(277 days)
DM96 is an automated cell-locating device.
The body fluid application is intended for differential count of white blood cells. The system automatically locates and presents images of cells on cytocentrifuged body fluid preparations. The operator identifies and verifies the suggested classification of each cell according to type.
DM96 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.
The CellaVision DM96 with the body fluid application is a laboratory instrument used to perform differential analysis by locating, digitally storing and displaying cells in human body fluid preparations.
The CellaVision DM96 with the body fluid application is a new intended use that follows the same process as the currently cleared DM96 with white blood cell differential, RBC characterization and platelet estimation (K033840).
Here's a breakdown of the acceptance criteria and the study information for the CellaVision DM96 with the body fluid application, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative "acceptance criteria" or specific "reported device performance" metrics (like accuracy percentages, sensitivity, specificity) for the CellaVision DM96 with the body fluid application. Instead, it focuses on demonstrating substantial equivalence to existing devices and validating its performance through various tests.
However, based on the context, the implied acceptance criteria were likely:
- Accuracy: The device's ability to correctly classify white blood cells in body fluid preparations when compared to manual microscopic methods.
- Precision: The consistency and reproducibility of the device's cell classification.
- Cell Location: The device's ability to effectively locate white blood cells for an operator to review.
- Substantial Equivalence: The device performing as well as or better than the predicate devices and the manual method without raising new safety or effectiveness concerns.
| Acceptance Criterion (Implied) | Reported Device Performance (Summary) |
|---|---|
| Accuracy | "Tests on cytocentrifuged body fluid preparations... were conducted and successfully completed... Tests were also conducted to validate performance including accuracy..." |
| Precision | "...and precision..." (from the summary of testing) |
| Cell Location | "...and cell-location." (from the summary of testing) |
| Substantial Equivalence | "Based on extensive performance testing including comparison to the predicate devices, it is the conclusion of CellaVision AB that DM96 with the body fluid application is substantially equivalent to devices already on the market..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states, "Tests on cytocentrifuged body fluid preparations including specimen types such as cerebrospinal fluid, serous fluid and related fluids were conducted and successfully completed." However, the exact numerical sample size for the test set is not specified.
- Data Provenance: The text does not explicitly state the country of origin or whether the data was retrospective or prospective. It just mentions "Tests on cytocentrifuged body fluid preparations."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: The text does not specify the number of experts used to establish ground truth or details about their involvement in the "accuracy" testing.
- Qualifications of Experts: The intended use section states, "DM96 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells." This implies that the comparison or ground truth would be based on the assessment of such "skilled operators" or experts, but their specific qualifications (e.g., years of experience, certifications) are not detailed within the provided snippets. The comparison table mentions "The examiners usually locate/count white blood cells..." which suggests manual review by trained personnel.
4. Adjudication Method for the Test Set
- The text does not specify an explicit adjudication method (e.g., 2+1, 3+1). It only mentions that "the operator identifies and verifies the suggested classification of each cell according to type" which implies a human-in-the-loop review process as the final step.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- MRMC Study: The provided text does not explicitly mention a "Multi Reader Multi Case (MRMC) comparative effectiveness study." The focus is on demonstrating substantial equivalence to manual methods rather than quantifying the improvement of human readers with AI assistance versus without AI assistance.
- Effect Size: Therefore, no effect size for human reader improvement with AI assistance is reported. The device's function is to "pre-classify" cells, which are then "verified" by an operator, implying assistance rather than a direct comparison of assisted vs. unassisted reader performance metrics.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: The core function of the CellaVision DM96 is described as "The cell images are pre-classified and the operator verifies the suggested classification by accepting or reclassifying." This clearly indicates that the device operates with a human-in-the-loop. Therefore, a standalone (algorithm only) performance study and its results are not provided or implied by this documentation, as the device is not intended for standalone use for final diagnosis. The device's regulatory pathway is likely as an aid to the human operator.
7. The Type of Ground Truth Used
- The ground truth appears to be expert consensus or expert review (manual light microscopic process). The comparison table repeatedly references the "Manual light microscopic process" as the standard against which the device's functionality is compared. The device's output is also subject to "verification of results by skilled human operator."
8. The Sample Size for the Training Set
- The text does not provide any information regarding the sample size used for the training set for the artificial neural networks (ANNs).
9. How the Ground Truth for the Training Set Was Established
- The text states that the device uses "deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells." However, it does not elaborate on how the ground truth for this training data was established. Based on the overall context, it would logically be established by expert morphologists/pathologists classifying cells.
§ 864.5260 Automated cell-locating device.
(a)
Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)(b)
Classification. Class II (performance standards).