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The Chempaq XBC Analyzer is an in vitro diagnostic method intended for the quantitative determination of the concentration of white blood cells ("WBC"); granulocytes ("GRN"); lymphocytes ("LYM"); monocytes ("MON"); and total hemoglobin ("HGB") in whole-blood samples (finger stick or venous sample).

The Chempaq XBC Analyzer is indicated for use in: clinical laboratories, and for point-of-care hematology determinations in doctors' offices or by healthcare professionals in hospital settings to identify and classify one or more of the formed elements of blood.

Automated differential cell counter

This document is a 510(k) summary for a modification to the Chempaq XBC Analyzer, a device already on the market. The summary focuses on functional and safety testing to demonstrate that the modifications did not compromise existing white blood cell or hemoglobin measurement functionality and that new functionalities perform as intended. Therefore, this submission does not contain a standalone study or a detailed report of clinical performance against acceptance criteria for the core diagnostic measures (WBC, GRN, LYM, MON, HGB) as it refers to an existing device and modifications.

Based on the provided text, the device is considered substantially equivalent to its predicate, meaning its performance is implied to be similar to the existing (predicate) device. However, specific acceptance criteria and detailed performance data for the diagnostic measurements themselves are not presented in this summary for the modified device.

Here's an analysis based on the information available:

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

The provided text does not contain a table of acceptance criteria or reported device performance for the diagnostic accuracy of WBC, GRN, LYM, MON, or HGB. The document focuses on the functional and safety testing of the modifications to the existing Chempaq XBC Analyzer.

The acceptance criteria mentioned are related to successful operation of:

• Quality Control Cassette (QCC) for PAQ electrical connection and Hemoglobin photometric function.
• Liquid Quality Controls (LQCs) with WBC PAQs.
• Linearity materials with the Analyzer in Linearity mode using WBC PAQs.
• Associated print-out of LQC, QCC, Linearity, and patient ID.
• Detection of mismatches (e.g., wrong PAQ in wrong mode).
• Uncompromised WBC functionality after modifications.
• Software verification and validation.

The "reported device performance" against these specific acceptance criteria is summarized qualitatively: "Results of testing demonstrate that the modifications to the Chempaq XBC Analyzer did not modify white blood cell or hemoglobin measurement functionality, that the added functionality performs as intended, and that potential risks (such as mismatching of PAQ/QCC and test mode) have been mitigated by software changes to detect such mismatches to deliver an error message and prevent reporting of results."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document describes "bench tests" for functional and safety aspects. It does not specify the sample sizes (e.g., number of PAQs, QCCs, or samples tested) for these tests. Data provenance is not mentioned, but given the submitter is Chempaq A/S in Denmark, it's likely the testing was conducted internally by the manufacturer. The tests appear to be prospective, laboratory-based bench testing of the modified device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This 510(k) summary describes functional and safety testing, not clinical performance for diagnostic accuracy. Therefore, there is no mention of experts establishing ground truth in the context of clinical interpretation or diagnosis. The ground truth for functional tests would be the expected correct behavior of the device (e.g., a printout should occur, an error message should display for incorrect input).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is functional and safety testing, not a clinical study requiring adjudication of diagnostic outcomes.

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

Not applicable. This device is an automated differential cell counter, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data alongside AI.

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

This document is a 510(k) for device modifications. It confirms that "Bench performance testing was done to show that all WBC functionality was uncompromised by the modifications." This implies that the device's automated functions (i.e., algorithm only) were tested. However, detailed results of this standalone performance are not provided, as the purpose of the submission is to demonstrate equivalence and safety of the modifications, not to re-establish the primary diagnostic performance. The original Chempaq XBC Analyzer's standalone performance would have been established in a previous 510(k) submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the functional and safety testing described, the "ground truth" is the expected behavior and output of the device and its components, determined by engineering specifications and quality control standards (e.g., known values for liquid quality controls, expected printout content, correct error messages).

8. The sample size for the training set

Not applicable. This is a submission for modifications to an existing device, and the testing described is verification and validation of these modifications and their impact on existing functionality. It does not describe the development or training of new algorithms for diagnostic purposes.

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

Not applicable, as there is no mention of a training set for new algorithms in this submission.

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The Chempaq XBC Analyzer is an in vitro diagnostic method intended for the quantitative determination of the concentration of white blood cells ("WBC"); granulocytes ("GRN"); lymphocytes ("LYM"); monocytes ("MON"); and total hemoglobin ("Hb") in whole-blood samples (finger stick or venous sample).

The Chempaq XBC Analyzer is indicated for use in: clinical laboratories, and for point-of-care hematology determinations in doctors' offices or by healthcare professionals in hospital settings to identify and classify one or more of the formed elements of blood.

The Chempaq XBC Analyzer consists of a single use cartridge, called the PAQ (Particle Analyzer and Quantifier), and a stationary Reader with a docking station, called a Cradle. The PAQ is connected to the Cradle by a simple push fit. The PAQ includes all required reagents and will, when connected to the Cradle, perform all sample manipulations required for the analysis. The sample manipulation is facilitated by electrical and pneumatic connections between the PAQ and the Cradle. The user is not required to add any reagent to the Reader.

The test procedure is very simple, as the user is only required to apply blood to the PAQ and place it into the Cradle. The rest of the test is carried out automatically within 3 minutes. No manipulation of reagents or other materials by the user is required.

The Chempaq XBC Analyzer is an in vitro diagnostic method for the quantitative determination of the concentration of various blood components. The provided text, however, focuses primarily on the general performance and special studies conducted to validate the device, rather than specifying explicit acceptance criteria with numerical targets. It states that "In all instances, the Chempaq XBC Analyzer functioned as intended," which implies that the device met internal, pre-defined acceptance criteria, but these criteria are not explicitly detailed.

Here's a breakdown of the requested information based on the provided text:

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

As mentioned, specific numerical acceptance criteria are not explicitly stated in the provided text. The text confirms that the device "functioned as intended" in all tests, implying all criteria were met.

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

• Sample Size: Not explicitly stated. The text mentions "Testing was performed under two separate situations: 1) laboratory bench testing; and 2) point-of-use clinical testing, including point-of-care and physician office laboratory locations." However, the number of samples used in these tests is not provided.
• Data Provenance: The studies were conducted in "laboratory bench testing" and "point-of-use clinical testing, including point-of-care and physician office laboratory locations." The country of origin for the data is not specified, but the submitter, Chempaq A/S, is based in Copenhagen, Denmark, suggesting that some or all studies might have been conducted there or in clinics/labs associated with their operations. The studies appear to be prospective as they were conducted specifically for the validation of the Chempaq XBC Analyzer following approved test protocols.

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. The text does not detail how ground truth was established for the test set, nor does it mention the involvement or qualifications of experts for this purpose.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the document.

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:

This is not applicable to the Chempaq XBC Analyzer. This device is an automated differential cell counter, meaning it performs the analysis itself, rather than assisting human readers in interpreting images or data. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this type of device.

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

Yes, a standalone performance study was done for the Chempaq XBC Analyzer. This is indicated by the "Performance Data" section which describes various tests directly evaluating the device's capabilities (precision, accuracy, linearity, stability, etc.) without human intervention in the analysis process. The device is described as operating "automatically within 3 minutes" after blood application.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The document does not explicitly state the specific type of ground truth used. For diagnostic devices measuring blood cell concentrations, ground truth would typically be established using reference methods or established laboratory techniques known for their accuracy and precision. For example, manual differential counts by trained technologists, or comparison with results from highly accurate predicate devices or gold standard instruments. The mention of "NCCLS" (National Committee for Clinical Laboratory Standards) and "ICSH" (International Council for Standardization in Haematology) documents as references suggests that recognized industry standards for establishing ground truth and evaluation were followed.

8. The sample size for the training set:

This information is not provided in the document. For a device like this, the "training set" might refer to data used during the development and optimization of the underlying algorithms, but the document does not specify this.

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

This information is not provided in the document. Similar to the test set, it would likely involve highly accurate reference methods, but the specifics are not detailed.

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