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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/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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