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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 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 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 < X%"). Instead, it reports the observed performance characteristics. For a quality control material, the expectation is that these values demonstrate suitability for their intended use in monitoring laboratory procedures.

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

• Sample Size for Test Set:
  • Precision Study: "Ten vials of one lot were tested."
  • Stability Study: Not explicitly stated, but typically involves a series of measurements over time, possibly using multiple vials from different lots.
• Data Provenance: Not explicitly stated (e.g., country of origin). The manufacturer is based in Germany, and the distributor in the USA. Given this is a lab control material, the data likely comes from internal laboratory testing.
• Retrospective or Prospective: These studies (precision and stability) are prospective internal laboratory studies conducted to characterize the product's performance.

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

This type of information is not applicable for this device. The N/T Protein Control PY is a quality control material, not a diagnostic device that requires expert interpretation of results to establish ground truth. Its "ground truth" is its inherent concentration of the specified proteins, which is determined through reference methods and internal standardization by the manufacturer. The "truth" being evaluated in the studies is the device's ability to consistently provide these known values.

4. Adjudication Method for the Test Set

Not applicable. As stated above, this is a quality control material, not a diagnostic device requiring expert adjudication for establishing a "ground truth" based on clinical cases. The "results" are quantitative measurements of protein concentrations.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is evaluated. The N/T Protein Control PY is a laboratory reagent; there are no "readers" in the context of interpreting clinical cases.

• Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.

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

Not applicable in the typical sense of an AI algorithm. This device is a consumable reagent used in analytical instruments (Behring Nephelometer Systems and TurbiTimeSystem). Its "performance" is its intrinsic chemical stability and measurement consistency, not an algorithm's output. The instrument itself performs the detection.

7. The Type of Ground Truth Used

The "ground truth" for the N/T Protein Control PY is the assigned target values (concentrations) of the various proteins (fibrinogen, antithrombin III, etc.) within the control material. These values are established by the manufacturer through rigorous analytical methods and are provided with each lot (as indicated by "Table of Values Provided"). The studies aim to demonstrate that the device measures these known ground truth values consistently and stably.

8. The Sample Size for the Training Set

Not applicable. This device is a chemical reagent and not an AI algorithm that requires a training set. The concept of a "training set" is not relevant here.

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

Not applicable. Since there is no training set for this type of device, the method of establishing ground truth for it is irrelevant.

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