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Clinical immunophenotyping using the CyAn DXD flow cytometer, a lyse wash sample preparation method, for identification and enumeration of CD3, CD4 and CD8 lymphocyte subsets using TC-660. For In-Vitro Diagnostic Use

The Dako CyAn™ DXD device is a bench-top flow cytometer system relying on multiple (up to three) laser stimulation of fluorescence tagged lymphocytes. It is used with the Dako MultiMix, a triple color reagent; one each to CD3, CD4 and CD8, conjugated to fluorochromes APC(allophycocyanin), r-phycoerythrin, and fluorescein isothiocynate, which are balanced to identify the dual positive T-cell populations (CD3+CD4+ and CD3+CD8+) in peripheral blood lymphocytes. The instrument requires daily set-up with Dako FluoroSpheres consisting of a set of 5 bead populations having different fluorescent intensities and one nonfluorescent bead population. The combination of fluorochromes enables excitation by light of any wavelength from 365-650 nm. The CyAn DXD utilizes anti-human CD3 conjugated with FITC, RPE and APC to perform autocompensation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dako CyAn™ DXD device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for performance metrics like precision, accuracy, specificity, or linearity. Instead, it makes a general statement about the study's findings:

Important Note: The document focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific quantitative performance targets. This is a common approach in 510(k) submissions.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data). It only mentions "Results of all testing conducted."

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

The document does not mention the use of experts or how ground truth was established for the test set. For a flow cytometer, the "ground truth" would typically be derived from the instrument's own measurements or comparison to a gold standard method.

4. Adjudication Method for the Test Set

Since the document does not mention the use of experts to establish a ground truth or subjective assessments, there is no adjudication method described.

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

No. The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The device is an automated differential cell counter, which typically doesn't involve human readers in the same way an imaging AI would.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, implicitly. The study evaluates the "Performance characteristics evaluated in support of the CVAn DXD and its associated components." This implies the performance of the device itself, including its automated algorithms for identification and enumeration of lymphocyte subsets, in a standalone manner. The device is a "bench-top flow cytometer system" with "Summit™ software" and "automated quality control algorithms."

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, given the nature of a flow cytometer that measures cell populations, the "ground truth" would likely be:

• Reference standard measurements: Comparison to established flow cytometry methods or other validated laboratory techniques for cell counting and phenotyping.
• Intra-device consistency: Demonstrating that the device consistently identifies and enumerates cell populations.

The claim of "substantial degree of equivalency to the predicate devices" suggests that the predicate devices themselves served as a de facto "ground truth" or a benchmark for comparison.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This device is a flow cytometer for direct measurement and analysis, not an AI/machine learning model in the contemporary sense that typically requires a separate training set for model development. The software (Summit™) and algorithms are likely part of the device's inherent design and calibration, rather than being "trained" on a specific dataset in the modern ML context.

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

Since no training set is mentioned in the context of an AI/ML model, the document does not describe how ground truth for a training set was established.

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The DakoCytomation ER/PR pharmDx™ assay is an immunohistochemical (IHC) kit system to identify human estrogen receptor (ER) and human progesterone receptor (PR) expression in breast cancer tissues routinely processed and paraffin-embedded for histological evaluation. ER/PR pharmDx specifically detects the ER alpha protein as well as the PR located in the cell nucleus of ER and/or PR-expressing cells.

ER/PR pharmDx is indicated as an aid in identifying patients eligible for treatment with antihormonal or aromatase inhibitor therapies, as well as an aid in the prognosis and management of breast cancer.

The DakoCytomation Monoclonal Mouse Anti-Human Progesterone Receptor, clone PgR 1294, is intended for laboratory use as a semi-quantitative detection of progesterone receptor by light microscopy in routinely processed normal and pathological human paraffinembedded tissue. This antibody is indicated for use as an aid in the management, prognosis and prediction of outcome of breast cancer. The clinical interpretation of any positive staining or its absence should be complemented by morphological and histological studies with proper controls. Evaluations should be made within the context of the patient's clinical history and other diagnostic tests by a qualified individual

The DakoCytomation ER/PR pharmDx™ assay is a semi-quantitative immunohistochemical (IHC) kit system to identify estrogen receptor (ER) and progesterone receptor (PR) expression in normal and neoplastic tissues routinely processed and paraffin-embedded for histological expressing cells respectively.

ER/PR pharmDx assay is available in two configurations, both manual and automated and is optimized for use with DakoCytomation detection systems.

The DakoCytomation Monoclonal Mouse Anti-Human Progesterone Receptor, clone PgR 1294, is a component of the ER/PR pharmDx kit, which will also be commercially available as a concentrate.

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and study proving device performance for the DakoCytomation ER/PR pharmDx™ Kit and the Monoclonal Mouse Anti-Human Progesterone Receptor, clone PgR 1294:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding reported device performance values. Instead, it describes performance characteristics that were evaluated and states that the results demonstrated "a substantial degree of equivalency to the predicate devices" and "substantially equivalent staining results" to a reference method.

The primary acceptance criteria appear to be substantial equivalence to predicate devices and high concordance with a recognized reference method.

Table of Acceptance Criteria and Reported Device Performance (Inferred)

Study Description and Details:

The summary refers to a single study that encompassed evaluations of specificity, sensitivity, reproducibility, and concordance testing.

1. Sample Size and Data Provenance:

   • Test Set Sample Size: Not explicitly stated for any of the performance characteristics.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

2. Number of Experts and Qualifications for Ground Truth:

   • The document does not provide information on the number of experts used to establish ground truth or their specific qualifications.

3. Adjudication Method:

   • The document does not specify any adjudication method used for the test set.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study is mentioned. The comparison is between the new device and predicate devices/reference methods, not an assessment of human reader improvement with or without AI assistance.

5. Standalone Performance (Algorithm Only):

   • Yes, the performance characteristics (specificity, sensitivity, reproducibility, and concordance) are described for the device itself (the IHC kit and its components) when used according to its intended purpose. This represents a standalone assessment of the assay's performance.

6. Type of Ground Truth Used:

   • The ground truth for the concordance testing was established using the "Allred method." The Allred score is a semi-quantitative scoring system for ER/PR expression in breast cancer, combining the proportion of positive cells and the staining intensity. This can be considered a type of expert consensus/established semi-quantitative scoring method based on histopathology. For specificity, sensitivity, and reproducibility, the ground truth would also be based on established histopathological evaluation or comparison to the predicate devices, which are already considered validated.

7. Training Set Sample Size:

   • Not specified. The document primarily focuses on the validation study demonstrating substantial equivalence. It does not provide details about any internal development or training data used in the creation of the assay itself, as this would typically be a chemical/biological assay rather than a machine learning algorithm requiring a separate "training set" in the computational sense.

8. How Ground Truth for Training Set was Established:

   • Not applicable as this is not a machine learning device and no "training set" is described. The development of such IHC kits typically involves chemical formulation, antibody selection, and optimization against known positive and negative tissue samples, but these are not referred to as a "training set" in the context of this document.

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