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Control Plasma N is an assayed control for use in monitoring performance of the following parameters in the normal range:

1. Prothrombin time (PT)
2. Activated partial thromboplastin time (APTT)
3. Thrombin time (TT)
4. Batroxobin time
5. Fibrinogen
6. Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, XII
7. Inhibitors: Antithrombin III, protein C, protein S, α2 –antiplasmin
8. Plasminogen
9. Lupus anticoagulants
10. Factor V Leiden

ProC® Control Plasma is an assayed control used to monitor the performance of Factor V Leiden assay in the pathological range.

Control Plasma N is a lyophilized control prepared from pooled human plasma, stabilized with HEPES buffer solution. ProC® Control Plasma is a lyophilized control prepared from pooled human plasma and rabbit plasma, and stabilized with HEPES buffer solution.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "pooled human plasma" for both Control Plasma N and ProC® Control Plasma, and "rabbit plasma" additionally for ProC® Control Plasma, but doesn't specify the number of samples or their origin. The study appears to be prospective, as it involves testing the stability of the new control plasmas.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not a study assessing diagnostic performance or requiring expert consensus for ground truth. The "ground truth" for this device would be its expected performance within established ranges for coagulation parameters.

3. Adjudication method for the test set: Not applicable. There's no subjective assessment requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a stability study for in vitro diagnostic (IVD) control plasmas, not a comparative effectiveness study involving human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, in the sense that the device's performance (stability) was evaluated directly without human interpretation of clinical cases. However, this isn't an "algorithm-only" study in the typical AI context; it's a performance study of a laboratory control.

6. The type of ground truth used: The "ground truth" here refers to the pre-established analytical values and expected stability of the control plasmas. The study assesses if the reconstituted plasmas remain within these assigned values over time under various storage conditions.

7. The sample size for the training set: Not applicable. This device is a control plasma, not an AI/ML algorithm that requires training data.

8. How the ground truth for the training set was established: Not applicable.

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Control Plasma N is an assayed control for use in monitoring the performance of the following parameters in the normal range:

1. Prothrombin time (PT)
2. Activated partial thromboplastin time (APTT)
3. Thrombin time (TT)
4. Batroxobin time
5. Fibrinogen
6. Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, XII
7. Inhibitors: Antithrombin III, protein C, protein S, a2 -antiplasmin
8. Plasminogen
9. Lupus anticoagulants

Control Plasma P is an assayed control for use in monitoring the performance of the following parameters in the pathological range:

1. Prothrombin time (PT)
2. Activated partial thromboplastin time (aPTT)
3. Fibrinogen (Clauss method)
4. Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, XII
5. Inhibitors: Antithrombin III, protein C, protein S, a2 --antiplasmin
6. Plasminogen

Control Plasma N is a lyophilized control prepared from pooled human plasma, stabilized with HEPES buffer solution. Control Plasma P is a lyophilized control prepared from pooled human plasma, adjusted to defined factor concentrations, and then stabilized with HEPES buffer solution.

This 510(k) summary (K042209) is for Control Plasma N and Control Plasma P, which are assayed controls for monitoring in vitro coagulation studies. It does not describe an AI medical device, but rather a laboratory control product. Therefore, many of the requested details, such as those related to AI performance, human reader studies, and training/test set specifics, are not applicable to this document.

Here's an analysis based on the provided text, focusing on the concepts that are relevant to this type of device:

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable table as one would for an AI device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the acceptance criterion for these control plasmas is substantial equivalence to their legally marketed predicate devices.

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. For a medical device like a control plasma, the "test set" would typically refer to the samples used during the internal validation studies to demonstrate its performance and equivalence. The summary only states that the "value assignment process has changed for some of the reagents," implying internal testing was conducted to re-establish values and demonstrate equivalence, but no details on sample size or provenance are given.

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 is not applicable in the context of this device. "Ground truth" for an in vitro diagnostic control like this is established through analytical methods and calibration processes against reference materials, not typically by expert review in the way it would be for an image-based AI diagnostic. The "values" for the control plasmas are determined through laboratory procedures.

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

This is not applicable for this type of device. Adjudication methods are used to establish ground truth in complex, subjective diagnostic tasks, often in image interpretation or clinical diagnosis. For a coagulation control, the "truth" (i.e., the assigned values) is determined through analytical testing and statistical methods, not by expert consensus or adjudication.

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. MRMC studies are used to evaluate diagnostic imaging devices with human readers, often involving AI assistance. This document describes a quality control plasma, which does not involve "human readers" interpreting an output in the same way.

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

This is not applicable. This device is a consumable, assayed control plasma, not an algorithm.

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

For this device, the "ground truth" (the assigned values for the various coagulation parameters in the control plasmas) is established through analytical testing and calibration against reference methods/materials. The summary indicates a "value assignment process has changed for some of the reagents," suggesting a laboratory-based method for determining these values. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable. This is not an AI/machine learning device that requires a training set.

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

This is not applicable. As it's not an AI/machine learning device, there is no training set or ground truth in that context.

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Control Plasma N is assayed for use as an accuracy control of the following parameters in the normal range: Prothrombin time (PT); Activated partial thromboplastin time (aPTT); Thrombin time (TT); Batroxobin time; Fibrinogen; Coagulation factors II, V, VII, VIII, VWfF IX, X, XI, XII and XIII ; Inhibitors: Antithrombin III, Protein C, Protein S, as -antiplasmin, C, inhibitor: Plasminogen; Total complement activity**, Lupus anticoagulants. (* Not for BFT ™II analyzer, ** Not available in the U.S.)

Control Plasma N is a Iyophilized control prepared from pooled human plasma. stabilized with HEPES buffer solution. It is an assayed control intended to monitor and evaluate the precision and accuracy of coagulation and fibrinolysis tests in the normal range.

The provided text describes a 510(k) modification for "Dade Behring Inc. Control Plasma N." This product is a control plasma used to monitor the precision and accuracy of coagulation and fibrinolysis tests. The study described focuses on the stability of the control plasma.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states, "In duplicate determinations, reconstituted stability data met the acceptance criteria..." This indicates that the test for stability was performed in duplicate, meaning each stability condition was tested twice.

• Sample Size: "Duplicate determinations" (implies n=2 for each condition tested).
• Data Provenance: The document does not specify the country of origin of the data. Given the manufacturer is Dade Behring Marburg GmbH (Germany) and the contact is Dade Behring Inc. (USA), the testing could have occurred in either location or a combination. The study is prospective as it's testing the stability of the device under defined conditions.

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

This type of study (stability testing of a control plasma) does not typically involve human experts establishing a "ground truth" in the same way as, for example, a diagnostic imaging study. The "ground truth" here is the assigned values of the control plasma, which are determined through standardized assays and extensive validation by the manufacturer, likely involving laboratory scientists and statisticians. The document does not provide details on this process or the number/qualifications of individuals involved in establishing these assigned values.

4. Adjudication Method for the Test Set

Not applicable. As this is a quantitative analytical measurement (recovery within assigned values), there is no "adjudication method" in the sense of expert review or consensus. The results are compared directly against predefined acceptance limits.

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

No. This is a stability study for a laboratory control, not a diagnostic device involving human interpretation of cases. Therefore, an MRMC comparative effectiveness study is not applicable.

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

Yes, in a sense. The "device" (Control Plasma N) itself is a chemical reagent. Its performance is evaluated through laboratory assays. The "standalone" performance here refers to the Control Plasma N maintaining its intended characteristics (i.e., its concentrations/activity of various analytes) over time under specified storage conditions, as measured by standard laboratory tests. There is no "algorithm" in the context of image analysis or AI, but the performance is measured purely instrumentally/analytically without human intervention influencing the concentration results.

7. The Type of Ground Truth Used

The ground truth used here is the assigned values for each parameter (e.g., PT, aPTT, Fibrinogen, etc.) in the Control Plasma N. These assigned values are established by the manufacturer through rigorous testing using reference methods and/or calibrated instruments to determine the expected concentration or activity of each analyte within the control. The stability test then verifies if the values obtained after storage remain within acceptable limits of these assigned ground truth values.

8. The Sample Size for the Training Set

Not applicable. This is a stability study for a control plasma, 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. The "assigned values" for the control material (which serves as the "ground truth" for the stability study) are established by the manufacturer through extensive characterization and validation of the product, typically involving multiple lots and rigorous measurement protocols, prior to its use as a control in other assays. The document doesn't detail this process for the assigned values themselves, only their use in the stability test.

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