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The ADVIA™ 120 Hematology System Complete Blood Count (CBC) method is intended to quantitatively measure the following hematological parameters: White Blood Cell count (WBC) Red Blood Cell count (RBC) Total Hemoglobin concentration (HGBTotal) Cellular Hemoglobin concentration (HGBcell) Hematocrit (HCT) Mean Corpuscular Volume (MCV) Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Corpuscular Hemoglobin Concentration Mean (CHCM) Cellular Hemoglobin Content (CH) Red Cell Volume Distribution Width (RDW) Hemoglobin Concentration Distribution Width (HDW) Platelet Count (PLT) Mean Platelet Volume (MPV)

The difference between HGBToul and HGBcen can be used to discriminate between cellassociated hemoglobin and cell-free hemoglobin as found in hemoglobin-based blood substitutes.

Cellular hemoglobin is currently a "laboratory use only" parameter on the ADVIA 120 system. There are no changes to software, reagents, calibrators or controls necessary to derive the cellular hemoglobin parameter.

Acceptance Criteria and Device Performance Study for ADVIA 120 Cellular Hgb Method

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria. Instead, it defines acceptance in terms of "equivalence" to the predicate device (ADVIA 120 HgbTotal method, K971998) for several performance characteristics.

Note: The document states that the predicate method's specifications for Accuracy, Precision, Linearity, and Carryover are "As specified in product labeling." However, these specific values are not included in this 510(k) summary. Therefore, the exact numerical benchmarks for equivalence are not provided in this excerpt.

2. Sample Size and Data Provenance for the Test Set

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "test results included in this submission" but provides no details on these aspects.

3. Number and Qualifications of Experts Used to Establish Ground Truth for the Test Set

The document does not mention the use of experts to establish ground truth for the test set. Given the nature of the device (quantitative measurement of hemoglobin in whole blood), ground truth would typically be established through comparison with a reference method or highly accurate predicate device, not expert human interpretation.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is not applicable here as the device measures a quantitative parameter, and its performance is assessed against a predicate device or reference method, not through human consensus on image interpretation or complex diagnoses.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices that rely on human interpretation of images or other subjective data, often to assess the impact of AI assistance on human performance. The ADVIA 120 Cellular Hgb method is a quantitative laboratory instrument, not an AI-assisted diagnostic tool requiring human interpretation. Therefore, the effect size of human readers improving with or without AI assistance is not relevant or reported.

6. Standalone Performance Study

Yes, a standalone performance study was implicitly done, as the ADVIA 120 Cellular Hgb method is itself the "algorithm" (or rather, the method of calculation) being evaluated. The submission demonstrates the performance of this method in terms of accuracy, precision, linearity, and carryover, comparing it directly to the predicate device. This evaluation is of the device's inherent capability to measure cellular hemoglobin without human-in-the-loop intervention for the measurement itself.

7. Type of Ground Truth Used

The ground truth for the test set was established by the predicate method, the ADVIA 120 HgbTotal method (K971998). The study aims to demonstrate that the new cellular Hgb method is "equivalent" or "substantially equivalent" to this established and legally marketed predicate device.

8. Sample Size for the Training Set

The document does not mention a "training set" or its sample size. This is expected as the ADVIA 120 Cellular Hgb method is based on a deterministic calculation from existing RBC/Plt channel parameters (RBC count, MCV, CHCM) and does not involve machine learning algorithms that typically require a training phase with a distinct training set. The principles of operation describe a direct calculation: "The cellular hemoglobin concentration is then calculated as the product of the RBC count, the MCV, and CHCM, then scaled by a factor of 1/1000 to obtain units of grams per dL of whole blood."

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set or a machine learning algorithm, the concept of establishing ground truth for a training set is not applicable to this device and submission.

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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.

1. A reformulated reagent that can be used to obtain CSF counts from a single optical channel of the ADVIA 120 system.
2. Revised software to calculate the cell counts.
3. A software key to selectively allow access to the CSF mode of the system software.
4. 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.

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:

1. 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.

2. 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.

3. Adjudication method:

   • Not specified.

4. 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.

5. 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.

6. 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.

7. 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."

8. 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.

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The Advia 120 Cn-free Hgb method is intended to quantitatively measure hemoglobin concentration in a sample of whole blood.

The ADVIA 120 Cn-free Hgb Method consists of the following optional changes to the ADVIA 120 Hematology System:

1. A reformulated reagent used to measure hemoglobin without the use of potassium cyanide.
2. A special cap and straw for the reagent bottle that restricts air exchange with the reagent.
3. A modified colorimeter that measures the hemoglobin reaction at 565 nm.
4. Modified software to implement the algorithms necessary to calculate hemoglobin concentration when using the optional reagent and hardware for the method.

The provided text describes the ADVIA 120 Cn-free Hgb Method, a cyanide-free hemoglobin determination option for a hematology analyzer, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study that proves the device meets those criteria.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide specific quantitative acceptance criteria or detailed numerical performance data. Instead, it states that the new method is "Equivalent to predicate method" for several performance characteristics.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "The test results included in this submission demonstrate that the ADVIA 120 Cn-free Hgb Method has equivalent accuracy, precision, linearity, and carryover similar to the ADVIA 120 predicate method."

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is a quantitative measurement instrument. The "ground truth" would typically refer to a reference method or a highly accurate established measurement of hemoglobin concentration, rather than expert judgment.

4. Adjudication Method for the Test Set

Not applicable, as this involves objective quantitative measurements and comparison to a predicate device/reference method, not subjective expert assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically for image-based diagnostic aids where multiple human readers interpret cases with and without AI assistance. This device is an automated quantitative analyzer.

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

Yes, the study described is a standalone performance assessment of the ADVIA 120 Cn-free Hgb Method. It evaluates the device's ability to measure hemoglobin concentration without human intervention in the measurement process, against the performance of a predicate device.

7. The Type of Ground Truth Used

The "ground truth" for this type of device would implicitly be the results obtained by the ADVIA 120 cyanide containing Hgb predicate method (K971998) and/or other established, accurate reference methods for hemoglobin measurement. The study aimed to demonstrate equivalence to this predicate.

8. The Sample Size for the Training Set

Not applicable. This document describes a modification to an existing analytical instrument and its reagents, not a machine learning algorithm that requires a "training set" in the conventional sense. The "modified software to implement the algorithms" likely refers to analytical algorithms, not machine learning algorithms trained on large datasets.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of a training set for a machine learning algorithm.

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The ADVIA 120 Hematology System is a quantitative, automated hematology analyzer that provides a leukocyte differential count and reticulocyte analysis for In Vitro diagnostic use in clinical laboratories.

The ADVIA 120 Hematology System consists of the following: An analytical module that aspirates, dilutes, and analyzes whole blood samples. An autosampler that automatically mixes, identifies, and presents samples for processing. A computer workstation that controls the instrument, provides the primary user interface with the instrument, and manages the data produced by the instrument. A printer that optionally generates reports based on the instrument results.

The ADVIA 120 Hematology System reports the following hematological parameters:
White Blood Cell Parameters: WBC, Neut, Lymph, Mono, Eos, Baso, LUC
Red Blood Cell Parameters: RBC, Hct, MCV, RDW, CHCM, HDW
Hemoglobin Parameters: Hgb, MCH, MCHC
Platelet Parameters: Plt, MPV
Reticulocyte Count: retic, MCVg, MCVr, CHCMg, CHCMr, CHg, CHr

The ADVIA 120 Hematology System is considered substantially equivalent to the Technicon H-3 RTC for CBC, WBC differential, and reticulocyte parameters. The submission indicates that the test results demonstrate equivalent accuracy, precision, linearity, and carryover between the two systems.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and reported device performance:

The document doesn't explicitly define numerical acceptance criteria (e.g., specific thresholds for accuracy, precision, linearity, or carryover). Instead, it states that the ADVIA 120 Hematology System and the H-3 RTC demonstrate equivalent performance in these areas.

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

• Sample size: Not specified.
• Data provenance: Not specified. The document only mentions "test results included in this submission," but doesn't detail where or when these tests were conducted, or if the data was retrospective or prospective.

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

• This information is not provided in the document. Hematology analyzers typically compare results to a reference method, which might involve manual differentials performed by qualified lab professionals, but this detail is absent.

4. Adjudication method for the test set:

• Not specified. The document does not describe any adjudication process.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. An MRMC study is typically for evaluating a medical device's impact on human reader performance for tasks like image interpretation. This device (a hematology analyzer) is an automated system providing quantitative measurements, not directly assisting a human reader in interpreting qualitative data in a "case" setting. Therefore, this type of study is not applicable here.

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

• Yes, this is a standalone device. The ADVIA 120 Hematology System is described as a "quantitative, automated hematology analyzer." The performance evaluation would inherently be of the algorithm/instrument itself, without human-in-the-loop interaction for the core measurement tasks.

7. The type of ground truth used:

• The document implies that the Technicon H-3 RTC serves as the predicate device and implicitly, the "ground truth" or reference for comparison. The study aims to prove equivalence to this established device. While the H-3 RTC itself would have been validated against other methods (e.g., manual microscopy for differentials, reference chemical methods for hemoglobin), those details are not provided here for the ADVIA 120's validation.

8. The sample size for the training set:

• Not applicable / not specified. For an automated analyzer like this, the "training set" concept is usually associated with machine learning models. While there are algorithms involved, the document describes the principles of operation based on well-established methods (laser light scatter, absorption, modified cyanmethemoglobin method). It's unlikely a "training set" in the modern machine learning sense was used for this type of device at the time of its submission (1997).

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

• Not applicable / not specified. As above, the concept of a "training set ground truth" in the context of machine learning is not applicable here. The system's "ground truth" for calibration and validation would be established through reference methods and comparisons to a predicate device.

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