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N Protein Standard SL is intended to be used for the establishment of reference curves.

The proposed standard, N Protein Standard SL is a standard 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) to establish reference curves for the following tests: IgG, IgA, IgM, C3c, C4, Transferin, Albumin, Ceruloplasmin, RbP, Ig/L-chain, Kappa, Ig/L-chain, Lambda, IgG 1, IgG 2, IgG 3, Albumin α1-antitrypsin (α1-proteinase inhibitor) α2-macroglobulin Haptoglobin α1-acid glycoprotein Pre-albumin (transthyretin), laG 3, laG 4, B2-microalobulin, Ferritin, IGE.

Here's the information extracted from the provided text, structured according to your request:

Acceptance Criteria and Study for N Protein Standard SL

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and discussing performance characteristics such as precision and stability, rather than explicitly stating acceptance criteria as a table with numerical targets for a specific clinical outcome or diagnostic accuracy. Instead, the document describes the observed performance of the device, which implicitly serves as the demonstration of its suitability.

Here's a breakdown of the requested information based on the provided document:

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

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: The document states "Precision studies using one lot of N Protein Standard SL..." This indicates the study was conducted on one lot of the product. The number of individual measurements or replicates within that study is not specified.
• Data Provenance: The study appears to be prospective (generated specifically for this submission) as it describes performance characteristics of the "Proposed Device." There is no mention of country of origin for the data, but it's generated by Behring Diagnostics Inc. (distributed) and Behringwerke AG (manufactured), which are US and German entities, respectively.

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

This section is Not Applicable (N/A). The device is a calibrator, not a diagnostic device that interprets patient data. Therefore, there is no "ground truth" established by experts in the context of diagnostic accuracy. The performance data (precision, stability) are objective measurements from laboratory testing, not subjective expert interpretations.

4. Adjudication method for the test set

This section is Not Applicable (N/A) for the same reasons as (3). There is no adjudication required for objective laboratory measurements like precision and stability.

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

This section is Not Applicable (N/A). The device is a calibrator. It is not an AI-powered diagnostic tool, nor does it directly involve human readers interpreting cases.

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

This section is Not Applicable (N/A). The device is a physical calibrator standard, not an algorithm.

7. The type of ground truth used

This section is Not Applicable (N/A). As a calibrator, the concept of "ground truth" in the diagnostic accuracy sense (e.g., pathology, outcomes data) does not apply. The "truth" for the calibrator is its manufactured concentration values, which are the basis for its intended use in establishing reference curves. The performance metrics (precision, stability) assess the consistency and integrity of these established values over time and repeated use.

8. The sample size for the training set

This section is Not Applicable (N/A). The device is a calibrator, not a machine learning algorithm that requires a "training set."

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

This section is Not Applicable (N/A) for the same reasons as (8).

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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 CRP Standard SY is intended to be used for the establishment of reference curves.

The proposed calibrator, N CRP Standard SY is a calibrator prepared from human serum (lyophilized) 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 11 K943997) for the calibration of the N Latex CRP mono test.

Here's an analysis of the provided text regarding the N CRP Standard SY device, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "Precision studies using one lot of N CRP Standard SY were run on the Behring Nephelometer." It does not specify a sample size for the test set (e.g., number of replicates, number of runs).

The data provenance is implied to be from internal testing by the manufacturer, Behring Diagnostics Inc. There is no information about the country of origin of the data beyond the manufacturing location (Germany) and distributor location (USA). The study is unequivocally prospective as it involves direct testing of the proposed device.

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

This information is not applicable to this device. This device is a calibrator, and its performance is assessed through its inherent analytical characteristics (precision, stability) rather than by comparison to a "ground truth" derived from expert interpretation of clinical data. There are no clinical images or patient outcomes being evaluated by experts here.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no expert interpretation or consensus-building involved in assessing the performance of this calibrator.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices that assist human interpretation (e.g., AI for radiology), not for a calibrator.

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

This concept is not applicable in the context of this device. The device itself is a physical calibrator. Its performance is what is being evaluated directly through analytical studies. There isn't an "algorithm" in the sense of a standalone diagnostic tool.

7. The Type of Ground Truth Used:

The "ground truth" for evaluating this calibrator is its inherent analytical characteristics tested against predefined specifications for precision and stability. It's not based on expert consensus, pathology, or outcomes data. The concentrations of CRP in the calibrator are established during its manufacturing and qualification process, and the tests verify that these characteristics remain within acceptable limits over time and across measurements.

8. The Sample Size for the Training Set:

This information is not applicable. This device is a calibrator, not a machine learning algorithm that requires a "training set."

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

This information is not applicable as there is no training set for this type of device.

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N Protein Standard PY is intended to be used for the establishment of reference curves.

The proposed calibrator, N Protein Standard PY is a calibrator prepared from human serum (lyophilized) 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) for the calibration of the following tests:

Fibrinogen Antithrombin II Prothrombin Plasminogen alpha1-Antitrypsin C1 Inhibitor

The provided text describes a 510(k) summary for the N Protein Standard PY, a calibrator. It focuses on demonstrating substantial equivalence to a predicate device and includes information on the device's intended use, composition, and basic performance characteristics like precision and stability.

However, the document does not contain the following information required to answer your request:

• Acceptance Criteria Table and Reported Device Performance: While "Precision and reproducibility" and "Stability" are mentioned, no specific acceptance criteria (e.g., "CVs must be less than X%") are provided, nor is a direct comparison in a structured table format against such criteria.
• Sample size and data provenance for a test set: The document mentions "one lot of N Protein Standard PY" for precision studies, but this isn't a "test set" in the context of device performance validation against ground truth. There's no information on data provenance (country, retrospective/prospective).
• Number of experts and qualifications for ground truth: No experts are mentioned, as the device is a calibrator, not a diagnostic tool requiring expert interpretation of results.
• Adjudication method for the test set: Not applicable, as there's no test set requiring adjudication.
• MRMC comparative effectiveness study: Not applicable. The device is a calibrator, not a diagnostic algorithm that would be compared with human readers.
• Standalone (algorithm only) performance: Not applicable. This is a physical calibrator, not an algorithm.
• Type of ground truth used: For a calibrator, the "ground truth" would typically refer to the assigned values of the standards, which are established through a metrological traceability chain, not expert consensus, pathology, or outcomes data. This information is not detailed here.
• Sample size and how ground truth was established for the training set: Not applicable, as this is a calibrator, not an AI model that undergoes "training."

In summary, the provided submission is for a calibrator (a laboratory reagent) and therefore does not contain the type of clinical performance validation studies, ground truth establishment, or AI-related metrics that your request assumes for a diagnostic device or AI algorithm. The information needed to fill out most of your table is not present in the document because it's relevant to a different type of medical device submission.

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