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XN CHECK is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:

RBC(106/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F*(103/μL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/uL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(103/pL), LYMPH#(103/pL), MONO# (103/pL), BASO#(103/pL), IG#(103/ μL), IPF(%), IPF# (103/pL), RET#(106/μL), RET%, IRF%, RET-HE(pg), NRBC#* (100 WBC)

*Not Available on the XN-L.

XN CHECK™ is a three level hematology control the following: stabilized red blood cell component(s), stabilized white blood cell component(s) stabilized platelet component(s), and stablic on onnonent(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps with a 3 mL fill. The vials will be pacum formed clamshell container with the Instructions for Use (FU) / assay sheet. Product storage conditions are 2 - 8° C.

The provided text is a 510(k) Summary for the XN CHECK™ hematology quality control mixture. It details the device's intended use, comparison to a predicate device, and conclusions from tests. However, it does not fully elaborate on the detailed acceptance criteria for each claimed parameter or explicitly describe the "study that proves the device meets the acceptance criteria" in terms of specific statistical analyses, sample sizes for test sets with ground truth, expert qualifications, or multi-reader studies.

Therefore, many of the requested details cannot be extracted directly from this document. The information provided is at a high level, focusing on demonstrating substantial equivalence to a predicate device.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "XN CHECK is used for control and calibration verification... and that the product is stable for the entire product dating." It also mentions "reproducible" and "stable" in the conclusions. However, it does not provide specific numerical acceptance criteria (e.g., maximum allowable coefficient of variation for precision, or specific stability limits for each parameter) nor quantified performance data for each of the numerous assayed parameters. It only describes the types of studies conducted.

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XN-L CHECK is used for control and calibration verification of Sysmex XN-L analyzers. It is not, however, intended for actual calibration of this analyzer. Assayed parameters include:

RBC (10^6/uL), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), PLT (10^3/uL), RDW-SD (fL), RDW-CV (%), MPV (fL), WBC (10^3/uL), NEUT (%), LYMPH (%), MONO (%), EO (%), BASO (%), IG (%), NEUT# (10^3/uL), LYMPH# (10^3/μL), MONO# (10^3/μL), EO# (10^3/μL), BASO# (10^3/μL), IG# (10^3/μL), RET# (10^6/uL), RET%, IRF%, RET-He (pg).

XN-L CHECK™ is an in-vitro diagnostic, three level (Levels 1, 2, and 3) hematology product that contains the following stabilized red blood cell component(s), stabilized white blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vias with screw caps with a 3 ml fill. The vials will be pacum formed clamshell container with the Instructions for Use (FU) / assay sheet. Product storage conditions are 2 - 8° C.

The provided document is a 510(k) premarket notification for a medical device called "XN-L CHECK™", a hematology quality control mixture. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain specific acceptance criteria, study details, or results in the format requested.

The document broadly states:

• "The resultant data set established that XN-L CHECK is safe and effective for its intended use and that the product is stable for the entire product dating."
• "Study results show XN-L CHECK to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating."

It mentions the following types of studies were conducted:

• Multi-Site Precision Study
• Single-Site Precision Study
• Open-Vial Stability
• Closed-Vial Stability

However, it does not provide any quantitative acceptance criteria or the reported device performance measurements for these studies. Therefore, I cannot generate the requested table or answer most of the specific questions about sample sizes, ground truth, expert involvement, or MRMC studies.

Based on the information available, here's what can be inferred or explicitly stated:

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

• Cannot be provided. The document states that performance data was collected and the device was found safe, effective, and stable, but it does not specify the numerical acceptance criteria (e.g., specific thresholds for precision or stability over time) or the actual reported performance values.

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

• Cannot be provided. The document mentions "Multi-Site Precision Study, Single-Site Precision Study, Open-Vial Stability and Closed-Vial Stability" but does not specify the sample sizes (number of samples, runs, instruments, or sites) used for these studies, nor the provenance (e.g., country of origin, retrospective/prospective).

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

• Not applicable / Cannot be provided. This device is a quality control mixture and not an interpretive AI device that would require expert adjudication for a diagnostic ground truth. The "ground truth" for a quality control device typically involves reference methods or established performance specifications of the analyzer it controls. The document does not mention any experts in the context of establishing ground truth for testing.

4. Adjudication method for the test set

• Not applicable / Cannot be provided. As explained in point 3, this is a quality control material, not a diagnostic device requiring expert interpretation and adjudication of results for a reference standard.

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

• No. This device is a hematology quality control mixture, not an AI-assisted diagnostic tool, so an MRMC study is not relevant or mentioned.

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

• Not applicable / Cannot be provided. This is not an algorithm or AI device. It's a physical control material used to assess the performance of a hematology analyzer.

7. The type of ground truth used

• Inferred: For a quality control mixture, the "ground truth" or reference values are typically established through extensive testing against highly accurate reference methods or by comparison to another established quality control material (the predicate device in this case) on the target analyzer. The document doesn't explicitly state the "type of ground truth" but implies it involves demonstrating "consistent reproducibility" and "substantial equivalence to the predicate products."

8. The sample size for the training set

• Not applicable / Cannot be provided. This is not an AI/machine learning device, so there is no concept of a "training set."

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

• Not applicable / Cannot be provided. As explained in point 8, there's no training set for this type of device.

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XN CHECK BF is used for control and calibration of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:

WBC-BF (10^3/μL), RBC-BF (10^6/μL), MN# (10^3/μL), PMN# (10^3/μL), MN%, PMN%, TC-BF# (10^3/uL)

XN CHECK™ BF is an in-vitro diagnostic, two level, control. It contains the following: stabilized red blood cell component(s) and stabilized white blood cell component(s) in a preservative medium in polypropylene plastic vials with screw caps with a 3 mL fill. The vials will be packaged in (4) welled vacuum formed clamshell container with the Instructions for Use (IFU) / assay sheet. Product storage conditions are 2 - 8° C.

The provided document is a 510(k) premarket notification for a medical device called "XN CHECK BF." This device is a hematology quality control mixture, and the submission is for a new iteration of an already marketed product (K141957). The primary change in the new device is the addition of compatibility with the Sysmex XN-L analyzer.

The document does not contain the information requested regarding acceptance criteria for an AI/ML device, the study to prove it meets those criteria, sample sizes, expert involvement, or MRMC studies. This is because XN CHECK BF is a quality control material for laboratory analyzers, not an AI/ML diagnostic or image analysis device.

Therefore, I cannot extract the requested information from the provided text. The document focuses on performance testing relevant to a quality control material, such as precision and stability studies, which are different from the types of studies performed for AI/ML diagnostic tools.

To answer your request, I would need a document describing the regulatory submission for an AI/ML-driven medical device.

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BC-5D is an assayed whole blood control designed for Mindray BC-5390 (Mindray 5000 series) Auto Hematology Analyzer for the following parameters: WBC, Neu#, Lym#, Mon#, Eos#, Bas#, Neu%, Lym%, Mon%, Eos%, Bas%, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD. PLT. and MPV.

The BC-5D Hematology Control consists of three levels of controls (Low, Normal, and High). It is recommended to perform quality control check using these controls established by the laboratory procedures and/or local/national regulations.

BC-5D Hematology Control is an in vitro diagnostic reagent composed of human erythrocytes, simulated leukocytes, and mammalian platelets in a plasma-like fluid with preservatives. This control is contains stabilized materials that provide a means of monitoring the performance of hematology blood cell counters. It is sampled in the same manner as a patient specimen.

Here's an analysis of the acceptance criteria and study information for the BC-5D Hematology Controls, based on the provided text, while noting limitations due to the document's nature as an FDA 510(k) summary, which often doesn't contain detailed study protocols:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary states, "The BC-5D Hematology Control met the acceptance criteria, as determined during verification, over the life of the product." However, it does not explicitly list the quantitative acceptance criteria for each parameter (WBC, Neu#, Lym#, etc.) nor does it provide a table of the reported device performance values against those criteria. It only indicates that the device met the criteria.

Without the specific numerical ranges for acceptance criteria and the actual performance data, a table like the one requested cannot be constructed from the given text. The relevant section notes that an "assay range" was determined for each parameter, and subsequent validation lots "met the acceptance criteria." This implies that the acceptance criteria revolved around the ability of the control to consistently fall within these established assay ranges.

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

• Sample Size (Test Set): The study involved testing "3 validation lots" of BC-5D Hematology Controls. The document does not specify the number of individual control samples tested within each lot or the number of measurements taken for each parameter.
• Data Provenance: Not explicitly stated, but as a commercial product seeking FDA clearance in the U.S., it's implied that the testing was conducted in a laboratory setting. The data is prospective in the sense that these validation lots were manufactured and tested specifically for the 510(k) submission. No information is given about the country of origin of the data beyond the applicant being R&D Systems, Inc. in Minneapolis, MN, USA.

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

This information is not applicable and therefore not provided in the document because:

• The device is a hematology quality control (QC) mixture, not a diagnostic device that relies on expert human interpretation of results (like an imaging device or a histological slide).
• The "ground truth" for a QC material is its assayed value, typically established by the manufacturer through rigorous testing using a reference method or consensus methods, not by "experts" in the sense of clinicians or radiologists interpreting results.

4. Adjudication Method for the Test Set

This is not applicable and therefore not provided for the same reasons as point 3. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in human expert interpretations, which is not relevant for a quality control material where performance is assessed against pre-defined numerical ranges.

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 relevant for diagnostic devices where human readers (e.g., radiologists, pathologists) interpret data, and the effect of AI assistance on their performance is evaluated.
• The BC-5D Hematology Control is a quality control material for an automated hematology analyzer. It does not involve human interpretation or AI assistance in the diagnostic process itself. Its purpose is to monitor the performance of the analyzer.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not directly applicable in the context of this device.

• The BC-5D is a control material, not an algorithm. Its "performance" is its ability to produce consistent and accurate results within its specified assay range when run on the Mindray BC-5390 Hematology Analyzer.
• The analyzer itself (Mindray BC-5390) performs in a "standalone" fashion (algorithm-only processing of samples). The control is used to verify that this standalone analyzer is functioning correctly.
• The study did evaluate the performance of the control material (i.e., its own characteristics like stability and assayed values) without human intervention in the result generation, but this isn't the typical "standalone algorithm performance" evaluation for a diagnostic AI device.

7. The Type of Ground Truth Used

The "ground truth" (or reference standard) for a hematology quality control material is its assayed value for each parameter. These values are established by the manufacturer through a combination of:

• Reference methods: Using highly accurate and precise analytical methods.
• Consensus values: Often by analyzing the control material on multiple instruments or by comparing with primary reference standards.
• The document implies that an "assay range" for each parameter was determined during the "manufacture and analysis of three verification lots." This "assay range" essentially defines the expected "ground truth" for the control material when it is functioning correctly.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided.

• "Training set" refers to data used to train a machine learning algorithm.
• The BC-5D Hematology Control is a physical control material, not a machine learning algorithm. Therefore, there is no "training set" in this context.

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

This information is not applicable and therefore not provided for the same reasons as point 8.

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XN CHECK BF is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21) analyzers. It is not. however, intended for actual calibration of these analyzers. Assayed parameters include:

WBC-BF (10^3/μl), RBC-BF (10^6/ μl), ΜΝ# (10^3/μl), ΜΝ% (%), ΡΜΝ% (%), ΡΜΝ% (%), ΤC-ΒΓ# (10°3/μl)

XN CHECK™ BF is an in-vitro diagnostic product the following: stabilized red blood cell component(s) and stabilized white blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with a 3 m fill. The vials will be packaged in (4) welled vacuum formed clamshell container with the Instructions for Use / assay sheet. The product storage conditions are at 2 - 8° C.

The provided text describes a 510(k) premarket notification for a medical device called XN CHECK™ BF. This document focuses on the substantial equivalence of the new device to a predicate device, rather than providing a detailed study design with specific acceptance criteria and performance metrics typically found for AI/ML-based medical devices or diagnostic tests.

The XN CHECK™ BF is a hematology quality control mixture for Sysmex XN series analyzers, not an AI-powered diagnostic device. Therefore, many of the questions related to AI/ML device studies (such as sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) are not applicable to this submission.

However, based on the information provided, here's a breakdown of what can be articulated regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format with specific thresholds (e.g., "accuracy > 90%"). Instead, the "acceptance criteria" are implied by the nature of a quality control product and its intended use, which is to demonstrate stability, reproducibility, and substantial equivalence to a predicate.

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

The document does not specify the sample size used for the test set in terms of the number of samples or runs for the stability and precision studies. It mentions "product performance data" was collected but does not provide details on the experimental design, number of replicates, or number of lots tested.

• Data Provenance: Not explicitly stated, but the studies were conducted by Streck, Inc., implying internal company data.
• Retrospective or Prospective: Given the nature of stability and precision studies for a quality control material, they would typically be prospective studies designed and executed specifically for this submission, following predefined protocols.

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

This is not applicable. The device is a hematology quality control mixture, not a diagnostic device requiring expert interpretation for "ground truth." The "ground truth" for a control material would be its manufacturing specifications and the measured values on reference instruments.

4. Adjudication Method for the Test Set

This is not applicable for a quality control product study. Adjudication methods are typically used when subjective interpretations (e.g., image reads) are involved to resolve discrepancies among experts.

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

No, an MRMC study was not done. This type of study is relevant for diagnostic devices (especially those involving human readers like radiologists) to assess the impact of AI assistance on human performance. The XN CHECK™ BF is a quality control material.

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

No, a standalone performance study in the context of an "algorithm only" is not applicable. The device itself is a physical quality control material used with an analyzer, not an algorithm. The "performance" refers to the stability and reproducibility of the control material's measured parameters, not an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for a quality control material like XN CHECK™ BF would be the expected target values and ranges for its assayed parameters, established through a rigorous manufacturing and assay process using reference methods and calibrated instruments. This is analogous to a reference standard, not ground truth derived from pathology, expert consensus, or outcomes data used for diagnostic algorithms.

8. The Sample Size for the Training Set

This is not applicable. The XN CHECK™ BF is a manufactured quality control material, not an AI/ML algorithm that requires a "training set."

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

This is not applicable, as there is no "training set" for this type of device.

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XN CHECK is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-21) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:

RBC(10^6/uL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(10^3/uL), PLT-F(10^3/uL), RDW-SD(fL), RDW-CV(%), MBC(10^3/uL), NEUT(%), LYMPH (%), MONO(%), EQ(%), BASO(%), IG(%), NEUTH(10^3/uL), LYMPH#(10^3/uL), MONO# (10^3/uL), EO#(10^3/uL), BASO#(10^3/uL), IG#(10^3/μL), IPF(%), IPF# (10^3/μL), RET%, IRF%, RET-HE(pg), NRBC#(10^3/uL), NRBC% (/100 WBC)

XN CHECK™ is an in-vitro diagnostic product that onlowing: stabilized red blood cell component(s), stablized white blood cell component(s), stablized platelet component(s), and stabilized nuclement(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps with a 3 ml fill. The vials will be packaged in (4) welled vacuum formed clamshell ontainer with the Instructions for Use (FU) / assay sheet. Product storage conditions are 2 - 8° C.

Here's an analysis of the provided text regarding the acceptance criteria and study for the XN Check™ device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a dedicated section. Instead, it discusses the outcomes of the studies. Based on the "Discussion of Tests and Test Results" and "Conclusions Drawn From Tests" sections, the implied acceptance criteria were related to stability and reproducibility, with the reported performance indicating these criteria were met.

Since no specific numerical thresholds are given, the table below reflects what can be inferred:

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

The document does not specify the sample size used for the test set for any of the studies (Open-Vial Stability, Closed-Vial Stability, and Precision Performance).

The data provenance is not explicitly stated in terms of country of origin. However, the product is being submitted for FDA approval in the USA, implying studies were conducted to support this market. The studies are described as prospective in nature, as they are performed to "substantiate the product performance claims" for the device being submitted.

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

The document does not mention the use of experts to establish ground truth for the test set. Given that XN CHECK is a hematology quality control mixture, the "ground truth" would likely be established through predefined assay values and analytical methods, rather than expert interpretation of patient data.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method, as it does not involve expert review or interpretation that would typically require adjudication. The performance evaluation is based on analytical measurements against expected values for the control material.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted, or at least not described in this document. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. XN CHECK is a quality control material, not a diagnostic device involving human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study was implicitly done. The studies mentioned (Open-Vial Stability, Closed-Vial Stability, and Precision Performance) relate to the intrinsic performance of the XN CHECK control material itself when analyzed by the Sysmex XN series analyzers. There is no human-in-the-loop component for the function of the control material.

7. Type of Ground Truth Used

The ground truth for this type of device (a quality control mixture) would be the assigned target values and acceptable ranges for each hematology parameter. These values are typically established through rigorous analytical testing and cross-validation against reference methods or previously validated control materials. The document implies these established analytical expectations as the basis for evaluating "reproducibility" and "stability."

8. Sample Size for the Training Set

The document does not specify a training set sample size. For a quality control material, the concept of a "training set" as understood in machine learning (where algorithms learn from data) does not directly apply. The manufacturing and validation process would involve extensive analytical testing during development and manufacturing, but this is not typically referred to as a "training set."

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

As explained above, a "training set" in the context of machine learning is not applicable here. For the XN CHECK, the "ground truth" (i.e., the expected values and acceptable ranges for performance) would be established by:

• Manufacturing specifications: Parameters are designed to fall within specific ranges.
• Analytical testing: Extensive in-house testing under controlled conditions to determine the mean and standard deviation for each parameter.
• Methodology: Following established laboratory practices and potentially using reference instruments or methods.
• Comparison to predicate: Ensuring the new control material performs comparably to the previously accepted predicate (XN CHECK K120742).

In summary, the provided document focuses on the regulatory submission for a hematology quality control product. As such, the studies described are analytical performance studies (stability, precision) rather than diagnostic efficacy studies and therefore many of the requested elements (like experts, adjudication, MRMC, training sets for algorithms) are not directly relevant or discussed.

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R&D 5D Retic Control is a tri-level, assayed Hematology control designed to monitor RET%, RET#, IRF and MRV values on Coulter® hematology analyzers.

For in vitro Diagnostic Use Only.

The R&D 5D Retic Hematology Control is an in vitro diagnostic reagent composed of human in a plasma-like fluid with preservatives. It is composed of stabilized materials that provide a means of monitoring reticulocyte counting methods. It is sampled in the same manner as a patient specimen.

The provided document describes the R&D 5D Retic Hematology Control, an in vitro diagnostic reagent used to monitor reticulocyte counting methods on Coulter® hematology analyzers. The submission is a 510(k) for substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The study was a laboratory validation study comparing the R&D 5D Retic Hematology Control to its predicate device.

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

• Sample Size for Test Set: "3 validation lots" were used. The document does not specify the number of individual vials or measurements within each lot.
• Data Provenance: The study was conducted by R&D Systems, Inc. in Minneapolis, MN, USA. The data would be considered prospective, as it was generated specifically for this 510(k) submission to demonstrate performance.

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 device is a quality control material for hematology analyzers, not a diagnostic imaging or interpretive device that requires human expert opinion for ground truth. The "ground truth" for a quality control material is its expected range of values when tested on specified instruments, which is typically established through extensive internal testing by the manufacturer using validated reference methods and statistical analysis. The document does not mention the involvement of external experts in establishing the ground truth ranges for the control material itself. The performance comparison is against a predicate device, implying that the predicate's established performance serves as a benchmark.

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

Not applicable. As this is a quality control material, there is no "ground truth" established by human adjudication in the traditional sense of diagnostic assessments. Performance is determined by instrumental readings and statistical comparison to established ranges and predicate device performance.

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 control, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

Not applicable. This is a physical control material. The "performance" is its ability to produce expected results on a hematology analyzer, not an algorithm's output.

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

The "ground truth" for a hematology control is its pre-established assayed values and expected ranges for specific parameters (RET%, RET#, IRF, MRV) on designated hematology analyzers. These ranges are determined by the manufacturer through rigorous testing using calibrated instruments and reference methods. The study's aim was to demonstrate that the new control material performs substantially equivalently to the predicate device, meaning its values fall within comparable expected ranges or demonstrate similar precision and stability characteristics.

8. The sample size for the training set

Not applicable. This is a quality control material, not an AI or machine learning model 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." The performance characteristics and expected ranges of the control material are established through internal assay and validation processes by the manufacturer.

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XN CHECK BF is used for control and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:

WBC-BF (103/μl), RBC-BF (10°/μl), MN# (103/μl), PMN# (103/μl), MN% (%), PMN% (%), TC-BF# (103/ul)

XN CHECK™ BF is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s) and stabilized white blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps containing 3 ml. The vials will be packaged in (4) welled vacuum formed clamshell container with the product information sheet / assay sheet. The product must be stored at 2 - 8° C.

The provided document is a 510(k) summary for the Streck XN CHECK™ BF device, which is a hematology quality control mixture. It describes the device, its intended use, and compares it to a predicate device (Cell-Chex Auto-[K053362](https://510k.innolitics.com/search/K053362)). The document also includes information about the tests conducted to establish performance.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

**1. Table of Acceptance Criteria and Reported Device Performance**

The document does not explicitly state quantitative acceptance criteria in a table format for performance metrics. Instead, it makes general statements about the study results. The primary "performance" assessed for this type of device (a quality control mixture) relates to its stability and consistency, and its substantial equivalence to a predicate device.

| Performance Metric          | Acceptance Criteria (Implied)                                    | Reported Device Performance                                    |
|-----------------------------|------------------------------------------------------------------|----------------------------------------------------------------|
| Open-Vial Stability         | Stability for 30 days (matching predicate device)                | "Same" as predicate (30 days)                                  |
| Closed-Vial Stability       | Stability for at least 75 days (matching predicate device)       | 84 days (exceeds predicate's 75 days)                          |
| Precision Performance       | Consistency and reproducibility                                  | "consistently reproducible"                                    |
| Substantial Equivalence     | Performance comparable to the predicate device (Cell-Chex Auto)  | "substantially equivalent to the predicate product"            |
| Safety and Effectiveness    | Device is safe and effective for its intended use                | "XN CHECK™ BF is a safe and effective product, which fulfills its intended use" |

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

The document does not specify the exact sample sizes used for the Open-Vial Stability, Closed-Vial Stability, or Precision Performance tests. It simply states that "The following studies were conducted to establish performance of XN CHECK™ BF."

Data Provenance: Not explicitly stated, but these types of studies for in-vitro diagnostic controls are typically conducted internally by the manufacturer using fresh device samples, often in a laboratory setting. It is not mentioned whether the data is retrospective or prospective, but stability studies inherently involve prospective evaluation over time.

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

This information is not applicable and therefore not provided in the document. For a hematology quality control mixture, "ground truth" isn't established by human expert consensus on interpretations of images or clinical data. Instead, the "truth" is derived from the established values of the control material, measured on high-precision reference instruments or by defined methods. The stability and precision studies would involve comparing measurements over time and across different runs/lots, rather than expert interpretation.

**4. Adjudication Method for the Test Set**

Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in human readings or interpretations, typically in studies involving imaging or clinical diagnosis. This device is a quality control material, and its performance is assessed through quantitative laboratory measurements, not through subjective human interpretation requiring adjudication.

**5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and 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 in-vitro diagnostic control, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC study and a human-in-the-loop comparison with AI assistance are not relevant to its evaluation.

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

Not applicable. This device is a physical quality control material for analyzers, not a software algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this product. Its performance is inherent to its chemical and biological composition and how it performs on specific analyzers.

**7. The Type of Ground Truth Used**

The concept of "ground truth" as typically applied in AI/diagnostic imaging studies (e.g., pathology, clinical outcomes, expert consensus) does not directly apply here. For a quality control material like XN CHECK™ BF, the "ground truth" is established by:

*   **Reference Methodology:** The manufacturing process and characterization of the control material itself, which targets specific analyte concentrations (e.g., WBC-BF, RBC-BF counts).
*   **Assayed Values:** The expected range of values for each parameter (WBC-BF, RBC-BF, etc.) determined through rigorous testing on reference instruments and methods, often by the manufacturer. These assayed values serve as the "true" or target values against which the control material's performance (stability, precision) is measured when run on user instruments.
*   **Comparison to Predicate Device:** Substantial equivalence implies that the performance characteristics (including stability and precision of measurements) are comparable to an already legally marketed and accepted control material, the Cell-Chex™ Auto.

**8. The Sample Size for the Training Set**

Not applicable. This device is not an AI algorithm that requires a "training set" in the conventional machine learning sense. The "training" here would be the manufacturing process and initial characterization of the control material.

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

Not applicable, as there is no "training set" in the context of an AI algorithm. The "truth" for this control material is established through its manufacturing specifications and extensive testing to determine its assayed values and stability characteristics, often using validated laboratory methods and reference instruments.

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XN CHECK is used for control and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:

RBC(108/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F(102/pL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/pL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(103)µL), LYMPH#(103/pL), MONO# (10°/µL), EO#(10°/µL), BASO#(103/pL), IG#(103/pL), RET#(10°/μL), RET%, IRF%, RET-HE(pg), NRBC#(10°/μL), NRBC% (/100 WBC)

XN CHECK™ is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps containing 3 ml. The vials will be packaged in (4) welled vacuum formed clamshell container with the Instructions for Use / assay sheet. The product must be stored at 2 - 8° C.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for performance metrics (like accuracy, sensitivity, specificity, etc.) for the XN CHECK™. Instead, the performance objective was to be "consistently equivalent and effective" to the predicate product. The studies aimed to demonstrate stability (open and closed vial) and overall performance comparable to the predicate.

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

The document does not specify the exact sample size for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It only states that "The following studies were conducted to establish performance of XN CHECK™" and mentions "All testing" for stability. Given the nature of a hematology control product, the "test set" would likely refer to batches of the control material tested against the predicate, rather than patient data.

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

This information is not provided because this type of device (a quality control mixture) does not typically involve human expert interpretation for establishing ground truth in the same way an imaging AI diagnostic might. The ground truth for a control material is typically established through analytical methods and comparisons to a known standard or predicate device.

4. Adjudication Method for the Test Set

Not applicable for this type of device. The evaluation of a hematology control mixture relies on analytical measurements against established values and comparison to a predicate, not expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools that assist human readers (e.g., radiologists, pathologists). The XN CHECK™ is a quality control product, not a diagnostic tool that interacts with human readers in that capacity.

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

The XN CHECK™ is a physical control material, not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance does not apply. Its performance is assessed by how well it maintains its specified parameter values and how consistently it performs across analyzers, similar to a known reference standard.

7. The Type of Ground Truth Used

The ground truth for the XN CHECK™ would be the expected assayed values for each parameter (RBC, HGB, etc.) as determined by the manufacturer, and its performance is evaluated by demonstrating conformance to these expected values and equivalency to the predicate device. The predicate device (e-CHECK (XE)™) itself serves as a reference point for performance comparison.

8. The Sample Size for the Training Set

This product is a physical control material and not an AI algorithm, so the concept of a "training set" in the context of machine learning does not apply. Its manufacturing process and formulation are developed through R&D, and its performance is validated through testing batches of the product, not by training a model on a dataset.

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

Given that this is not an AI algorithm, there is no "training set" or ground truth established in that manner. The "ground truth" for the development of such a control would involve rigorous analytical methods, characterization of its components, and extensive testing to ensure stability and accuracy across different batches and on the target analyzers.

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The R&D Body Fluid-I Control is an assayed hematology control intended to monitor the reliability of hematology instruments that quantitatively measure red and white blood cell counts in cerebrospinal fluids, serous fluids, and synovial fluids.

For in vitro Diagnostic Use Only

The R&D Body Fluid-I is an assayed, in vitro, whole blood control composed of human and bovine cells in a plasma-like fluid with preservatives. Three levels are available and each level of control is packaged in a tube containing 3 mL of the control material. It is sampled in the same manner as a patient specimen.

The provided text describes the R&D Body Fluid-I Hematology Control, an in vitro diagnostic device. This device is a quality control material, not a diagnostic algorithm, and therefore the acceptance criteria and study design elements typically associated with AI/ML-based diagnostic devices (like sample size for test sets, ground truth establishment by experts, MRMC studies, or standalone performance) are not applicable in this context. The study performed is a stability and reproducibility study for a control material, not a clinical study to assess diagnostic accuracy.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "Three lots were tested to verify the closed vial and open vial stability and lot to lot reproducibility." Each lot contained 3 levels of control material. The specific number of individual samples tested per lot/level or the total number of measurements is not explicitly provided.
• Data Provenance: The studies were internal validation studies conducted by R&D Systems, Inc. The data is prospective, generated specifically for these validation tests. The country of origin for the data generation would be the USA, where R&D Systems, Inc. is located.

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

• This question is not applicable as the device is a quality control material, not a diagnostic algorithm. Ground truth, in the sense of a clinical diagnosis or expert-labeled data, is not established for this type of product. The "ground truth" for a control material is its expected target values and ranges, which are determined by the manufacturer through rigorous testing and assaying on reference instruments.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers on diagnostic tasks. This device is a control material, and its performance is assessed against predefined statistical ranges and stability profiles, not through expert consensus on qualitative interpretation.

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 question is not applicable. An MRMC study is designed to evaluate the impact of an AI diagnostic tool on human reader performance. This device is a quality control material and does not involve AI or human interaction in a diagnostic capacity that would necessitate such a study.

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

• This question is not applicable. A standalone performance study evaluates a diagnostic algorithm's accuracy independent of human intervention. The R&D Body Fluid-I Hematology Control is a physical control material, not a software algorithm. Its "performance" is its ability to maintain its assayed values within specified ranges over time and under various conditions.

7. The Type of Ground Truth Used

• The "ground truth" for this device (a hematology control) is its assigned target values and acceptable ranges for red and white blood cell counts. These values are established by the manufacturer through repeated measurements on calibrated reference instruments. The acceptance criteria for stability and reproducibility are defined relative to these established target values and ranges.

8. The Sample Size for the Training Set

• This question is not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• This question is not applicable. As it's not an AI/ML algorithm, there is no training set or associated ground truth in that context.

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