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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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Establishment of reference curves for the determination of IgG, IgG1-4, IgA, IgE, C3c, C4, Transferrin, Albumin, α1-antitrypsin, α2-macroglobulin, Haptoglobin, α3-acid glycoprotein, Prealbumin, Hemopexin, Ceruloplasmin, RbP, Ig/L-chain Iambda & kappa, soluble Transferrin Receptor (sTfR), Ferritin, ß2-microglobulin, and Total protein by immunonephelometry with BN™ Systems.

N Protein Standard SL is a liquid standard prepared from human serum with stabilizers and preservative. It is intended to establish reference curves for the quantitative determination of human serum proteins by immunonephelometry with BN™ Systems (particle-enhanced nephelometry).

This document describes various aspects of the N Protein Standard SL device. However, it does not contain information typically required to describe acceptance criteria and a study that proves a device meets them for a AI/ML-based medical device.

The provided text is a 510(k) summary for a calibrator, multi-analyte, which is a laboratory reagent used to establish reference curves for measuring human serum proteins. It is not an AI/ML-based device.

Therefore, I cannot provide the requested information in the format of a table detailing acceptance criteria and reported device performance (e.g., sensitivity, specificity, AUC) or address aspects like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. These criteria are relevant for evaluating AI/ML models, not for a chemical calibrator.

The only "performance characteristic" mentioned is stability:

Device Performance Characteristics:

• Stability: Stability was evaluated according to Dade Behring protocols and the standard was found stable as originally packaged and for at least 14 days at +2° to +8° C, once opened.

This describes a stability test, which is a common quality control measure for chemical reagents, but it doesn't involve the kind of rigorous clinical or radiological study described in your prompt for AI/ML devices. Therefore, a table of acceptance criteria and reported performance, as requested, cannot be generated from this document because the device type and the nature of its evaluation are fundamentally different.

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Establishment of reference curves for the determination of IgG, IgG14, IgM, C3c, C4, Transferrin, Albumin, α1-antitrypsin, α2-macroglobulin, Haptoglobin, α--acid glycoprotein, Prealbumin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, ß2microglobulin, Soluble transferrin receptor (sTfR), IgE, and Ferritin by immunonephelometry with the Behring Nephelometer Systems.

N Protein Standard SL is a liquid standard prepared from human serum with stabilizers and preservative. It is intended to establish reference curves for the quantitative determination of human serum proteins by immunonephelometry with the Behring Nephelometer Systems (particle-enhanced nephelometry).

The provided 510(k) summary for the Dade Behring N Protein Standard SL primarily focuses on establishing substantial equivalence to a predicate device and discussing device stability. It does not contain the kind of detailed clinical study information (acceptance criteria, sample sizes for test/training, expert qualifications, adjudication, MRMC studies, standalone performance, or ground truth details) typically found in submissions for diagnostic devices with complex performance claims involving human interpretation or nuanced clinical outcomes.

This document describes a calibrator (a reference material used to ensure the accuracy of a diagnostic test), not a diagnostic device that directly produces an output for patient care. Therefore, the questions related to clinical performance metrics (like sensitivity, specificity, reader performance) and the setup of clinical studies (expert ground truth, adjudication, MRMC) are not applicable in the usual sense for this type of device.

However, I can extract the relevant information that is present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not describe a "test set" in the context of clinical performance evaluation. The stability evaluation would typically involve multiple batches of the calibrator, tested at various time points, but the specific sample sizes for these tests are not provided.
• Data Provenance: Not explicitly stated, but "in-house protocols" suggests internal testing by the manufacturer. No country of origin for specific stability data is mentioned, but the manufacturer is based in Germany and the submission is to the FDA in the USA. The type of study (retrospective/prospective) for stability is not detailed, but it would have been prospective over the stated shelf-life.

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

• Not applicable. This device is a calibrator, not a diagnostic tool requiring expert interpretation or ground truth establishment based on clinical cases. The "truth" for a calibrator lies in its certified concentration values and stability characteristics, which are determined by analytical methods and quality control procedures, not human experts in a clinical setting.

4. Adjudication method for the test set

• Not applicable for the reasons stated in 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-assisted diagnostic device, nor does it involve human readers interpreting clinical cases.

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

• Not applicable. This is a biochemical calibrator, not an algorithm. Its performance is determined by its physical and chemical properties and its ability to accurately calibrate the intended assays.

7. The type of ground truth used

• For stability, the "ground truth" would be the known concentration of the analytes within the calibrator as determined by validated reference methods or master calibrators, and the acceptable limits of variation from these known concentrations over time. The document states it was evaluated according to "in-house protocols," implying internal reference standards and analytical methods were used.

8. The sample size for the training set

• Not applicable. This is not a machine learning device, so there is no "training set" in the conventional sense.

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

• Not applicable (see point 8).

In summary, this 510(k) submission is for a medical device calibrator. The performance evaluation focuses on the chemical and physical stability of the calibrator itself and its substantial equivalence to a previously marketed calibrator for its intended use in calibrating existing diagnostic assays. It does not involve complex clinical studies with human participants, expert ground truth, or AI algorithms.

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