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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® 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® 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® 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® 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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VALIDATE PSA Calibration Verification / 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 analytes: Total prostate-specific antigen (PSA) and free prostate-specific antigen (fPSA) on automated systems.

Quality control material (assayed and un-assayed)*
Each VALIDATE® PSA Calibration / Linearity Test Kit contains purified chemicals in a human serum base. Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes.

This document describes the VALIDATE® PSA Calibration Verification / Linearity Test Kit, a device intended for in vitro diagnostic use to verify calibration and linearity of automated systems for measuring Total Prostate-Specific Antigen (PSA) and free Prostate-Specific Antigen (fPSA).

Here's an analysis of the provided information relating to acceptance criteria and the study:

Acceptance Criteria and Device Performance

The provided document describes the device as behaving "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." However, specific numerical acceptance criteria (e.g., % bias, correlation coefficients, or specific ranges of linearity) are not explicitly stated in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed quantitative acceptance criteria for its own performance.

Therefore, the table below reflects what can be inferred.

Study Details

The provided text is a 510(k) summary, which often focuses on demonstrating substantial equivalence rather than providing a detailed study report. As such, many of the requested details about the study are not explicitly present in the provided document.

Here's what can be extracted or inferred:

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

   • Sample Size: Not explicitly stated. The description mentions "Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes." This suggests that a series of concentrations were tested, but the number of replicates or distinct samples is not specified.
   • Data Provenance: Not explicitly stated, but given that it's a submission to the FDA by a US company (Maine Standards Company), it implies the study was likely conducted with data relevant to the U.S. market. The study is retrospective in the sense that the results were generated and then submitted to the FDA.

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

   • Not applicable / Not stated. For calibration verification kits, "ground truth" is typically established by the known concentrations of the analytes in the manufactured control materials, rather than expert interpretation of a biological sample. The accuracy of these known concentrations would be verified through reference methods and quality control procedures during manufacturing.

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

   • Not applicable / Not stated. Adjudication methods are typically relevant for studies where subjective interpretation (e.g., medical imaging) forms the basis of ground truth. For a linearity/calibration verification kit, the assessment is based on quantifiable measurements against expected values.

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:

   • No. This type of study is completely irrelevant for a calibration verification/linearity test kit. MRMC studies are used for evaluating diagnostic aids, often involving human interpretation of images or other data with and without AI assistance. This device is a quality control material.

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

   • Not applicable / Not stated in these terms. The "performance" of this device is its inherent chemical and physical stability and its ability to provide accurate and linear responses across different analytes when measured by automated systems. The study likely involves running the kit on various automated systems and comparing the results to expected values and to the predicate device's performance. It's an "algorithm only" in the sense that the automated systems are the "algorithms" that process the kit, but the kit itself isn't an algorithm.

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

   • The "ground truth" for this type of device is the assigned target values/concentrations for each analyte at each level of the kit, established during the manufacturing process through precise analytical methods and verified against reference standards (e.g., gravimetric measurements, certified reference materials).

7. The sample size for the training set:

   • Not applicable / Not stated. This device is not an AI algorithm that requires a "training set." It is a physical chemical product.

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

   • Not applicable / Not stated. As above, it's not an AI algorithm requiring a training set. The "ground truth" for the device's performance is tied to the manufacturing and characterization of the control material itself.

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VALIDATE® VIT D 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 analyte: total 25 (OH) vitamin D (VIT D).

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

I am sorry, but the provided text does not contain the detailed information needed to answer your request about the acceptance criteria and study proving the device meets them.

The document is a 510(k) summary for the VALIDATE® VIT D Calibration Verification / Linearity Test Kit. It describes the device, its intended use, and states that it is "as safe and effective as the predicate device." However, it does not include the following crucial information that you asked for:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Information on a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

This document serves as a regulatory submission indicating substantial equivalence to a predicate device, rather than a detailed scientific study report outlining performance metrics against specific acceptance criteria.

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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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The MSC Lipid Control is intended for use as an assayed quality control material to monitor the ongoing precision of clinical laboratory systems for the following analytes: High-density Lipoprotein Cholesterol (HDL-C), Low-density Lipoprotein Cholesterol (LDL-C), Total Cholesterol (CHOL), Triglycerides (TRIG), Apolipoprotein AI (Apo AI), and Apolipoprotein B (Apo B), on instruments listed in the value sheet.

The MSC Lipid Control is a human serum based liquid quality control containing stabilized HDL-C, LDL-C, CHOL, TRIG, Apo AI, and Apo B of human origin.

The provided text describes a 510(k) summary for the "MSC Lipid Control" device, which is a quality control material. It details the device's intended use and substantial equivalence to predicate devices. However, the text does not contain information about acceptance criteria, a specific study design to prove device performance against acceptance criteria, or any details related to AI/algorithm performance.

Therefore, I cannot fulfill your request for the following sections based on the provided input:

1. A table of acceptance criteria and the reported device performance (Not provided in the text)
2. Sample sized used for the test set and the data provenance (Not applicable, as this is a quality control material, not an AI/diagnostic device with a test set in that context. The text also does not provide details on specific testing methodology for establishing equivalence beyond general statements.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (Not applicable/provided)
4. Adjudication method (Not applicable/provided)
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, as this is not an AI/diagnostic device)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (Not applicable, as this is not an AI/algorithm)
7. The type of ground truth used (Not applicable/provided)
8. The sample size for the training set (Not applicable, as this is not an AI/algorithm)
9. How the ground truth for the training set was established (Not applicable, as this is not an AI/algorithm)

The provided documentation is for a Class I medical device (quality control material), whose approval is based on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than explicit acceptance criteria demonstrated through a detailed clinical or performance study as would be expected for a diagnostic or AI-driven device. The equivalence for this type of device is typically established through analytical performance (e.g., stability, homogeneity, assigned values) relative to the predicate, but specific details of such studies are not provided in this 510(k) summary. The summary states that "the performance of MSC Lipid Control is substantially equivalent in form and function to the predicate devices for its stated intended use." This is the general "proof" for this type of submission.

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