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COULTER® LIN-X Linearity Controls are intended to assess calibration and verify the reportable range of Coulter® Cellular Analysis Systems listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents. Refer to Instructions for Use.

COULTER® LIN-X Linearity Controls are stabilized human blood components whose white blood cells (WBC), red blood cells (RBC), hemoglobin (HGB) and platelets (PLT) concentrations span the instrument's reportable range. Results from repeated measurements for each concentration are compared to the established expected range to assess the instrument's calibration and verify the reportable range.

Here's an analysis of the provided text regarding the COULTER® LIN-X Linearity Control, focusing on acceptance criteria and supporting studies.

Based on the provided K100790 submission for the COULTER® LIN-X Linearity Control, the device is a quality control product, not an AI or diagnostic device that would typically have performance metrics like sensitivity, specificity, or AUC for detecting a condition. Therefore, the acceptance criteria and study designs are geared towards demonstrating the stability and proper assignment of values for a control material, not diagnostic accuracy.

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

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

For a linearity control, acceptance criteria are generally related to the control material maintaining its specified performance characteristics (e.g., stability, assigned values) over its shelf life and under various conditions. The "performance" is that it "demonstrated acceptable results" within those criteria.

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

• Test Set Sample Size: For the stability study, it states "3 lots of Level 6". The specific number of individual measurements or vials tested within those lots is not provided. For the value assignment and range determination process, the text refers to "multiple analysis" but does not give a specific number of samples.
• Data Provenance: The document does not explicitly state the country of origin of the data. Given the manufacturer (Beckman Coulter, Inc.) is based in Miami, Florida, USA, and the submission is to the FDA, it is highly probable the studies were conducted in the USA. The studies are prospective in nature, as they involve testing newly manufactured lots and establishing ranges/stability for a new or modified product.

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)

• For the Range Determination Process, "The expected range for WBC on Level 6 was calculated by a bio-statistician". The specific number of biostatisticians or their qualifications (beyond being a "bio-statistician") are not provided.
• For Value Assignment, the text indicates determination "on validated systems" and confirmation by "multiple analysis," implying internal expert processes rather than external expert consensus studies. No specific number or qualification of experts is listed in the typical sense of a clinical diagnostic study.

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

This type of adjudication method is not applicable to this device. The device is a linearity control, not a diagnostic tool requiring expert review of findings. The "adjudication" (if one could even call it that) comes from internal laboratory processes and statistical analysis by a biostatistician to establish expected ranges and confirm assigned values.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation or complex decision-making, where human performance can be aided by AI). The COULTER® LIN-X Linearity Control is a laboratory quality control product, not a diagnostic or AI-assisted device.

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

No, a standalone algorithm performance study was not done. This device is a biochemical control, not an algorithm or AI system.

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

The "ground truth" for a linearity control is its assigned value and established expected range. This is determined through:

• Validated system measurements: Values are determined on "validated systems" using "specific COULTER reagents."
• Multiple analysis: Assigned values are confirmed by "multiple analysis of the control product."
• Statistical calculation: The expected range is calculated by a "bio-statistician" based on assigned values and expected ranges of other levels.

Essentially, the ground truth here is an empirically and statistically established reference value and range for the control material itself, rather than a clinical ground truth like pathology for a patient sample.

8. The sample size for the training set

This concept is not directly applicable. Linearity controls do not use "training sets" in the machine learning sense. The "training" for such a product involves:

• Manufacturing process control: Ensuring consistent quality of the control material.
• Extensive empirical testing: To establish stability and determine precise assigned values and expected ranges. The document mentions "3 lots" for stability, and "multiple analysis" for value assignment, but doesn't quantify this in terms of a "training set" size.

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

As noted above, there isn't a "training set" in the conventional sense. The "ground truth" (assigned values and expected ranges) for the control is established through:

• Standardized laboratory methods: Using validated instruments and COULTER reagents.
• Repeat measurements: "multiple analysis" confirming assigned values.
• Biostatistical analysis: A biostatistician calculates the expected range based on the empirically determined values and parameters from other known levels of the control. This is a scientific and statistical process for characterizing the properties of the control material itself.

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COULTER LIN-X linearity controls are intended to assess calibration and verify the reportable range of COULTER cellular analysis systems listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents Refer to your Product Manuals or On-Iıne Help System

COULTER LIN-X linearity controls are stabilized human blood components whose WBC, RBC, HGB, and PLT concentrations span the instrument's reportable range Results from repeated measurements for each concentration are compared to the established expected range to assess the instrument's calıbration and verify the reportable range

The provided text is a 510(k) summary for the COULTER® LIN-X Linearity Controls. It does not contain the specific details required to complete all sections of your request regarding acceptance criteria and a study demonstrating device performance. The document generally states that studies were conducted but does not provide the quantitative results or methodologies in detail.

Here's an attempt to answer your questions based on the available information, noting where information is missing:

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

The document states: "Stability, calibration assessment, value assignment and range determination studies were conducted and demonstrate acceptable performance per manufacturing specifications." However, specific acceptance criteria and the numerical results of the reported device performance are not provided in this summary. It only indicates that performance was "acceptable."

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 does not provide information on:

• The sample size used for any test set.
• The data provenance (e.g., country of origin) 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 (e.g. radiologist with 10 years of experience)

The document relates to linearity controls for hematology analyzers, not a diagnostic device requiring expert interpretation for ground truth. Ground truth for linearity controls typically involves reference methods and established ranges. Therefore, this question is not applicable in the context of this device.

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

As this is a linearity control product and not a device requiring human interpretation of results, an adjudication method for a "test set" in the traditional sense is not applicable. The performance is assessed against established ranges and manufacturing specifications.

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 a linearity control product, not an AI-assisted diagnostic device that would involve human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.

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

The device is a control product used to assess the calibration of an analyzer. Its performance is inherent in its chemical and biological properties (stability, assigned values). It is not an algorithm, so a "standalone" algorithm-only performance study in that sense is not applicable. The performance studies likely focused on the control material itself within the context of the analyzer.

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

For linearity controls, the "ground truth" (or "expected results") is typically established through:

• Reference methods: Highly accurate and precise methods, often manual or semi-automated, used to determine the true concentration of analytes (WBC, RBC, HGB, PLT) in each control level.
• Value assignment: Through rigorous testing on multiple calibrated instruments and comparison to reference materials or methods, a consensus true value (or an expected range) is established for each control level over its shelf life.

The document refers to "established expected range" and "manufacturing specifications," implying use of such methods.

8. The sample size for the training set

The document does not provide information on the sample size for any "training set." Linearity controls are not machine learning models that require a training set in the typical sense. Performance is likely validated through extensive manufacturing runs, stability studies, and evaluation on target instruments.

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

As the concept of a "training set" for a linearity control device is not applicable, the establishing of ground truth for such a set is also not applicable.

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