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STaK-Chex Plus Retics is an assayed whole blood control for evaluating the accuracy and precision of automated, semi-automated and manual procedures that measure blood cell parameters.

STaK-Chex Plus Retics is a stabilized suspension of human red blood cells, a nucleated red blood cell analog, a white blood cell component consisting of human analogs and a platelet component consisting of a non-human analog in a preservative medium. The product is packaged in plastic vials containing 5ml. The closures are polypropylene screw caps with polyethylene liners. There are three different levels (low, normal and high). The vials will be packaged in a six (6) or twelve (12) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 - 10° C.

The provided document describes the 510(k) submission for STaK-Chex® Plus Retics, an assayed hematology control. It details the device, its intended use, comparison to a predicate device, and the general types of studies conducted. However, it does not provide detailed acceptance criteria or the specific quantitative results of a study designed to prove the device meets those criteria in a format applicable to evaluating a medical diagnostic AI device.

This submission is for a quality control product, not an AI or diagnostic device that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth. The studies cited are focused on product stability and reproducibility to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested points cannot be answered based on the provided text, as they pertain to a different type of device evaluation (e.g., AI diagnostic device performance).

Here's an attempt to extract relevant information and note what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for parameters like accuracy, precision, sensitivity, or specificity. The evaluation is focused on demonstrating "substantial equivalence" to a predicate device and stability. The "reported device performance" is qualitative, indicating consistent reproducibility and stability.

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

• Test Set Sample Size: Not explicitly stated. The studies mentioned are: Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, and External Site recovery of values. The number of samples (vials, runs, sites) used for each of these tests is not quantified.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be internal (from Streck) and possibly external (for recovery of values), but no specific locations are provided.
• Retrospective or Prospective: Not specified. Stability studies are typically prospective over time, but the overall nature of the data collection isn't detailed.

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

This question is not applicable to this device type. The "ground truth" for a quality control product like STaK-Chex Plus Retics would be the expected values of the blood cell parameters it is designed to measure, established through manufacturing processes and validated assays, rather than expert interpretation of images or patient data. No experts are mentioned in the context of establishing ground truth for the test set.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for disputes in expert interpretation of diagnostic results, which is not relevant for a quality control product.

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 a hematology quality control mixture, not an AI or diagnostic system that human readers would use or that would assist human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this product type is its assigned values for blood cell parameters, which are established during manufacturing and validated through internal testing and calibration with reference methods. The document states it is an "assayed whole blood control," meaning its values are predetermined. The studies confirm that new lots or conditions (stability) maintain these expected values.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As above, there is no training set for this type of device.

In summary, the provided 510(k) summary focuses on demonstrating that a new version of a quality control product is substantially equivalent to an existing one by proving its stability and reproducibility. The type of acceptance criteria and study details requested are typically for diagnostic AI systems, which do not apply to this product.

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STaK-Chex Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell five-part differential, and reticulocyte parameters on Beckman/Coulter GenS series hematology instruments.

STaK-Chex Plus Retics is a suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes packaged in glass vials containing 4.5 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.

The provided text describes a medical device called "STaK-Chex Plus Retics," an assayed hematology control. The 510(k) summary outlines its intended use and provides a brief discussion of test results.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state acceptance criteria in a quantitative format (e.g., specific thresholds for accuracy, precision, sensitivity, specificity). Instead, it describes general findings from its studies.

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

The document does not specify the sample size for any of the studies (I: Run to Run Reproducibility and Comparison to Whole Blood; II: Site to Site Reproducibility; III: Long Term Stability; IV: Open Vial Stability). It also does not mention the country of origin of the data or whether the studies were 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. The device is a control for hematology instruments, implying that the "ground truth" would likely be derived from established laboratory protocols and instrument readings rather than expert consensus on patient cases.

4. Adjudication method for the test set

This information is not provided. Given the nature of a hematology control device, an adjudication method like 2+1 or 3+1 typically used for subjective image interpretation is not applicable. The "ground truth" for a control device is usually based on its known and verified values when used with calibrated instruments.

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

An MRMC study was not done. This device is a quality control product for laboratory instruments, not an AI-assisted diagnostic tool that involves human readers.

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

This concept is not applicable to the described device. STaK-Chex Plus Retics is a physical control material used with hematology analyzers, not an algorithm.

7. The type of ground truth used

The ground truth for this type of device would be the expected and verified values of the control material (stabilized human red blood cells, human white cells, simulated platelets, and simulated human reticulocytes) when analyzed by properly calibrated Beckman/Coulter GenS series hematology instruments. This is established through rigorous internal testing and characterization of the control material itself, rather than expert consensus on individual cases, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable. The term "training set" typically refers to machine learning algorithms, which is not relevant for this device. The studies mentioned (Run to Run Reproducibility, Site to Site Reproducibility, Long Term Stability, Open Vial Stability) are performance validation studies, not training.

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

This information is not applicable, as there is no "training set" in the context of this device.

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