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VALIDATE® Heparin Calibration Verification / Linearity Test Kit solutions are assayed quality control materials intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for Heparin Anti-Xa activity on automated instruments in a clinical laboratory setting by laboratory personnel. The product is intended for use on the IL ACL TOP® analyzer.

Each VALIDATE® Heparin Calibration Verification / Linearity Test Kit contains one analyte set of Heparin in a human plasma base matrix. The kit includes a set containing five liquid levels, 3.0 mL each. The set is provided to establish the relationship between theoretical and actual performance of Heparin Anti-X activity. Material of human origin used in the manufacture of this test kit was tested at the donor level using FDA approved methods and was found to be non-reactive for HBsAG and to antibodies to HCV and HIV-1/2.

The provided text describes the performance data for the VALIDATE® Heparin Calibration Verification / Linearity Test Kit. Here's a breakdown of the acceptance criteria and study details based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state the numerical acceptance criteria for linearity, precision, or reproducibility in a table format. However, it indicates qualitative acceptance.

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

• Precision Test: 80 replicates per kit level (5 levels, so 5 * 80 = 400 total replicates for precision across three lots of the VALIDATE® Heparin product).
• Reproducibility Test: 75 replicates per kit level (5 levels, so 5 * 75 = 375 total replicates for reproducibility for one lot of the VALIDATE® Heparin product).
• Stability Test: Four product lots were tested. The number of replicates per time point is not specified, but time points included "date of manufacture (DOM), followed by testing at specific intervals post manufacture."
• Freeze-thaw/open vial stress stability assessment: Not specified, but involved testing "All product levels."
• Data Provenance: The document states "All supporting data is retained on file at Maine Standards Company LLC." This suggests the data was generated internally by Maine Standards Company LLC. It is a prospective study as the testing was conducted to evaluate the performance of the new device. The country of origin is implicitly the USA (Maine Standards Company LLC is located in Maine, USA).

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

Not applicable. This device is an in vitro diagnostic (IVD) calibration verification/linearity test kit, not a device that relies on expert interpretation of results. Its performance is measured against established analytical targets and statistical criteria like CV% (Coefficient of Variation).

4. Adjudication Method for the Test Set

Not applicable. The performance is assessed based on quantitative measurements and meeting predefined statistical criteria (e.g., CV% limits, recovery percentages). There is no "ground truth" established through expert consensus requiring adjudication.

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 typically performed for diagnostic imaging devices where multiple human readers interpret cases, and their performance with and without AI assistance is compared. This device is an IVD calibration product.

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

The device itself is a test kit used on an automated instrument (IL ACL TOP 500® analyzer). Its "performance" is inherently standalone in that it is a measurement tool. The studies described (precision, reproducibility, linearity, stability) evaluate the performance of the physical test kit itself when run on the specified automated instrument without direct human interpretation of the analytical results beyond operating the instrument and collecting data.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Known concentrations: Levels 1 and 5 are prepared independently, and intermediate levels are prepared by equal part dilutions following CLSI EP6-A guidelines, establishing a known linear relationship and target concentrations.
• Reference Standards: The VALIDATE® Heparin kit is traceable through the IL HemosIL® calibrator to the 5th International WHO Standard 97/578 for UF heparin and the 2nd International WHO Standard 01/608 for LMW heparin. This establishes a "gold standard" for the analyte measurement.
• Statistical Performance Metrics: Meeting specified CV% acceptance criteria quantifies the precision and reproducibility against statistical norms.
• Recovery Targets: For stability, acceptance criteria are defined as 90 to 110% of the Date of Manufacture (DOM) value.

8. The Sample Size for the Training Set

Not applicable. This device is an IVD calibration verification/linearity test kit, not an AI/ML algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of medical device.

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VALIDATE® Anemia Calibration Verification/Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range for the following analytes: Ferritin Set: ferritin (FERR), Vitamin B12(VITB) and folate (FOL), on automated instrument systems. The product is intended for use with quantitative assays on the indicated analyzers specified in the labeling.

Each VALIDATE® Anemia Calibration Verification / Linearity Test Kit contains two analyte sets of purified chemicals in a human serum base. The kit includes a Ferritin set containing five liguid levels, 3.0mL each, and a Vitamin B12/Folate set containing five liquid levels, 4.0 mL each. The sets are provided to establish the relationship between theoretical and actual performance of the included analytes: Ferritin, Vitamin B12 and Folate. Material of human origin used in the manufacture of this test kit was tested at the donor level using FDA approved methods and was found to be non-reactive for HBsAG and to antibodies to HCV and HIV-1/2.

The provided text describes the performance data for the VALIDATE® Anemia Calibration Verification/Linearity Test Kit. This product is a quality control material, not a device that directly measures a patient's condition or relies on AI. Therefore, the common acceptance criteria and study designs typically associated with AI-powered medical devices (such as sensitivity, specificity, MRMC studies, and ground truth established by experts for a test set) are not applicable here.

Instead, the acceptance criteria and study detailed focus on the technical performance of the calibration verification/linearity kit itself, to ensure it provides accurate and linear results when used with automated instrument systems.

Here's an analysis based on the information provided, reinterpreting some categories to fit the context of a calibration verification kit:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The number of individual test kit units or measurements used for "value assignment" and "stability" testing is not explicitly stated as a numerical sample size. It refers to testing on "Levels 1 through 5" of the kit. For stability, testing was done at "date of manufacture (DOM), followed by testing at specific intervals post manufacture" and "one month post-expiration." Freeze/thaw stability was assessed for "four (4) freeze/thaw events claim" and tested after "6 freeze/thaw events."
• Data Provenance: The studies were conducted internally by Maine Standards Company LLC. The text does not specify the country of origin of the raw data, but the company is based in the US. The studies appear to be prospective to validate the manufacturing and stability of the product.

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

This question is not directly applicable in the typical sense of expert review for medical imaging or diagnostic algorithms. For this device, the "ground truth" or reference values are established by the manufacturing process itself:

• "Levels 1 and 5 are prepared independently by the addition of Ferritin, Vitamin B12 and Folate to a human serum base."
• "Intermediate 2, 3, and 4 are subsequently prepared from Levels 1 and 5 by equal part dilutions following EP6-A guidelines."
• The actual "ground truth" for the performance evaluation is the predetermined theoretical concentrations that the calibration verification kit levels should represent based on their formulation. The device's performance is then measured by how well instruments recover these known concentrations and demonstrate linearity.

There's no mention of external experts adjudicating results for the test set.

4. Adjudication Method for the Test Set:

Not applicable in the conventional sense. The test results are compared against internal, pre-determined acceptance criteria based on the known composition and expected behavior of the calibration verification material, and adherence to CLSI EP6-A guidelines.

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 is a quality control material intended for instrument calibration and linearity verification, not a diagnostic device that assists human readers.

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

Not applicable. This device is used by automated analytical instruments (Roche Cobas, Beckman Access) to verify their performance. Its "standalone" performance means its inherent accuracy in representing known concentrations, which is what the "Value Assignment" and "Linearity" sections address. The analytical instruments are the "algorithm" in this context, and this device checks their accuracy.

7. The Type of Ground Truth Used:

The ground truth is based on:

• Known concentrations: The product is manufactured with specific, known concentrations of analytes (Ferritin, B12, Folate) at Levels 1 and 5.
• Dilution principles: Intermediate levels (2, 3, 4) are prepared by precise dilutions from Levels 1 and 5, following CLSI EP6-A guidelines, establishing their theoretical concentrations.
• Reference Standards: The product is described as "traceable to a reference standard based on the automated instrument platform it is used on." This implies a higher-level standard (e.g., NIST traceable or other internationally recognized standards) against which the instrument's calibrators are established, and by extension, this product helps verify that performance.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a "training set." The product is a manufactured reagent with a defined chemical composition.

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

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

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VALIDATE® GC3 Calibration Verification / Linearity Test Kit is intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range. See the package insert for the list of all analytes claimed.

Each VALIDATE® GC 3 Calibration Verification / Linearity Test Kit contains purified chemicals in a human serum albumin base. Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes.

This document is a 510(k) summary for the VALIDATE® GC3 Calibration Verification / Linearity Test Kit. It focuses on establishing substantial equivalence to a predicate device, rather than providing details of a standalone study for performance. Therefore, many of the requested data points related to a specific study design (e.g., sample sizes for test/training sets, expert consensus, MRMC studies) are not present.

However, I can extract the available information and state where the requested details are not provided within this document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria or device performance in the format typically seen for a new medical device study with specific metrics like sensitivity, specificity, or AUC. Instead, it states that the device behaves in a manner suitable for its intended use and is "as safe, as effective, and perform as well as or better than the predicate device." This indicates the acceptance criterion was likely substantial equivalence to the predicate device based on its performance characteristics for linearity, calibration verification, and reportable range verification.

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

This document does not provide details on the specific sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The determination of substantial equivalence likely involved internal testing and comparison with the predicate device's established performance, rather than a clinical trial with a defined test set of patient samples.

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

Not applicable. This device is a quality control material intended to verify the performance of other in vitro diagnostic devices. Its "ground truth" relates to its chemical composition and its expected behavior on a diagnostic instrument, rather than clinical interpretation by experts.

4. Adjudication method for the test set

Not applicable, as no external test set requiring expert adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a quality control material, not an AI-powered diagnostic tool, and therefore MRMC studies or human reader improvement with AI assistance are not relevant.

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

A "standalone" performance evaluation was effectively done in the context of comparing the new device's performance to the predicate. The device's performance (its ability to demonstrate linearity, verify calibration, and define reportable range) was measured directly on analytical instruments, independent of human interpretation of complex images or data. The summary statement "The VALIDATE® GC3 Calibration Verification / Linearity Test Kits behave in a manner suitable for the evaluation of calibration, verification of reportable range, and the linear response of the listed analytes over the ranges tested when compared to the predicate device" serves as the high-level conclusion of this evaluation. Specific methods and results (e.g., linearity plots, statistical comparisons) would typically be found in the full 510(k) submission, not in this summary.

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

The "ground truth" for this type of device (calibration verification/linearity test kit) is based on:

• Chemical composition and known analyte concentrations: The kit contains purified chemicals at specific, known concentrations across multiple levels. These concentrations are the "ground truth" against which the instrument's measurements are challenged to verify linearity and calibration.
• Predicate device's established performance: The new device's performance is compared to a legally marketed predicate device, with the predicate's established performance serving as a benchmark for "ground truth" in the context of substantial equivalence.

8. The sample size for the training set

Not applicable. This device is a ready-to-use quality control material, not an algorithm that requires a training set.

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

Not applicable.

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