(55 days)
The ADVIA 120 cerebrospinal fluid (CSF) cell count is intended to provide an in vitro diagnostic, quantitative determination of blood cells in CSF specimens analyzed in the manual open tube mode. The ADVIA 120 provides leukocyte (WBC) and erythrocyte (RBC) counts along with both absolute and proportional counts for the WBC differential.
The revised ADVIA 120 CSF method consists of the following changes to the ADVIA 120 Hematology System.
- A reformulated reagent that can be used to obtain CSF counts from a single optical channel of the ADVIA 120 system.
- Revised software to calculate the cell counts.
- A software key to selectively allow access to the CSF mode of the system software.
- Control products to maintain quality control of the CSF method.
The following parameters are reported with the ADVIA 120 CSF method:
White Blood Cell Parameters
WBC - white blood cell count
Neut - neutrophil count (percentage and absolute counts)
Lymph - lymphocyte count (percentage and absolute counts)
Mono - monocyte count (percentage and absolute counts)
Eos - eosinophil count (percentage and absolute counts)
MN - mononuclear count (percentage and absolute counts)
PMN -- polymorphonuclear count (percentage and absolute counts)
Red Blood Cell Parameters
RBC - red blood cell count
- For Laboratory Use Only (not reportable)
Here's a breakdown of the acceptance criteria and study information for the revised ADVIA 120 CSF method, based on the provided text:
Acceptance Criteria and Device Performance
The submission states that the revised ADVIA 120 CSF method "meets the manufacturer's intended specifications." However, specific numerical acceptance criteria were not explicitly provided in the given text. The comparison focuses on the methods of operation between the predicate and revised device, rather than quantitative performance targets. Therefore, the table below will reflect the characteristics of the method comparison described.
| Acceptance Criteria (Implied by Comparison) | Reported Device Performance (Revised Method) |
|---|---|
| Intended Use | Same as predicate (quantitative determination of blood cells in CSF specimens) |
| Specimen Analyzed | Same as predicate (CSF collected in a sterile specimen tube) |
| WBC Count Method | Manual dilution with cell counts performed using RBC optics. RBCs are not lysed. |
| RBC Count Method | Manual dilution with cell counts performed using RBC optics. |
| WBC Differential Method | Manual dilution with cell performed using RBC optics. RBCs are not lysed, and WBCs are differentiated based on morphology only. |
Study Details
The provided text describes a submission for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study report with all the elements typically found in such a report. Many of the requested details are therefore not explicitly stated in this summary.
Here's what can be inferred or explicitly stated:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified. The abstract mentions "The test results included in this submission," implying internal testing by Bayer Corporation. There is no information about country of origin or whether the data was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. Given that this is a hematology analyzer, the ground truth would typically be established by manual microscopy by trained laboratory professionals (e.g., medical technologists or hematologists), but this is not explicitly stated.
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Adjudication method:
- Not specified.
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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:
- Not applicable / Not done. This device is an automated hematology analyzer, not an AI diagnostic tool intended to assist human readers in image interpretation. The study evaluates the analyzer's performance directly, not human reader improvement.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes. This is an automated device designed to operate in "standalone" mode, performing the cell counts and differentiations without human interpretation of raw data in the loop during the analysis process. The "manual open tube mode" refers to how the sample is introduced to the system, not that human interpretation is integrated into the result generation.
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The type of ground truth used:
- Not explicitly stated in detail. For automated cell counters, the established ground truth is typically obtained through manual microscopy by skilled laboratory personnel using a hemocytometer for counts and stained slides for differentials. This is implied by the nature of the device but not directly stated.
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The sample size for the training set:
- Not applicable / Not specified. This device is an automated system based on light scatter and absorbance measurements, not a machine learning model that requires a distinct "training set" in the common sense of AI/ML. The development likely involved internal validation and calibration with various samples, but these are not referred to as a "training set."
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How the ground truth for the training set was established:
- Not applicable / Not specified. As noted above, there's no explicit mention of a "training set" in the context of an AI/ML model for which ground truth would be established for training purposes.
§ 864.5200 Automated cell counter.
(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).