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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 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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