Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The George King Coumadin® Plasma is an assayed control plasma derived from a single donor on Coumadin® therapy and is intended for in vitro diagnostic use in monitoring the accuracy of the coagulation analyzer and thromboplastin using the clottable prothrombin time/INR on an optical instrument with appropriate commercial reagents. George King Coumadin® Plasma may be used when evaluating a new lot of thromboplastin reagent or new coagulation analyzer.

Each lot of George King Coumadin® Plasma is from a single human donor stabilized on at least 6-weeks of Coumadin® therapy. The donor plasma is obtained via plasmapheresis using 4.0% sodium citrate and frozen immediately at -70°C.

The INR of the donor plasma is determined using the ACL Top 500 using RecombiPlastin 2G and each plasma is then categorized into one of the three INR levels of control material based on the testing results obtained using the following INR calculation: INR = (Patient PT / Mean of normal range) ISI.

Level 1 - INR Control: 1.5-2.8
Level 2 - INR Control: 2.9-4.0
Level 3 - INR Control: >4.0

The George King Coumadin® Plasma is an assayed control plasma for in vitro diagnostic use in monitoring the accuracy of coagulation analyzers and thromboplastin using the clottable prothrombin time/INR.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Precision Study: For each of the three INR ranges, three different lots of GK Coumadin® Plasma were tested. For each lot, 80 replicates (n=80) were analyzed (20 days with 2 runs per day and 2 replicates per run). The study was conducted in-house. Data provenance is therefore in-house, prospective testing.
• Reproducibility Study: For each of the three INR ranges, three different lots were tested. For each lot, samples were assayed for 5 days, one run per day, for a total of N=75 samples. This study was performed across three different clinical laboratories, implying prospective, external data, presumably from the US.
• Stability Studies: Three lots of GK Coumadin® Plasma were used for both open vial and shelf-life stability studies. Data provenance is in-house, prospective testing.

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

This information is not provided in the document. The studies conducted are analytical performance studies (precision, reproducibility, stability) for a control plasma, not diagnostic accuracy studies that rely on expert ground truth. The "ground truth" here is the measured INR or Prothrombin Time value.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are analytical performance studies of a control material and do not involve human diagnostic interpretation or adjudication of results.

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

No, a Multi-Reader Multi-Case (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. The George King Coumadin® Plasma is a control material for laboratory instruments.

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

Yes, the studies presented (precision, reproducibility, stability) evaluate the performance of the device (George King Coumadin® Plasma) in a standalone manner, as measured by laboratory instruments (ACL TOP series) using specified reagents (RecombiPlastin 2G). There is no "human-in-the-loop" component being evaluated for the performance of the device itself; rather, it is a control used to monitor the accuracy of an instrument.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance studies is the measured INR and Prothrombin Time values obtained from the specified laboratory instruments and reagents. For the initial categorization of donor plasma into INR levels, the INR was determined using the ACL Top 500 and RecombiPlastin 2G.

8. The Sample Size for the Training Set

There is no explicit mention of a separate "training set" in the provided document. The development of a control plasma does not typically involve a machine learning algorithm that is trained on a dataset. The document describes the manufacturing and analytical validation of a control material.

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

As there is no explicit training set mentioned for an algorithm, the concept of "ground truth for the training set" is not applicable in the context of this device. The INR of the donor plasma is determined by standard laboratory methods using a calibrated instrument for categorization into control levels.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended "For In Vitro Diagnostic Use".

The VisuCon-F Low Fibrinogen Control plasma is a pool of de-fibrinated citrated human plasma buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.

The provided text describes a 510(k) premarket notification for a medical device called "VisuCon-F Low Fibrinogen Control Plasma." This document is a regulatory submission to the FDA (Food and Drug Administration) for a Class II medical device.

The core of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials. Therefore, the information provided focuses on the comparison to a predicate device and performance characteristics that support this equivalence, rather than a classical study design with acceptance criteria for a novel AI/imaging device.

Because the request asks for specific details relating to AI/imaging device acceptance criteria and study methodology (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance), it's important to note that the provided document does not contain this type of information. This document is for an in-vitro diagnostic control plasma, not an imaging or AI diagnostic device.

However, I will extract the information that is present in the document and clearly state when the requested information is not available or not applicable based on the document's content.

Here's a breakdown based on the provided text:

Device Description and Intended Use:

• Trade/Device Name: VisuCon-F Low Fibrinogen Control Plasma
• Regulation Number: 21 CFR 864.5425
• Regulation Name: Multipurpose system for in vitro coagulation studies
• Regulatory Class: Class II
• Product Code: GGN
• Predicate Device: Cryocheck Low Fibrinogen Control Plasma (Precision Biologic Inc.)
• Device Description: A pool of de-fibrinated citrated human plasma buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
• Device Intended Use: An assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. It may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. Intended for "In Vitro Diagnostic Use" by trained laboratory personnel in clinical laboratories.

Acceptance Criteria and Device Performance (based on comparison to Predicate):

The document details a "technical comparison" to the predicate device to demonstrate substantial equivalence, rather than defining explicit acceptance criteria in the sense of a target performance threshold for a new AI/imaging algorithm. The study proves the device meets the criteria by exhibiting similar characteristics and performance ("precision") to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are implied by the characteristics and performance of the chosen predicate device, as the goal is to show equivalence, not superiority or meeting an arbitrary threshold. The "study" described is the "technical comparison" presented in the table.

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

• Sample Size for Test Set: The document reports precision data for the proposed device (VisuCon-F Low Fibrinogen Control Plasma) as: Within Run = 3.15%, Between Day = 0.54%, Between Run = 0%, Within Device = 8.44%. It also states the predicate's precision as 2.8 - 3.7% (n=36). However, the specific sample size (N) for the VisuCon-F device's precision calculations (e.g., number of runs, number of days, number of plasma samples) is not explicitly stated in this summary.
• Data Provenance: Not specified in terms of country of origin or whether it's retrospective/prospective. This is an in vitro diagnostic control, so "data provenance" in the sense of patient data is not applicable. The plasma is "human plasma" but no further detail on its origin is provided.

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

• Not Applicable. This is an in vitro diagnostic control plasma used for quality control of lab assays, not an imaging/AI device requiring expert interpretation or ground truth establishment by medical specialists like radiologists. The "ground truth" for this product would be the established fibrinogen concentration values from the manufacturer's own assay methods and validation, which is common for control plasmas.

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

• Not Applicable. As per point 3, this is an in vitro diagnostic control; expert adjudication methods for imaging or clinical cases are not relevant here.

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 an in vitro diagnostic control and does not involve human readers or AI assistance in the context of diagnostic interpretation.

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

• Not Applicable. This is an in vitro diagnostic control, not an algorithm or an AI device.

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

• For a control plasma, the "ground truth" (or accepted value) is typically the assigned value from the manufacturer's reference method, established through meticulous testing and calibration. This is not derived from expert consensus, pathology, or outcomes data in the clinical sense, but rather from the analytical performance of laboratory instruments and reagents.

8. The sample size for the training set:

• Not Applicable. This is a physical biological control product, not a software algorithm that requires a training set.

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

• Not Applicable. As per point 8, there is no training set for this type of medical device.

In summary, the provided document is a 510(k) submission for an in vitro diagnostic control plasma. The "study" described is a comparison to a predicate device to demonstrate substantial equivalence, focusing on analytical performance characteristics like precision and stability. It does not contain the types of information (e.g., expert-based ground truth, MRMC studies, training/test sets for algorithms) that would be relevant for an AI or imaging-based medical device.

Ask a specific question about this device

The Pool Norm is a normal human plasma pool intended for use as a normal control for the activated partial thromboplastin time (APTT) and dilute Russell's viper venom time (dRVVT) assays carried out with the following tests:

• APTT: STA® - PTT A (REF 00595) on STA-R®, STA Compact® and STA Satellite® analyzers
• dRVVT: STA® - Staclot® dRVV Screen (REF 00339, 00333), STA® - Staclot® dRVV Confirm (REF 00334) on STA-R® and STA Compact® analyzers.
  This reagent is to be used in clinical laboratories by certified medical laboratory personnel. For in vitro diagnostic use only. For prescription use.

Pool Norm is a lyophilized pool of at least 20 citrated normal human plasmas, containing buffer, stabilizers and preservatives.

The provided document describes the Pool Norm device, a normal human plasma pool intended for use as a normal control for activated partial thromboplastin time (APTT) and dilute Russell's viper venom time (dRVVT) assays. The study presented focuses on the device's precision performance.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for the reported precision study. However, the study aims to demonstrate repeatability (within-run precision) and within-laboratory precision, which are standard measures for the performance of control materials. The reported performance is given as Standard Deviation (SD) in seconds and Coefficient of Variation (CV) in percentage for three different lots of Pool Norm on three different analyzer types.

Since explicit acceptance criteria are not provided, we will assume that the reported precision values are considered acceptable by the manufacturer for the intended use of the device. A common industry expectation for coagulation controls is a CV of less than 5% for within-laboratory precision, though this can vary. All reported CVs are well below this general benchmark.

Ask a specific question about this device

HemosIL D-Dimer HS 500 Controls are assayed, human-sourced controls intended for the quality control of the HemosIL D-Dimer HS 500 assay as performed on the ACL TOP Family System, in a clinical laboratory setting. The controls are intended for in vitro diagnostic use.

Level 1 D-D HS 500 Control is intended for the assessment of the assay around the clinical cutoff for VTE (500 ng/mL FEU).

Level 2 D-D HS 500 Control is intended for the assessment of precision and accuracy of the assay at abnormal D-Dimer levels (above the cut-off).

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter for the HemosIL D-Dimer HS 500 Controls, outlining its intended use and regulatory information. It does not contain details about specific performance studies, sample sizes, ground truth establishment, or expert reviews.

Ask a specific question about this device

The directCHECK® Whole Blood ACT+ Level 1 (normal) and ACT+ Level 2 (abnormal) Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation test: HEMOCHRON® ACT+ assay on the HEMOCHRON® Jr. Signature+ and HEMOCHRON® Signature Elite instruments.

The directCHECK® Whole Blood ACT-LR Level 1 (normal) and ACT-LR Level 2 (abnormal) Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation test: HEMOCHRON® ACT-LR assay on the HEMOCHRON® Jr. Signature+ and HEMOCHRON® Signature Elite instruments.

The directCHECK® Whole Blood Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation tests. The directCHECK® whole blood control material is prepared from animal plasmas to which fixed animal red blood cells have been added. No human-based materials are contained in directCHECK® Whole Blood Controls. The whole blood control material is lyophilized in glass ampoules, and placed into an individual assembly with liquid diluent. When the glass ampoule is broken (activation of the assembly), the diluent rehydrates the lyophilized material, forming a liquid whole blood control.

The acceptance criteria and study proving device performance are described below based on the provided text.

Acceptance Criteria and Device Performance

Device: directCHECK® Whole Blood Control for HEMOCHRON® ACT+ assay and directCHECK® Whole Blood Control for HEMOCHRON® ACT-LR assay

Study Type: Non-clinical precision and stability testing. Clinical studies were not performed.

Note: The text explicitly states "this satisfies the Level 2 acceptance criteria of CV

Ask a specific question about this device

The i-STAT PT Control Level 1 (normal) and PT Control Level 2 (abnormal) are used for quality control of i-STAT PT cartridges on i-STAT handheld and wireless systems.
The i-STAT ACT Control Level 1 (normal) and ACT Control Level 2 (abnormal) are used for quality control of i-STAT ACT cartridges on i-STAT handheld and wireless systems.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA to CLINIQA CORPORATION regarding their i-STAT PT Control and i-STAT ACT Control devices. This type of document declares substantial equivalence to a legally marketed predicate device, primarily focusing on regulatory compliance and the device's intended use (quality control for other in vitro diagnostic devices). It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found for a novel diagnostic device's performance claims.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory approval letter, not a performance study report.

Ask a specific question about this device