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Cryov Check™ Factor XI Deficient Plasma is recommended for use as a substrate in clot-based Factor XI assays using the activated partial thromboplastin time (APTT).

Cryo Check™ Factor XI Deficient Plasma is frozen human plasma deficient in the Factor XI coagulation factor. It is prepared from citrated pooled normal human plasma which has been depleted of Factor XI by immunoadsorption. Activity levels of Factor XI are assayed at less than 1% normal levels while all other coagulation factors are within normal ranges.

The provided text describes the 510(k) summary for CryoCheck™ Factor XI Deficient Plasma, focusing on its non-clinical performance data for open vial stability.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided input:

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

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

• Sample Size (Test Set): 5 samples at 0 hours and 5 samples at 24 hours (total of 10 measurements for summary statistics).
• Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. However, it's a non-clinical performance test conducted by the manufacturer, Precision Biologicals Incorporated, located in Dartmouth, Nova Scotia, Canada. The study appears to be prospective as it involves specifically testing the device's stability over time.

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 text. The "ground truth" here is the "known reference plasma" to which the Factor XI assays are compared, but details about its establishment or expert involvement are absent. The test is comparing the device's performance to a "known reference plasma," implying an established standard, but no human expert consensus process is described for this specific test.

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

• This information is not applicable to this type of non-clinical performance study. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where discrepancies among evaluators need to be resolved. This study focuses on objective measurements of Factor XI recovery.

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. This is a non-clinical performance study for an in vitro diagnostic reagent, not an AI-assisted diagnostic tool involving human readers or interpretation.

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

• This information is not applicable. This device is a reagent for laboratory testing; it does not involve algorithms or AI in the way implied by "standalone performance."

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

• The ground truth for this test is a known reference plasma. The Factor XI assays were performed on this reference plasma, and the "recovered factor XI values" using the CryoCheck™ Factor XI Deficient Plasma as a substrate were compared to it. The "reference value" is also implied as the basis for the acceptance criteria "Mean (+/-) 5% of reference value."

8. The sample size for the training set

• This information is not applicable. The device is a diagnostic reagent, not a machine learning model, so there is no concept of a "training set" in this context.

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

• This information is not applicable for the same reasons as point 8.

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Cryo✓Check™ PNP Platelet Lysate is intended for use in the Platelet Neutralization Procedure (PNP) which is useful in detecting the presence of lupus anticoagulants (LA) in human plasma.

Cryo Check™ PNP Platelet Lysate is prepared from human platelets obtained from normal healthy donors. The platelets are collected, washed, and resuspended in buffer and then frozen and thawed to yield a suspension of ruptured platelet membranes. This suspension is aliquoted into cryovials and stored frozen.

The provided text describes the performance of the Cryo✓Check™ PNP Platelet Lysate, but it does not explicitly state acceptance criteria in a formal, quantifiable manner. Instead, the conclusions of the non-clinical performance data serve as the de facto acceptance criteria, implying that the device's performance should be "comparable," "consistent," and "stable" to that of the predicate device or under various conditions.

Here's an attempt to structure the information based on the provided text, interpreting the conclusions as the performance goals the device met:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test 1 (PNP Comparison to Predicate Device):

  • Sample Size: 5 normal plasma samples, 10 lupus plasma samples.
  • Data Provenance: Not explicitly stated, but clinical samples are implied ("normal and known lupus anticoagulant positive patient samples"). Likely in vitro/laboratory-based.

• Test 2 (8 Hour Open Vial Stability):

  • Sample Size: 5 vials of Cryo✓Check™ PNP Platelet Lysate paired with one "Normal Plasma: Cryo✓Check™ Normal (CCN)" and one "Lupus Plasma: Cryo✓Check™ Lupus (CCLP)".
  • Data Provenance: In vitro, using commercially available control plasmas.

• Test 3 (14 Hour On-Board Stability):

  • Sample Size: One lot of Cryo✓Check™ PNP Platelet Lysate tested with three control plasmas (Normal, Lupus Positive, HRF "in-house" positive control) over 14 time points.
  • Data Provenance: In vitro, using commercially available and "in-house" control plasmas.

• Test 4 (Coagulation Analyzer Comparison):

  • Sample Size: 25 normal patient samples.
  • Data Provenance: Not explicitly stated, but "Normal Patient Samples" implies retrospective or prospective collection from patients. Likely from Canada, given the submitter's location.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is a diagnostic reagent, and the 'ground truth' in these studies is established by the clinical classification of the plasma samples (normal vs. lupus anticoagulant positive) and measurement against established laboratory methods (APTT, Platelet Neutralization Procedure). No human expert interpretation of images or other subjective data is involved. The ground truth for plasma samples (e.g., "Lupus Plasma") would have been established through prior diagnostic testing, but the details of those classifications are not provided.

4. Adjudication Method for the Test Set

Not applicable. As this involves laboratory measurements with quantitative outputs (seconds for APTT and correction), not subjective interpretation, an adjudication method for a test set is not relevant in the way it would be for, e.g., image analysis by multiple readers.

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 used for diagnostic imaging devices where human readers interpret cases with or without AI assistance. The described studies are non-clinical performance evaluations of a laboratory reagent.

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

Yes, the studies described are standalone performance evaluations in the context of a laboratory reagent. The device (Cryo✓Check™ PNP Platelet Lysate) is evaluated on its own performance characteristics (specificity, stability, consistency) in conjunction with standard laboratory instruments and established protocols (PNP, APTT). There is no "human-in-the-loop" AI component.

7. The Type of Ground Truth Used

The ground truth used for these studies is clinical classification of patient plasma samples (normal vs. known lupus anticoagulant positive) and established laboratory methods (specifically, the Platelet Neutralization Procedure (PNP) and Activated Partial Thromboplastin Time (APTT) measurements). For the stability and analyzer comparison studies, commercially available control plasmas and patient samples classified as "normal" or "lupus positive" served as the reference.

8. The Sample Size for the Training Set

Not applicable. This device is a laboratory reagent; there is no mention of an algorithm or AI that would require a "training set." The studies performed are validation studies for the performance characteristics of the physical reagent.

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

Not applicable, as there is no training set for an algorithm.

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CryovCheck™ Factor XII Deficient Plasma is recommended for use as a substrate in clot-based Factor XII assays using the activated partial thromboplastin time (APTT) assay.

Cryo✓Check™ Factor XII Deficient Plasma is frozen human plasma deficient in the Factor XII coagulation factor. It is prepared from citrated pooled normal human plasma which has been depleted of Factor XII by immunoadsorption. Activity levels of Factor XII are assayed at less than 1% normal levels while all other coagulation factors are greater than 50%.

Acceptance Criteria and Study Details for Cryo✓Check™ Factor XII Deficient Plasma

The device's performance was evaluated through an "Open Vial Stability" study.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Sample Size for Test Set: 5
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, given that Precision Biologicals Incorporated is located in Dartmouth, Nova Scotia, Canada, it is likely the study was conducted in Canada. The nature of stability testing suggests it was a prospective study.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This study focuses on the stability of a diagnostic reagent, not on interpreting images or clinical cases that would require expert consensus for ground truth. The "ground truth" reference value would be established by the assay's own internal standards.

4. Adjudication Method

Not applicable. The study involved quantitative measurements of factor XII activity, not subjective assessments requiring adjudication.

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

Not applicable. This is not a study comparing human readers with and without AI assistance. It's a stability study for a diagnostic reagent.

6. Standalone Performance

The study primarily evaluates the standalone performance of the Cryo✓Check™ Factor XII Deficient Plasma in terms of its ability to maintain its reference value over time.

7. Type of Ground Truth Used

The ground truth used is a reference value established by the assay itself. The document states "Reference Value =" and implies the reported mean, maximum, and minimum values are compared against this reference. The specific method for determining this absolute reference value is not detailed, but it would typically involve calibrating against known standards.

8. Sample Size for Training Set

Not applicable. This is not a machine learning or AI-based device that requires a training set.

9. How Ground Truth for Training Set was Established

Not applicable. No training set was used.

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The Prothrombin Time (PT) was first described by Quick and is a common method of monitoring oral anticoagulant treatment in patients receiving warfarin and related drugs. The safety and efficacy of oral anticoagulant therapy is dependent on regular and appropriate laboratory monitoring of the PT test which measures the depression of clotting factors II, VII and X. In 1983 the World Health Organization (WHO) described a scheme for PT standardization based on the International Normalized Ratio (INR). The INR is defined as the Prothrombin Ratio (PR) of the patient raised to the power of the International Sensitivity Index (ISI) of the thromboplastin reagent in use such that INR=PR'S!

With the recent proliferation in both commercial thromboplastins and automated coagulation analyzers, the number of PT system combinations has increased significantly. This, in conjunction with the increasing prevalence of the INR reporting system, has resulted in a heightened awareness of variability in test results between laboratories reporting INR's.

CryoCheck INR Validation Set has been designed to enhance the effective monitoring of oral anticoagulant therapy by providing a set of well characterized warfarinized plasmas with system specific INR assigned ranges.

CryoCheck INR Validation Set is indicated for use in monitoring the accuracy and control of oral anticoagulant therapy using the International Normalized Ratio (INR) on a variety of prothrombin time systems. CryoCheck INR Validation Set is not intended for use as calibration or reference plasma and should not be used for calibrating the local International Sensitivity Index (ISI) of commercial. thromboplastins.

Not Found

The provided text is a 510(k) premarket notification approval letter for the "CryoCheck™ INR Validation Set" and does not contain information regarding acceptance criteria, device performance, or a study report. The document primarily focuses on the FDA's determination of substantial equivalence to a legally marketed predicate device.

Therefore, I cannot extract the requested information such as acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study results, standalone performance, ground truth types, or training set details from the provided text.

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CryoCheck APC Resistant Plasma is indicated for use as a positive control in the clot based assessment of activated protein C resistance in citrated human plasma.

CryoCheck APC Resistant Plasma

The provided text is a 510(k) clearance letter from the FDA for a device called "CRYOV CHECK™ APC RESISTANT PLASMA." It confirms that the device is substantially equivalent to a predicate device and can be marketed.

However, the document does not contain any information about acceptance criteria for device performance, nor does it detail any study that proves the device meets specific performance criteria. It is a regulatory approval document, not a scientific study report.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based only on the provided text. The requested information (sample size, data provenance, expert details, adjudication, MRMC study, standalone performance, ground truth, training set size, training set ground truth) is not present in this regulatory letter.

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CryoCheck Factor V Deficient Plasma is human plasma deficient in the factor V coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor V deficiencies in in vitro clot-based factor V assays using the one stage prothrombin time.

CryoCheck Factor V Deficient Plasma is human plasma deficient in the factor V coagulation protein while having all other coagulation factors within normal limits.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "CryoCheck Factor V Deficient Plasma." This document confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed.

However, the document does not contain any information regarding acceptance criteria, study data, sample sizes, expert qualifications, adjudication methods, or detailed performance metrics of the device as requested in your prompt. It is a regulatory approval letter, not a detailed technical or clinical study report.

Therefore, I cannot extract the requested information from this text.

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CryoCheck Factor X Deficient Plasma is human plasma deficient in the factor X coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor X deficiencies in in vitro clot-based factor X assays using the one stage prothrombin time.

CryoCheck Factor X Deficient Plasma is human plasma deficient in the factor X coagulation protein while having all other coagulation factors within normal limits.

This document is a 510(k) clearance letter for the "CryoCheck Factor X Deficient Plasma" device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (i.e., with performance metrics like sensitivity, specificity, or accuracy compared to a ground truth).

The letter merely states that the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device, allowing it to be marketed. The described "Indications For Use" explain how the device functions to assess factor X deficiencies but do not provide performance metrics or details of a study.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval, not a scientific study report or clinical trial summary.

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CryoCheck Factor IX Deficient Plasma is human plasma deficient in the factor IX coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor IX deficiencies in in vitro clot-based factor IX assays using the activated partial thromboplastin time.

CryoCheck Factor IX Deficient Plasma is human plasma deficient in the factor IX coagulation protein while having all other coagulation factors within normal limits.

This document, a 510(k) clearance letter for the CryoCheck Factor IX Deficient Plasma, does not contain the requested information about acceptance criteria and the study proving the device meets those criteria.

The letter is a regulatory document from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. It focuses on:

• Regulatory classification: Class II, Product Code GJT.
• Substantial equivalence: The FDA's determination that the device is as safe and effective as a predicate device.
• Compliance requirements: Mentioning general controls, GMP, and other regulations.
• Instructions for marketing: Allowing the manufacturer to market the device.
• Contact information: For further regulatory questions.
• Indications for Use: Briefly describing what the device is used for.

The information you are looking for (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) would typically be found in the 510(k) summary or the detailed study reports submitted by the manufacturer to the FDA, not in the clearance letter itself.

Therefore, I cannot provide a table of acceptance criteria, device performance, or details about the study, as that information is not present in the provided text.

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CryoCheck Factor VII Deficient Plasma is human plasma deficient in the factor VII coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor VII deficiencies in in vitro clot-based factor VII assays using the one stage prothrombin time.

CryoCheck Factor VII Deficient Plasma is human plasma deficient in the factor VII coagulation protein while having all other coagulation factors within normal limits.

This document does not contain the information required to answer your request. It is a 510(k) clearance letter for a medical device (CryoCheck Factor VII Deficient Plasma), which primarily focuses on establishing substantial equivalence to a predicate device and regulatory compliance. It does not include details on acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment.

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CryoCheck Factor VIII Deficient Plasma is human plasma deficient in the factor VIII coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor VIII deficiencies in in vitro clotbased factor VIII assays using the activated partial thromboplastin time.

CryoCheck Factor VIII Deficient Plasma is human plasma deficient in the factor VIII coagulation protein while having all other coagulation factors within normal limits.

The provided text is a 510(k) clearance letter from the FDA for a device called "CryoCheck Factor VIII Deficient Plasma." This document does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment relevant to an AI/ML device.

The letter is a regulatory approval for an in vitro diagnostic product, not a software device, and primarily states that the device is substantially equivalent to existing devices. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, or AI/ML specific metrics.

To provide the requested information, a different type of document, such as a clinical study report, a performance evaluation report, or a 510(k) summary for an AI/ML device, would be necessary.

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