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VALIDATE® D-Dimer Calibration Verification / Linearity Test Kit solutions are assayed quality control materials intended for in vitro diagnostic use in the quantitative determination verification verification and verification of reportable range for the following analyte: D-Dimer in a clinical laboratory personnel. The product is intended for use with quantitative assays on the indicated analyzers specified in the labeling.

Each VALIDATE® D-Dimer Calibration Verification / Linearity Test Kit contains one analyte set of D-Dimer 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 the included analyte D-Dimer. 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 a 510(k) premarket notification for an in vitro diagnostic device, the VALIDATE® D-Dimer Calibration Verification / Linearity Test Kit. This document does not pertain to an AI/ML medical device, but rather to a quality control material used for calibrating laboratory instruments.

Therefore, many of the requested criteria for describing an AI/ML device's acceptance criteria and study proving its performance (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this document.

However, I can extract information related to the device's performance validation as presented in the document:

Acceptance Criteria and Device Performance (for a Calibration Verification/Linearity Test Kit - Not an AI/ML Device)

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance in terms of precision/reproducibility and linearity, rather than typical AI metrics like sensitivity, specificity, or AUC. The "acceptance criteria" are implied by the statements that "All levels of the VALIDATE® D-Dimer kit met the CV% acceptance criteria on the Siemens CS-2500 instrument system." and that linearity testing was carried out. Specific numerical acceptance criteria for CV% are not explicitly stated in the provided text.

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

• Precision/Reproducibility Study:

  • Sample Size (Replicates): 80 replicates per kit level for precision study; 75 replicates per kit level for reproducibility study.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be from internal lab testing ("on the Siemens Sysmex CS-2500 instrument system" at "multi-site" for reproducibility). The studies are prospective in nature, as they involve active testing of the device.

• Linearity Study:

  • Sample Size: Not explicitly stated in terms of number of runs or replicates, beyond "Linearity testing was carried out."
  • Data Provenance: Internal lab testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This is a quality control material for an in vitro diagnostic test, not an AI/ML device that requires human expert annotation for ground truth. The "ground truth" (or target values) for this device is based on its intended concentration levels (Levels 1 through 5) and the expected linear relationship between them.

4. Adjudication Method for the Test Set

• Not applicable. No human interpretation or qualitative assessment requiring adjudication is described.

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

• No. This type of study is relevant for AI/ML devices that assist human readers in image interpretation or similar tasks. This device is a quantitative control material.

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

• Not applicable. This is a physical kit used to verify instrument performance, not a standalone algorithm. Its "performance" is its ability to reproducibly produce expected values and demonstrate linearity when run on an instrument.

7. The Type of Ground Truth Used

• Internal Reference Standard / Expected Values: The "ground truth" for this device revolves around the predetermined concentrations of D-Dimer in each level (1-5) and their designed linear relationship.
  • Level 1 and 5 are prepared independently with D-Dimer added to a human plasma base.
  • Levels 2, 3, and 4 are subsequently prepared from Levels 1 and 5 by equal part dilutions following CLSI EP6-A guidelines.
  • "Typical recovery values" are established by testing 30 replicates of Levels 1 and 5.
  • The device is traceable to the instrument's (Siemens Sysmex CS-2500) calibrator curve (Innovance® reagent calibrator).

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML model that undergoes "training" in the computational sense. Its formulation and design are based on established laboratory quality control guidelines (e.g., CLSI EP6-A).

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

• Not applicable. See point 8. The "ground truth" for the development of the kit (i.e., establishing the target values and linearity across levels) is described by:
  • Independent preparation of Levels 1 and 5.
  • Subsequent preparation of Levels 2, 3, and 4 via equal part dilutions from Levels 1 and 5.
  • Determination of "typical value ranges" and "typical recovery values" for Levels 1 and 5 through 30 replicates of testing.
  • Adherence to CLSI EP6-A guidelines for linearity.

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VALIDATE® D-Dimer 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 the following analyte: D-Dimer in a clinical laboratory setting by laboratory personnel. The product is intended for use with quantitative assays on the indicated analyzers specified in the labeling.

Each VALIDATE® D-Dimer Calibration Verification / Linearity Test Kit contains one analyte set of D-Dimer in a human plasma base matrix. The kit includes a set containing five liguid levels. 3.0 mL each. The set is provided to establish the relationship between theoretical and actual performance of the included analyte D-Dimer. 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 document describes the FDA 510(k) summary for the VALIDATE® D-Dimer Calibration Verification / Linearity Test Kit (K162705). This device is an assayed quality control material, not an AI-powered diagnostic device. Therefore, the specific questions related to AI performance, such as multi-reader multi-case studies, human reader improvement with AI assistance, and AI-specific ground truth, are not directly applicable.

However, I can extract information related to the acceptance criteria and the studies performed for this device based on the provided text.

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this device, a calibration verification/linearity test kit, is its ability to demonstrate linearity between specified levels and to perform consistently with a predicate device. The performance is primarily evaluated through precision/reproducibility studies and linearity testing.

Table 1: Acceptance Criteria (Implicit) and Reported Performance

Study Details:

2. Sample sizes used for the test set and the data provenance:

• Precision Study (Test Set 1):
  • Sample Size: 80 replicates per kit level (for Levels 1 through 5). Total 400 replicates (5 levels * 80 reps).
  • Methodology: 3 lots of devices, 1 lot of reagent and quality controls, tested over 20 days, 2 runs per day, 2 replicates per run.
  • Provenance: Data appears to be prospective, collected specifically for this submission. Country of origin is not explicitly stated but implied to be within the US given the submission to the FDA. The testing was done on a Stago STA-R® Evolution instrument system.
• Reproducibility Study (Test Set 2):
  • Sample Size: 75 replicates per kit level (for Levels 1 through 5). Total 375 replicates (5 levels * 75 reps).
  • Methodology: 1 lot of device, 1 lot of reagent and quality controls, tested on 3 instruments, multi-site, over 5 days, 1 run per day, 5 replicates per run.
  • Provenance: Data appears to be prospective, collected specifically for this submission. Multi-site indicates varied data sources geographically, likely within the US. The testing was done on a Stago STA® instrument system.
• Value Assignment (Levels 1 & 5) (Test Set 3):
  • Sample Size: 30 replicates for Level 1 and Level 5.
  • Methodology: Testing was performed to establish typical recovery values.
  • Provenance: Not explicitly stated, but part of the manufacturing and quality control process.

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 quantitative control material for D-Dimer, not an AI or diagnostic imaging device that requires human expert interpretation for ground truth. The "ground truth" for this device's performance is its measured concentration and its linearity, verified against instrument performance and established industry standards (e.g., CLSI EP6-A).

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

• Not Applicable: As this is a quantitative control material, there is no subjective interpretation requiring adjudication by experts. The "adjudication" is based on objective statistical analysis (e.g., CV% calculation) of the measured 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:

• Not Applicable: This device is not an AI-powered diagnostic system. It is a calibration and linearity verification kit.

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

• Not Applicable: This device does not involve an algorithm being tested in a standalone capacity. Its performance is intrinsically tied to human laboratory personnel using it on an analytical instrument.

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

• The "ground truth" for this device essentially comes from:
  • Expected Quantitative Values: The known, manufactured concentrations of D-Dimer at each level (Levels 1 and 5 prepared independently, Levels 2, 3, and 4 derived from equal part dilutions).
  • Industry Standards: Adherence to guidelines like CLSI EP6-A for linearity and calibration verification.
  • Instrument Reference Standard: Traceability to the Stago LiaTest calibrator on the Stago STA-R® Evolution instrument system.

8. The sample size for the training set:

• Not Applicable in the context of machine learning model training. For a calibration verification kit, the concept of a "training set" doesn't apply in the same way. The device's characteristics are designed and controlled during manufacturing based on established analytical chemistry principles and instrument performance specifications.

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

• Not Applicable in the context of machine learning. The "ground truth" for the various levels of the calibration kit is established during its manufacturing process. Levels 1 and 5 are prepared independently by adding D-Dimer to a human plasma base matrix to target specific concentrations. Levels 2, 3, and 4 are then prepared from these by equal part dilutions according to EP6-A guidelines, ensuring a known linear relationship (equal delta) between all five levels. This forms the basis of the expected "truth" for validating linearity and calibration on user instruments.

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VALIDATE® D-Dimer Calibration Verification / Linearity Test Kit solutions are an assayed quality control materials intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analyte: D-Dimer in a clinical laboratory setting by laboratory personnel. The product is intended for use with quantitative assays on the indicated analyzers specified in the labeling.

Each VALIDATE® D-Dimer Calibration Verification / Linearity Test Kit contains one analyte set of D-Dimer 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 the included analyte D-Dimer. 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 document describes the VALIDATE® D-Dimer Calibration Verification / Linearity Test Kit, an in vitro diagnostic device. Here's an analysis of its acceptance criteria and the study proving it:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily focused on the precision/reproducibility and linearity of the device when used with specific instrumentation (IL TOP® instrument system).

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

• Precision Test Set:
  • Sample Size: Eighty (80) replicates per kit level (for each of 5 levels). This means 5 levels * 80 replicates/level = 400 data points.
  • Data Provenance: Not explicitly stated as retrospective or prospective, but the description of "tested over 20 days, 2 runs per day, 2 replicates per run" implies a prospective study. The data was generated using the VALIDATE® D-Dimer product, IL system HemosIL D-Dimer reagent, and TOP® instrument system.
• Reproducibility Test Set:
  • Sample Size: Seventy-five (75) replicates per kit level (for each of 5 levels). This means 5 levels * 75 replicates/level = 375 data points.
  • Data Provenance: Not explicitly stated as retrospective or prospective, but "tested over 5 days, with 1 run per day of Level 1-5, 5 replicates per run" implies a prospective study. Data was generated on three instruments, multi-site.
• Stability Test Set:
  • Sample Size: Not explicitly stated, but includes "three lots" for both real-time shelf life and freeze-thaw studies.
  • Data Provenance: Prospective ("study testing time points included date of manufacture (DOM), followed by testing at specific intervals post manufacture" and "Real time stability studies are ongoing").

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

Not applicable. This device is a calibration verification/linearity test kit, designed to verify the performance of an instrument, not to make a diagnostic interpretation requiring expert human judgment for a "ground truth" diagnosis. The "ground truth" in this context is the known, expected relationship (linearity and target recovery values) between the different levels of the kit, established by the manufacturer's formulation and scientific principles of dilution (EP6-A guidelines).

4. Adjudication Method for the Test Set

Not applicable, as human expert adjudication for diagnostic interpretation is not relevant for this type of device and its performance studies. The "adjudication" is based on predefined statistical acceptance criteria (e.g., %CV, % recovery range) applied to quantitative measurements.

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 devices where human readers interpret medical images or data, and AI assistance is evaluated for its impact on reader performance. This device is a quality control material for an automated instrument.

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

Yes, the performance studies (precision, reproducibility, linearity, stability) represent standalone performance of the device (test kit) when used with the specified automated instrument system. The device itself is not an "algorithm" in the typical sense of AI, but a reagent system. The studies demonstrate the performance of the kit on the instrument without human interpretive intervention beyond setting up the tests and reviewing the quantitative output.

7. The Type of Ground Truth Used

The ground truth used is based on:

• Known Concentration Relationships: The manufacturer states, "VALIDATE® D-Dimer Calibration Verification / Linearity Test Kits are manufactured such that an equal relationship exists among Levels 1 through 5; Level 1 being the lowest concentration and Level 5 being the highest." And, "Specific recovery targets for Levels 1 through 5 are determined by the upper and lower detection limits for D-Dimer. Intermediate Levels 2, 3, and 4 are subsequently prepared from Levels 1 and 5 by equal part dilutions following EP6-A guidelines."
• CLSI EP6-A guidelines: This clinical laboratory standard provides guidance on evaluating the linearity of quantitative measurement procedures, which is the basis for establishing the expected linear relationship.
• Established Target Ranges: For stability, acceptance criteria are defined as 90 to 110% of the date of manufacture (DOM) value, with DOM values themselves being established through rigorous testing.

8. The Sample Size for the Training Set

Not applicable. This device is a calibration verification/linearity test kit, not an AI or machine learning algorithm that requires a "training set." The product is manufactured to known specifications and then its performance is verified through testing.

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

Not applicable, as there is no "training set" for this type of device. The ground truth for the device's inherent design and expected performance is established through controlled manufacturing processes, gravimetric/volumetric preparation, and adherence to accepted laboratory standards like CLSI EP6-A for linearity.

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VALIDATE® FERRITIN Calibration Verfication / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analyte, ferntin, on automated instrument systems. The product is intended for use with quantitative assays on the indicated analyzers specified in the labeling.

Each VALIDATE® FERRITIN Calibration Verfication / Linearity Test Kit contains purfied chemicals in a human serum base. Five Iliguit Invelos, 3.0mL each, ranging from 0.5.to.2000 ng/mL typical values, are provided to establish the relationship between theoretical and actual performance of the included analyte ferritin. 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the VALIDATE® FERRITIN Calibration Verification / Linearity Test Kit:

Acceptance Criteria and Device Performance

Device Study Information:

1. Sample size used for the test set and the data provenance:

   • Test Set Size: Not explicitly stated as a numerical sample size in terms of unique patient samples. The "test set" in this context refers to the five liquid levels (0.5 to 2000 ng/mL typical values) of the VALIDATE® FERRITIN Calibration Verification / Linearity Test Kit itself. These levels are tested on different instruments and over time.
   • Data Provenance: The study was conducted by Maine Standards Company LLC. It involved stability testing (real-time and freeze/thaw) and linearity testing using representative instruments (Beckman Coulter Access II and Roche COBAS 6000). The materials are "purified chemicals in a human serum base." The exact country of origin for the human serum base is not specified, but the submitter is a US company (Maine Standards Company LLC, Cumberland Foreside, ME). The studies appear to be prospective as they involved testing at specific intervals post-manufacture and over a period of 431 days for linearity.

2. 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 and calibration verification kit. Its "ground truth" is established by the known concentrations of ferritin in each of the five levels, manufactured to have an "equal relationship" among them. Expert adjudication of individual results is not part of this type of study. The concentrations are determined by the manufacturing process and validated against instrument performance.

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

   • Not applicable, as expert adjudication is not relevant for this type of device. The performance is assessed against predefined statistical criteria (e.g., 90-110% recovery) based on the known values of the control material.

4. 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 an in-vitro diagnostic quality control product, not an AI-assisted diagnostic tool that involves human readers.

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

   • Not applicable. This device is a physical calibration verificaion/linearity solution, not a software algorithm. Its performance is evaluated on automated instrument systems directly.

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

   • The "ground truth" for this device is based on pre-defined, manufactured concentrations of ferritin in the different levels of the kit. Level 1 and 5 are "prepared independently by the addition of ferritin to a human serum base," and intermediate levels (2, 3, 4) are prepared by equal part dilutions. The "known relationship between each of the levels of the product (in this case equal deltas as outlined in the CLSI EP6A referenced standard)" serves as the basis for evaluating linearity and calibration verification.

7. 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 manufactured to specific specifications.

8. 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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