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The Albumin BCP2 assay is used for the quantitation of albumin in human serum or plasma on the ARCHITECT c System.

The Albumin BCP2 assay is to be used as an aid in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

The Albumin BCP2 assay is an automated clinical chemistry assay. The Albumin BCP2 procedure is based on the binding of bromocresol purple specifically with human albumin to produce a colored complex. The absorbance of the complex at 604 nm is directly proportional to the albumin concentration in the sample.

Methodology: Colorimetric (Bromocresol Purple)

This document is a 510(k) premarket notification for a new in vitro diagnostic device, the Albumin BCP2 assay, which measures albumin in human serum or plasma. It seeks to prove substantial equivalence to a predicate device, Albumin BCP.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a formal "acceptance criteria" table with pass/fail thresholds for each performance characteristic. Instead, it describes various studies conducted and reports the results, implying that meeting standard analytical performance metrics demonstrates acceptable performance and substantial equivalence.

However, we can infer the acceptance criteria from the reported performance and the context of typical FDA 510(k) submissions for in vitro diagnostic assays. The studies are designed to demonstrate the new device performs comparably to established standards and the predicate device.

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

The document describes test methods rather than specific "test sets" in the context of an AI/ML algorithm that might have a dedicated validation dataset. Instead, for an in-vitro diagnostic device, studies are conducted across various analytical performance characteristics.

• Precision Study: "2 controls and 3 human serum panels were tested in duplicate, twice per day on 20 days on 3 reagent lot/calibrator lot/instrument combinations." This means 80 data points for each control/panel (2 tests/day * 20 days * 2 replicates).
• Accuracy Study: "2 lots of the Albumin BCP2 reagent, 2 lots of the Consolidated Chemistry Calibrator, and 1 instrument." (No specific sample count for patient samples, but implied to be sufficient for bias estimation against a reference material).
• Lower Limits of Measurement: "n ≥ 60 replicates of zero-analyte samples" for LoB, and "n ≥ 60 replicates of low-analyte level samples" for LoD and LoQ.
• Linearity: No specific sample size mentioned, but typically involves preparing multiple dilutions.
• Interference Study: "Each substance was tested at 2 levels of the analyte (approximately 3.5 g/dL and 5.0 g/dL)."
• Method Comparison: 127 serum samples.
• Tube Type: "Samples were collected from a minimum of 40 donors".
• Dilution Verification: 5 human serum samples prepared by spiking.

Data Provenance: The document doesn't explicitly state the country of origin for the human samples used in the studies. Given that Abbott Ireland Diagnostics Division submitted the application, the studies were likely conducted in a setting compliant with international standards, possibly in Ireland or the US given the FDA submission. The studies described are nonclinical laboratory studies, not human clinical trials. They are retrospective or prospective in the sense of laboratory-controlled experiments designed to evaluate performance characteristics.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This section is not applicable as this is an in-vitro diagnostic (IVD) device, specifically a clinical chemistry assay, not an AI/ML diagnostic software. The "ground truth" for an IVD device is established through:

• Reference Methods: Using highly accurate and precise laboratory methods (e.g., mass spectrometry, enzymatic methods, or other established validated assays) or certified reference materials (like ERM-DA470k/IFCC for accuracy testing).
• Standardization: Traceability to international standards (like IFCC).
• Analytical Performance: Rigorous testing against defined analytical parameters (precision, linearity, limits of detection/quantitation).

There is no "ground truth" derived from human expert consensus for this type of device.

4. Adjudication Method for the Test Set:

This is not applicable for the same reasons as #3. Adjudication methods (like 2+1, 3+1) are common in AI/ML studies where human readers are establishing ground truth for image interpretation or similar tasks. For an IVD assay, performance is judged against analytical accuracy and precision, not human consensus on results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This is not applicable. MRMC studies are specific to AI/ML software that assists human readers (e.g., radiologists, pathologists) in interpreting medical images or data. This device is a quantitative laboratory assay. There is no human "reader" assisted by this device in the same way. The device directly measures a biochemical analyte.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

This isn't an "algorithm" in the AI/ML sense but rather a chemical assay method run on an automated analyzer. The entire performance data presented (precision, accuracy, linearity, interference, method comparison) represents the "standalone" analytical performance of the assay without human intervention influencing the measurement itself. Human involvement is in the operation of the instrument, quality control, and interpretation of the results, but not in the measurement process being evaluated here.

7. Type of Ground Truth Used:

The ground truth for this chemical assay is primarily established by:

• Standard Reference Materials (SRMs): For accuracy, the device's results are compared against ERM-DA470k/IFCC, which are certified reference materials with highly accurate assigned values.
• Reference Measurement Procedures: Implied by the use of standard methods and CLSI (Clinical and Laboratory Standards Institute) guidance, which dictates how analytical performance (e.g., LoB, LoD, LoQ, linearity, precision) should be determined using robust statistical methods and replicates.
• Predicate Device Comparison: For method comparison, the "ground truth" (or comparative truth) is the performance of the legally marketed predicate device (Albumin BCP) on patient samples.

8. Sample Size for the Training Set:

This concept of a "training set" is specific to AI/ML models. For an IVD assay, calibration and internal method development (which could be analogous to "training") would involve various reagent lots, calibrators, and QC materials provided by the manufacturer. The document does not specify a "training set size" in the AI/ML context because the development of a chemical assay follows different principles.

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

Again, this is not applicable in the AI/ML sense. For chemical assays, the establishment of the assay (analogous to "training") involves:

• Reagent Formulation and Optimization: Developing the chemical reagents (Bromocresol Purple, buffers, etc.) to ensure proper reaction kinetics, stability, and specificity.
• Calibrator Assignment: Assigning accurate values to calibrator materials used by the assay, often traceable to international standards (like ERM-DA470/IFCC).
• Method Development on Platform: Optimizing the assay parameters (volumes, incubation times, temperatures, wavelength) on the specific ARCHITECT c System to achieve optimal performance.
• Internal Validation: Initial testing during development to ensure the assay performs as expected before formal verification and validation studies are conducted for regulatory submission. This internal validation would use similar principles of analytical testing as described in Section 8 (e.g., accuracy, precision, linearity using reference materials and pooled human samples).

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The Albumin BCG2 assay is used for the quantitation of albumin in human serum or plasma on the ARCHITECT c System.

The Albumin BCG2 assay is to be used as an aid in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

The Albumin BCG2 assay is an automated clinical chemistry assay. The Albumin BCG2 procedure is based on the binding of bromocresol green in the assay reagent specifically with albumin in the patient sample to produce a colored complex. The absorbance of the complex at 604 nm is directly proportional to the albumin concentration in the sample.

Methodology: Colorimetric (Bromocresol Green)

The device in question is the Albumin BCG2 assay, used for the quantitation of albumin in human serum or plasma.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Within-Laboratory Precision: For each of the 2 controls and 3 human serum panels, 80 replicates were tested (2 duplicates per day for 20 days). The provenance of the human serum panels is not specified (e.g., country of origin, retrospective or prospective).
• Accuracy: The sample size for the accuracy study is not specified, but it involved determining bias relative to a standard reference material.
• Lower Limits of Measurement: For LoB, LoD, and LoQ, n ≥ 60 replicates of zero-analyte (LoB) or low-analyte (LoD, LoQ) samples were used.
• Linearity: The sample size for the linearity study is not explicitly stated.
• Potentially Interfering Substances: The sample size for this study is not explicitly stated.
• Method Comparison: 128 serum samples were used. The provenance of these samples is not specified.
• Tube Type: Samples were collected from a minimum of 40 donors. The provenance of these samples is not specified.

The studies described are non-clinical laboratory studies, suggesting they were conducted in a controlled lab setting rather than directly on patient data in a clinical environment. Whether the data is retrospective or prospective is not explicitly stated, but the nature of the studies (e.g., precision, linearity) typically involves prospective experimental designs.

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

This information is not applicable to the Albumin BCG2 assay studies described. This device is an in vitro diagnostic (IVD) quantitative assay, and its performance is evaluated against analytical benchmarks, reference materials, or a predicate device, not by expert interpretation of images or clinical outcomes that require a ground truth established by human experts.

4. Adjudication Method

Not applicable for this type of IVD device and studies. Performance is measured using quantitative analytical methods, not involving human adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a quantitative laboratory assay, not an imaging device or AI-assisted diagnostic tool that would involve human readers or MRMC studies.

6. Standalone Performance Study

Yes, the studies described are standalone performance studies of the Albumin BCG2 assay. The results reflect the algorithm/device's analytical performance (precision, accuracy, linearity, etc.) without human intervention in the result generation or interpretation to arrive at the reported quantitative values. The "human-in-the-loop" for this type of device typically refers to standard laboratory procedures for running samples and interpreting flagged results, which is inherent to its use but not a part of the core performance metrics discussed here.

7. Type of Ground Truth Used

• Accuracy: The ground truth for accuracy was established using a standard reference material: European Reference Materials Standard Reference Material - DA470k/ International Federation of Clinical Chemistry and Laboratory Medicine (ERM - DA470k/IFCC).
• Method Comparison: The predicate device, Albumin BCG (K981758; List No. 7D53), served as the reference for comparison, effectively acting as a "ground truth" or established method against which the new device's measurements were assessed for agreement.
• For other analytical performance characteristics (precision, linearity, limits of measurement, interference), the "ground truth" is understood as the expected or known concentrations in spiked samples, controls, or reference materials, or ideal analytical behavior.

8. Sample Size for the Training Set

Not applicable. This document describes a traditional in vitro diagnostic device, not one utilizing machine learning or artificial intelligence that would typically involve a "training set."

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for this device.

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Medicon Hellas Albumin: Reagent for the quantitative measurement of albumin in serum. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Medicon Hellas Calcium: Reagent for the quantitative measurement of calcium in serum or urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Medicon Hellas Creatinine: Reagent for the quantitative measurement of creatinine in serum and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

Medicon Hellas Glucose: Reagent for the quantitative measurement of glucose in serum and urine. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Medicon Hellas Direct Bilirubin; Reagent for the quantitative measurement of direct bilirubin (conjugated) in serum. Measurements of the level of direct bilirubin is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall blader block.

Medicon Hellas Total Bilirubin: Reagent for the quantitative measurements of total bilirubin in serum. Measurements of the levels of total bilirubin is used in the diagnosis and treatment of liver. hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Medicon Hellas Urea Nitrogen: Reagent is for the quantitative measurement of urea nitrogen in serum and urine. Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

The Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Glucose, Medicon Hellas Direct Bilirubin, Medicon Hellas Total Bilirubin, and Medicon Hellas Urea Nitrogen are reagents for use with Diatron Pictus 500 Clinical Chemistry Analyzers. They are test systems for the quantitative measurement of albumin, calcium, creatinine, glucose, direct and total bilirubin, and urea nitrogen in human serum and urine where clinically applicable. The methods employed are photometric, utilizing reactions between the sample and reagents to produce a colored chromophore or a change in absorbance that is proportional to the concentration of the analyte. The analyzer photometer reads the absorbances at time intervals dictated by the method application stored in the analyzer memory, and the change in absorbance is calculated automatically.

The provided text describes the performance of several Medicon Hellas assays (Albumin, Calcium, Creatinine, Glucose, Direct Bilirubin, Total Bilirubin, and Urea Nitrogen) when run on the Diatron Pictus 500 Clinical Chemistry Analyzer, demonstrating their substantial equivalence to predicate devices (Beckman Coulter AU reagents on AU2700 analyzer, and Abbott Architect Direct Bilirubin on Architect c8000 analyzer).

Here's an analysis of the provided information, structured to address your specific points regarding acceptance criteria and study details:

1. A Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a single, overarching table with pass/fail remarks. Instead, it describes each performance characteristic and then presents the results. The "Summary" sections for each study type imply that the results met the pre-defined acceptance criteria for demonstrating substantial equivalence. For instance, for accuracy, it states "Accuracy studies completed on at least three lots of each candidate reagent confirm that Medicon albumin... are substantially equivalent to the related predicate devices." This implies that the statistical analyses (Deming regression, R2, slope, intercept) fell within acceptable ranges. Similarly, for precision, it states "All lots passed acceptance criteria for each applicable sample type at each level."

Since explicit acceptance criteria are not presented, they are inferred from the demonstrated performance and the statement that the devices "passed acceptance criteria" or "met statistical acceptance criteria." Below is a table summarizing the reported device performance for each analyte. The "Acceptance Criteria" column will reflect the general statements of success or the implied ranges from the results themselves, as explicit numerical targets for individual tests are not given.

Implied Acceptance Criteria and Reported Device Performance

2. Sample sizes used for the test set and the data provenance:

• Sample Size for Test Set:

  • Accuracy (Method Comparison): "A minimum of 70 clinical specimens, spanning the dynamic ranges, were assayed." Specific numbers are provided per analyte:
    • Medicon Hellas Albumin: 112 samples (Serum)
    • Medicon Hellas Calcium: 94 samples (Serum), 81 samples (Urine)
    • Medicon Hellas Creatinine: 126 samples (Serum), 98 samples (Urine)
    • Medicon Hellas Direct Bilirubin: 77 samples (Serum)
    • Medicon Hellas Glucose: 99 samples (Serum), 100 samples (Urine)
    • Medicon Hellas Total Bilirubin: 95 samples (Serum)
    • Medicon Hellas Urea Nitrogen: 116 samples (Serum), 81 samples (Urine)
  • Reportable Range (Linearity): "At least nine levels of each sample types were tested." (N=4 per level on Pictus P500)
  • Sensitivity (LOD/LOQ):
    • LoB/LoD: "5 Blank samples and 5 Low Levels samples respectively which were measured 4 times each day for a total of 60 measurements in 3 days."
    • LoQ: "10 samples that span the low end of linearity were measured 5 times each day for a total of 150 measurements in 3 days."
  • Interferences: "Serum and urine sample pools at low and high levels were prepared." The exact number of individual samples forming these pools is not specified beyond being "pools."
  • Precision: "Precision study results from running applicable serum and urine samples (Level 1, Level 2 and Level 3) were tested in duplicate, twice a day, for 20 days, for a total of 80 results per level."

• Data Provenance (e.g., country of origin of the data, retrospective or prospective):

  • The document implies that the studies were conducted by Medicon Hellas, S.A. in Greece, given their address on the first page.
  • The data appears to be prospective as it describes experiments conducted ("studies were performed," "testing confirmed," "protocol followed"). It references the collection and analysis of clinical specimens specifically for these validation studies. It does not mention retrospective analysis of existing patient data.

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

This is not applicable in the context of this 510(k) submission. This type of submission is for in vitro diagnostic (IVD) reagents, which measure specific analytes in bodily fluids. The "ground truth" for these measurements is typically established by comparative analysis against predicate devices and well-characterized reference methods (e.g., those detailed in CLSI guidelines for accuracy, linearity, precision). These are not image-based AI models requiring human expert interpretation for ground truth.

The "experts" involved would be the laboratory personnel performing the assays according to established clinical laboratory standards and the statistical analysis, rather than medical experts providing subjective interpretations. The document does not specify the number or qualifications of the laboratory personnel who conducted the tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This concept (e.g., 2+1, 3+1 reader adjudication) is primarily used in studies where human readers provide subjective interpretations (e.g., radiology studies). For IVD devices, the "ground truth" is based on the analytical performance against established reference methods or predicate devices, which involves quantitative measurements and statistical analysis, not human adjudication of subjective interpretations.

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 imaging device. It is a chemical reagent intended for quantitative measurement of analytes in bodily fluids. Therefore, MRMC studies and the effect size on human readers are not relevant.

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

The device (reagent) essentially operates in a "standalone" fashion in terms of its chemical reaction and measurement, independent of human interpretive intervention for the measurement itself. The performance data (accuracy, precision, linearity, etc.) presented is the standalone performance of the reagent on the specified analyzer. Human involvement is in operating the instrument, quality control, and interpreting the numerical results in a clinical context, but not in the measurement process being tested for substantial equivalence.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" in this context is established by:

• Comparative Method: The primary method for proving substantial equivalence is by demonstrating strong correlation and agreement with legally marketed predicate devices (Beckman Coulter AU reagents and Abbott Architect Direct Bilirubin reagent) using real patient clinical specimens. This acts as the standard for comparison.
• CLSI Guidelines: Various performance characteristics (linearity, sensitivity, precision, interferences) were evaluated according to Clinical and Laboratory Standards Institute (CLSI) guidelines (e.g., CLSI EP09c for accuracy, CLSI EP06-A for linearity, CLSI EP17-A2 for sensitivity, CLSI EP07-A and EP37 for interferences, CLSI EP05-A3 for precision). These guidelines represent accepted industry standards for validating in vitro diagnostic devices, thereby defining the "ground truth" for these analytical measurements.
• Reference Values: For linearity studies, "samples were assigned their reference values arithmetically from serial dilutions of the high-level sample," indicating a quantitatively derived reference for linearity.

Therefore, the ground truth is based on a combination of comparison to predicate devices and adherence to established analytical reference methods and industry standards (CLSI guidelines).

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. It is a chemical reagent. The "training" here would be the chemical formulation and manufacturing process, which is established through R&D and QA/QC, not data input to an algorithm.

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

Not applicable, as there is no "training set" for a chemical reagent. The "ground truth" for the development of the reagent itself would be the established chemical principles and desired analytical performance characteristics (e.g., reactivity, specificity, stability, sensitivity) based on scientific literature and previous experience with similar assays.

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The Albumin BCP assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

The assay is intended for professional use only.

For In Vitro Diagnostic use only.

Albumin BCP reagent is ready to use liquid reagent that is supplied in two configurations: fill volume 20 mL in a 20 mL wedge or 50 mL in a 50 mL wedge, 6 wedges/kit.

Here's the breakdown of the acceptance criteria and study information for the Albumin BCP device, based on the provided text:

Acceptance Criteria and Device Performance

Note regarding "Test Set" and "Training Set" terminology: For in vitro diagnostic assays measuring specific analytes, the concepts of "test set" and "training set" (as typically used in machine learning or image analysis) are not directly applicable in the same way. Instead, performance studies use different sample types (e.g., control materials, patient samples, spiked samples) to validate the analytical performance characteristics. The following answers reflect this distinction.

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Limit of Blank (LoB): Not explicitly stated, but performed with three different reagent lots (F0390, F0391, F0480) and one calibrator lot (E0179). LoB is typically determined using replicate measurements of blank samples.
   • Limit of Detection (LoD): Not explicitly stated, but inferred to be similar to LoB determination as it also uses reagent and calibrator lots.
   • Limit of Quantitation (LoQ): Not explicitly stated, inferred to be similar to LoB/LoD determination.
   • Precision Study: 80 replicates per level for three different reagent lots (F0390, F0391, F0480) across three levels (26.26-26.62 g/L, 40.53-40.67 g/L, 49.96-50.47 g/L) using human serum. An additional lot (90228) used 88 replicates per level (19.10 g/L, 40.18 g/L, 51.33 g/L).
   • Intra Assay Precision Study: 20 replicates per level for three different reagent lots (F0390, F0391, F0480) across three levels (21.4-21.5 g/L, 35.6-35.8 g/L, 50.2-50.3 g/L) using human serum.
   • Linearity (Measuring Range): Three different reagent lots (F0390, F0391, F0480) were tested across specified ranges (e.g., 4.17 to 78.30 g/L). Number of distinct samples within these ranges not explicitly stated.
   • Endogenous Interferences Study: "2 aliquots of serum pool were prepared (Base and Test pool)" for two albumin concentrations (~35 g/L and ~50 g/L), with the test pool divided into 4 sub-aliquots and diluted. Specific number of interference samples not stated, but covered a range of dilution levels (100% down to 0%).
   • Reagent Stability: Four different lots (F0390, F0391, F0480, 90228) were evaluated across three different concentration levels.
   • Method Comparison: 128 serum samples, including 8 altered samples, covering the measuring interval 6.0 - 70 g/L.
   • Matrix Comparison: 77 paired plasma/serum samples, including 7 altered samples, covering the assay's range, for both Lithium-Heparin plasma and Potassium EDTA plasma.

   Data Provenance: The studies used human serum and plasma samples. The document does not explicitly state the country of origin of the data or whether the samples were collected retrospectively or prospectively. Given the context of a medical device submission, these would typically be from clinical laboratory settings.

2. 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):

   This is an in vitro diagnostic (IVD) assay for measuring a biochemical analyte (albumin). The "ground truth" for such assays is established by the reference methods or highly characterized materials used to calibrate and validate the assay. It does not involve human experts interpreting images or diagnosing conditions, but rather relies on established analytical standards and predicate devices.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., image reading) where disagreement among experts might arise. For quantitative IVD assays, performance is assessed against defined analytical criteria and reference values.

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:

   Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool that would involve human readers.

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

   Yes, the performance studies described are for the standalone functioning of the Albumin BCP assay on the AU680 Automatic Analyzer. This is inherent to the nature of an in vitro diagnostic test, where the device performs the measurement independently.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   The "ground truth" for this IVD device is established through:

   • Reference materials and calibrators: Used to ensure accuracy and traceability of measurements (e.g., ERM-DA 470k/IFCC for standardization).
   • Predicate device measurements: The method comparison study used a legally marketed predicate device (Siemens ADVIA 2400, ADVIA® Chemistry Albumin BCP assay) as a comparative standard.
   • Analytical standards: Performance is measured against accepted analytical performance guidelines (e.g., CLSI documents EP17-A2, EP05-A3, EP15-A3, EP6-A, EP07-A2, EP09-A3) which define acceptable limits for various performance characteristics.
   • Known concentrations: For studies like LoB, LoD, LoQ, Precision, and Intra-Assay Precision, samples with known or characterized concentrations (e.g., control materials, spiked samples, serum pools) are used to assess the device's accuracy and reproducibility.

7. The sample size for the training set:

   Not applicable in the machine learning sense. The device is a chemical assay, not an algorithm trained on a dataset. Its analytical characteristics are inherently designed and validated through laboratory studies.

8. How the ground truth for the training set was established:

   Not applicable. As explained above, this device does not utilize a "training set" in the context of machine learning. The analytical methods and performance targets are established through scientific principles of chemistry and validated using established laboratory practices and reference standards.

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Yumizen C1200 ALP reagent is intended for the quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma based on a kinetic photometric test using p-Nitropherylphosphate. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Yumizen C1200 Albumin reagent is intended for the quantitative in vitro diagnostic determination of albumin in human serum and plasma by colorimetry. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Not Found

The provided text describes analytical performance characteristics and comparison studies for two in vitro diagnostic reagents, Yumizen C1200 ALP and Yumizen C1200 Albumin, intended for use on the Yumizen C1200 clinical chemistry analyzer. The document is a 510(k) summary, demonstrating substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and the studies performed, structured according to your request:

Acceptance Criteria and Reported Device Performance

For both assays, the acceptance criteria are implicitly defined by the successful demonstration of performance characteristics within established guidelines (CLSI) and comparison to their respective predicate devices. The "Results are within predefined acceptance criteria" statements affirm that the tested parameters met the company's internal benchmarks, which are aligned with industry standards for analytical performance.

Here's a table summarizing the reported device performance for key analytical characteristics:

Study Details:

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

   • Yumizen C1200 ALP:
     • Measuring Range/Linearity: Data not explicitly stated for individual samples, but the study showed linearity from 0 to 1620 U/L.
     • Precision: "Single site: 20x2x2" and "Multi site: 3x5x2x3". This notation often refers to runs x replicates x instrument/lots, but the exact number of unique "samples" (control and general) for precision is stated as N=240 for single site, and N=90 for multi-site across various levels (control and patient samples). The provenance of these samples is not specified (e.g., country of origin) but they are "control" or "patient" samples. It's an analytical performance study, not a clinical study on specific patient populations.
     • Interferences: Specific sample numbers for this study are not provided, but the tested interferent concentrations are listed.
     • Method Comparison: 165 native serum samples.
     • Matrix Comparison: 40 lithium-heparin plasma samples (individual donors).
   • Yumizen C1200 Albumin:
     • Measuring Range/Linearity: Data not explicitly stated for individual samples, but the study showed linearity from 0 to 60.2 g/L.
     • Precision: "Single site: 20x2x2" and "Multi site: 3x5x2x3". Again, N=240 for single site and N=90 for multi-site across various levels.
     • Interferences: Specific sample numbers for this study are not provided.
     • Method Comparison: 111 native serum samples.
     • Matrix Comparison: 70 lithium-heparin plasma samples (individual donors).
   • Data Provenance: The document does not specify the country of origin for the samples. The studies are described as analytical performance validations, which are typically retrospective using banked/collected samples. The term "native serum samples" and "individual donors" implies real patient samples.

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

   • This is an in vitro diagnostic device (measurement of lab analytes), not an imaging AI or diagnostic AI device where human experts establish "ground truth" in the typical sense of clinical interpretation.
   • The ground truth for the test set is established by the predicate devices (Roche Diagnostics ALP IFCC Gen2 on COBAS INTEGRA systems, and HORIBA ABX SAS ABX Pentra Albumin CP on ABX Pentra 400/Pentra C400) or by established analytical methods for measuring concentrations (e.g., gravimetric for linearity, standard additions for LoD/LoQ).
   • The "experts" involved are likely laboratory professionals, biochemists, and statisticians who design and execute these analytical validation studies according to CLSI (Clinical and Laboratory Standards Institute) guidelines. Their specific qualifications (e.g., MD, PhD) or number are not explicitly stated in this document but are assumed to be standard for medical device development.

3. Adjudication Method for the Test Set:

   • Not applicable in the context of analytical performance studies of laboratory reagents. Adjudication (e.g., 2+1, 3+1 consensus) is typical for clinical studies involving subjective interpretations (e.g., radiology reads). For a quantitative IVD, the "truth" is the measured value from a reference method or known concentration.

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

   • No, an MRMC study was not done. This type of study is relevant for diagnostic imaging interpretation or other scenarios where human readers make subjective judgments, and AI provides assistance. This document is for quantitative lab reagents, where the assessment is about the accuracy and precision of the measurement itself.

5. If a Standalone Performance Study Was Done:

   • Yes, the entire document describes standalone performance of the Yumizen C1200 ALP and Albumin reagents on the Yumizen C1200 analyzer. This is not an "algorithm only without human-in-the-loop" performance as the device itself is an integrated system of reagent, instrument, and software. "Standalone" in this context means the performance of the new device/reagent system as a complete unit, not in comparison to human interpretation.

6. The Type of Ground Truth Used:

   • External Reference Measurement: For method comparison studies, the "ground truth" is the result obtained from the legally marketed predicate device (Roche Diagnostics ALP IFCC Gen2 for ALP, and HORIBA ABX SAS ABX Pentra Albumin CP for Albumin).
   • Known Concentrations/Standards: For linearity, limit of detection/quantitation, and interference studies, the ground truth is established by preparing samples with known concentrations of analytes and/or interferents.
   • Consensus/Literature: For reference ranges, the ground truth is based on established bibliographic references and a verification study using "normal samples" from a blood bank.

7. The Sample Size for the Training Set:

   • This document describes the validation/test phase for regulatory submission (510(k)). It does not detail the training set used for the development of the reagents or the analyzer's measurement algorithms. For IVDs, the "training" analogous to machine learning often involves extensive R&D, chemical optimization, and instrument calibration development using a variety of samples, but these are not explicitly quantified in terms of a "training set" size in this regulatory summary.

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

   • As above, details about the "training set" are not provided. However, for the development of quantitative IVD assays, ground truth for initial development/training would typically be established through:
     • Primary Reference Methods: Highly accurate and precise methods (e.g., isotope-dilution mass spectrometry) for specific analytes, often used for calibrator assignment.
     • Certified Reference Materials: Materials with an assigned value and uncertainty for an analyte, traceable to recognized metrological standards.
     • Large Sample Cohorts: A diverse range of clinical samples (with values determined by established methods) to ensure robustness across different patient populations and disease states.
     • Experimental Design: Controlled experiments to characterize reagent stability, reaction kinetics, and potential interferents.

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Rx Only

For in vitro diagnostic use only

The ALB test within the VITROS XT Chemistry Products ALB-TP Slides quantitatively measures albumin (ALB) concentration in serum and plasma using the VITROS XT 7600 Integrated System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

The new device, the VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur and test results are generated for each analyte independently of the other analyte.

The ALB test is a multilayered, analytical element coated on a polyester support.

For the albumin measurement, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. When the fluid penetrates the reagent layer, the bromcresol green (BCG) dye diffuses to the spreading layer and binds to albumin in the sample. This binding results in a shift in wavelength of the reflectance maximum of the free dye. The color complex that forms is measured by reflectance spectrophotometry. The amount of albumin-bound dye is proportional to the concentration of albumin in the sample.

The provided document describes the analytical performance of the VITROS XT Chemistry Products ALB-TP Slides for measuring albumin (ALB) concentration, and its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study data:

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

The document does not explicitly state formal "acceptance criteria" for each performance metric in a dedicated table. Instead, performance is demonstrated through studies and compared against established clinical laboratory guidelines (CLSI protocols) or by showing strong correlation to the predicate device. For some metrics, an implied acceptance based on clinical relevance and comparison to the predicate can be inferred.

Here's a table summarizing the reported device performance, with inferred acceptance criteria based on the context of the studies:

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

• Test Set Sample Sizes:
  • Method Comparison: 127 patient samples.
  • Matrix Comparison: Not explicitly stated as a number of unique patient samples, but various collection devices (serum: glass red top, plastic red top, SST; plasma: Na-heparin, Li-heparin, PST) were evaluated. The comparison used two replicates for the reference serum and two replicates for each feature tube.
  • Precision: Patient pools and quality control materials. "80 observations (2 replicates per run, 2 runs per day over 20 days)" were used for the precision study, which implies that a smaller number of initial patient pools were tested multiple times.
  • Linearity: A series of seventeen proportionally related admixtures of low and high test fluids were tested in quadruplicate.
  • Specificity: Not explicitly stated as a number of unique patient samples; it likely used spiked samples or patient samples with known levels of interferents.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It refers to "patient samples" and "patient pools" but provides no further details on their source.

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

Not applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement of albumin. "Ground truth" is established by the analytical method itself (measurement against a reference standard or validated method) rather than by expert consensus on qualitative interpretation of images or clinical findings. The predicate device (VITROS Chemistry Products ALB Slides) serves as the reference for method comparison.

4. Adjudication method for the test set

Not applicable. As this is an IVD device measuring a quantitative analyte, there is no subjective interpretation requiring an adjudication process for a "test set" in the way it would be applied to, for example, image-based diagnostic systems. The performance is assessed by comparing quantitative results against reference methods or established analytical performance criteria.

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 an in vitro diagnostic device for quantitative measurement of a biochemical analyte. It does not involve human readers interpreting images or data, nor does it involve AI assistance for such interpretation.

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

Yes, in essence, the performance studies described are for the standalone device (VITROS XT Chemistry Products ALB-TP Slides on the VITROS XT 7600 Integrated System) measuring albumin concentration. The device operates as a laboratory instrument without direct human-in-the-loop interpretation of the measurement itself. Human involvement is in operating the instrument and interpreting the quantitative result in a clinical context, but the device's analytical performance (accuracy, precision, linearity, etc.) is assessed independently.

7. The type of ground truth used

The "ground truth" for the performance studies is primarily established by:

• Comparison to a legally marketed predicate device: The VITROS Chemistry Products ALB Slides (K023875) on the VITROS 5600 Integrated System served as the reference for the method comparison study.
• Reference standards and established analytical methods: Precision, linearity, and detection limit studies rely on the inherent accuracy of the measurement procedure itself against known concentrations (e.g., patient pools, quality control materials, spiked samples, or reference materials).
• Clinical Laboratory Standards Institute (CLSI) protocols: The studies specifically cite adherence to CLSI EP09-A3 (Method Comparison), EP05-A3 (Precision), EP17-A2 (Detection Limits), EP06-A (Linearity), EP07-A3, and EP37 (Interference), which are widely accepted guidelines for validating IVD performance.

8. The sample size for the training set

Not applicable. This is not an AI/Machine Learning device that requires a "training set" in the conventional sense. It is a traditional in vitro diagnostic chemical assay. Its development involves chemical and engineering principles, not statistical learning from a data set.

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

Not applicable, as there is no "training set" for this type of device.

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BA400: The BA400 analyser is used to determine analyte concentrations by in vitro biochemical and turbidimetric measurements of human samples of serum, urine, plasma, cerebrospinal fluid or total blood. This device is intended to replace manual analytical procedures by performing automatically various steps such as pipetting, heating, and measuring color intensity.

ALBUMIN: Reagent for the measurement of albumin concentration in human serum or plasma. The obtained values are useful as an aid in the evaluation of protein synthesis of the liver in the chronic liver diseases and for the nutritional status. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

ALKALINE PHOSPHATASE (ALP) - AMP: Reagent for the measurement of alkaline phosphatase (ALP)-AMP concentration in human serum or plasma. The obtained values are useful as an aid in the diagnosis and treatment of hepatobiliary and bone diseases with impaired osteoblastic activity diseases. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

GLUCOSE-HEXOKINASE: Reagent for the measurement of glucose concentration in human serum, plasma, urine or cerebrospinal fluid. The obtained values are useful as an aid in the diagnosis and monitoring of the diabetes mellitus. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for several in vitro diagnostic reagents and an analyzer. It only provides information about the intended use of the devices and their regulatory classification. It does not contain any data, studies, acceptance criteria, or performance results for the devices mentioned (ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE reagents, or the BA400 analyzer).

Therefore, I cannot provide the requested information in the requested format because the input document does not contain it.

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The Siemens Atellica™ Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.

The Atellica™ A-L YTE Integrated Multisensor (Na, K, Cl) is intended for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma, and urine using the Atellica™ CH system. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The Atellica™ CH Albumin BCP Reagent (Alb P) is intended for in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on Atellica™ CH system. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

The Atellica™ IM Thyroid Stimulating Hormone (TSH) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum, and plasma (EDTA and lithium heparin) using the Atellica™ IM system. Measurements of the thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The Atellica™ CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum or plasma on the Atellica™ CH System. Vanc test results may be used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.

The Atellica™ Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. The Atellica™ Solution consists of any combination of Atellica Sample Handler component, an Atellica Magline Magnetic Sample Transport system component, Atellica IM and all software and hardware needed to support a customizable array of analyzers. The submission also covers the Atellica™ A-LYTE Integrated Multisensor (Na, K, Cl), Atellica™ CH Albumin BCP Reagent (Alb P), Atellica™ IM Thyroid Stimulating Hormone (TSH) assay, and Atellica™ CH Vancomycin (Vanc) assay, which are reagents/assays used with the Atellica Solution.

The provided document is a 510(k) Premarket Notification from the FDA regarding the Siemens Atellica™ Solution. It details the device's indications for use, its substantial equivalence to predicate devices, and some performance characteristics.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., "The device must achieve a precision CV of X% or less"). Instead, it demonstrates performance by comparing the new Atellica™ Solution (new device) to the predicate devices (Trinidad IM and CH modules) by showing precision and method comparison studies. The implicit acceptance criterion is that the new device's performance should be comparable to the predicate device, as confirmed by the statistical results (slope, intercept, correlation, and precision CVs falling within generally acceptable laboratory ranges).

Given the nature of this 510(k) submission, the "acceptance criteria" are implied by the performance demonstrated and compared to the established performance of the predicate devices. The clinical relevance of the reported performance is tied to the previously cleared predicate devices.

Implicit Acceptance Criteria (Performance should be comparable to predicate):

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

• Precision Studies:
  • Sample Size: N = 25 for each control/serum pool per assay. This means 5 replicates per day over 5 days (5 x 5 = 25).
  • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective, conducted by Siemens Healthcare Diagnostics. The samples are described as "controls and serum pools."
• Method Comparison Studies:
  • Sample Size:
    • Na: 121
    • K: 125
    • Cl: 122
    • Albumin (Alb_P): 105
    • Vancomycin (Vanc): 112
    • TSH: 116
  • Data Provenance: Not explicitly stated (e.g., country of origin). The studies used "patient samples" as per CLSI EP09-A3. This implies a prospective collection for the purpose of the study or retrospective collection of anonymized patient samples.

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

Not applicable. This document describes the performance of in-vitro diagnostic (IVD) assays, not the diagnostic performance of an image analysis algorithm or a device requiring human interpretation for ground truth. The "ground truth" for the method comparison studies is the result obtained from the predicate device's analytical modules (Trinidad IM and CH), which are already cleared for clinical use.

4. Adjudication method for the test set

Not applicable. As noted above, this is an IVD assay performance study, not a study requiring adjudication of expert interpretations.

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 an IVD device, not an AI-assisted diagnostic tool that involves human readers.

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

Yes, the performance studies described (Precision and Method Comparison) represent the standalone performance of the Atellica™ Solution analytical modules. There is no human-in-the-loop component mentioned for the analytical measurement process itself. The "device" in this context is the automated analyzer system.

7. The type of ground truth used

The "ground truth" for the method comparison studies is the measurement obtained from the predicate devices (Trinidad IM module and Trinidad CH module as cleared under K151792, K151767, and K160202). The new device's results are compared to these established methods. For precision studies, it's about the reproducibility of the device's own measurements against its internal calibration and controls.

8. The sample size for the training set

Not applicable. This is an IVD instrument and assay system, which does not involve a "training set" in the context of machine learning or AI models. The assays are based on established chemical and immunological principles, with parameters (e.g., calibration curves) set during manufacturing and validated through performance studies.

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

Not applicable. See point 8.

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The Trinidad CH System is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. The system's chemical and immunochemical assay applications utilize photometric and ion selective electrode technology for clinical use.

The TD-LYTE Integrated Multisensor (Na, K, Cl) is intended for in the quantitative determination of sodium, potassium and chloride (Na, K, Cl) in human serum, plasma and urine using the Trinidad CH System. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The TD-LYTE IMT Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System.

The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na. K, and Cl on the Trinidad CH System.

The Albumin BCP Reagent (Alb) P) is intended for in the quantitative measurement of albumin in human serum or plasma on the Trinidad CH System. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

The Albumin BCP calibrator is for in vitro diagnostic use in the Trinidad CH Albumin BCP Assay (Alb P) on the Trinidad CH System.

The Siemens Healthcare Diagnostics Trinidad CH System is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged reagent packs to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric and integrated ion selective multisensor detection technologies for clinical use. The system includes the analytical module and the sample handler (Direct Load, DL).

Na, K, Cl uses indirect Integrated Multisensor Technology (IMT). There are four electrodes used to measure electrolytes. Three of these electrodes are ion selective for sodium, potassium and chloride. A reference electrode is also incorporated in the multisensor.

A diluted sample (1:10 with IMT Diluent) is positioned in the sensor and Na*, K* or Cl ions establish equilibrium with the electrode surface. A potential is generated proportional to the logarithm of the analyte activity in the sample. The electrical potential generated on a sample is compared to the electrical potential generated on a standard solution, and the concentration of the desired ions is calculated by use of the Nernst equation.

Serum, plasma and urine specimens may be used. The sensor is stored unopened at 2 – 8 °C and is stable for use on board for 14 days or 5000 samples.

The Trinidad CH System TD-LYTE Integrated Multisensor system performs a two point automatic calibration in duplicate every 4 hours. In addition, the system will routinely perform a one point calibration check with each sample measurement. Auto-calibration occurs after power-on, with the changing of standards A. B. or a sensor and when the system software is reset.

The target concentrations of the TD-LYTE IMT Standard A include: Nat at 14 mmol/L, K* at 0.4 mmol/L and Cl¯ at 10.4 mmol/L. The target concentrations of the TD-LYTE Standard B include: Na 7 mmol/L, K* at 6 mmol/L and Cli at 16 mmol/L. The target concentrations of the Salt Bridge include: K* at 120.0 mmol/L and Cl¯ at 120.3 mmol/L.

The Trinidad CH System Albumin BCP Reagent (Alb_P) assay is an adaptation of the bromocresol purple (BCP) dye-binding method reported by Carter and Louderback, et al. In the Trinidad CH System , the Alb_P assay, serum or plasma albumin quantitatively binds to BCP to form an albumin-BCP complex that is measured as an endpoint reaction at 596/694 nm.

Alb P is calibrated with Trinidad CH Diluent(11099300) and ALBP Calibrator (1 level). It is a 2-point linear curve.

Serum and plasma specimen types may be used. The reagent is stored at 2 - 8 °C and each well is stable on the sytem for 20 days.

The Albumin BCP (Alb P) calibrator is a lyophilized human serum-based product containing albumin. It is used to calibrate the Albumin BCP (Alb_P) assay on the Trinidad CH System.

The target concentration of the albumin is 4.3 g/dL.

The provided document describes the Siemens Healthcare Diagnostics Trinidad CH System and its associated assays for Sodium (Na), Potassium (K), Chloride (Cl), and Albumin (Alb_P). The document is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to predicate devices. It presents various performance characteristics of the device.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a single, consolidated table with pass/fail results. Instead, it presents performance data for various characteristics, and the underlying implication is that these results are acceptable for demonstrating substantial equivalence. The following table summarizes the reported performance characteristics:

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

Detection Limit (LoB, LoD):

• Na, K, Cl (Serum): 4 blank samples, 4 low/diluted patient serum samples. Each tested N=5, for 3 days, one run per day, 2 reagent lots (Total determinations: 4 x 5 x 3 x 2 = 120 per analyte for LoB, similar for LoD).
• Na, K, Cl (Urine): 4 blank samples, 4 low/diluted patient urine samples. Each tested N=5, for 3 days, one run per day, 2 reagent lots (Total determinations: 4 x 5 x 3 x 2 = 120 per analyte for LoB, similar for LoD).
• Albumin (Alb_P): 6 blank samples, 5 low/diluted serum samples. Blank samples: N=5 for 3 days, one run per day, 3 reagent lots (90 measurements per reagent lot). Low samples: N=5 for 3 days, one run per day, 3 reagent lots (75 measurements per reagent lot).

Limit of Quantitation (LoQ):

• Na, K, Cl (Serum/Urine): 4 low samples of diluted serum/urine. Processed on 2 IMT sensor lots for 3 days, on one instrument (Total determinations: 4 x 5 x 3 x 2 = 120 per analyte per matrix).
• Albumin (Alb_P): 5 low samples of diluted serum pools. Processed on 3 reagent lots for 3 days, on one instrument (Total determinations: 5 x 5 x 3 x 3 = 225).

Linearity Study:

• Na, K, Cl, Albumin: 9 equally spaced samples (prepared by mixing high and low concentration samples). Three replicates were measured for each sample. (Total determinations: 9 x 3 = 27 per analyte).

Precision Studies:

• Na, K, Cl (Serum & Urine Pools/QCs), Albumin (Serum Pools/QCs): Tested n = 2 replicates, two times a day for at least 20 days. (Total replicates: 2 x 2 x 20 = 80 replicates for each sample type/level, and in some cases 84).

Interferences:

• Na, K, Cl, Albumin: Samples spiked with interfering substances at varying concentrations (specific numbers of samples not explicitly stated, but it was a "worst case scenario" approach using low and high levels of measurand in serum pools).

Method Comparison (vs. Predicate Device):

• Na: 106 serum samples, 101 urine samples.
• K: 103 serum samples, 105 urine samples.
• Cl: 108 serum samples, 102 urine samples.
• Albumin: 130 serum samples.
• Data Provenance: Remnant de-identified samples. Country of origin not specified, but the study was "conducted internally by Siemens Healthcare Diagnostic Inc. R&D organization personnel." This typically implies a US-based or corporate lab setting. The data is retrospective as it used "remnant de-identified samples" and "no patient history information was obtained."

Method Comparison (vs. Reference Method):

• Na, K, Cl: 25 serum and plasma samples.
• Data Provenance: The reference measurements were made at INSTAND e.V, Ubierstrasse 20, 40223 Düsseldorf, GERMANY. This implies European provenance for the reference method data, likely used against test samples generated by Siemens.

Matrix Equivalency:

• Na, K, Cl: 50 matched serum and lithium heparin plasma samples.
• Albumin: 59 matched sample sets (Serum vs. Lithium Heparin, Serum vs. EDTA plasma).

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

The document describes performance studies for an in-vitro diagnostic device measuring analytes (Na, K, Cl, Albumin) directly. For such devices, "ground truth" is typically established by reference methods or predicate devices, rather than expert human interpretation of images or clinical findings.

• For Method Comparison against a Predicate Device: The predicate device is the ADVIA 1800 Chemistry System (cleared under K990346), which itself is a legally marketed device and provides the comparative "truth." The document states that "laboratory technicians with training similar to personnel who would conduct the tests in a hospital laboratory setting" conducted the tests.
• For Method Comparison against Reference Methods: The reference methods used were flame emission spectrophotometry for Na and K, and coulometry for Cl. These are established analytical techniques. The measurements were made at INSTAND e.V, an organization involved in external quality assessment and reference materials, implying high-level analytical expertise. No "experts" in the sense of clinicians or radiologists are involved in establishing ground truth for chemical measurements in this context.

4. Adjudication method for the test set

Not applicable. This is an in-vitro diagnostic device for quantitative chemical measurements. The "test set" refers to patient samples measured by the device itself or compared against a predicate/reference device, not assessments requiring clinical adjudication or consensus among experts.

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 an in-vitro diagnostic device for automated chemical analysis, not an AI-assisted diagnostic imaging or clinical decision support tool for human readers. Therefore, an MRMC study and evaluation of human reader improvement with/without AI assistance are not relevant to this device.

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

Yes, the studies described are standalone performance studies of the device (Trinidad CH System and its assays). The device performs automated, quantitative chemical analysis without continuous human intervention in the result generation. The results are compared against predicate devices or reference methods, which is a standalone comparison. Human involvement is limited to sample preparation, loading, and result review, which are standard for laboratory instruments.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance studies was established through:

• Comparison to a Legally Marketed Predicate Device: The ADVIA 1800 Chemistry System. This represents a "standard of care" or "established method" ground truth.
• Comparison to Reference Methods: Flame emission spectrophotometry (for Na and K) and coulometry (for Cl). These are highly accurate and precise analytical techniques considered definitive for these analytes.
• Spiked and Diluted Samples: For linearity, LoQ, and matrix equivalency studies, samples were artificially manipulated (spiked with analytes or diluted) to create samples with known or controlled concentrations.

8. The sample size for the training set

The document does not explicitly delineate a "training set" in the context of machine learning or AI. This is an automated clinical chemistry analyzer. The "training" of such a system typically refers to factory calibration and internal algorithm development based on extensive R&D data. The performance characteristics described are "test set" evaluations demonstrating the device's accuracy and precision in a real-world (or simulated real-world) setting after development. Therefore, a specific sample size for a machine learning training set is not provided or applicable in the way it would be for an AI/ML medical device.

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

Not applicable as there is no explicitly defined "training set" in the machine learning sense. The device's underlying principles (photometric and ion selective electrode technology) are based on established chemical and physical laws. The process of making the instrument accurate and precise involves internal calibration and characterization using various standards and control materials with known values, rather than a "training set" with ground truth assigned by human experts for interpretive tasks.

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For in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on ADVIA Chemistry systems. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

For in vitro diagnostic use in the calibration of the ADVIA Chemistry Albumin BCP Assay (ALBP) on ADVIA Chemistry systems.

The Albumin BCP reagents are ready-to-use liquid reagents packaged for use on the automated ADVIA 1650 Chemistry systems. Reagents are supplied in two configurations: fill volume of 18 mL in a 20 mL wedge or 35 mL in a 40 mL wedge, 4 wedges/kit.

The calibrator is a multi-analyte human serum based product containing albumin derived from human serum. The kit consists of 3 vials of one-level calibrator which are lyophilized. The target concentration of this calibrator is 4.3 g/dL. The volume per vial (after reconstitution with deionized water) is 2.0 mL.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate section with specific numerical thresholds for each performance characteristic. Instead, it describes various performance studies and concludes that the results were "acceptable" and support "substantial equivalence" to the predicate device. For the purpose of this analysis, I will infer general acceptance by demonstrating performance comparable to or better than the predicate, or by meeting internal and CLSI guidelines for analytical performance.

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

• Precision:
  • Serum sample pools and serum-based controls were assayed.
  • Each sample was assayed 2 replicates per run, 2 runs per day, for at least 20 days.
  • Number of data points (N) for each control/pool: 80.
  • Provenance: Not explicitly stated, but clinical laboratory studies typically use samples from diverse patient populations to represent the intended use environment. The term "Serum Control" and "Serum Pool" suggest internally generated or purchased control materials, which are representative of human serum. Retrospective, as these are controlled studies based on pre-collected samples or control materials.
• Linearity/Assay Reportable Range:
  • Eleven dilutions across the measuring range.
  • Provenance: Not explicitly stated, but likely laboratory-prepared dilutions of human serum or control materials. Retrospective.
• Limit of Blank, Limit of Detection, Limit of Quantitation:
  • 720 determinations: 240 blank replicates and 480 low-level sample replicates.
  • Provenance: Not explicitly stated, but laboratory-prepared blank and low-level samples. Retrospective.
• Method Comparison with Predicate Device:
  • Sixty-nine (69) serum samples.
  • Provenance: Not explicitly stated, but these would be human serum samples covering a range of albumin concentrations. Retrospective, as samples are collected and then tested.
• Matrix Comparison:
  • Forty-seven (47) paired plasma/serum samples (Lithium Heparin and Potassium EDTA plasma vs. serum).
  • Provenance: Human plasma and serum samples. Retrospective.
• Analytical Specificity (Interference):
  • Not specified, but likely involved multiple spiked samples for each interferent at varying concentrations.
  • Provenance: Laboratory-prepared samples spiked with interferents. Retrospective.

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

This document describes a diagnostic assay for quantitative measurement of albumin. The "ground truth" in this context is the actual albumin concentration in the samples, determined by a reference method or validated control materials, not by expert interpretation of images or clinical cases.

• No human experts are used for establishing "ground truth" in the interpretive sense (e.g., radiologist for imaging).
• The "ground truth" is established analytically:
  • Through the inherent reference values of commercial controls.
  • By the established methodology of the predicate device.
  • By traceability to the ERM-DA470k Reference Material.
  • By preparing samples with known (expected) concentrations for linearity and LoQ studies.
  • The "experts" involved are implied to be laboratory scientists and method developers who establish and validate these analytical reference points based on established scientific principles and guidelines (e.g., CLSI).

4. Adjudication Method for the Test Set:

Not applicable. This is an analytical chemistry assay, not a device requiring human interpretation and multi-reader adjudication for ground truth establishment. The performance is assessed against quantitative analytical targets.

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 imaging or other interpretive devices where human readers provide diagnoses, and the AI assists or performs the interpretation. This device is a quantitative chemistry assay.

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

Yes, all studies described (precision, linearity, LoB/LoD/LoQ, method comparison, matrix comparison, analytical specificity) are standalone performance evaluations of the ADVIA Chemistry Albumin BCP Assay on the ADVIA 1650 Chemistry system. The device (assay and instrument combination) performs the measurement automatically without human intervention once the sample is loaded.

7. The Type of Ground Truth Used:

The ground truth for the performance studies is primarily derived from:

• Known concentrations: For linearity, LoB, LoD, and LoQ studies, samples are prepared with known (expected) albumin concentrations or are blank.
• Reference materials: Traceability to ERM-DA470k Reference Material provides a foundation for accurate quantification.
• Predicate device measurements: For method comparison, the results from the legally marketed predicate device (Dimension Clinical Chemistry System Albumin Flex® reagent cartridge) serve as a comparative ground truth.
• Validated control materials: Commercial serum controls with established target values.

8. The Sample Size for the Training Set:

The document describes an analytical assay, not an AI/ML algorithm that undergoes a distinct "training" phase. Therefore, there is no explicit "training set" in the context of machine learning. The assay's performance characteristics (e.g., reagent formulations, instrument parameters, calibration curves) are developed and validated through extensive internal R&D and optimization processes, which would involve numerous samples, but these are not referred to as a "training set" in the same way an ML model would have one.

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

As noted above, there isn't a "training set" in the AI/ML sense. The "ground truth" for the development and optimization of the assay and its associated calibrator involves:

• Reference methods for quantifying albumin.
• Gravimetric or optical methods for preparing known concentration standards.
• Traceability to international reference materials like ERM-DA470k.
• Empirical data collected during the assay development process to optimize reagent concentrations, reaction conditions, and instrument parameters to achieve desired analytical performance.

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