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In vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, IgA and IgM) in human serum, heparinized and EDTA plasma, and IgG in human urine and cerebrospinal fluid (CSF) by means of immunonephelometry on the BNTM Systems. Measurement of immunoglobulins aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

N/T Protein Control LC is intended for use as an assayed intralaboratory quality control for assessment of precision and analytical bias in immunochemical determination of the proteins IgG in CSF, IgA in CSF, IgM in CSF, IgG in urinc, transferrin in urine, albumin in urine and CSF, a1-microglobulin in urine and total protein in urine and CSF, using the BNTM Systems.

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM): Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

N/T Protein Control LC: The N/T Protein Control LC is a multi-analyte, lyophilized, polygeline and rabbit albumin based product.

The provided text describes a 510(k) summary for N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) and N/T Protein Control LC. However, it does not contain detailed acceptance criteria and a study proving the device meets these criteria in the format requested.

The document primarily focuses on establishing substantial equivalence to previously marketed devices based on the general operating principle, reagent composition, and a single method comparison dato point. There is no mention of a traditional "acceptance criteria" table with specific thresholds for performance metrics (such as sensitivity, specificity, accuracy) and corresponding study results to demonstrate compliance.

Therefore, many of the requested sections, such as sample size for the test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for the training set, are not available in the provided text.

Based on the available information, here's an attempt to answer the questions:

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

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The "Method Comparison Data" section does not provide these details.

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 provided. This is a comparison of quantitative assays, not an expert-driven diagnostic review. The "ground truth" for the method comparison appears to be the results obtained by the predicate device.

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

Not applicable / Not provided. Adjudication methods are typically relevant for expert review in image analysis or clinical diagnosis scenarios.

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 a submission for in vitro diagnostic reagents and controls, not an AI-assisted diagnostic device involving human readers.

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

This refers to the performance of the device itself (the N Antisera and N/T Protein Control LC reagents/systems) as a standalone diagnostic tool. The method comparison data is effectively a standalone performance assessment of the device against a predicate, focusing on quantitative agreement. The reported correlation coefficient of 0.99 for IgG demonstrates its standalone performance relative to the predicate.

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

The "ground truth" for the method comparison study was the measurements obtained from the legally marketed predicate device, the Beckman Coulter IMMAGE® Immunochemistry Systems Urine Immunoglobulin G (IGU) (K951635).

8. The sample size for the training set

Not applicable / Not provided. This is a traditional IVD device clearance, not an AI/machine learning device that would typically involve a separate "training set." The development of the reagents/system itself would have involved extensive R&D and calibration, but not in the context of a "training set" for an algorithm.

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

Not applicable / Not provided for the reasons stated in point 8.

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N Latex HCY: In vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry on the BN™ II and BN ProSpec® Systems. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

N Protein Standard SL: Establishment of reference curves for the determination of IgG, IgG14, IgA, IgM, IgE, C3c, C4, transferrin, albumin, α-antitrypsin, α--macroglobulin, haptoglobin, α -- acid glycoprotein, prealbumin, hemopexin, ceruloplasmin, RbP, (g/L-chain lambda & kappa, soluble transferrin receptor, ferritin, ß2-microglobulin, total protein and homocysteine by immunonephelometry with BN™ Systems.

N/T Protein Control SL/L, M and H: N/T Protein Controls SL/L, M, and H are for use as accuracy and precision assayed controls in the determination of the following human serum proteins by immunonephelometry with BN™ Systems: IgG, IgGr.4, IgM, C3c, C4, transferrin, albumin, αγ-antitrypsin, α₂-macroglobulin, haptoglobin, α - acid glycoprotein, prealbumin, hemopexin, ceruloplasmin, RbP, Ig/L-chain lamhda & Rogioa, βmicroglobulin, soluble transferrin receptor, ferritin, IgE, total protein and homocysteine.

Bound homocysteine in the sample is reduced to free homocysteine by the action of dithiothreitol, and converted enzymatically to S-adenosyl-homocysteine (SAH) in the next step. Conjugated S-adenosyl-cysteine (SAC), added at the onset of the reaction, competes with the SAH in the sample for bonding by anti-SAH antibodies bound to polystyrene particles. In the presence of SAH, there is either no aggregation or a weaker aggregation of particles. In the absence of SAH in the sample, an aggregation of the polystyrene particles by the conjugated SAC occurs. The higher the SAH content of the reaction mixture is, the smaller the scattered light signal. The result is evaluated by comparison with a standard of known concentration.

Here's a breakdown of the acceptance criteria and study details for the N Latex HCY device, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document states that the N Latex HCY assay was compared to the Abbott IMx HCY assay, and the regression analysis results (slope, intercept, and correlation coefficient) are presented. The implicit acceptance criteria here is that the N Latex HCY assay demonstrates strong agreement and equivalence with the legally marketed predicate device. A correlation coefficient of 0.99, a slope close to 1, and an intercept close to 0 typically indicate excellent agreement between two assays.

Study Details

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

   • Sample Size: 73 plasma samples.
   • Data Provenance: Not specified within the provided text (e.g., country of origin, retrospective or prospective).

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

   • Not applicable as this is a quantitative chemical assay being compared to a predicate device, not, for example, an image-based diagnostic relying on expert reads. The "ground truth" for the test set is established by the measurements from the predicate device (Abbott IMx HCY assay).

3. Adjudication method for the test set:

   • Not applicable. The study involves a direct comparison of quantitative results between the candidate device and a predicate device, not an expert panel adjudication.

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:

   • No. This is a comparison study of a diagnostic assay (N Latex HCY) against a predicate device (Abbott IMx Homocysteine Assay) and does not involve human readers or AI assistance in the context of MRMC studies.

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

   • Yes, the study describes the standalone performance of the N Latex HCY device by comparing its quantitative results directly to those of the Abbott IMx HCY assay. The device itself is an automated in vitro diagnostic reagent system.

6. The type of ground truth used:

   • The "ground truth" in this context is the results obtained from the legally marketed Abbott IMx Homocysteine Assay (K992858), which serves as the reference method for establishing substantial equivalence.

7. The sample size for the training set:

   • Not applicable. This document describes a clinical comparative study for substantial equivalence, not the development or training of an algorithm via a training set. The N Latex HCY system is a reagent and instrument-based assay, not an AI/ML algorithm that requires a separate training set.

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

   • Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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N/T Protein Control LC is intended for use as an assayed accuracy and precision control for immunochemical determination of IgA, IgG and IgM in CSF, transferrin and a - microglobulin in urine, albumin and total protein in urine and CSF using the BN™ Systems and also for IgG in CSF and albumin in urine and CSF, using the TurbiTime System.

N/T Protein Control LC is a lyophilized control prepared from human urine and serum proteins with polygeline, rabbit albumin, and preservative. It is intended to be used as an accuracy control for the determination of human proteins in urine and CSF by immunonephelometry with the BN™ Systems and by immunoturbidimetry with the TurbiTimeSystem.

The provided text describes a 510(k) Notification-Modification for Dade Behring Inc.'s N/T Protein Control LC. This is a quality control material, not a medical device in the typical sense that would diagnose or treat a condition, and as such, the performance criteria and supporting data differ significantly from what would be expected for an AI-powered diagnostic device.

Therefore, many of the typical questions for AI acceptance criteria (like effect size with AI assistance, expert qualifications, adjudication methods, training set details) are not applicable to this type of device.

Here's the information that can be extracted and a clear indication of what is not applicable:

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: Not explicitly stated in terms of a "test set" for performance evaluation in the way a diagnostic device would typically have. The stability was evaluated "according to in-house protocols," implying internal testing rather than a large, independent clinical test set.
• Data Provenance: The stability evaluation was done "according to in-house protocols" by Dade Behring Marburg GmbH and Dade Behring Inc. This indicates internal, company-generated data. It's likely prospective testing conducted in a laboratory setting. No country of origin for external data is mentioned as it's an internal study.

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

• Not Applicable. This is a quality control material. Ground truth for its performance would be established by analytical methods and reference standards for stability, not by expert consensus on clinical findings.

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

• Not Applicable. See point 3.

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 not an AI-powered diagnostic device; it's a quality control material.

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

• Not Applicable. This is not an algorithm or AI device. Its performance is inherent to its chemical composition and manufacturing control.

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

• Analytical Standards/Internal Protocols: The ground truth for stability would be based on established analytical chemistry methods and internal stability protocols, comparing the control's performance over time against its initial validated values using specified instrumentation (BN™ Systems and TurbiTimeSystem).

8. The sample size for the training set

• Not Applicable. This product is not an AI algorithm that requires a "training set."

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

• Not Applicable. See point 8.

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N/T Protein Controls SL/L, M, and H are for use as accuracy and precision assayed controls in the determination of the following human serum proteins by immunonephelometry with BN™ Systems: IgG, IgG7, IgA, IgM, C3c, C4, Transferrin, in Innonophobionou y ma2-macroglobulin, Haptoglobin, α--acid glycoprotein, Prealbumin, Albumin, c.y antill Jpon) @2 maor J.g/L-chain lambda & kappa, β2-microglobulin, soluble Transferrin Receptor (STFR), Ferritin, IgE, and Total protein; and by immunoturbidimetry with the TurbiTimeSystem: IgG, IgA, IgM, C3c, C4, Transferrin, Albumin, Haptoglobin, α4acid glycoprotein.

N/T Protein Control SL is a liquid control prepared from human serum with sfabilizers and preservative. It is intended to be used as an accuracy and precision control for the presentation of human serum proteins by immunonephelometry with BN™ Systems and by immunoturbidimetry with the TurbiTimeSystem.

Here's an analysis of the provided text, outlining the acceptance criteria and the study details for the N/T Protein Control SL device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document primarily focuses on stability as the performance characteristic. It doesn't explicitly state quantitative acceptance limits for accuracy or precision, but rather implies they are met based on the "substantially equivalent" claim to a predicate device.

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

The provided document does not explicitly state the sample size used for the test set. It mentions "Dade Behring protocols" for stability evaluation but gives no details about the number of samples or runs.

The data provenance is not specified in terms of country of origin. The study appears to be prospective in nature, as it describes evaluations performed to support the 510(k) submission for this specific device.

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. The device is a quality control material and its performance evaluation for stability would not typically involve expert ground truth in the same way a diagnostic imaging device would. The "ground truth" here would be the measured analyte concentrations and their stability over time, determined by the instrument itself.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable for this type of device and study. Adjudication methods are typically used to resolve discrepancies in expert interpretations (e.g., in clinical trials or diagnostic studies), which is not relevant for evaluating the stability of a control material.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. The N/T Protein Control SL is a quality control material, not a diagnostic device requiring human reader interpretation or AI assistance.

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

A standalone performance study was not applicable/not done in the context of an algorithm. This device is a chemical control material for laboratory instruments, not an AI algorithm. Its "performance" refers to its chemical and physical stability and its ability to produce consistent results on specified analytical systems.

7. The Type of Ground Truth Used

For this device (a quality control material), the "ground truth" for the performance evaluation (stability) is established through instrument measurements of known analyte concentrations at different time points and under different conditions. The "accuracy" and "precision" mentioned in the intended use refer to the device's ability to verify the accuracy and precision of an analytical system using its known analyte values. The stability study aims to ensure these known values remain constant over time.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. This device is a control material, not an algorithm that requires training data.

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

Since there is no "training set" for this device, this question is not applicable.

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N/T Protein Control LC is intended for use as an assayed accuracy control for immunonephelometric determination of the proteins α--microglobulin in urine, IgA in CSF, IgG in CSF, transferrin in urine, albumin in urine and CSF, and total protein in urine and CSF using the Behring Nephelometer Systems and also for IgG in CSF and albumin in urine and CSF, using the TurbiTimeSystem.

N/T Protein Control LC is a lyophilized control prepared from human urine and serum proteins with polygeline, rabbit albumin, and preservative. It is intended to be used as an accuracy control for the determination of human proteins in urine and CSF by immunonephelometry with the Behring Nephelometer Systems and by immunoturbidimetry with the TurbiTimeSystem.

Here's an analysis of the provided text regarding the acceptance criteria and study for the N/T Protein Control LC device:

Important Note: The provided document is a 510(k) summary for a quality control material, not a diagnostic device that performs interpretations on patient data. Therefore, many of the typical acceptance criteria and study details relevant to AI/ML diagnostic tools (like sensitivity, specificity, human reader performance, expert consensus, etc.) are not applicable to this type of device. The primary performance characteristic for a control material is its stability and its ability to provide known, consistent values for assay accuracy.

Acceptance Criteria and Device Performance for N/T Protein Control LC

Given that this is a quality control material, the primary "acceptance criteria" revolve around its stability and its ability to consistently produce expected values within a defined range when used with the specified systems. The document explicitly mentions stability.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not specify a "test set" in the context of patient samples or a dataset for diagnostic performance. For a quality control material, the "test set" would typically refer to the batches of the control material manufactured and tested. The document only mentions "in-house protocols" for stability evaluation. No specific number of control vials or batches tested is provided.
• Data Provenance: Not applicable in the traditional sense for a diagnostic device. The stability data would be generated internally by the manufacturer (Dade Behring Marburg GmbH) through laboratory testing.

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

• Not Applicable. This device is a quality control material, not an AI/ML diagnostic device requiring expert interpretation or ground truth establishment based on clinical cases. Its "ground truth" (i.e., the expected concentration of an analyte) is established during its manufacturing and assaying process, typically against certified reference materials or established calibration methods.

4. Adjudication Method for the Test Set

• Not Applicable. As this is a quality control material, there is no "adjudication" in the sense of resolving discrepancies in expert interpretations of patient data. The evaluation of its performance (e.g., stability) would be based on predefined analytical criteria and instrumental measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

• No. An MRMC comparative effectiveness study is not relevant for a quality control material. Such studies are designed to assess the impact of a diagnostic aid (like AI) on human reader performance, which doesn't apply here.

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

• No. This is not an algorithm-driven device. It is a consumable laboratory reagent.

7. The Type of Ground Truth Used

• For a quality control material, the "ground truth" for the analyte concentrations in the control is established through analytical assaying using standardized methods and traceable calibrators. The product is "assayed" which means the manufacturer defines the expected ranges for the target proteins based on their internal testing and calibration. It is implied to be based on established analytical chemistry principles and potentially certified reference materials or primary standards for the relevant proteins.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of machine learning or AI for this product. The manufacturing process of a control material involves formulation, lyophilization, and subsequent quality control steps; it doesn't involve training an algorithm on a dataset.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The "ground truth" for the control values themselves is established through the manufacturing and assaying process against established analytical standards.

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N/T Protein Controls SL/L, M, and H are for use as accuracy and precision assayed controls in the determination of the following human serum proteins by immunonephelometry with the Behring Nephelometer Systems: IgG, IgGirl IgA, IgM, C3c, C4, Transferrin, Albumin, a-antitrypsin, α2-macroglobulin, Haptoglobin, a - acid glycoprotein, Prealbumin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, β>-microglobulin, Soluble transferrin receptor (sTfR), Ferritin, lgE; and, by immunoturbidmetry with the TurbiTimeSystem: (gG, IgGj1, IggA, controls con also be has be haptoglobin, a ;- acid glycoprotein, The controls can also be used for quality control in the Total Protein assay, using the Behring Nephelometer Systems.

N/T Protein Control SL is a liquid control prepared from human serum with stabilizers and preservative: 16 minin serum proteins by immunonephelometry with the Behring Nephelometer Systems and by immunoturbidimetry with the TurbiTimeSystem.

The provided document describes the N/T Protein Control SL, a liquid control prepared from human serum for use as an accuracy and precision control for human serum proteins. The only performance characteristic mentioned and evaluated in this document is Stability.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "Stability was evaluated according to in-house protocols".

• Sample Size: Not explicitly stated.
• Data Provenance: The study was conducted in-house by Dade Behring. It is a retrospective evaluation of the control's stability under specified conditions. The country of origin of the data is Germany (Dade Behring Marburg GmbH) and/or USA (Dade Behring Inc.).

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

• Number of Experts: Not applicable. The "ground truth" for stability testing of a control material typically involves analytical measurements and comparison to defined specifications, not expert consensus in the traditional sense.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of images or clinical cases to establish ground truth, which is not relevant for this type of chemical stability testing.

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

• MRMC Study Done: No. This is a quality control material for laboratory assays, not a diagnostic imaging device that would typically involve human readers.

6. Standalone Performance Study

• Standalone Study Done: Yes. The stability evaluation is inherently a standalone assessment of the control material's performance over time, independent of human intervention beyond the initial testing and storage conditions.

7. Type of Ground Truth Used

• Type of Ground Truth: Analytical measurements (e.g., immunonephelometry, immunoturbidimetry) against predefined specifications for the various proteins, monitored over time. The "ground truth" for stability is maintaining the established concentration/activity levels within acceptable limits over the specified period.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This is a quality control material intended for use in an assay, not an algorithm that requires a training set in the machine learning sense. The "development" of the control material would involve formulation refinement and extensive analytical testing, but not a "training set" as understood in AI/ML.

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

• Ground Truth for Training Set: Not applicable, as there is no training set in the AI/ML context. The formulation and initial characterization of the control material (its 'ground truth' values for protein concentrations) would be established through a rigorous process of assaying the prepared material against traceable reference materials or highly characterized methods.

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N/T Protein Control SL is intended to be used as accuracy and precision controls in the determination of human serum proteins.

The proposed control, N/T Protein Control SL is a control prepared from human serum (liquid) with stabilizers and preservative. It is intended to be used together with the Behring Nephelometer systems (Behring Nephelometer K860894, Behring Nephelometer 100 K892223 and the Behring Nephelometer II K943997) and with the TurbiTimeSystem™ as accuracy and precision controls for the following tests: IgG, IgA, IgM, C3c, C4, Transferin, Ceruloplasmin, RbP, Ig/L-chain, Kappa, Ig/L-chain, Lambda, IgG 1, IgG 2, Albumin, alpha1-antitrypsin (alpha1-proteinase inhibitor), 02-macroglobulin, Haptoglobin, alpha1-acid_αλνcoprotein, Pre-albumin (transthyretin), laG 3, laG 4, B2-microglobulin, Ferritin, laE.

This is a 510(k) summary for a quality control material, not a diagnostic device that detects disease. Therefore, many of the typical performance metrics for diagnostic devices (like sensitivity, specificity, AUC) and associated study design elements (like ground truth establishment with experts, training/test sets, MRMC studies) are not applicable here.

The "acceptance criteria" for a control material primarily revolve around its stability and its performance in precision/reproducibility.

Here's an analysis based on the provided text:

Acceptance Criteria and Study to Prove Device Meets Them: N/T Protein Control SL/L, M, and H

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical "acceptance criteria" but presents performance data that would implicitly meet expected standards for a quality control material. For instance, precision (CV%) values in the single digits are generally considered good for these types of assays.

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

• Sample Size: Not explicitly stated. The text mentions "one lot of N/T Protein Control SL" was used for precision studies. The number of replicates or individual measurements within this lot is not provided.
• Data Provenance: Not specified, but implied to be from internal laboratory testing conducted by Behringwerke AG or Behring Diagnostics Inc. It is retrospective in the sense that the data was collected prior to submission. Country of origin not explicitly stated, but the manufacturer is based in Germany, and the distributor in the USA.

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

• Not applicable. For a quality control material, there isn't a "ground truth" established by experts in the same way there would be for a diagnostic test (e.g., radiologists interpreting images). The purpose is to ensure the control itself provides consistent and reproducible results on the target instruments.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication is typically used when human interpretation or a subjective clinical assessment is involved in establishing a ground truth for diagnostic accuracy, which is not the case here.

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

• No. An MRMC study is designed to compare the performance of human readers, often with and without AI assistance, on a set of cases. This is not relevant for a quality control material.

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

• Not applicable in the typical sense of a diagnostic algorithm. The "device" is a physical control material. Its performance is evaluated on automated nephelometry systems (which are themselves algorithms/instruments). The precision and stability studies represent the "standalone" performance of the control material when used with these systems.

7. The Type of Ground Truth Used

• For the precision studies, the "ground truth" is essentially the expected consistent performance of a stable control material. The acceptable variation (precision) defines what constitutes "truth" in this context. The reference values for the analytes within the control are established during its manufacturing and characterization, but the study here focuses on its performance as a control.
• For the stability studies, the "ground truth" is the established concentration of the analytes within the control material at the initial time point. Stability is demonstrated by showing that these concentrations remain within acceptable limits over time under specified storage conditions.

8. The Sample Size for the Training Set

• Not applicable. This is a quality control material, not an AI or machine learning algorithm that requires a "training set." The product is manufactured and then its performance (precision, stability) is characterized.

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

• Not applicable. As there is no training set for an AI/ML algorithm.

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N/T Protein Control PY is used for control of accuracy and precision in the quantitative immunochemical determination of alpha -- Antitrypsin, fibrinogen, antithrombin III, prothrombin, plasminogen, fibronectin*, C+ Inhibitor with the Behring Nephelometer Systems and with the TurbiTimeSystem.
*not available in the U.S.

The N/T Protein Control PY is a lyophilized pool of citrate plasma consisting of one level containing the following proteins:
fibrinogen antithrombin III prothrombin plasminogen alpha 1 - Antitrypsin C1 Inhibitor

Below is an analysis of the provided text regarding acceptance criteria and study details for the "N/T Protein Control PY" device. Please note that the document primarily focuses on demonstrating substantial equivalence and provides limited information typically found in a comprehensive medical device performance study, especially for AI-based devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a quality control material and focuses on its precision and stability, rather than diagnostic accuracy against a specific condition. Therefore, typical acceptance criteria like sensitivity, specificity, or AUC are not applicable here. The acceptance criteria for this type of device generally revolve around its ability to provide consistent and stable control values.

Note: The document does not explicitly state numerical "acceptance criteria" for precision or stability (e.g., "%CV must be

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