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This kit is intended for the quantitative in vitro determination of human C4 in serum using the Binding Site SPAPLUS™ turbidimetric analyser. This test should be used in conjunction with other laboratory and clinical findings

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The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. It is a 510(k) clearance letter from the FDA for a device called "Human C4 Kit for use on SPAPLUS™," indicating that the device is substantially equivalent to legally marketed predicate devices.

The document includes:

• Device Name: Human C4 Kit for use on SPAPLUS™
• Intended Use: For the quantitative in vitro determination of human C4 in serum using the Binding Site SPAPLUS™ turbidimetric analyser. To be used in conjunction with other laboratory and clinical findings.
• Regulatory Information: Regulation Number, Regulation Name, Regulatory Class, Product Code, and 510(k) Number.

However, it does not provide the following information requested in the prompt:

1. A table of acceptance criteria and the 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. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with AI vs without AI assistance.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document is a regulatory approval notice, not a detailed study report describing performance characteristics against acceptance criteria.

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In vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative immunological determination of human complement C4 in serum and plasma. Aid in detecting the presence and level of C4 found in autoimmune diseases, infections and inflammatory disorders.

The Tina-quant Complement C4 Test System is based on the activation of the complement system which takes place via a classical and alternative route. Complement factor C4 participates in activation by the classical route. Human C4 forms a precipitate with a specific antiserum which is determined turbidimetrically.

Here's an analysis of the provided information regarding the acceptance criteria and study for the Tina-quant Complement C4 ver.2 Test System:

This document is a 510(k) summary for a diagnostic test, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results and acceptance criteria in the same way one might find for a novel therapeutic device. Therefore, some of the requested information (like expert qualifications, adjudication methods, MRMC studies, and detailed ground truth for training) is not explicitly present or directly applicable in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated for substantial equivalence to a predicate device, focusing on analytical performance rather than a specific clinical outcome with acceptance criteria. The "acceptance criteria" here are implied by the comparison to the predicate's performance specifications.

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

The provided 510(k) summary does not explicitly state the sample size used for any specific test set related to validation studies. It focuses on the descriptive comparison to the predicate device.

The data provenance is not specified. For in vitro diagnostic devices, studies typically involve human serum and/or plasma samples, which could be collected prospectively or retrospectively from various geographical locations. However, this detail is not present in the summary.

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 510(k) summary. For a diagnostic test like C4, the "ground truth" for analytical performance (sensitivity, measuring range) is established through laboratory methods and reference materials, not typically by expert interpretation of individual cases. If clinical correlation studies were performed, expert medical opinion might be involved, but this document does not detail such studies.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary, as it's not relevant for demonstrating analytical performance through comparison to a predicate device. Adjudication methods are typically used in studies involving human interpretation or subjective assessments.

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, nor would it be expected for this type of in vitro diagnostic device (a quantitative immunological assay for C4). MRMC studies are typically performed for imaging devices or other tools where human readers interpret complex data.

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

Yes, the testing described implicitly represents a "standalone" performance evaluation. The Tina-quant Complement C4 ver.2 Test System is an automated in vitro diagnostic assay. Its performance (analytical sensitivity, measuring range, etc.) is measured directly by the instrument, without human interpretation of the primary data output. Human "in-the-loop" would involve clinicians interpreting the numerical results, but the device's performance itself is standalone.

7. The Type of Ground Truth Used

For the analytical performance metrics (analytical sensitivity, measuring range), the ground truth is established through:

• Reference materials/calibrators: Known concentrations of C4 used to calibrate the assay and determine its range.
• Performance characteristics of the predicate device: The predicate's established performance serves as the benchmark against which the modified device is compared to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

The provided 510(k) summary does not specify a "training set" size. For an in vitro diagnostic assay, development and optimization would involve various samples, but this is distinct from "training data" in artificial intelligence/machine learning contexts.

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

Since a "training set" as understood in AI/ML is not applicable here, the method of establishing ground truth for it is also not applicable. The development and validation of an IVD assay involve rigorous analytical studies with characterized samples and reference materials to establish its performance specifications.

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The C4 Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure complement C4 (C4) in serum as an aid in the diagnosis of immunologic disorders associated with complement C4 protein.

The C4 Flex® reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay using endpoint detection, based on the precipitation of complement C4 by its polyclonal antibody.

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

Acceptance Criteria and Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: 94 clinical patient samples.
   • Data Provenance: Not explicitly stated, but the reference to "clinical patient samples" typically implies data from a clinical setting, often prospective or collected retrospectively for validation. The country of origin is not specified.

2. 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. The study compares the new device to a predicate device, and the "ground truth" essentially comes from the established method of the predicate device.

3. Adjudication Method for the Test Set:

   • Not applicable. This was a direct comparison study (split sample comparison) between two methods of measuring C4, not an interpretive one requiring adjudication of expert opinions.

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

   • No. This was a technical performance comparison between two in vitro diagnostic devices, not a study involving human readers interpreting results or making clinical decisions.

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

   • Yes, this was a standalone performance study of the C4 Flex® Reagent Cartridge. Its performance was compared against the Beckman Array® Complement C4 Assay.

6. The Type of Ground Truth Used:

   • The "ground truth" in this context is the results obtained from the predicate device, the Beckman Array® Complement C4 Assay. This method is assumed to be an established and accepted method for measuring C4.

7. The Sample Size for the Training Set:

   • Not specified. The document describes a validation study comparing the new device to a predicate, not the development or training of the new device itself.

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

   • Not applicable, as a training set and its ground truth establishment are not discussed in this document, which focuses on the validation of the device against a predicate.

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This assay is designed for the in vitro measurement of human C4 in serum using the MININEPH analyzer as an aid in the diagnosis of abnormal C4 metabolism.

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I am sorry, but based on the provided document, the information you are requesting about acceptance criteria and a study proving a device meets these criteria is not present. The document is an FDA 510(k) clearance letter for a device called "C4 Minineph Antiserum." It confirms the device's substantial equivalence to a predicate device and its regulatory classification, but it does not detail:

• Specific acceptance criteria for performance metrics.
• A study proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance, expert qualifications, or adjudication methods.
• Results of MRMC comparative effectiveness or standalone studies.
• How ground truth was established for training or test sets.

The document primarily states the device's "Indications for Use" which is for "in vitro measurement of human C4 in serum using the MININEPH analyzer as an aid in the diagnosis of abnormal C4 metabolism."

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The K-ASSAY C4 Assay is intended to be used for the quantitative determination of C4 in human serum. Complement is a group of serum proteins which destroy cells by immunologically mediated lysis. Quantitative determination of these proteins aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components.

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This is a 510(k) clearance letter for the K-ASSAY C4 device, dated November 30, 1999. It states that the device is substantially equivalent to legally marketed predicate devices. This type of document, particularly one from 1999, typically does not contain the detailed study information you are requesting. The focus of a 510(k) is to demonstrate substantial equivalence, not to provide comprehensive performance study results in the same way a PMA or a more recent device submission might.

Therefore, many of the requested data points (acceptance criteria, specific performance metrics, sample sizes, ground truth details, expert qualifications, MRMC studies, etc.) are not available in this document.

However, I can extract the following limited information:

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

This document does not contain a table of acceptance criteria or reported device performance metrics. The FDA letter grants clearance based on substantial equivalence to a predicate device, meaning detailed performance data against specific acceptance criteria is not typically outlined in the clearance letter itself. Such data would be found in the 510(k) submission itself, which is not provided here.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not available in this document.

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/Not available in this document. For an in-vitro diagnostic device like K-ASSAY C4, "ground truth" would typically be established by reference methods or clinical diagnosis, not by experts adjudicating image data. However, the details of how any reference range or accuracy was established are not present here.

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

Not applicable/Not available in this document.

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. The K-ASSAY C4 is an in-vitro diagnostic assay for quantitative determination of C4, not an AI-assisted diagnostic imaging device that would involve human readers.

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

Not applicable. As an in-vitro diagnostic assay, its performance is inherently "standalone" in its measurement, but the specific validation study details are not provided.

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

For an in-vitro diagnostic assay like K-ASSAY C4 (which quantifies C4 in human serum or plasma), "ground truth" for validation would typically be established through reference methods, comparison to established predicate devices, and potentially clinical correlation with disease states known to affect C4 levels. However, the specifics of how this was established for this particular submission are not described in this document.

8. The sample size for the training set:

Not applicable/Not available in this document. This is a clearance letter for a 1999 device, likely not an AI/ML device that would refer to "training sets."

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

Not applicable/Not available in this document. (See above, not an AI/ML device in the context of "training set").

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The C4 assay is used for the quantitation of C4 in human serum or plasma. Complement is a group of serum proteins which destroy infectious agents. Measurement of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 604 nm, which correlates with the concentration of C4 in the sample.

Here's an analysis of the provided text regarding the C4 assay's acceptance criteria and the study proving its performance:

Considering the nature of the device (an in vitro diagnostic assay for quantitative C4 determination), some of the requested information (like multi-reader multi-case studies, ground truth established by experts like radiologists, or pathology) are not directly applicable to this type of medical device. The focus for IVD assays is typically on analytical performance characteristics and comparison to a predicate device.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • The document states "Comparative performance studies were conducted." However, the exact sample size for the method comparison or precision studies (e.g., number of patient samples, number of replicates) is not explicitly mentioned in the provided summary.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) submission for an in vitro diagnostic, it's highly likely to be prospective clinical laboratory testing.

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

   • Not applicable in the traditional sense for this type of in vitro diagnostic device. "Ground truth" for an IVD assay's analytical performance is typically established by:
     • Reference Methods: The predicate device itself (K-ASSAY C4 assay on Hitachi 717 Analyzer) serves as the "reference standard" against which the new device's performance is compared.
     • Control Materials: Certified or well-characterized control materials are used for precision studies.
     • Standard Analytical Procedures: Following established laboratory protocols for performing the tests.
   • There isn't a need for a panel of "experts" (like radiologists interpreting images) to establish ground truth for quantitative biochemical measurements in this context.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments (e.g., image interpretation) where multiple human readers disagree. For quantitative assays comparing numerical results, statistical methods like correlation coefficients, slope, and intercept are used for comparison, and precision is measured directly.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. This type of study is primarily relevant for imaging devices or other diagnostic tools where human interpretation plays a significant role and the benefit of AI assistance for human readers can be quantified. The C4 assay is an automated in vitro diagnostic test, so there is no "human reader" in the loop for interpretation in the same way.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, effectively. The reported performance characteristics (correlation, precision, assay range, sensitivity) are inherently "standalone" as they describe the analytical performance of the C4 assay system (reagents and AEROSET™ Analyzer) without human interpretive input. The C4 assay is the algorithm/device under evaluation.

6. Type of Ground Truth Used:

   • For the method comparison, the "ground truth" was established by the results obtained from the legally marketed predicate device (K-ASSAY C4 assay on the Hitachi 717 Analyzer). This is a common form of "truth" for demonstrating substantial equivalence for new IVD devices.
   • For precision, the ground truth involves the known values of the control materials and the statistical calculation of variability from repeated measurements.

7. Sample Size for the Training Set:

   • Not applicable/Not mentioned. This device is an in vitro diagnostic assay, not an AI/Machine Learning algorithm that undergoes a "training phase" in the traditional sense. The development of such assays involves reagent formulation, instrument calibration, and optimization based on chemical and analytical principles, not on "training data" for a learning algorithm.

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

   • Not applicable for the reasons stated above. There isn't a "training set" with established ground truth in the context of this chemical assay.

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The N-4ssay TIA Test Kit is intended to be used for the quantitative determination of human (4 (4th complement component) in human serum by immunoturbidimetric assay. Cl4 aids in the diagnosing of immunological disorders, especially the entile with complement deficiency disorders, with complement deficiency disorders.

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The provided text is a 510(k) clearance letter from the FDA for a device called "N-Assay TIA C4 Test Kit." This document does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth establishment or expert involvement.

The letter primarily confirms that the device has been found substantially equivalent to a legally marketed predicate device and can therefore be marketed. It also provides regulatory information and contact details.

Therefore, I cannot extract the requested information from the provided input.

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The N-Assay TIA Multi V-NL Calibrator is intended to be used to calibrate the Crestat N-Assay TIA test Kits used To Carrorate the Orosas av C4 Test Kit, N-Assay Transferrin Test Kit, N-Assay Haptoglobin Test Kit, N-A66ay Alphael-Acid Glycoprotein Test Kit. The test kits are to be run on human serum.

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This document is a marketing approval letter from the FDA for a medical device (N-Assay TIA Multi V-NL Calibrator). It confirms that the device is substantially equivalent to previously marketed devices and can be sold. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information based solely on the text provided. This document is a regulatory approval, not a scientific study report.

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