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The AMAX Destiny™ Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

The AMAX Destiny™ Coagulation Analyzer is an automated random access multipurpose analyzer. The AMAX Destiny™ Coagulation Analyzer can be used for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In addition, the AMAX Destiny™ Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III) and for microparticle agglutination assays such as d-dimer.

The provided document is a 510(k) summary for the AMAX Destiny™ Coagulation Analyzer. It focuses on demonstrating substantial equivalence to a predicate device (AMAX 190™ Coagulation Analyzer) through performance comparisons, specifically regression statistics and precision studies. Since this is a submission for an in-vitro diagnostic device (an analyzer), the typical acceptance criteria and study designs for imaging AI/ML devices (which involve human readers, ground truth establishment by experts, etc.) are not directly applicable.

However, I will extract relevant information and reframe it to align with the spirit of your request to the best of my ability, highlighting what "acceptance criteria" and "study" mean in this context.

1. Table of Acceptance Criteria and Reported Device Performance

For this in-vitro diagnostic device, "acceptance criteria" are implicitly defined by the demonstration of "substantial equivalence" to the predicate device, the AMAX 190™ Coagulation Analyzer. The performance metrics are regression statistics (correlation coefficient 'r' indicating linearity/agreement, and the regression equation 'y = mx + b' indicating bias and slope) and precision (within-run and total coefficients of variation).

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Sigma Diagnostics ACCUCLOT™ LA Control is a human plasma control that is suitable for use as a positive control for lupus anticoagulant testing such as activated partial prothrombin time (APTT) and dilute Russell's viper venom time (dRVVT). Plasma controls are routinely used in the coagulation laboratory as a means of quality control.

Sigma Diagnostics ACCUTROL™ LA Control is a lyophilized human plasma based product. After reconstitution with water, ACCUTROL™ LA Control is stable for 48 hours when stored at 2-8°C and 4 weeks when stored at -20°C.

This submission focuses on a control material used for in-vitro diagnostic tests, rather than an AI/ML device that would typically generate performance metrics like sensitivity, specificity, or AUC. Therefore, many of the requested categories (e.g., sample size for test sets, number of experts, MRMC studies) are not applicable in this context.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for specific test sets. The submission relies on demonstrating substantial equivalence to a predicate device, which implies that the performance characteristics were compared against established parameters of the predicate, rather than an independent "test set" in the context of an AI/ML diagnostic.
• Data Provenance: Not specified. As a human plasma control, the source of the plasma itself (e.g., country of origin) is not detailed in the provided summary. The data presented is for the characterization of the control material (stability, intended use) to demonstrate equivalence.

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

• This is not applicable as this is a control material for in-vitro diagnostic tests, not a device requiring expert interpretation for ground truth establishment. The effectiveness is determined by its behavior as a control in laboratory assays, which have their own established validation procedures.

4. Adjudication method for the test set

• Not applicable for the reasons stated above.

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 material, not an AI/ML diagnostic tool.

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 material.

7. The type of ground truth used

• The "ground truth" for this device is its performance characteristics as a control material, primarily its ability to mimic a positive sample for lupus anticoagulant testing and its stability. This is established through laboratory experiments and comparison to a legally marketed predicate device with established performance. The "ground truth" here refers to the expected behavior and stability of the control plasma itself, not a diagnosis for a patient.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, and therefore does not have a "training set" in that conventional sense. The product development would involve manufacturing and quality control batches, but these are not analogous to training data for an algorithm.

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

• Not applicable for the reasons stated above.

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Sigma Diagnostics AUTO D-Dimer Calibrator is a human plasma calibrator that is suitable for use as calibrator for the Sigma Diagnostics AUTO D-Dimer kit Procedure CRS126 for the quantitative determination of fibrin degradation products containing Ddimer in citrated human plasma in D-dimer agglutination assays.

Sigma Diagnostics AUTO D-Dimer Calibrator is a human plasma control that is suitable for use as a calibrator in the Sigma Diagnostics AUTO D-dimer assay. Sigma Diagnostics AUTO D-Dimer Calibrator is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Calibrator is stable for 3 days when stored at 2-8°C and 8 hours when stored at 18-26°C.

The provided text describes a 510(k) summary for the Sigma Diagnostics AUTO D-Dimer Calibrator. It states that the safety and effectiveness of this new calibrator were demonstrated by its substantial equivalence to a previously marketed calibrator (Sigma Diagnostics AUTO D-Dimer Calibrator, Cat. No. A4842, K003267).

However, the document does not provide specific acceptance criteria, a detailed study report with performance metrics, or information about sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies. The 510(k) summary focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone performance study with explicit acceptance criteria and results.

Therefore, I cannot populate the requested table and answer many of the questions based solely on the given text. The text essentially states "it's equivalent to the old one" without detailing the performance data.

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Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 2 is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in Ddimer agglutination assays. Plasma controls are routinely used in the coagulation laboratory as a means of quality control.

Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 2 is a human plasma control that is suitable for use as a elevated control with patient citrated plasma in the Sigma Diagnostics AUTO D-dimer assay.
Sigma Diagnostics AUTO D-Dimer Control, Level 2 is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Control, Level 2 is stable for 3 days when stored at 2-8°C and 24 hours when stored at 18-26°C.

This 510(k) summary describes a device that is a control solution for a diagnostic assay, not an AI/ML powered device. Therefore, many of the requested categories (such as sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, etc.) are not applicable in this context.

However, I will extract and present the information that is relevant to the provided document.

Acceptance Criteria and Device Performance

This submission is for a control solution, and its "performance" is assessed by showing substantial equivalence to a previously cleared control solution. The primary acceptance criterion here is the demonstration of substantial equivalence.

Study Details (Applicable Information)

1. Sample size used for the test set and the data provenance: Not applicable. This is a control solution, not a diagnostic device evaluated with patient samples in a traditional test set. The evaluation focuses on equivalence to another control product.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic performance is not relevant for a control solution's substantial equivalence review.
3. Adjudication method for the test set: Not applicable.
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 not an AI/ML powered device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML powered device.
6. The type of ground truth used: For demonstrating substantial equivalence for a control solution, the "ground truth" implicitly refers to the established performance characteristics and intended use of the legally marketed predicate device. The comparison would be made against the predicate's known behavior in the specified assay.
7. The sample size for the training set: Not applicable. This is not an AI/ML powered device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML powered device.

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Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 3 is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in D-dimer assays. Plasma controls are routinely used in the coagulation laboratory as a means of quality control.

Sigma Diagnostics AUTO D-Dimer Control, Level 3 is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Control, Level 3 is stable for 3 days when stored at 2-8°C and 24 hours when stored at 18-26°C.

The provided text is a 510(k) summary for the Sigma Diagnostics AUTO D-Dimer Control, Level 3. This document describes a control product used in laboratory assays, not a diagnostic device that directly measures patient parameters or relies on an algorithm. Therefore, many of the requested categories in the prompt are not applicable to this type of product.

Here's an attempt to answer the questions based on the available information, noting where information is not relevant or not provided:

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

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. The document focuses on demonstrating substantial equivalence to a predicate device, which for a control product often involves analytical performance testing rather than clinical study data with human patient samples. The control itself is human plasma-based.

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)

Not applicable. For a control product, "ground truth" typically refers to the expected value or range of the control, which is established through analytical testing and characterization against reference methods or the assay it's designed to control. It does not involve expert consensus in the same way a diagnostic imaging device might.

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

Not applicable. Adjudication methods are typically associated with expert review of complex diagnostic cases, not with the analytical performance assessment of a laboratory control.

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

Not applicable. This is a laboratory control product, not an AI-powered diagnostic device, and thus MRMC studies are irrelevant.

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

Not applicable. There is no algorithm or AI component in this product.

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

For a control product, the "ground truth" refers to its characterized properties and values, often established through:

• Analytical testing using established reference methods.
• Comparison to existing, legally marketed controls (as implied by substantial equivalence to Level 2 control).
• Quantitative measurements made with the assay the control is designed to monitor.

The document indicates it is a human plasma-based product, and its intended use is as an "abnormal control" (Level 3) with patient citrated plasma in D-dimer assays. This implies its D-dimer level is elevated and characterized accordingly.

8. The sample size for the training set

Not applicable. This is a control product, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set.

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Sigma Diagnostics INFINITY™ HbA1c assay is an in vitro assay for the quantitative determination of hemoglobin A1c (HbA1c) in whole blood for use on automated analyzers.

Sigma Diagnostics INFINITY™ HbA1c is a device to measure the percent hemoglobin A1c in anticoagulated whole blood. Hemoglobin A1c is indicated for the monitoring of long-term glucose control in individuals with diabetes mellitus.

The INFINITY HbA1c assay is a microparticle enhanced turbidimetric immunoassay.

The INFINITY™ HbA1c assay is an in vitro assay for the quantitative determination of hemoglobin A1c (HbA1c) in whole blood for use on automated analyzers.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state formal "acceptance criteria" in terms of predefined performance thresholds (e.g., "correlation coefficient must be ≥ 0.95"). Instead, the substantial equivalence is demonstrated through correlation and regression analysis against two predicate devices. The implicit acceptance criterion is that the correlation coefficients and regression equations should indicate a strong linear relationship and equivalence in measurements.

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

• Sample Size: 45 patient samples were used for each comparison study.
• Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission from Sigma Diagnostics Inc. (a US company) to the FDA, it is highly probable that the samples were collected in the United States. The data is retrospective, as patient samples were tested using established methods (predicate devices) and the new device.

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

Not applicable. This device is an in vitro diagnostic (IVD) assay that quantitatively measures a biomarker (HbA1c). The "ground truth" for each sample is assumed to be the measurement obtained by the predicate devices, which are also IVD assays. There is no mention of human expert interpretation of results to establish ground truth for individual samples.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth is established by the measurements from the predicate devices. There is no human interpretation or adjudication involved for the individual sample 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 imaging devices where human interpretation is a key component of the diagnostic process. The INFINITY™ HbA1c assay is an IVD for quantitative measurement, not an imaging device requiring human reader interpretation. No effect size for human readers with or without AI assistance is reported.

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

Yes, the studies presented are standalone performance studies of the INFINITY™ HbA1c assay. The device directly produces a quantitative result (%HbA1c) without human interpretation steps in the measurement process. Its performance is compared directly against results from predicate devices.

7. The Type of Ground Truth Used

The "ground truth" for the test set was established by the measurements obtained from the predicate devices: the Roche Diagnostics HbA1c II and the Bio-Rad VARIANT™ II Hemoglobin A1c. These are established in vitro diagnostic assays.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the INFINITY™ HbA1c assay. As this is a turbidimetric immunoassay, its development likely involves calibration and optimization rather than a machine learning training phase in the conventional sense. The 45 patient samples per comparison would be considered the validation/test set for demonstrating substantial equivalence.

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

Not applicable, as a distinct "training set" with ground truth in the context of machine learning is not described or likely relevant for this type of immunoassay. The development and calibration of the assay would typically rely on reference methods and calibrators, which are not detailed in this summary.

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