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510(k) Data Aggregation
(83 days)
The CellSearch™ Epithelial Cell Control kit is intended for use as an assayed control, when performing the CellSearch™ Epithelial Cell Kit on the CellTracks® AutoPrep System, to ensure that the sample detection and identification systems are working. For in vitro diagnostic use.
The CellSearch™ Epithelial Cell Control contains single-use vials of fixed cells from a breast carcinoma cell line (SKBR-3). Each vial contains two populations of cells for high and low level control. A CellSearch™ Epithelial Cell Control vial is substituted for a patient sample to verify the performance of the CellSearch™Epithelial Cell Kit reagents (K031588), sample processing by the CellTracks® AutoPrep System (K040077), and cell analysis by the CellSpotter® Analyzer(K031588).
Each single use vial in the CellSearch™ Epithelial Cell Control Kit contains two populations of SKBR-3 cells at different concentrations (low and high). The two cell populations are distinguished from each other by use of fluorescent dyes that are specific for each population. This permits simultaneous enumeration of low and high control cell populations by the CellSpotter® Analyzer. The control cells are fully compatible with CellSearch™ Epithelial Cell Kit reagents and are magnetically captured by the CellSpotter® Analyzer and acquired as images that are displayed to the user for final classification. The cells are differentiated as control cells by the detection of fluorescence in the high or low control channels of the CellSpotter® Analyzer.
The CellSearch™ Epithelial Cell Control Kit contains 24 single-use bottles of CellSearch™ Epithelial Cell Controls. Each bottle contains 3.5 mL of two populations of fixed SKBR-3 cells (a human breast carcinoma derived cell line) in Histopaque®(Sigma Aldrich Trademark), 5% bovine serum albumin and 0.1% sodium azide.
The document describes the CellSearch™ Epithelial Cell Control Kit, an assayed control for the CellSearch™ Epithelial Cell Kit assay. The primary study described aims to demonstrate the control's function, the substantial equivalence of its matrix to whole blood for the CellSearch Assay, and acceptable precision.
Here's the breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a single, consolidated format. However, it states the purpose of the control kit and the types of performance data assessed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Control Functionality: Ability to assess the performance of the CellSearch™ Epithelial Cell Kit, CellTracks® AutoPrep System, and CellSpotter® Analyzer in detecting and enumerating circulating tumor cells (CTC). | "performance data that describes the assessment done to verify the CellSearch™ Epithelial Cell Control function" and "The assay results support that the controls can monitor that assay performance is working." (Specific metrics for "working" are not detailed in this summary.) |
| Matrix Equivalence: The control matrix (Histopaque®) is substantially equivalent to whole blood for the CellSearch Assay. | "demonstration that the Control Matrix is substantially equivalent to whole blood for the CellSearch Assay" (Specific metrics or comparison data are not detailed in this summary.) |
| Precision: Acceptable precision of the control kit. | "and has acceptable precision." (Specific metrics for "acceptable precision" are not detailed in this summary.) |
| Expected Target Values: Two populations of cells; High (1000 cells/test); Low (50 cells/test). | This is a design characteristic rather than an acceptance criterion result itself, but implies the device should consistently demonstrate these target values within acceptable ranges. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for the "performance data that describes the assessment done to verify the CellSearch™ Epithelial Cell Control function." The document mentions the control kit contains "24 single-use bottles of CellSearch™ Epithelial Cell Controls," which might hint at the scale of testing or how the product is packaged, but not directly the sample size of a specific test set.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This device is a control kit for an assay, not an AI/image-based diagnostic requiring expert interpretation for ground truth establishment. The ground truth for this device would be its known cell concentrations.
4. Adjudication Method for the Test Set
Not applicable. As a quality control kit, the "ground truth" is the known concentration of cells spiked into the control.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
No. This is a quality control kit, not a diagnostic device requiring human reader interpretation or assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not directly applicable in the context of an "algorithm." The control kit itself, when run through the CellTracks® AutoPrep System and CellSpotter® Analyzer, is evaluating the performance of that system and its associated reagents and detection/identification components. The study assessed the control's function in verifying the system's performance.
7. The type of ground truth used
The ground truth used for the control kit itself is the known concentration of fixed cells (SKBR-3) at two specified levels: High (1000 cells/test) and Low (50 cells/test). These are "assayed controls," meaning their expected values are pre-determined.
8. The sample size for the training set
Not applicable. This is a quality control kit with known cell concentrations, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. (See #8)
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