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The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended "For In Vitro Diagnostic Use".

The VisuCon-F Low Fibrinogen Control plasma is a pool of de-fibrinated citrated human plasma buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.

The provided text describes a 510(k) premarket notification for a medical device called "VisuCon-F Low Fibrinogen Control Plasma." This document is a regulatory submission to the FDA (Food and Drug Administration) for a Class II medical device.

The core of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials. Therefore, the information provided focuses on the comparison to a predicate device and performance characteristics that support this equivalence, rather than a classical study design with acceptance criteria for a novel AI/imaging device.

Because the request asks for specific details relating to AI/imaging device acceptance criteria and study methodology (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance), it's important to note that the provided document does not contain this type of information. This document is for an in-vitro diagnostic control plasma, not an imaging or AI diagnostic device.

However, I will extract the information that is present in the document and clearly state when the requested information is not available or not applicable based on the document's content.

Here's a breakdown based on the provided text:

Device Description and Intended Use:

• Trade/Device Name: VisuCon-F Low Fibrinogen Control Plasma
• Regulation Number: 21 CFR 864.5425
• Regulation Name: Multipurpose system for in vitro coagulation studies
• Regulatory Class: Class II
• Product Code: GGN
• Predicate Device: Cryocheck Low Fibrinogen Control Plasma (Precision Biologic Inc.)
• Device Description: A pool of de-fibrinated citrated human plasma buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
• Device Intended Use: An assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. It may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. Intended for "In Vitro Diagnostic Use" by trained laboratory personnel in clinical laboratories.

Acceptance Criteria and Device Performance (based on comparison to Predicate):

The document details a "technical comparison" to the predicate device to demonstrate substantial equivalence, rather than defining explicit acceptance criteria in the sense of a target performance threshold for a new AI/imaging algorithm. The study proves the device meets the criteria by exhibiting similar characteristics and performance ("precision") to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are implied by the characteristics and performance of the chosen predicate device, as the goal is to show equivalence, not superiority or meeting an arbitrary threshold. The "study" described is the "technical comparison" presented in the table.

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

• Sample Size for Test Set: The document reports precision data for the proposed device (VisuCon-F Low Fibrinogen Control Plasma) as: Within Run = 3.15%, Between Day = 0.54%, Between Run = 0%, Within Device = 8.44%. It also states the predicate's precision as 2.8 - 3.7% (n=36). However, the specific sample size (N) for the VisuCon-F device's precision calculations (e.g., number of runs, number of days, number of plasma samples) is not explicitly stated in this summary.
• Data Provenance: Not specified in terms of country of origin or whether it's retrospective/prospective. This is an in vitro diagnostic control, so "data provenance" in the sense of patient data is not applicable. The plasma is "human plasma" but no further detail on its origin is provided.

3. 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 control plasma used for quality control of lab assays, not an imaging/AI device requiring expert interpretation or ground truth establishment by medical specialists like radiologists. The "ground truth" for this product would be the established fibrinogen concentration values from the manufacturer's own assay methods and validation, which is common for control plasmas.

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

• Not Applicable. As per point 3, this is an in vitro diagnostic control; expert adjudication methods for imaging or clinical cases are not relevant here.

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 and does not involve human readers or AI assistance in the context of diagnostic interpretation.

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, not an algorithm or an AI device.

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

• For a control plasma, the "ground truth" (or accepted value) is typically the assigned value from the manufacturer's reference method, established through meticulous testing and calibration. This is not derived from expert consensus, pathology, or outcomes data in the clinical sense, but rather from the analytical performance of laboratory instruments and reagents.

8. The sample size for the training set:

• Not Applicable. This is a physical biological control product, not a software algorithm that requires a training set.

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

• Not Applicable. As per point 8, there is no training set for this type of medical device.

In summary, the provided document is a 510(k) submission for an in vitro diagnostic control plasma. The "study" described is a comparison to a predicate device to demonstrate substantial equivalence, focusing on analytical performance characteristics like precision and stability. It does not contain the types of information (e.g., expert-based ground truth, MRMC studies, training/test sets for algorithms) that would be relevant for an AI or imaging-based medical device.

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The VisuCon-F Frozen Coag Screen N plasma is an assayed normal control plasma intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated partial thromboplastin time (APTT) and fibrinogen, in the normal range. The VisuCon-F Frozen Coag Screen N plasma may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents.

The VisuCon-F Frozen Coag Screen ABN plasma is an assayed abnormal control plasma intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated partial thromboplastin time (APTT), in the mid-level abnormal range. The VisuCon-F Frozen Coag Screen ABN plasma may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents.

The VisuCon-F Frozen Coag Screen N is a pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.

The VisuCon-F Frozen Coag Screen ABN is a pool of normal citrated human plasma collected from a minimum of 20 donors, diluted to defined concentrations, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.

The provided text describes two devices, VisuCon-F Frozen Coag Screen N (Normal) and VisuCon-F Frozen Coag Screen ABN (Abnormal), and their substantial equivalence to predicate devices, not a study performing a traditional acceptance criteria evaluation with a test set of data. The document is a 510(k) summary for medical devices, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with a specific set of acceptance criteria and associated results.

Therefore, many of the requested sections (sample size for test set, data provenance, ground truth experts, adjudication, MRMC study, standalone performance, type of ground truth, training set sample size and ground truth) are not applicable to this type of submission.

However, I can extract the "acceptance criteria" in the context of what the device is intended to do and how it compares to its predicate, which serves as the "study" for its claims of substantial equivalence.

Here's the breakdown based on the provided text, focusing on the available information:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate)

The "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate device, as the submission aims to demonstrate substantial equivalence. The "reported device performance" is the device's ability to meet these very similar characteristics.

VisuCon-F Frozen Coag Screen N (Normal Control Plasma)

VisuCon-F Frozen Coag Screen ABN (Abnormal Control Plasma)

Study Details (As applicable to a 510(k) Substantial Equivalence Submission)

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

   • Not Applicable. This document is a 510(k) summary demonstrating substantial equivalence to a predicate device, not a performance study with a specific test set of cases or data. The device itself is a control plasma used in studies, not a diagnostic device being evaluated on patient samples. The device description mentions that the plasmas are collected from a minimum of 20 donors, but this is for the composition of the device, not a test set for performance evaluation.

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

   • Not Applicable. There is no "test set" in the context of diagnostic performance evaluation requiring expert ground truth in this submission.

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

   • Not Applicable. No test set requiring adjudication is described or performed.

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 device is a quality control plasma for coagulation assays, not an AI-assisted diagnostic tool.

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

   • Not Applicable. This is a quality control reagent, not an algorithm.

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

   • Not Applicable. The "ground truth" for these control plasmas is established by their formulation (e.g., normal vs. abnormal range, specific analytes) and performance against recognized reference methods during their manufacturing and validation. The 510(k) focuses on demonstrating that these formulations and expected performance are substantially equivalent to existing, legally marketed controls.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" as this is not a machine learning or AI device.

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

   • Not Applicable. As there is no training set.

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The VisuCal-F Frozen Calibrator plasma is intended for use in the calibration of coaqulation and fibrinolysis assays including the following: fibrinogen (Clauss Method), coaqulation factors II, V, VII, VIII, IX, X, XI, XII, antithrombin activity, alpha-2-antiplasmin, plasminogen, Protein C activity and antigen, Protein S activity and total antigen and von Willebrand factor antigen and Ristocetin Cofactor.

The VisuCon-F Frozen Abnormal Control plasma is intended for use in the quality control of coagulation assays in the borderline pathological range for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, IX, X, XI, XII, antithrombin activity, Protein C activity and Protein S activity.

The VisuCon-F Frozen Normal Control plasma is intended for use in the quality control of coagulation assays in the normal range for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, VIII, IX, X, XI, XII, antithrombin activity, Protein C activity and Protein S activity.

The VisuCal-F Frozen Calibrator Plasma is a pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.

The VisuCon-F Frozen Normal Control Plasma is a pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.

The VisuCon-F Frozen Abnormal Control Plasma is a pool of normal citrated human plasma collected from a minimum of 20 donors, diluted to defined concentrations, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.

The provided document describes three devices: VisuCal-F Frozen Calibrator Plasma, VisuCon-F Frozen Normal Control Plasma, and VisuCon-F Frozen Abnormal Control Plasma. However, the document does not contain an acceptance criteria table or performance study results for any of these devices. Instead, it provides a comparison of the proposed devices to predicate devices to establish substantial equivalence based on similar intended use, product matrix, and performance characteristics.

Therefore, I cannot fulfill your request for an acceptance criteria table or details of a study that proves the device meets specific acceptance criteria. The document focuses on establishing substantial equivalence for regulatory purposes rather than presenting detailed performance data against predefined acceptance criteria.

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The VisuLize™ Factor VIII Antigen Kit is an Enzyme Immunoassay for the quantitative determination of Factor VIII Antigen in human plasma samples and Factor VIII concentrates using the double antibody enzyme linked immuno-sorbent assay (ELISA)

The VisuLize™ Factor VIII Antigen kit is a sandwich enzyme-linked immuno-sorbent assay (ELISA) using a polyclonal antibody coated 96-microwell format. Plasma samples are diluted and applied to the pre-coated wells. After washing away unbound proteins, a horseradish peroxidase (HRP) labelled polyclonal antibody is applied to detect the captured Factor VIII. A chromogenic substrate (TMB) is added to allow for color development. The color formed is measured spectrophotometrically at 450 nm, with the absorbance being directly proportional to the concentration of Factor VIII that was in the sample.

Here's a breakdown of the acceptance criteria and study information for the VisuLize™ Factor VIII Antigen Kit, based on the provided text:

Acceptance Criteria and Device Performance Study for VisuLize™ Factor VIII Antigen Kit

The study compares the performance of the VisuLize™ Factor VIII Antigen Kit (Proposed Device) against the Coamatic® Factor VIII assay (Predicate Device). The primary focus for demonstrating substantial equivalence is correlation in clinical performance, as well as technical performance metrics.

1. Acceptance Criteria and Reported Device Performance

The provided text doesn't explicitly state numerical "acceptance criteria" but rather presents a comparison of performance characteristics and clinical correlation results, implying that demonstrating equivalent performance to the predicate device is the overarching acceptance criterion.

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

• Sample Sizes:
  • Internal Testing: 142 samples
  • External Testing Site #1: 100 samples
  • External Testing Site #2: 81 samples
• Data Provenance: The data was collected through "internal" testing and "two external testing sites." The country of origin is not explicitly stated, but the applicant (Affinity Biologicals Inc.) is based in Canada. The nature of the samples ("clinical samples across the entire detection range") suggests they are human plasma samples. It is not specified if the data is retrospective or prospective.

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

The term "ground truth" is not directly applicable in the sense of expert consensus for image or diagnosis interpretation here. For this type of in vitro diagnostic device (ELISA kit), the "ground truth" for the test set is established by the measurements obtained from the predicate device. The study compares the results of the proposed device against the predicate device on the same clinical samples. Therefore, there are no "experts" establishing a ground truth in the traditional sense; rather, the predicate device serves as the reference standard.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, the predicate device serves as the reference, not a human-adjudicated ground truth. The comparison is quantitative, based on correlation coefficients.

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 done. This study is for an in vitro diagnostic (IVD) kit that measures a biomarker (Factor VIII antigen) directly, not for an AI-assisted diagnostic tool that aids human readers.

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

Yes, the study is a standalone performance evaluation of the IVD kit. The performance metrics (precision, linearity, detection limit, and clinical correlation) directly reflect the kit's ability to measure Factor VIII antigen. It's a "kit-only" performance assessment without explicit human-in-the-loop interaction affecting the measurement results.

7. The Type of Ground Truth Used

The "ground truth" is the results obtained from the predicate device (Coamatic® Factor VIII assay) on the same clinical samples. The study demonstrates correlation between the proposed device's measurements and the predicate device's measurements.

8. The Sample Size for the Training Set

The document does not mention an explicit "training set" or its size. For an IVD kit like this, the development process involves internal validation and optimization, but the concept of a "training set" as used in machine learning is not directly applicable here. The data presented is for the performance evaluation or "test set."

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

Not applicable, as no explicit training set is described in the provided information.

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The VisuLize™ Factor IX Antigen Kit is intended for use as an in vitro diagnostic assay for the quantitative determination of Factor IX antigen in human plasma samples and Factor IX concentrates using the double antibody enzyme linked immuno-sorbent assay (ELISA).

The VisuLize™ Factor IX Antigen kit is a sandwich enzyme-linked immuno-sorbent assay (ELISA) using a polyclonal antibody coated 96-microwell format. Plasma samples are diluted and applied to the pre-coated wells. After washing away unbound proteins, a horseradish peroxidase (HRP) labelled polyclonal antibody is applied to detect the captured Factor IX. A chromogenic substrate (TMB containing H2O2) is added to allow for color development. The color formed is measured spectrophotometrically at 450 nm, with the absorbance being directly proportional to the concentration of Factor IX that was in the sample.

Here's the breakdown of the acceptance criteria and the study details for the VisuLize Factor IX Antigen Kit, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document does not explicitly state numerical acceptance criteria for the VisuLize kit. Instead, it demonstrates "substantial equivalence" to the predicate device by showing comparable or better performance for analytical metrics (precision, linearity, detection limit) and excellent correlation in clinical studies. The "acceptance criteria" are therefore inferred from the comparison to the predicate device, implying that performance similar to or better than the predicate is acceptable.

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

• Internal Testing: 134 samples
• External Testing Site #1: 114 samples
• External Testing Site #2: 109 samples
• Total Test Set Sample Size: 357 samples (134 + 114 + 109)
• Data Provenance: The document states "Testing of clinical samples across the clinical range was conducted internally and by two external testing sites." It doesn't explicitly state the country of origin for the samples or whether they were retrospective or prospective, but the company is based in Ancaster, ON, Canada, hinting at Canadian origin for internal testing. The external sites are not specified geographically. Given this is a 510(k) summary, it's highly likely these were retrospective samples from stored banks, or an observational study, rather than a prospective clinical trial, focused on method comparison.

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

This information is not provided in the document. For an immunoassay like this, the "ground truth" for the clinical performance comparison is the result obtained from the predicate device (Asserachrom IX:AG Kit). The study compares the results of the proposed device to the predicate device, assuming the predicate device provides the established "truth" for Factor IX antigen levels. It doesn't involve expert consensus on the diagnosis of a condition but rather the measurement of an analyte.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication typically refers to resolving discrepancies between multiple readers or diagnostic methods for qualitative assessments (e.g., presence/absence of a disease). In this quantitative assay, the comparison is made between two analytical methods, and statistical measures like Pearson correlation and ANOVA are used to assess agreement, not adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study focuses on human readers' performance with and without AI assistance, which is not relevant for a standalone in-vitro diagnostic (IVD) kit that quantitatively measures an analyte. The study conducted was a method comparison study between a new IVD kit and a legally marketed predicate IVD kit.

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

Yes, a standalone performance study was done. The VisuLize™ Factor IX Antigen Kit is an in-vitro diagnostic assay. Its performance (precision, linearity, detection limit, and correlation with the predicate) was evaluated based on the kit's direct output, without human interpretation or intervention in the measurement itself. The human involvement is limited to performing the assay according to instructions and interpreting the quantitative result.

7. The Type of Ground Truth Used:

The "ground truth" for the clinical performance comparison was the quantitative Factor IX Antigen measurements obtained from the predicate device, the Asserachrom IX:AG Kit. The study aimed to show that the new device produced results consistent with an already legally marketed and accepted device.

8. The Sample Size for the Training Set:

The document does not provide information about a specific "training set" or its sample size. For an ELISA kit, "training" is more about optimizing the assay components and protocol during development rather than training a machine learning model on a distinct dataset. The presented data are for validation/testing of the finalized kit's performance against the predicate.

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

As there is no explicit mention of a "training set" in the context of machine learning, this question is not applicable. The development of the assay would have involved standard laboratory practices for optimizing reagent concentrations, incubation times, wash steps, etc. The "ground truth" during this development phase would have been established through internal validation experiments, likely using reference materials and potentially comparing early versions of the assay to existing methods, but this is not explicitly detailed as a formal "training set" with established ground truth in the context of this 510(k) submission.

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