. These patients are commonly described as having androgen-independent, hormone-resistant, or castration-resistant prostate cancer.

The CellSearch® Circulating Tumor Cell Kit contains a ferrofluid-based capture reagent and immunofluorescent reagents. The ferrofluid reagent consists of small particles with a magnetic core surrounded by a polymeric layer coated with antibodies targeting the EpCAM antigen for capturing CTC. After immunomagnetic capture and enrichment, fluorescent reagents are added for identification and enumeration of CTC. The fluorescent reagents include the following: anti-CK-Phycoerythrin (PE) specific for the intracellular protein cytokeratin (characteristic of epithelial cells), DAPI, which stains the cell nucleus, and anti-CD45-Allophycocyanin (APC) specific for leukocytes.

The 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® device attracts the magnetically labeled epithelial cells to the surface of the cartridge. The CellTracks Analyzer II® or CellSpotter® Analyzer automatically scans the entire surface of the cartridge, acquires images and displays any event to the user where CK-PE and DAPI fluorescence are co-located. Images are presented to the user in a gallery format for final classification. An event is classified as a tumor cell when its morphological features are consistent with that of a tumor cell and it exhibits the phenotype EpCAM+, CK+, DAPI+ and CD45-.

The provided document (K103502) describes a 510(k) submission for a modified CellSearch® Circulating Tumor Cell Kit. However, it does not contain a study with acceptance criteria and a detailed report of device performance against those criteria in the way typically expected for a new or significantly modified device efficacy trial.

Instead, this 510(k) is a Special 510(k), which is submitted when there are minor changes to a legally marketed device that do not affect the intended use, fundamental scientific technology, mode of operation, or specimen type. In this particular case, the changes were labeling changes to assist the operator.

Therefore, the submission demonstrates equivalence to the predicate device (K073338) through verification of labeling specifications for the modified device and labeling process validation, rather than through a new clinical study with performance metrics against acceptance criteria.

Due to the nature of this particular 510(k) submission, many of the requested details about a clinical study, such as sample size, ground truth establishment for test and training sets, expert adjudication, and MRMC studies, are not present in the provided text.

Here's a breakdown of the available information:

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

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

• Not applicable / Not provided. The submission focused on equivalence based on labeling and process validation, not a new clinical performance study.

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

• Not applicable / Not provided. No new clinical test set requiring expert ground truth was described.

4. Adjudication method for the test set:

• Not applicable / Not provided.

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:

• No. This device is for circulating tumor cell enumeration, not an imaging device requiring human reader interpretation in the context of an MRMC study comparing AI assistance. The CellTracks Analyzer II® or CellSpotter® Analyzer presents images to the user for final classification, but the 510(k) does not detail MRMC studies for this specific change.

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

• Not explicitly stated as a new study for this 510(k). The device involves an automated process for capture, enrichment, and initial scanning, with a user performing final classification. The submission focuses on the impact of labeling changes, not on a standalone algorithm performance study.

7. The type of ground truth used:

• Not applicable / Not provided for this specific 510(k). For the original predicate device, the "ground truth" for CTC identification would likely be based on the biological markers detected (EpCAM+, CK+, DAPI+, CD45-) and morphological features recognized by trained operators. However, this 510(k) does not present new performance data.

8. The sample size for the training set:

• Not applicable / Not provided. No new algorithm training was described for this submission.

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

• Not applicable / Not provided.

In summary: K103502 is a Special 510(k) for minor labeling changes to an already cleared device. It establishes substantial equivalence by demonstrating that these changes do not affect the device's fundamental performance, rather than by presenting new clinical performance data from a dedicated study with specific acceptance criteria and detailed methodologies for establishing ground truth, sample sizes, or reader studies. The "study" proving the device meets acceptance criteria in this context is the verification of labeling specifications and validation of the labeling process, demonstrating that the modified device remains functionally identical to the predicate.

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