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PT-Multi Calibrator is intended as a calibrator set for local PT/INR calibration and/or local verification of the INR system for plasma based procedures with designated Siemens thromboplastins Dade® Innovin® or Thromborel® S on the BCS® / BCS® XP Systems.

PT-Multi Calibrator is a set of certified plasmas for local PT/INR calibration and/or local verification of the INR system for plasma based procedures using Siemens Dade® Innovin® or Thromborel® S reagents on Siemens BCS® Coaguiation Systems.

The calibrator levels are manufactured using a combination of normal and depleted human plasma.

Here's a summary of the acceptance criteria and the study details for the PT-Multi Calibrator, based on the provided document:

This device is an in-vitro diagnostic (IVD) calibrator, not an AI/ML powered device, therefore some of the requested information (e.g., number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable. I will provide information relevant to IVD calibrator performance evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner as typically seen for novel medical devices. Instead, it presents performance data from "Method Comparison studies" and "Precision studies," implying that the suitability of the device is demonstrated by these results, generally expected to align with established clinical performance for such calibrators. For the purpose of this response, I will interpret the presented study results as demonstrating the device meets the implicit performance standards for a calibrator.

Implicit Performance Criteria (Demonstrated by Study Results)

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

• Method Comparison Studies (Test Set):

  • Sample Size (n):
    • For Thromborel S (without extrapolation): Individual sites had 'n' values ranging from 118 to 138.
    • For Thromborel S (with extrapolation): Individual sites had 'n' values ranging from 119 to 139.
    • For Innovin: Individual sites had 'n' values ranging from 102 to 136.
    • Total for Thromborel S: 738 (without extrapolation) and 768 (with extrapolation) samples.
    • Total for Innovin: 693 samples.
  • Data Provenance: The studies were conducted at three different sites: Denver (presumably USA), Munich (Germany), and Marburg (Germany). The data is prospective as these are controlled validation studies for regulatory submission.

• Precision Studies (Test Set):

  • Sample Size: The tables indicate 20-day ANOVA precision studies. While specific 'n' values per measurement are not explicitly stated for individual data points, the nature of ANOVA precision studies typically involves multiple measurements over multiple days, runs, and replicates for each calibrator level. The tables report mean INR values and various CV% metrics, derived from this systematic measurement process. The number of independent measurements is substantial given the 20-day duration and multiple types of CVs.
  • Data Provenance: The studies were conducted at the same three sites: Denver, Munich, and Marburg. The data is prospective as these are controlled validation studies for regulatory submission.

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

Not Applicable (N/A) for this device.

This device is an in vitro diagnostic calibrator. Its "ground truth" is established by its intrinsic chemical properties and its ability to accurately calibrate an instrument to a known standard (e.g., International Normalized Ratio - INR). The ground truth for calibrators is typically established through:

• Traceability: Ensuring the calibrator's assigned values are traceable to recognized international reference materials or methods (e.g., WHO international standards for PT/INR).
• Manufacturing Control: Strict quality control during manufacturing to ensure consistency and accuracy of the calibrator's analyte concentrations.
• Method Comparison: Comparison against established, conventional calibration methods (as presented in the documentation).

Therefore, "experts" in the sense of clinical decision-makers (like radiologists) are not used to establish the ground truth for this type of calibrator.

4. Adjudication Method for the Test Set

Not Applicable (N/A) for this device.

Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of data where consensus is needed to define a ground truth (e.g., image interpretation). For an IVD calibrator, the results are quantitative measurements, and the accuracy and precision are determined by statistical analysis of these measurements against a known reference or by internal consistency, not by human adjudicators.

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 (N/A) for this device.

This device is an in vitro diagnostic calibrator, not an AI-powered diagnostic tool used by human readers. Therefore, MRMC studies and "improvement with AI vs without AI assistance" are not relevant to its evaluation.

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

Not Applicable (N/A) for this device.

This device is a "standalone" product in the sense that it is a physical calibrator kit. Its performance is evaluated intrinsically (precision) and in comparison to other calibration methods (accuracy) when used with an instrument, not as an algorithm separate from human interaction. The concept of "human-in-the-loop performance" or an "algorithm only" study does not apply to a physical calibrator.

7. The type of Ground Truth Used

For an in vitro diagnostic calibrator, the "ground truth" is intrinsically linked to:

• Reference Methods/Materials: The calibrator's values are ultimately traceable to established reference methods and/or internationally recognized reference materials for the specific analyte (in this case, Prothrombin Time/INR).
• Conventional Local Calibration Methods: In the method comparison studies, the PT-Multi Calibrator's performance is compared against "conventional local ISI/MNPT" (International Sensitivity Index / Mean Normal Prothrombin Time). This conventional method serves as the established "truth" or reference for evaluating the new calibrator's accuracy.

8. The Sample Size for the Training Set

Not Applicable (N/A) for this device in the context of machine learning.

The concept of a "training set" typically applies to machine learning algorithms. As a physical IVD calibrator, the device itself does not undergo machine learning training. Its development involves chemical and manufacturing processes, and its specifications are derived from extensive R&D and validation studies. The method comparison and precision studies described above represent the validation/test sets for demonstrating the device's performance.

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

Not Applicable (N/A) for this device.

As explained in point 8, there is no "training set" in the machine learning sense for this product. The ground truth for calibrators is established through traceability to international standards, rigorous manufacturing controls, and analytical validation against existing, validated methods.

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The IGG method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G in human serum, heparinized plasma, cerebrospinal fluid (CSF) and urine on the Dimension Vista® System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: a1-Acid Glycoprotein (A1AG), a ;- Antitrypsin (A1AT), B2-Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG) [serum/plasma], Immunoglobulin G (IGG-C) [cerebrospinal fluid] and Immunoglobulin G (IGG-U) (urine), Immunoglobulin G Subclass 1 (IGG1), Immunoglobulin G Subclass 2 (IGG2), Immunoglobulin G Subclass 3 (IGG3), Immunoglobulin G Subclass 4 (IGG4), lmmunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), soluble Transferrin Receptor (STFR), Transferrin (TRF)

PROT3 CON is an assayed, low level intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista System in the determination of α Microglobulin (A1MIC), specialty Albumin (sALB), Immunoglobulin G (IGG -C), Immunoglobulin G (IGG-U)** and Microalbumin (MALB). * For Cerebrospinal fluid (CSF) ** For urine

Dimension Vista® System Immunoglobulin G Flex® reagent cartridge: Proteins contained in human body fluids from immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista® System Protein 1 Calibrator: PROT1 CAL is a multi-analyte, liquid human serum based product containing: α₁-Acid Glycoprotein, α₁-Antitrypsin, β₂-Microglobulin, C3 Complement, C4 Complement, Ceruloplasmin, Haptoglobin, Hemopexin, Homocysteine, Immunoglobulin A, Immunoglobulin E, Immunoglobulin G, Immunoglobulin G Subclass 1, Immunoglobulin G Subclass 2, Immunoglobulin G Subclass 3, Immunoglobulin G Subclass 4, Immunoglobulin M, Prealbumin, Retinol Binding Protein, soluble Transferrin Receptor, Transferrin.

Dimension Vista® System Protein 3 Control: PROT3 CON is a multi-analyte, lyophilized, polygeline and rabbit albumin based product containing: a - Microglobulin, Immunoglobulin G, Albumin.

The provided document is a 510(k) premarket notification for in vitro diagnostic devices, namely the Dimension Vista® System IGG Flex® reagent cartridge, Protein 1 Calibrator, and Protein 3 Control. It states that these devices are substantially equivalent to legally marketed predicate devices. This type of submission does not typically include detailed studies with acceptance criteria and device performance in the format of a clinical trial for an AI/ML medical device. Instead, it focuses on demonstrating analytical performance (e.g., correlation, precision, analytical bias) for a laboratory diagnostic system.

Therefore, the requested information about acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert adjudication, MRMC studies, standalone performance, and how ground truth was established is not present in the provided text.

The document primarily makes claims of substantial equivalence to predicate devices based on intended use and analytical studies, rather than reporting on a clinical effectiveness study with defined acceptance criteria for diagnostic accuracy, sensitivity, or specificity in the way an AI/ML device might.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided. The document states that "studies included in this submission demonstrate correlation to and equivalent performance between the predicate Beckman Coulter IMMAGE® Immunochemistry System Urine Immunoglobulin G for urine sample matrix and the predicate N Antisera to Human Immunoglobulins (IgG IgA, and IgM) on the BN ProSpec® System for the addition of a pre-reaction step to the Dimension Vista® IGG-C assay."

This indicates that correlation and equivalent performance were the acceptance criteria, but the specific metrics (e.g., correlation coefficient thresholds, mean difference limits) and the resultant device performance values are not detailed in this summary.

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

Not provided. The summary mentions "studies" but does not give details about the sample sizes of patients or samples used in these studies, nor their country of origin or whether they were retrospective or prospective.

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

Not applicable/Provided. For an in vitro diagnostic device measuring immunoglobulin G, the "ground truth" would typically be established by a reference method or known concentrations of analytes in control materials, not by expert interpretation of images or clinical data. Therefore, the concept of "experts" in this context is not relevant.

4. Adjudication Method for the Test Set

Not applicable/Provided. Adjudication methods (e.g., 2+1) are usually relevant for human expert interpretation and resolving discrepancies, which is not pertinent to the analytical performance of an in vitro diagnostic assay.

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

No. MRMC studies are associated with diagnostic imaging or other interpretive tasks where multiple human readers assess cases. This is an IVD device for quantitative measurement, so an MRMC study would not be applicable.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, implicitly. The device is an in vitro diagnostic system designed to quantitatively measure Immunoglobulin G. Its performance is inherently "standalone" in that it processes samples and produces numerical results without human interpretive input into the measurement itself. The "correlation" and "equivalent performance" mentioned would be standalone analytical performance. However, specific metrics are not provided.

7. The Type of Ground Truth Used

Implicitly, reference methods or known concentrations. For an IVD device, the ground truth for performance studies is typically established by:

• Comparison to a legally marketed predicate device (as stated in the conclusion).
• Known concentrations of analytes in control samples or calibrators.
• Reference methods that are considered the gold standard for measuring the analyte.
  The document states "correlation to and equivalent performance between the predicate...", suggesting the predicate device's results serve as the ground truth reference for comparison.

8. The Sample Size for the Training Set

Not applicable/Provided. This device is an analytical instrument and reagents, not an AI/ML algorithm that is "trained" on a dataset in the conventional sense. The "training set" concept is not relevant here.

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

Not applicable/Provided. As mentioned, the concept of a "training set" with established ground truth is not applicable for this type of IVD device.

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Dimension Vista® A2MAC Flex® reagent cartridge: The A2MAC method is an in vitro diagnostic test for the quantitative measurement of a2-macroglobulin in human serum and plasma on the Dimension Vista® Systems. Measurements of a2 -macroglobulin aid in the diagnosis of blood clotting or blood lysis disorders.

Dimension Vista® PROT 1 CAL: PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® Systems for: a1-Acid Glycoprotein (A1AG), a-Antitrypsin (A1AT), a2-macroglobulin (A2MAC), b2-Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT),Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG, IGG-C*), Immunoglobulin G subclass 1(IGG1), Immunoglobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), soluble Transferrin Receptor (STFR). Transferrin (TRF) *For cerebrospinal fluid

Dimension Vista® Protein 1 Control L: PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® Systems in the quantitative determination of: a1-Acid Glycoprotein (A1AG), a1-Antitrypsin (A1AT), a2-macroglobulin (A2MAC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG),Immunoglobulin G subclass 1 (IGG1), Immunoglobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), specialty Albumin (sALB*), soluble Transferrin Receptor (STFR) and Transferrin (TRF). *For serum and plasma

Dimension Vista® Protein 1 Control M and H: PROTI CON M and PROT1 CON H are assayed, mid-level and high level, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: a2-Acid Glycoprotein (A1AG), a1 -Antitrypsin (A1AT), a]-Macroglobulin (A2MAC), b2 -Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4),Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA),Immunoglobulin E (IGE), Immunoglobulin G (IGG),Immunoglobulin G Subclass 1 (IGG1), Immunoglobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP),soluble Transferrin Receptor (STFR), specialty Albumin (sALB) and Transferrin (TRF). *For serum and plasma

Dimension Vista® A2MAC Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista® Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing; ar-acid glycoprotein, a1 -antitrypsin, a2 -macroglobulin, b2 -microglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E,, immunoglobulin G, immunoglobulin G Subclass , immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein, homocysteine, soluble transferrin receptor and transferrin.

Dimension Vista® Protein 1 Control L: Protein 1 Control L is a multi-analyte, low level liquid human serum based product containing : a1-acid glycoprotein, a1-antitrypsin, a2 -macroglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin,immunoglobulin E, immunoglobulin A, immunoglobulin G, immunoglobulin G Subclass , immunoglobulin G subclass 2. immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein,homocysteine, soluble transferrin receptor and transferrin

Dimension Vista® Protein 1 Control M and H: Protein 1 Control M and H are multi-analyte, mid and high level respectively, liquid human scrum based products containing: aj -acid glycoprotein, a1 -antitrypsin, a2 -macroglobulin, b2microglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G Subclass . immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein, homocysteine, soluble transferrin receptor, and transferrin.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista® A2MAC Flex® reagent cartridge:

The document describes a medical device, the Dimension Vista® A2MAC Flex® reagent cartridge, and its associated calibrator and controls, which are intended for the quantitative measurement of alpha-2-macroglobulin (A2MAC) in human serum and plasma. The study presented is a method comparison study to demonstrate substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria for slope, intercept, or correlation coefficient. However, in method comparison studies for substantial equivalence, the implicit acceptance criteria are typically a slope statistically close to 1, an intercept statistically close to 0, and a high correlation coefficient (usually >0.975 or >0.98, depending on the analyte and regulatory guidance). The reported performance (slope 1.042, intercept +6.3 mg/dL, correlation 0.993) is stated to demonstrate correlation and equivalent performance. The context of a 510(k) submission implies that these results met the FDA's unstated (or internal) acceptance criteria for substantial equivalence.

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

• Sample Size: 143 samples (n=143)
• Data Provenance: The data used were human serum and plasma samples, with concentrations ranging from 28 - 637 mg/dL. The document does not specify the country of origin or whether the samples were retrospective or prospective.

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

This type of study does not utilize experts to establish ground truth in the way an imaging or diagnostic algorithm might. Instead, the "ground truth" for each sample is the quantitative value obtained from the predicate device (Dade Behring N Antisera to Human a2-macroglobulin assay on the BN ProSpec® System). This is a comparison between two instruments/reagents, not a subjective interpretation.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this study compares quantitative measurements from two automated systems. There is no human adjudication process involved in establishing the "ground truth" for the test set or for managing discrepancies between human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not conducted. This study compares the performance of a new in vitro diagnostic reagent and system to a predicate device, not the performance of human readers or the impact of AI assistance.

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

Yes, this is a standalone performance study of the Dimension Vista® A2MAC assay. The comparison is between the new device and the predicate device, both operating as automated systems without direct human interpretation in the results generation. Human involvement is limited to sample handling, instrument operation, and data analysis, not diagnostic interpretation of raw data for each test.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for comparison was the quantitative measurement obtained from the legally marketed predicate device, the Dade Behring N Antisera to Human a2-macroglobulin assay on the BN ProSpec® System. This is a reference method comparison.

8. The Sample Size for the Training Set

The document does not specify a training set or its size. This is common for traditional in vitro diagnostic device submissions like this one, as they typically involve analytical performance validation (e.g., method comparison, precision, accuracy) rather than machine learning algorithm development which requires distinct training, validation, and test sets. The assay, calibrator, and controls are likely developed and optimized internally by the manufacturer, but the specific "training set" in an AI/ML context is not disclosed or applicable here.

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

Not applicable, as a distinct "training set" with established ground truth in the context of an AI/ML device is not mentioned or relevant to this type of traditional IVD submission. The assay's performance characteristics (linearity, sensitivity, etc.) would have been established during its development using internal methods, but this is not equivalent to "ground truth establishment for a training set" as understood in AI/ML validation studies.

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The CEA method is an in vitro diagnostic test for the quantitative measurement of carcinoembryonic antigen in human serum and sodium or lithium heparinized plasma on the Dimension Vista System. Measurements of carcinoembryonic antigen are used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed.

For the calibration of the Carcinoembryonic Antigen (CEA) method on the Dimension Vista® System.

Dimension Vista® CEA Flex® reagent cartridge: The CEA method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI™ technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated anti-CEA monoclonal antibody fragment. The first bead reagent (Chemibeads) is coated with an anti-CEA monoclonal antibody and contains chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. Sample is incubated with biotinylated antibody and Chemibeads to form bead-CEA-biotinylated antibody sandwiches. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Ulumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the CEA concentration in the sample.

Dimension Vista® LOCI 5 Calibrator: LOCI 5 CAL is a liquid, multi-analyte, bovine serum albumin based product containing CEA from human tissue culture.

Here's a breakdown of the acceptance criteria and study information for the Dimension Vista® CEA Flex® reagent cartridge and Dimension Vista® LOCI 5 Calibrator, based on the provided text:

Acceptance Criteria and Device Performance

The study demonstrates substantial equivalence to the predicate device, Beckman Access® CEA Reagents on the Access® Immunoassay System. The acceptance criteria are implicitly defined by showing comparable performance characteristics, particularly in method comparison (correlation) and precision.

Study Details

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

   • Method Comparison:
     • 141 values for correlation study, range 0.8 - 974 ng/mL [µg/L].
     • 46 values for correlation study, range 0.8 - 17.1 ng/mL [ug/L].
   • Precision:
     • Multiple test materials (Liquichek™ Immunoassay Plus Control Levels 1 & 2, Serum pools 1-5, Plasma pool) were analyzed. Specific sample numbers for each material are not explicitly stated, but the testing involved "two separate runs, with two test samples, for each test material, were analyzed for 20 days."
   • Data Provenance: Not explicitly stated, but clinical laboratory studies are typically prospective. No country of origin is specified.

2. 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 device for quantitative measurement, and "ground truth" is established by the reference method (predicate device) and analytical precision. No human expert interpretation of results is part of this type of study for device performance.

3. Adjudication method for the test set: Not applicable. This is an analytical performance study, not a study involving human interpretation or adjudication.

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 is an in vitro diagnostic device, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, this is a standalone analytical performance study of the Dimension Vista® CEA Flex® reagent cartridge on the Dimension Vista® System. The performance metrics (correlation, precision) are for the assay system itself.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for method comparison was established by the predicate device (Beckman Access® CEA Reagents on the Access® Immunoassay System). For precision, standard reference materials and pooled samples were used as typical in analytical chemistry.

7. The sample size for the training set: Not applicable. This is not a machine learning or AI device that uses a "training set" in the conventional sense. The device is a chemical reagent and instrument system.

8. How the ground truth for the training set was established: Not applicable. (See #7).

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The AFP method is an in vitro diagnostic test for the quantitative measurement of alpha-fetoprotein in human serum on the Dimension Vista® system. Measurements of alpha-fetoprotein are used as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures.

For the calibration of the Alpha-Fetoprotein (AFP) method on the Dimension Vista® System.

Method: The AFP method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI™ technology. The LOCT™ reagents include two synthetic bead reagents and a biotinylated anti-AFP monoclonal antibody fragment. The first bead reagent (Chemibeads) is coated with an anti-AFP monoclonal antibody and contains chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dve. Sample is incubated with biotinylated antibody and Chemibeads to form bead-AFP-biotinylated antibody sandwiches. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the AFP concentration in the sample.

Calibrator: The LOCI 5 Calibrator is a liquid multi-analyte product containing AFP from human cord serum. An additional analyte (CEA from human tissue culture) is contained in the product and will be included in the submission to FDA with its respective method. The kit consists of ten vials, two each of five levels containing 2 mL per vial. Description of the manufacturing, value assignment and stability testing processes are provided.

For the Siemens Healthcare Diagnostics Inc. Dimension Vista® AFP reagent cartridge and LOCI 5 calibrator (K071597):

1. Table of Acceptance Criteria and Reported Device Performance

   The document does not explicitly state acceptance criteria in a quantitative format (e.g., a specific threshold for correlation coefficient or slope). Instead, it presents performance data and concludes "good analytical and clinical agreement." The substantial equivalence claim is based on this agreement with the predicate device.

   Performance Metric (Device: Dade Behring Dimension Vista® AFP Method)	Reported Device Performance (vs. Predicate Abbott AxSYM® AFP Method)
   Slope (Passing-Bablok linear regression)	0.93
   Intercept (ng/mL)	0.1
   Correlation Coefficient	0.995

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

   • Sample Size for Test Set: 317 patient samples.
   • Data Provenance: Not specifically mentioned, but the study is a "split sample method comparison," implying prospective collection of human serum samples for comparison against a predicate device. The country of origin is not specified.

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

   This study describes a method comparison for an in vitro diagnostic test measuring AFP levels in serum. The "ground truth" in this context is the quantitative result provided by the predicate device (Abbott AxSYM® AFP method). This is not a study requiring expert readers to establish ground truth from images or clinical assessments.

4. Adjudication Method for the Test Set

   Not applicable. This is a quantitative method comparison study against a predicate device, not a study involving expert adjudication of interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

   No. This document describes a method comparison study for an in vitro diagnostic device, not a comparative effectiveness study involving human readers and AI assistance for interpretation.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

   Yes, in essence. The study evaluates the performance of the Dimension Vista® AFP method (the "algorithm/device") by directly comparing its quantitative results to those of a predicate device using patient samples. This is a standalone performance evaluation of the assay itself.

7. Type of Ground Truth Used

   The "ground truth" for this method comparison study is the quantitative Alpha-Fetoprotein (AFP) concentration obtained from the predicate device (Abbott AxSYM® AFP method) for each human serum sample.

8. Sample Size for the Training Set

   The document does not provide information about a separate "training set" for the Dimension Vista® AFP method itself. This is a performance validation of a finished assay and calibrator. The development and internal validation of the assay (e.g., defining reagent concentrations, detection parameters) likely involved numerous experiments and historical data, but these are not disclosed as a distinct "training set" in a machine learning sense. Clinical validation studies for IVDs typically focus on demonstrating performance against established methods or clinical outcomes.

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

   As noted in point 8, a "training set" in the context of a machine learning algorithm is not explicitly described. For the development of the assay, the "ground truth" for calibrating and establishing the assay's performance characteristics would involve using certified reference materials (e.g., traceable to WHO Reference preparation for human AFP (72/225)) and well-characterized human samples. The document states that the device is "Traceable to the World Health Organization (WHO) Reference preparation for human AFP (72/225)," indicating the standard used for establishing accuracy and calibration.

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The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXL™ with LM system. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease.

The LOCI® Thyroid Calibrator is an in vitro diagnostic product for the calibration of the FT4L method on the Dimension® EXLTM with LM system.

The Dimension® EXL™ with LM system is an in vitro diagnostic device that is intended to measure a variety of analytes in human body fluids. The system utilizes photometric, turbidimetric, chemiluminescence and integrated ion selective multisensor technology for chemical and immunochemical applications for clinical use.

The Dimension® EXL™ with LM clinical chemistry system is a floor model, fully automated, microprocessor-controlled, integrated instrument system which uses prepackaged Dade Behring Flex® reagent cartridges to measure a variety of analytes in human body fluids. The system can process samples in random access, batch or stat modes.

The Dimension® FT4L Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight-well cartridge for use on the Dimension® EXL™ with LM system.

The LOCI® Thyroid Calibrator is a liquid, bovine serum albumin based product containing thyroxine. There are four calibrator levels with target values of 0.8, 1.6, 4.0 and 8.4 ng/dL.

The provided text describes a 510(k) premarket notification for the Dimension® EXL™ with LM clinical chemistry system, Dimension® FT4L Flex® reagent cartridge, and LOCI® Thyroid Calibrator. The primary study described is a method comparison study between the new Dimension® FT4L Flex® reagent cartridge and its predicate device, the Dimension® Vista FT4 Flex® reagent cartridge.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined quantitative acceptance criteria (e.g., "slope must be between 0.95 and 1.05 and r > 0.98"). However, the study aims to demonstrate "excellent correlation" and substantial equivalence to the predicate device. The results indicate that this goal was met.

2. Sample Size and Data Provenance

• Sample Size for Test Set: One hundred-and-eighty (180) serum samples.
• Data Provenance: Not explicitly stated whether the data is retrospective or prospective, nor the country of origin. It's common for such studies to use prospectively collected samples or a mix, but this information is absent.

3. Number of Experts and Qualifications for Ground Truth

The study described is a method comparison study between two in vitro diagnostic devices. It does not involve human interpretation or subjective assessment that would require experts to establish a "ground truth" in the traditional sense (like in image analysis or clinical diagnosis). Instead, the "ground truth" in this context is the measurement obtained from the predicate device.

4. Adjudication Method

Not applicable. This was a direct comparison of measurements between two automated analytical methods, not a study requiring adjudication of subjective interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of an in vitro diagnostic assay, comparing its measurements to a predicate device. It does not assess the diagnostic effectiveness with or without AI assistance for human readers.

6. Standalone (Algorithm Only) Performance

Yes, the study primarily assesses the standalone performance of the Dimension® FT4L Flex® reagent cartridge on the Dimension® EXL™ with LM system by comparing its quantitative measurements to those of the predicate device. The "algorithm" here refers to the entire analytical process of the device, from reagent interaction to signal detection and calculation.

7. Type of Ground Truth Used

The ground truth used for the comparison was the measurements obtained from the predicate device, the Dimension® Vista FT4 Flex® reagent cartridge. This is a common approach for demonstrating substantial equivalence for new in vitro diagnostic devices.

8. Sample Size for Training Set

The document does not explicitly mention a "training set" or "training data" in the AI/machine learning sense. For in vitro diagnostic devices, method comparison studies typically use a test set to validate performance against a predicate. If method development and internal validation occurred, they would have used various samples, but these are not referred to as a "training set" in this context and their size is not provided.

9. How Ground Truth for Training Set Was Established

Not applicable, as a "training set" in the machine learning sense is not described. For the general development of such IVD assays, ground truth for initial development and calibration would typically be established using reference materials, certified calibrators, and samples characterized by a reference method or highly accurate established methods. However, these details are not provided in the summary.

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The IGG method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G in human serum, heparinized plasma and cerebrospinal fluid (CSF) on the Dimension Vista® System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista System for: a1-Acid Glycoprotein (A1AG), a1-Antitrypsin (A1AT), B2-Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG) [serum/plasma] and Immunoglobulin G (IGG-C) [cerebrospinal fluid], Immunoglobulin G Subclass 1 (IGG1), Immunoglobulin G Subclass 2 (IGG2), Immunoglobulin G Subclass 3 (IGG3), Immunoglobulin G Subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), soluble Transferrin Receptor (STFR), Transferrin (TRF).

PROT3 CON is an assayed, low level intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the determination of a1-Microglobulin (A1MIC), specialty Albumin (sALB), Immunoglobulin G (IGG -C) and Microalbumin (MALB). * For Cerebrospinal fluid (CSF)

Dimension Vista® System Immunoglobulin G Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista® System Protein 1 Calibrator: PROT1 CAL is a multi-analyte, liquid human serum based product containing: α₁-Acid Glycoprotein, α₁-Antitrypsin, β₂-Microglobulin, C3 Complement, C4 Complement, Ceruloplasmin, Haptoglobin, Hemopexin, Homocysteine, Immunoglobulin A, Immunoglobulin E, Immunoglobulin G, Immunoglobulin G Subclass 1, Immunoglobulin G Subclass 2, Immunoglobulin G Subclass 3, Immunoglobulin G Subclass 4, Immunoglobulin M, Prealbumin, Retinol Binding Protein, soluble Transferrin Receptor, Transferrin.

Dimension Vista® System Protein 3 Control: PROT3 CON is a multi-analyte, lyophilized, polygeline and rabbit albumin based product containing: a -Microglobulin, Immunoglobulin G, Albumin.

The provided text is a 510(k) summary for the Dimension Vista® System Immunoglobulin G Flex® Reagent Cartridge, Dimension Vista® System Protein 1 Calibrator, and Dimension Vista® System Protein 3 Control. This document primarily focuses on demonstrating substantial equivalence to previously cleared devices for adding Cerebrospinal Fluid (CSF) as a sample matrix for IgG measurement. It does not contain specific acceptance criteria, performance data, or details of a comprehensive study as typically requested for AI/ML device evaluations.

Therefore, many of the requested items (sample size, data provenance, expert qualifications, adjudication methods, MRMC study, training set details) are not applicable or not available in this type of submission. This 510(k) is for an in-vitro diagnostic (IVD) test, which typically has different evaluation criteria and reporting compared to AI/ML devices for image analysis or other diagnostic tasks involving human readers.

However, I can extract the information that is present and indicate where information is missing based on the context of the document.

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

The document does not explicitly state acceptance criteria in a quantitative table format or report performance against such criteria. Instead, it states that "The studies included in this submission demonstrate correlation to and equivalent performance between the predicate N Antisera to Human IGG for CSF sample matrix." This implies that the performance (likely accuracy, precision, and linearity for CSF samples) was deemed equivalent to the predicate, but the specific numerical values for performance or acceptance criteria are not provided.

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

This information is not provided in the 510(k) summary. Given the nature of a 510(k) summary for an IVD test, such detailed study design specifics are often contained in the full 510(k) submission and not in the public summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable for this type of IVD device. The "ground truth" for a quantitative IVD test like this would typically involve reference methods, calibrator values, and quality control materials, not expert consensus on interpretations.

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

This information is not applicable for this type of IVD device. Adjudication methods are typically used in studies involving human readers or AI output where there can be discretionary interpretation.

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

This information is not applicable for this type of IVD device. This is a laboratory diagnostic test for quantitative measurement of a marker, not an AI-assisted diagnostic tool for human readers interpreting images or complex data.

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

This information is not applicable in the context of an AI/ML algorithm. This device is an automated IVD test system. Its standalone performance is inherent to its function, but it's not an "algorithm only" in the way an AI model is, as it relies on reagent chemistry and instrument mechanics. The summary implies "standalone" performance was demonstrated through "correlation" and "equivalent performance" studies against a predicate device.

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

For a quantitative diagnostic assay of Immunoglobulin G in CSF, the ground truth would be established by:

• Reference methods: Highly accurate and precise laboratory methods (e.g., nephelometry, turbidimetry, or potentially a gold standard method if available) used to determine true concentrations in samples.
• Calibrators: Materials with known, assigned concentrations of the analyte (IgG) used to establish the measurement curve of the assay. The Dimension Vista® System Protein 1 Calibrator is mentioned for this purpose.
• Quality Control materials: Materials with known, assigned ranges of analyte concentration used to monitor the assay's performance and ensure accuracy and precision. The Dimension Vista® System Protein 3 Control is mentioned for this purpose.

The summary itself does not detail how the ground truth for the specific 'studies' was established, but these are the general principles for such assays.

8. The sample size for the training set

This information is not applicable for this type of IVD device. The Dimension Vista® system and its reagents are based on established immunochemical principles (light scattering) and are calibrated, not "trained" in the machine learning sense. There is no training set in the context of AI/ML.

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

This information is not applicable for this type of IVD device, as there is no "training set" in the AI/ML sense. Calibration is performed using materials with established concentrations (as outlined in point 7).

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The AHDL method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension® clinical chemistry system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.

The AHDL assay measures HDL cholesterol levels directly without the need for sample pretreatment or specialized centrification steps, using a two reagent format. In the first reaction, chylpmicrons, VLDL and LDL form water soluble complexes with dextran sulfate in the presence of magnesium sulfate. These complexes are resistant to the polyethylene glycol (PEG)-modified cholesteril esterse and cholesterol oxidase that react with HDL cholesterol. In the presence of oxygen, the HDL cholesterol is oxidized to 24-cholestenone and hydrogen peroxide. The generated hydrogen peroxide then reacts with 4-aminoantipyrine and sodium N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxyaniline (HSDA) in the presence of peroxidase to form a colored dye that is measured using a bichromatic (600/700 nm) endpoint technique. The color intensity of the dye is directly proportional to the serum HDL-C concentration.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Dade Behring Dimension® AHDL Method:

This document is a 510(k) summary for a new version of an in vitro diagnostic (IVD) device, specifically a reagent cartridge for measuring HDL cholesterol. The study presented here is a method comparison study to demonstrate that the new device (DF48B) is substantially equivalent to a previously cleared predicate device (DF48A).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a traditional table format with pass/fail thresholds. Instead, it demonstrates substantial equivalence through a direct comparison with a predicate device and reports statistical measures of agreement.

Note: The "acceptance criteria" are implied by the goal of demonstrating substantial equivalence to the predicate device. The reported performance metrics (slope, intercept, correlation coefficient) are used to support this claim, showing "good analytical and clinical agreement."

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

• Sample Size for Test Set: 130 human serum samples.
• Data Provenance: The data provenance is not explicitly stated regarding country of origin. It is a retrospective study using human serum samples. The statement "using Leftover Human Specimens that are Not Individually Identifiable" from the cited FDA guidance document suggests these samples were collected previously and then used for this study.

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

This type of study (method comparison for an in vitro diagnostic device) does not typically involve "experts" establishing a ground truth in the way one might for an imaging or clinical diagnosis device.
Instead, the "ground truth" for this study is implicitly the measurement obtained by the predicate device (Dimension® AHDL method, DF48A), as the goal is to show agreement of the new device (DF48B) with the established predicate. There are no external experts adjudicating the results of the predicate device.

4. Adjudication Method for the Test Set

No adjudication method is described, as it is not applicable to this type of chemical assay comparison study. The comparison is between two quantitative measurement methods.

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 (e.g., imaging devices) where human readers interpret results, and the AI's impact on human performance is assessed. This document describes a chemical assay, so human reader involvement in the measurement itself (beyond operating the instrument) is not a relevant factor.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance study was inherently done. This is a standalone performance study of the device (reagent cartridge on a clinical chemistry system). The algorithm in this context refers to the chemical reaction and measurement method rather than a software algorithm making diagnostic decisions. The "performance" being evaluated is the analytical agreement of the new reagent cartridge with the predicate reagent cartridge in measuring HDL-C.

7. Type of Ground Truth Used

The "ground truth" used for this method comparison study is the quantitative measurement of HDL-C obtained from the predicate device (Dimension® AHDL method, DF48A) for the same 130 human serum samples. The study aims to demonstrate that the new device's readings are in close agreement with the predicate's readings. It is not pathology, outcomes data, or expert consensus in the typical sense.

8. Sample Size for the Training Set

The document does not mention a training set. This is expected for an in vitro diagnostic (IVD) reagent cartridge. Unlike machine learning algorithms that require training data, these chemical assays are developed and validated based on their chemical properties and analytical performance without a "training" phase on patient data.

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

As there is no mention of a training set, the establishment of ground truth for a training set is not applicable.

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The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension® clinical chemistry system. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.

The Dimension® ECRE Flex® reagent cartridge is a prepackaged in-vitro diagnostic test method that is specifically designed to be used on the Dade Behring Dimension® Clinical Chemistry System. The reagents contained in the Dimension® ECRE Flex® reagent cartridge are: Reagent 1 - TAPS buffer, creatinase, sarcosine oxidase, HTIB; Reagent 2 - TAPS buffer, creatininase, horseradish peroxidase, 4-aminophenazon, and potassium hexacyanoferrate (II).

Here's a breakdown of the acceptance criteria and study information for the Dimension® Enzymatic Creatinine (ECRE) Flex® Reagent Cartridge (DF270), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a quantitative sense as distinct thresholds that were met. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The performance is assessed through comparative testing with the predicate device.

However, based on the comparative table and the assertion of "substantial equivalent performance," we can infer the targeted performance characteristics by looking at the predicate device's typical performance (which is not detailed here beyond the measuring range) and the new device's reported characteristics.

Note: The measuring range of the new device (0.03 - 20.00 mg/dL) is narrower than the predicate (0.03 - 30 mg/dL). While this might typically be a point of divergence, the FDA's clearance implies that this difference was considered acceptable for substantial equivalence, perhaps because the narrower range is still clinically acceptable or covers the vast majority of relevant clinical values, and no specific acceptance criteria for the range were provided. The document states a "comparison of the important similarities and differences" and concludes "substantial equivalent performance."

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

• Sample Size for the Test Set: Not explicitly stated. The document mentions "Comparative testing described in the protocol included in this submission," but doesn't provide the number of samples or subjects used in this testing.
• Data Provenance: Not explicitly stated (e.g., country of origin). The document provides no information about whether the data was retrospective or prospective.

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

This information is not provided in the document. For in-vitro diagnostic devices like this, "ground truth" is typically established by reference methods or established clinical laboratory practices, not by expert consensus in the way it might be for image analysis or clinical assessments. The comparison is made against the predicate device, implying that the predicate's performance serves as the benchmark.

4. Adjudication method for the test set:

This information is not provided. Given the nature of a chemical assay, adjudication by multiple experts is not a standard practice for establishing a single "ground truth" value for creatinine concentration. The performance is likely assessed by comparing results directly against a reference method or the predicate device.

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

This is not applicable to this device. An MRMC study is relevant for AI systems that assist human readers in tasks like image interpretation. The Dimension® ECRE Flex® Reagent Cartridge is an in-vitro diagnostic (IVD) assay designed to directly measure a chemical analyte (creatinine) in biological samples, not to assist human readers in interpretation.

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

This is not applicable in the context of an IVD reagent cartridge. The "algorithm" here is the chemical reaction and measurement process performed by the Dimension clinical chemistry system using the reagent. The performance of the system (reagent + instrument) is inherently standalone in that it provides a quantitative result directly without human interpretation influencing the measurement itself.

7. The type of ground truth used:

The "ground truth" for evaluating this device would implicitly be results obtained from a legally marketed predicate device (Roche's Creatinine Plus Reagent) or a recognized reference method for creatinine measurement. The document states: "Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance [to the predicate]."

8. The sample size for the training set:

This information is not provided. For a chemical reagent, the "training set" concept is not analogous to machine learning. Instead, the reagent formulation and assay parameters are developed and optimized through extensive R&D and analytical validation experiments. The document does not detail the number of samples used in this development and optimization phase.

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

This information is not provided. Similar to point 8, the concept of "ground truth" for a training set in the context of an IVD reagent typically relates to the accuracy and precision established during the development and optimization phase, often by running samples with known creatinine concentrations (e.g., NIST traceable standards, patient samples quantified by a gold-standard reference method). The document does not describe these specific procedures.

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Dimension Vista® C1IN Flex® reagent cartridge: The C1IN method is an in vitro diagnostic test for the quantitative measurement of C1 inhibitor in human serum and plasma on the Dimension Vista® System. Measurements of C1 Inhibitor aid in the diagnosis of hereditary angioneurotic edema (increase blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

Dimension Vista® C1IN CAL: The C1IN CAL is an in vitro diagnostic product for the calibration of the C1 Inhibitor (C1IN) method on the Dimension Vista® System.

Dimension Vista® C1IN CON: C1 Inhibitor Control is an assayed, mid level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of C1 Inhibitor (C1IN).

Dimension Vista® C1IN Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista® C1IN CAL: C1 Calibrator is a lyophilized, human plasma based product containing C1 Inhibitor (C1IN).

Dimension Vista® C1IN CON: C1 Control is a lyophilized, mid-level, human plasma based products containing C1 Inhibitor (C1IN).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 196 (serum and plasma samples)
• Data Provenance: The text does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "human serum and plasma samples."

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

The document does not describe the use of experts to establish a "ground truth" for the test set in the conventional sense of clinical interpretation. This is a comparison study between two assays, not a diagnostic study where human readers are making interpretations.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this study compares the performance of two analytical assays, not diagnostic interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This study is an analytical method comparison between a new device (Dimension Vista® C1IN assay) and a legally marketed predicate device (Dade Behring N Antisera to Human C1 Inhibitor assay) on two different laboratory platforms. It does not involve human readers evaluating cases or the effect of AI assistance.

6. Standalone Performance Study

Yes, a standalone study was done in the sense that the performance of the Dimension Vista® C1IN assay was evaluated on its own by comparing its results to results from a predicate device. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices. It's not "algorithm only" in the context of AI, but "device only" performance in the context of analytical measurement.

7. Type of Ground Truth Used

The "ground truth" in this context is the results obtained from the legally marketed predicate device, the Dade Behring N Antisera to Human C1 Inhibitor assay on the BN ProSpec® System. The study aims to show that the new device produces results that are comparable or equivalent to the established method.

8. Sample Size for the Training Set

Not applicable. This is an in vitro diagnostic assay, not an AI/ML device that requires a training set in the machine learning sense. The "training" for such a device typically involves method development and optimization, but not with a distinct "training set" of patient data as understood in AI.

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

Not applicable. See point 8.

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