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Sigma Diagnostics ACCUCLOT™ CONTROL II is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in the one-stage prothrombin time (PT), in the activated partial thromboplastin time (APTT), the chromogenic Antithrombin III (AT-III) assay and in fibrinogen determinations using a clotting method. Plasma controls are routinely used in the coagulation laboratory as a means of quality control for coagulation testing.

Sigma Diagnostics ACCUCLOT™ Control II is a lyophilized human plasma based product. After reconstitution with water, ACCUCLOT™ Control II is stable for 48 hours when stored at 2-8°C.

The provided text describes a 510(k) submission for a medical device (ACCUCLOT™ Control II) that is seeking substantial equivalence to a predicate device (Sigma Diagnostics Coagulation Control, Level II). The document focuses on regulatory approval rather than a detailed device performance study against specific, quantified acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory submission. The primary "study" proving its meeting of criteria is the demonstration of substantial equivalence to a previously approved device.

Here's an attempt to answer based on the provided text, with many fields indicating "Not specified" or "Not applicable" due to the nature of the document:

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

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

• Sample Size (Test Set): Not specified. The submission relies on demonstrating equivalence, which likely involved comparative testing, but the number of samples used for this comparison is not detailed here.
• Data Provenance: Not specified.

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

• Number of Experts: Not applicable/Not specified. For substantial equivalence of a control material, ground truth isn't typically established by expert consensus on individual cases in the same way it would be for a diagnostic algorithm. Performance is assessed against a predicate device.
• Qualifications of Experts: Not applicable/Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/Not specified.

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

• MRMC Study: No, this is not applicable. This device is a plasma control material, not an AI-assisted diagnostic tool for human readers.

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

• Standalone Performance: Not applicable. This device is a diagnostic reagent/control, not an algorithm. Its performance is intrinsic to the material itself when used in laboratory assays.

7. The type of ground truth used

• Type of Ground Truth: For a control material, "ground truth" would implicitly refer to its established and expected performance characteristics (e.g., target ranges for clotting times or AT-III activity) when run on validated diagnostic systems. The study likely involved demonstrating that the ACCUCLOT™ Control II performed within acceptable ranges relative to the Sigma Diagnostics Coagulation Control, Level II. The specific values or ranges are not provided here.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. This is a manufactured control product, not a machine learning algorithm that requires a training set.

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

• Ground Truth Establishment (Training Set): Not applicable.

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Sigma Diagnostics ACCUCLOT™ CONTROL III is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in the one-stage prothrombin time (PT), in the activated partial thromboplastin time (APTT), the chromogenic Antithrombin III (AT-III) assay and in fibrinogen determinations using a clotting method. Plasma controls are routinely used in the coagulation laboratory as a means of quality control for coagulation testing

Sigma Diagnostics ACCUCLOT™ Control III is a lyophilized human plasma based product. After reconstitution with water, ACCUCLOT™ Control III is stable for 48 hours when stored at 2-8°C.

The provided text is a 510(k) summary for the Sigma Diagnostics ACCUCLOT™ Control III, which is a human plasma control. The document states that the safety and effectiveness of this device were demonstrated by its substantial equivalence to a legally marketed predicate device, the Sigma Diagnostics Coagulation Control, Level III (Cat. No. 9916).

Crucially, this document does not detail specific acceptance criteria for the ACCUCLOT™ Control III or a study with performance data against those criteria. Instead, it relies on the concept of substantial equivalence to an existing device.

Therefore, for many of your specific questions, the information is not available in the provided text, as the method of demonstrating effectiveness was comparative to a predicate, not through a study with pre-defined acceptance criteria and reported performance metrics.

Here is what can be extracted and what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The submission relies on substantial equivalence to a predicate device rather than presenting specific acceptance criteria for the ACCUCLOT™ Control III and then reporting its performance against those criteria.

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

Not available. No specific test set or study data is presented for the ACCUCLOT™ Control III. Its effectiveness is based on equivalence to the predicate device.

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

Not applicable/Not available. No specific test set requiring expert-established ground truth is described for the ACCUCLOT™ Control III.

4. Adjudication Method for the Test Set

Not applicable/Not available.

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

No. This type of study is typically for evaluating diagnostic imaging or interpretation systems with human readers. The ACCUCLOT™ Control III is a laboratory control, not a diagnostic imaging device.

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

Not available/Applicable in the way usually meant for devices with algorithms. The ACCUCLOT™ Control III is a laboratory quality control product, not an algorithmic diagnostic tool. Its performance is inherent in its chemical and biological properties when used in assays. The "standalone" performance would refer to its stability and performance in the coagulation assays, but specific data is not provided, only the claim of equivalence.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data) does not directly apply here. For a quality control product, the "ground truth" in showing effectiveness is its ability to consistently yield expected results within specified ranges when used with reference methods, and its stability. However, explicit data on this for the ACCUCLOT™ Control III is not provided; rather, its equivalence to a predicate control is asserted.

8. The Sample Size for the Training Set

Not applicable/Not available. This device is a control material, not a machine learning algorithm that requires a training set.

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

Not applicable/Not available.

Summary of Device and Basis for Approval per Provided Text:

• Device Name: Sigma Diagnostics ACCUCLOT™ Control III
• Intended Use: A human plasma control suitable for use as an abnormal control with patient citrated plasma in one-stage prothrombin time (PT), activated partial thromboplastin time (APTT), chromogenic Antithrombin III (AT-III) assay, and fibrinogen determinations using a clotting method. Routinely used for quality control in coagulation testing.
• Demonstration of Safety and Effectiveness: By its substantial equivalence to the Sigma Diagnostics Coagulation Control, Level III (Cat. No. 9916).
• Key Characteristics: Lyophilized human plasma-based product, stable for 48 hours when stored at 2-8°C after reconstitution with water.

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