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Clinical Chemistry - The Sentinel Clin Chem Cal is a device intended for medical purposes for use in Pancreatic amylase, Cholinesterase, Creatinine, Lithium, Alpha-Hydroxybutyrate Dehydrogenase and "Cholinesterase Dibucaine-Inhibited" assays to establish points of reference that are used in the determination of values in the measurement of Pancreatic amylase, Cholinesterase, Creatinine, Lithium, Alpha-Hydroxybutyrate Dehydrogenase and "Cholinesterase Dibucaine-Inhibited" in human specimens.

The Sentinel Clin Chem Cal is a lyophilized Calibrator prepared with human based serum. It consists of 4 x 3 mL bottles of lyophilized material containing pancreatic amylase, cholinesterase Creatinine, Lithium, Alpha-Hydroxybutyrate Dehydrogenase and "Cholinesterase Dibucainedi in a lyophilized human serum matrix. This material is stable until the date printed on the label when stored as directed.

The provided text is a 510(k) summary for the Sentinel Clin Chem Cal, a multiparameter calibrator. It describes modifications to an existing device, adding new analytes. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of typical diagnostic device performance metrics like sensitivity, specificity, or accuracy.

The document focuses on the calibration process for assigning values to the calibrator itself, rather than evaluating the performance of a diagnostic device that uses the calibrator. Therefore, many of the requested categories for a diagnostic device study are not applicable or cannot be extracted from this specific document.

Here's an attempt to answer based only on the provided text, noting where information is absent or not relevant for this type of device:

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

The document describes the process for assigning values to the calibrator analytes and the quality control steps during that assignment process. It doesn't present acceptance criteria for a diagnostic device's performance (e.g., sensitivity, specificity, accuracy).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is for the calibrator value assignment process, not a diagnostic device's test set.

• Sample Size: 30 randomly selected vials of calibrator material were used for value assignment.
• Data Provenance: Not explicitly stated. The submitter is from Milano, Italy, but the location where the testing was performed is not specified. It's an internal process for calibrator characterization.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This document describes the process of assigning values to a calibrator using an instrument (Abbott ARCHITECT® c8000 System) and predefined internal protocols. It does not involve human experts establishing ground truth in the context of, for example, image interpretation or clinical diagnosis. Traceability to certified reference materials/organizations (DGKC, IFCC, NIST) is mentioned for the analytes.

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

Not applicable. This is not a study involving human interpretation or adjudication. The value assignment process involves calculations of mean, standard deviation, and %CV, with outlier detection, based on instrument readings.

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 document is for a chemical calibrator, not an AI-assisted diagnostic device.

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

This concept doesn't directly apply. The "standalone" performance here refers to the calibrator's assigned values being determined by an automated analytical instrument (Abbott ARCHITECT® c8000 System) following a defined protocol, without human interpretive input for the final value.

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

For the calibrator, the "ground truth" (assigned values) is established through a rigorous internal process involving:

• Measurement on a qualified instrument (Abbott ARCHITECT® c8000 System).
• Calibration against an Internal Master Lot.
• Confirmation using control materials.
• Traceability to recognized international and national standards: Deutsche Gesellschaft für Klinische Chemie (DGKC), International Federation of Clinical Chemistry (IFCC), and NIST, SRM 909b.

8. The sample size for the training set

Not applicable. Calibrators are characterized, not "trained" in the machine learning sense. The process described is for determining the values of a batch of calibrators.

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

Not applicable. As above, there's no "training set." The ground truth for the calibrator's values is established by measuring reconstituted vials on a calibrated instrument against an Internal Master Lot, with traceability to external reference standards, and applying statistical analysis (mean, SD, %CV, outlier detection).

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The Sentinel Pancreatic Amylase is used for the quantitation of pancreatic amylase levels in human serum or plasma. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). For In Vitro use only.

The Sentinel Pancreatic Amylase is an in vitro diagnostic assay for the quantitative determination of pancreatic amylase in serum or plasma. The Sentinel Pancreatic Amylase is a two-reagent format that is carried out in two successive steps. In the first incubation step, the activity of the human salivary alpha-amylase is inhibited using two different monoclonal antibodies with no effect on the pancreatic alpha-amylase. In the second reaction step, the pancreatic alpha-amylase catalyses the hydrolysis of the EPS substrate (Ethylidene Protected Substrate) p-nitrophenyl-maltoheptaoside 4,6ethylidene-blocked (Ethylidene-G7PNP) forming 2 ethylidene-G4 + 2 G3PNP + ethylidene-G3 + G4PNP. The a-glycosidase hydrolyses all fragments of G2PNP. G3PNP, and G4PNP into p-nitro phenol (PNP) and glucose (G). The increase of absorbance, due to PNP formation, is proportional to the activity of pancreatic alphaamylase in the examined sample.

The Sentinel Pancreatic Amylase is an in vitro diagnostic assay for the quantitative determination of pancreatic amylase in serum or plasma. The study conducted aimed to demonstrate substantial equivalence to the Roche Pancreatic Amylase assay (K895880) on the Roche analyzer.

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

1. Table of Acceptance Criteria and Reported Device Performance

• Correlation Coefficient: 0.9994
• Slope: 0.965
• Y-intercept: 3.843
  ARCHITECT c8000 vs. Sentinel Pancreatic Amylase (AEROSET):
• Correlation Coefficient: 0.9998
• Slope: 1.011
• Y-intercept: -0.796 |
  | Precision | Acceptable within-run, between-run, and between-day variability. (Specific %CV targets likely defined internally, comparable to the predicate device) | AEROSET Analyzer:
• Total %CV for Level 1: 3.99%
• Total %CV for Level 2: 1.64%
• Total %CV for Level 3: 1.11%
  ARCHITECT c8000 Analyzer:
• Total %CV for Level 1: 1.50%
• Total %CV for Level 2: 0.60% |
  | Linearity | Linear range comparable to or exceeding the predicate device. | Up to 2200 U/L |
  | Limit of Detection (Sensitivity) | Limit of detection comparable to or better than the predicate device. | 1 U/L |

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

• Method Comparison (AEROSET vs. Roche): Samples ranged from 5 to 2428 U/L. The exact number of individual samples is not explicitly stated, but the range indicates a broad spectrum of pancreatic amylase levels were tested.
• Method Comparison (ARCHITECT c8000 vs. AEROSET): Samples ranged from 4 to 2290 U/L. The exact number of individual samples is not explicitly stated.
• Precision Studies: Three levels of control material for the AEROSET and two levels of control material for the ARCHITECT c8000. For each level, within-run, between-run, and between-day studies were performed, implying multiple replicates were run over several days. The exact number of replicates is not specified.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given it's an in vitro diagnostic assay, the samples would typically be human serum or plasma originating from patients, and the study would be conducted prospectively (collecting samples and running tests according to a defined protocol).

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 to this type of in vitro diagnostic assay. For quantitive chemical assays like the Pancreatic Amylase test, "ground truth" is established by the highly accurate and precise measurements from a reference method (the predicate device in this case, and potentially higher-order reference methods for calibration), not by expert consensus or interpretation of images.

4. Adjudication method for the test set

This is not applicable for a quantitative chemical assay. Adjudication methods like "2+1" or "3+1" are typically used in clinical imaging or pathology studies where there's subjectivity in interpretation by multiple experts. For this device, the comparison is directly between numerical results from two different assays.

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 is not applicable. An MRMC study is relevant for diagnostic imaging or pathology, specifically to assess the impact of a device (often AI-powered) on the performance of human readers. The Sentinel Pancreatic Amylase is a fully automated in vitro diagnostic assay that provides a quantitative numerical result; it does not involve human "readers" in the diagnostic interpretation process that an AI might assist.

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

Yes, the studies described are standalone performance studies (algorithm only). The Sentinel Pancreatic Amylase is an automated instrument-based assay, and its performance characteristics (precision, linearity, limit of detection, and method comparison) are evaluated based on the analytical measurements produced by the device itself, without human intervention in the diagnostic interpretation. The comparison is made against another standalone diagnostic assay (the predicate).

7. The type of ground truth used

The "ground truth" for the test set was essentially the measurements obtained from the legally marketed predicate device, the Roche Pancreatic Amylase assay (K895880) on the Roche analyzer (and Hitachi 911 Analyzer). For precision, linearity, and limit of detection, the ground truth is established by the inherent analytical capabilities of the assay and potentially by preparing reference materials with known concentrations. The goal of the study was to show substantial equivalence to this established method.

8. The sample size for the training set

This is not applicable in the context of this 510(k) summary for an in vitro diagnostic reagent kit. "Training set" refers to data used to develop and optimize a model or algorithm, typically for AI/machine learning applications. For a chemical assay like this, there isn't an "algorithm" in the same sense that requires a training set. The assay's performance is based on its chemical reactions and instrument calibration, which are developed through R&D and analytical validation, not by training on a data set.

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

As noted above, the concept of a "training set" and its associated ground truth is not applicable to this type of device submission. The chemical and enzymatic reactions, as well as the measurement principles, are based on established scientific principles and analytical chemistry, not on machine learning from a training data set.

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The Ammonia Ultra is intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye's syndrome. The Ammonia Controls are intended as a means of monitoring Sentinel Ammonia Ultra assay method.

The Sentinel Ammonia Ultra Diagnostic Assay described in this 510(k) submission is composed by reagent, calibrator and controls, packaged and distributed in different kits. The device is intended to be sold as an in-vitro test for professional use. The Ammonia Ultra is an enzymatic in vitro diagnostic assay for the quantitative determination of ammonia in human plasma. Ammonia, in the presence of glutamate dehydrogenase (GLDH), combines with alpha-ketoglutarate and NADH to yield glutamate and NAD*. The decrease in absorbance due to the NADH oxidation, at 340 nm, is proportional to the ammonia concentration in the examined plasma. The reagent contains lactate dehydrogenase (LDH) in excess, to rapidly reduce endogenous pyruvate so that it does not interfere with the assay system. The actual concentration of ammonia is determined multiplying the rate of absorbace per the calibration factor obtained during the calibration with the ammonia standard of 500 microgram/dL included in the kit. To ensure a correct determination during quantification of ammonia samples, a quality control procedure is required. The Ammonia Controls are liquid controls at 3 levels, prepared in bovine albumin matrix, and are used to verify the performance of the Ammonia Ultra assay. The value and range assigned to each level is specific for each lot and has been determined in rigorously standardized condition by the calculation of the median obtained in multiple determinations using reagents and standard relative to the Ammonia Ultra.

This document describes the Sentinel Ammonia Ultra Diagnostic Assay, an in-vitro diagnostic device for the quantitative determination of ammonia in human plasma. The information provided in the 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than detailing specific acceptance criteria and the comprehensive study results to prove device performance against those criteria. Therefore, several requested categories cannot be fully addressed from the provided text.

Here's the available information:

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

The document does not explicitly state pre-defined acceptance criteria with numerical targets. Instead, it mentions that "Performance evaluations included sensitivity, intra- and inter-assay imprecision, and method comparison." The conclusion states that "The performance and safety data presented in this premarket notification support a finding of substantial equivalence between the Sentinel Ammonia Ultra Diagnostic Assay and the predicate devices specified in this submission." This implies that the performance measured for sensitivity, imprecision, and method comparison was deemed acceptable relative to the predicate devices. Without the full study report, specific acceptance criteria and detailed quantitative performance values are not available.

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

The document does not specify the sample sizes used for sensitivity, intra- and inter-assay imprecision, or method comparison studies. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature).

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

This information is not provided in the document. The "ground truth" for an in-vitro diagnostic device like this would typically be established by a reference method or known concentrations of ammonia in control samples. Expert interpretation of results is usually less relevant than the analytical accuracy against a gold standard.

4. Adjudication method for the test set

This information is not provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which are not the primary focus for an enzymatic in-vitro diagnostic assay's performance evaluation.

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

An MRMC study is not applicable to this device. This is an in-vitro diagnostic assay for quantitative determination of ammonia, meaning there are no "human readers" or "AI assistance" involved in interpreting results in the way they would be in an imaging or diagnostic support system. Its performance is based on analytical accuracy.

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

This device is a standalone algorithm (an enzymatic assay, which functions like an algorithm in its chemical reactions and measurement). Its performance is inherently "standalone" in the context of its operation (i.e., it determines ammonia concentration without human-in-the-loop interpretation influencing the measurement result itself). The performance studies mentioned (sensitivity, imprecision, method comparison) would be a direct assessment of its standalone capability.

7. The type of ground truth used

For an in-vitro diagnostic device measuring a specific analyte like ammonia, the "ground truth" for performance evaluations would generally be:

• Known concentrations: For sensitivity and imprecision, this would involve using commercially available or custom-prepared control samples with a precisely known concentration of ammonia.
• Reference method comparison: For method comparison, it would involve testing patient samples using both the Sentinel Ammonia Ultra Diagnostic Assay and a legally marketed, well-established reference method (predicate device in this case) or a recognized gold standard method to assess concordance.

The document states that "The reagent contains lactate dehydrogenase (LDH) in excess, to rapidly reduce endogenous pyruvate so that it does not interfere with the assay system. The actual concentration of ammonia is determined multiplying the rate of absorbace per the calibration factor obtained during the calibration with the ammonia standard of 500 µg/dL included in the kit." This implies using a calibrated standard for accurate quantification, which serves as a form of ground truth for instrument calibration.

8. The sample size for the training set

The concept of a "training set" in the context of machine learning is not directly applicable to this enzymatic in-vitro diagnostic assay. These assays are based on established biochemical reactions, and their performance is optimized through reagent formulation, calibration, and validation, not typically through machine learning model training on large datasets in the conventional sense. Therefore, no "training set sample size" is reported.

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

As explained above, there isn't a "training set" in the machine learning sense for this type of device. The accuracy of the assay is based on the chemical principle (enzymatic reaction converting NADH) and the use of a calibrated standard (500 µg/dL ammonia standard) to establish the relationship between absorbance change and ammonia concentration.

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The Sentinel UIBC Liquid (Unsaturated Iron Binding Capacity) assay is intended to measure the unsaturated iron-binding capacity in serum and plasma. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. CFR 862.1415

The Sentinel UIBC Liquid described in this 510(k) submission is composed of reagents and standard, packaged and distributed in the same kit. The device is intended to be sold as an in vitro test for professional use. Serum is added to an alkaline buffer/reductant solution containing a known concentration of iron to saturate the available binding sites on transferrin. The iron that remains free after transferrin saturation is reduced to a ferrous state and then complexed by Ferene-S to form a stable complex, of which the color intensity is measured at 580-600nm. UIBC is therefore determined by subtracting the quantity of unbound iron from the total added quantity.

The document describes the Sentinel UIBC Liquid device and its comparison to a predicate device. Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria." However, it presents a method comparison study as evidence of performance. The implicit acceptance criterion for substantial equivalence is a strong correlation with the predicate device.

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

• Sample Size for Test Set: 60 serum samples
• Data Provenance: Not explicitly stated, but it's a clinical evaluation of human serum samples, likely prospective for the purpose of the 510(k) submission. No country of origin is mentioned.

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

This type of information is not applicable and not provided in the document. For in vitro diagnostic devices like the Sentinel UIBC Liquid, "ground truth" is typically established by the results from a legally marketed predicate device, not by expert consensus in the same way it would be for image-based diagnostic AI.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for this type of device is the measurement from the predicate device, not a subjective assessment requiring adjudication.

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 document describes an in vitro diagnostic device for laboratory analysis, not an AI-assisted diagnostic tool for human readers.

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

This is an in vitro diagnostic assay, meaning its performance is inherently standalone (algorithm/reagent only). The method comparison study is effectively a standalone performance evaluation against a gold standard (the predicate device).

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

The ground truth for the performance evaluation was the results obtained from the predicate device (Roche UIBC). For this type of IVD, the predicate device's performance is considered the established method against which the new device is compared for substantial equivalence.

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. The device's performance is based on chemical principles and reagent formulations.

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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Clinical Chemistry – The Sentinel Clin Chem Cal is a device intended for medical purposes for use in pancreatic amylase and cholinesterase assays to establish points of reference that are used in the determination of values in the measurement of pancreatic amylase and cholinesterase in human serum and plasma.

The Sentinel Clin Chem Cal is a device intended for medical purposes for use in pancreatic amylase and cholinesterase assays to establish points of reference that are used in the determination of values in the measurement of pancreatic amylase and cholinesterase in human serum and plasma. Sentinel Clin Chem Cal contains the analytes in human serum matrix. The analytes consist of pancreatic amylase and cholinesterase.

The provided text describes the acceptance criteria and the study that proves the device (Sentinel Clin Chem Cal) meets the acceptance criteria for Calibrator Shelf-life Stability and Calibrator After Reconstitution Stability.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Calibrator Shelf-life Stability: One lot of Sentinel Clin Chem Cal was used for the test. The stability was monitored prospectively by testing at multiple time points through a minimum of 30 months (and reported up to 33 months). The origin of the data is not explicitly stated but is implicitly from the manufacturer, Sentinel CH. Srl in Milan, Italy.
• Calibrator After Reconstitution Stability: Three lots of calibrator were used for the test (one expired from 13 months, one expired from 8 months, and one still in validity). The study was prospective in nature, assessing stability at specific time points after reconstitution. The origin of the data is implicitly from the manufacturer, Sentinel CH. Srl in Milan, Italy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is a calibrator for in-vitro diagnostic assays, not an AI or imaging device requiring expert ground truth for interpretation. The ground truth for this device's performance is based on analytical measurements against defined reference standards and the inherent property of a calibrator to maintain its assigned value over time and under specified conditions.

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

Not applicable. This is not an imaging or diagnostic device requiring adjudication of human-interpreted results.

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.

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

Not applicable. This is an IVD calibrator, not an algorithm. The "standalone" performance is equivalent to the reported analytical performance of the calibrator itself.

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

The "ground truth" for the calibrator's assigned values and stability assessments is based on:

• Traceability to Reference Standards: The Pancreatic Amylase is traceable to IFCC EPS / 37 °C using $\varepsilon$ p-Nitrophenol. Cholinesterase is traceable to DGKC Butyrylthiocholine 37 °C using $\varepsilon$ Hexacyano-ferrate (III).
• Methodology of Value Assignment: Assigned values are determined by taking the mean of measurements from multiple replicates across different instruments (Hitachi 717 and Abbott ARCHITECT® c8000), calibrated against a previous calibrator lot. This establishes the initial "true" or assigned value.
• Recovery Method: For stability studies, the performance is measured as a percentage recovery compared to the "time zero" measurement, which serves as the reference or ground truth for that specific lot.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that typically requires a 'training set'.

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

Not applicable. There is no training set for this type of device.

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The Sentinel Ceruloplasmin assay is used for the quantitation of ceruloplasmin (copper-transporting serum protein) levels in human serum or plasma. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorder.

Sentinel Ceruloplasmin is an in vitro diagnostic assay for the quantitative determination of ceruloplasmin in serum or plasma. The Sentinel Ceruloplasmin assay is a two-reagent format based on the immunological reaction between anti-ceruloplasmin antibonds specific for ceruloplasmin. The turbidity of the immunocomplex is proportional to the concentration of the analyte in the sample.

Here's an analysis of the provided text regarding the Sentinel Ceruloplasmin assay, broken down according to your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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The Sentinel Iron Liquid is a direct colorimetric in vitro diagnostic assay for the quantitative determination of Iron without deproteinization in human serum and plasma (heparin salts, only).

Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

The Iron Liquid described in this 510(k) submission is composed of reagents and standard, packaged and distributed in the same kit. The device is intended to be sold as an in vitro test for professional use.

The Iron Liquid is a direct colorimetric in vitro diagnostic assay for the quantitative determination of iron without deproteinization in human serum and plasma (heparin salt, only). In a pH 4.0 buffer system, iron is released from transferin to which it is bound, and then quantitatively reduced to a ferrous state. The iron forms with Ferene-S a stable colored complex of which the color intensity is proportional to the amount of iron in the sample. Particular reaction conditions and a specific masking agent eliminate the interference from copper.

The provided document is a 510(k) summary for the Sentinel Iron Liquid, an in vitro diagnostic assay. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria or a detailed study section with performance data that would allow for a comprehensive answer to all parts of your request.

Based on the information available in the document, here's what can be extracted and what cannot:

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

The document mentions "Performance evaluations included sensitivity, intra- and inter-assay precision and method comparison." However, it does not provide a table of specific acceptance criteria (e.g., target precision values, sensitivity thresholds) nor does it report the actual device performance metrics (e.g., measured sensitivity, CVs for precision, regression statistics for method comparison). It only states that these evaluations were performed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the performance evaluations (test set). It also does not mention the country of origin of the data or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable as the device is an in vitro diagnostic assay for quantitative determination of iron. The "ground truth" for such devices is typically established through reference methods or established biochemical standards, not expert interpretations of images or clinical cases. The document does not mention experts being used to establish ground truth.

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

This question is not applicable for this type of in vitro diagnostic device, where ground truth is based on quantitative measurements rather than expert consensus requiring adjudication. The document does not mention any adjudication method.

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 question is not applicable as the device is an in vitro diagnostic assay for quantitative determination of iron, not an AI-assisted diagnostic tool for human readers. The document does not mention an MRMC study or AI assistance.

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

The Sentinel Iron Liquid is a reagent-based assay for quantitative determination of iron. It operates standalone in the sense that it produces a quantitative result; there isn't a "human-in-the-loop performance" in the same way there would be for an image-based AI diagnostic. The comparative study was against a predicate device (IL Test Iron), indicating a standalone performance comparison. The document confirms that "Performance evaluations included sensitivity, intra- and inter-assay precision and method comparison." This implies a standalone evaluation of the device's performance.

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

For an in vitro diagnostic assay like Sentinel Iron Liquid, the "ground truth" would be the true concentration of iron in the samples, likely determined by a precise reference method or by using certified reference materials and calibrators. The document does not explicitly state the specific reference method or approach used to establish the ground truth for the performance evaluations. It only implicitly suggests that the predicate device serves as a comparison for accuracy.

8. The sample size for the training set

The concept of a "training set" is primarily relevant for machine learning or AI models. The Sentinel Iron Liquid is a chemical reagent-based assay. Therefore, there is no training set in the context of an AI model. The document does not refer to a training set.

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

As there is no training set for this type of device, this question is not applicable.

Summary of what is present:

• Intended Use: Quantitative determination of iron in human serum and plasma (heparin salts, only).
• Comparison to Predicate Device: IL Test Iron (Instrumentation Laboratory Company, K972363).
• Performance Evaluations Conducted (but not reported in detail): Sensitivity, intra- and inter-assay precision, and method comparison.
• Conclusion: The performance and safety data support a finding of substantial equivalence to the predicate devices.

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CRP Vario is an in vitro diagnostic test for the quantitative determination of C-reactive protein in human serum and lithium heparin or EDTA plasma samples by immunoturbidimetry. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders.

CRP Calibrators (CRP Calibrator Set, CRP Calibrator US and CRP Calibrator WR) are intended to be used for the calibration of the CRP Vario for the quantitative determination of C-reactive protein in human serum and EDTA or lithium heparinized plasma samples.

CRP Control US is intended for use as an assayed quality control material for serum C-reactive protein analysis.

The Sentinel CRP Vario kit is a latex in vitro diagnostic immunoassay for the quantitative determination of C-reactive protein (CRP) in human serum and in heparinized and EDTAplasma. Human CRP antigens in the sample bind to the specific anti-CRP antibody absorbed to latex particles, and agglutination occurs. This agglutination is detected as an absorbance change when read on an automated chemistry analyzer at wavelengths between 550 - 580 nm. The magnitude of the change in absorbance is proportional to the quantity of CRP in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentration using the CRP Calibrator Set, CRP Calibrator US, or CRP Calibrator WR.

The Sentinel CRP Calibrator Set, CRP Calibrator US and CRP Calibrator WR are prepared by diluting purified CRP with normal human serum to reach CRP concentrations of 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 16.0, 32.0 and 48.0 mg/dL.

By using the CRP Vario with the Sentinel calibrator kits, each used with specific analyzer settings called Methods, three measuring ranges can be achieved. The combinations of calibrators, method used and analytical ranges are listed in Table 5.1.

The Standard and the Wide Range Methods can be used with any available commercial quality control materials. The CRP Vario with the Ultrasensitive Method requires a Sentinel control, CRP Control US, for the approximate CRP concentration of 0.05 mg/dL to ensure the effectiveness of CRP measurements at very low CRP concentrations.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided K050836 510(k) summary for the Sentinel CRP Diagnostic Assay:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary provided does not explicitly state pre-defined acceptance criteria (e.g., a specific target for sensitivity, precision, or correlation coefficient). Instead, it relies on demonstrating substantial equivalence to predicate devices. The performance data presented is comparative, showing "equivalence" rather than meeting pre-set numerical thresholds.

However, based on the information provided, we can infer the performance aspects evaluated and summarize the reported findings:

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

The 510(k) summary does not explicitly state the sample size used for the performance evaluations (sensitivity, precision, prozone, interference, and method comparison).

It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective). Given that the submitter is from Italy (Sentinel CH Srl) and the contact person is also based in Rome, Italy, the studies might have been conducted in Italy or Europe, but this is not explicitly stated. The summary does not indicate whether the data was retrospective or prospective.

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

This information is not applicable in the context of this diagnostic assay submission. The "ground truth" for quantitative laboratory tests like CRP is typically established by reference methods or accepted clinical laboratory practices, not by expert consensus interpreting images or clinical cases. The comparison is done against existing, cleared diagnostic devices or reference standards.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth is not established through expert review requiring adjudication in this type of diagnostic assay. The comparison is a quantitative measurement against known values or an established predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor would it typically be relevant for this type of in-vitro diagnostic device (IVD). MRMC studies are usually associated with diagnostic imaging devices or other tests that rely on human interpretation of complex data, where reader variability is a significant factor. The Sentinel CRP Diagnostic Assay is an automated immunoassay.

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

Yes, the device performance described (sensitivity, precision, prozone, interference, method comparison) represents standalone performance. The Sentinel CRP Vario is an automated immunoassay where human interaction is primarily for sample loading, initiating the test, and interpreting the numerical result from the automated analyzer. The "performance data" section explicitly discusses evaluations of the assay itself.

7. The Type of Ground Truth Used

The ground truth for evaluating the Sentinel CRP Diagnostic Assay consisted of:

• Reference materials/standards: For evaluating sensitivity, precision, prozone, and interference, these would typically involve samples with known CRP concentrations (e.g., spiked samples, control materials).
• Results from a predicate device: For the method comparison study ("comparison between the Sentinel CRP assay and the Beckman Coulter IMMAGE Immunochemistry System CRP reagent"), the results obtained from the predicate device (Beckman Coulter IMMAGE) served as a form of "ground truth" or reference for demonstrating equivalence.

8. The Sample Size for the Training Set

The 510(k) summary does not provide information regarding a "training set" sample size. This concept of a distinct training set is more common for machine learning or AI-based devices rather than traditional in-vitro diagnostic assays, which are typically developed and validated using a series of experiments with various samples.

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

As no training set is explicitly mentioned or relevant for this type of IVD in the provided summary, information on how its ground truth was established is not provided. The development of such assays involves established chemical and immunological principles, and calibration is performed using materials of known concentration (as described for the calibrator sets), rather than learning from a "training set" with established ground truth in the AI sense.

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The Sentinel Plasmaproteins Cal 3x is a device intended for medical purpose for use in ceruloplasmin, kappa light chains and lambda light chains assay to establish points of reference that are used in the determination of values in the measurement of ceruloplasmin, kappa and lambda light chains in human serum and plasma.

Sentinel Plasmaproteins Cal 3x contains analytes (plasmaproteins) in human serum matrix. The analytes consist of ceruloplasmin, kappa light chains, and lambda light chains.

The provided text describes Sentinel Plasmaproteins Cal 3x, a calibrator for ceruloplasmin, kappa light chain, and lambda light chain assays. The device's performance is primarily assessed through its calibrator shelf-life stability.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample size: One lot (lot P0387) of Plasmaproteins Cal 3x was used for the shelf-life stability study.
• Data provenance: Not explicitly stated, but it's a prospective study since it involves storing the calibrator and testing it at different time points to determine shelf-life. The country of origin is not specified for the data collection itself, but the submitter is from Milan, Italy.

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

This information is not applicable as the study is for the stability of a calibrator, not a diagnostic device requiring expert interpretation for ground truth. The 'ground truth' here is the assigned value at manufacturing, which is determined by a value assignment process, not expert consensus.

4. Adjudication method for the test set:

This is not applicable as the study does not involve expert review or adjudication of results. The 'ground truth' is the initial assigned value, and results are compared against this instrumental determination.

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 is not applicable. The device is a calibrator, not an AI-powered diagnostic tool, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

This is not applicable. The device is a calibrator, not an algorithm.

7. The type of ground truth used:

The ground truth for the stability study is the assigned value at manufacturing time. This value is established through a specific value assignment process (testing five replicates per three runs for each analyte, with the assigned value being the average of all replicates).

8. The sample size for the training set:

This is not applicable. The device is a calibrator, not a machine learning model, so there is no training set in the conventional sense.

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

This is not applicable, as there is no training set. The "ground truth" for the calibrator's value itself (the assigned value at manufacturing) is established by:

• Testing the new lot.
• Assessing five replicates per three runs for Kappa light chain, Lambda light chain, and Ceruloplasmin assays.
• Calculating the assigned value as the average of all replicates for each assay.
• Using quality control materials to verify assay performance and fresh reagents/new calibrations at each run.

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The Sentinel Cholinesterase Liquid assay is used to measure cholinesterase in human specimens. There are two principal type of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is note present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition and disorders. For In Vitro diagnostics use only. CFR 862.3240

Sentinel Cholinesterase Liquid is an in vitro diagnostic assay for the quantitative determination of cholinesterase in serum and plasma.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text.

Note: The provided text describes a submission for a chemical assay (Cholinesterase Liquid), not an AI-powered device or an image-based diagnostic. Therefore, many of the requested criteria related to AI, ground truth, expert review, MRMC studies, and training/test sets are not applicable to this type of submission and are not mentioned in the documentation. The description focuses on demonstrating substantial equivalence of a modified in-vitro diagnostic assay to a previously cleared one.

Acceptance Criteria and Device Performance

The acceptance criteria for this device revolve around demonstrating substantial equivalence to a predicate device for its intended use and performance characteristics, specifically after adapting it to new analyzer systems.

Due to the nature of this submission (modification of an IVD assay to run on different analyzers), the acceptance criteria are implicitly met when the comparative performance studies show acceptable correlation.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study was a comparative performance study aimed at demonstrating the substantial equivalence of the modified Sentinel Cholinesterase Liquid assay when run on the Abbott AEROSET® and ARCHITECT® c8000® Analyzers, compared to the previously cleared Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 assay on Hitachi 717.

2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample size used for the comparative performance studies (method comparison studies). It states "comparative performance studies were conducted" but does not detail the number of samples or patients included. The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
This is not applicable as the device is an in-vitro diagnostic assay for quantitative determination of cholinesterase, not an AI or image-based diagnostic requiring expert interpretation for ground truth. The "ground truth" for method comparison in an IVD context is typically the results obtained from a reference method or a legally marketed predicate device.

4. Adjudication Method:
This is not applicable for the reasons stated above. There is no expert adjudication process described for the performance of a quantitative chemical assay.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No. This is definitively not applicable as this device is a laboratory assay, not an AI or imaging device involving human readers.

6. If a standalone (algorithm only without human-in-the loop performance) was done:
The device itself is standalone in the sense that it is a quantitative assay performed by an analyzer. Its performance is evaluated intrinsically through comparison to a predicate, not in interaction with a human "in the loop" in a diagnostic workflow like an AI algorithm might be. So, yes, the performance assessed is of the assay independent of immediate human interpretative input in a diagnostic decision-making context.

7. The Type of Ground Truth Used:
For the comparative performance studies, the "ground truth" was established by the results obtained from the legally marketed predicate device, Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 assay on Hitachi 717, and also by the AEROSET system's results being used as a comparator for the ARCHITECT c8000 system. This is a common approach for demonstrating substantial equivalence of IVD modifications.

8. The Sample Size for the Training Set:
Not applicable. This device is a chemical assay, not a machine learning algorithm that requires a "training set." The development of the assay itself would have involved method optimization and validation, but not in the context of a "training set" for an AI model.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. See point 8.

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