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For in vitro quantitative determination of immunoglobulin E in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers. Determination of total serum IgE is useful as an aid in the diagnosis of allergic disease.

The Elecsys® IgE test is based on the sandwich principle of heterogeneous immunological complex formation. First Step: Biotinylated monoclonal antibodies (R1) and ruthenium labeled antibodies (R2), both specific for IgE, bind IgE present in the sample forming a sandwich complex Second Step: Microparticles coated with streptavidin (M) bind the biotin portion of the complex and are captured magnetically onto the surface of the electrode. Application of a voltage to the electrode induces chemiluminescent emission, which is measured by a photomultiplier.

Here's a breakdown of the acceptance criteria and study information for the Elecsys® IgE Test, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

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The Accu-Chek HQ system is a bedside unit that can help health care professionals provide quality patient care by measurement of glucose on an Accu-Chek monitor, and by automating the record keeping associated with blood glucose and quality control tests.

The Accu-Chek HO system is a bedside data management unit that helps provide quality patient care by automating the record keeping associated with blood glucose and quality control tests. The Accu-Chek HQ system collects, stores, transfers information, and generates reports about the monitor, test strips, control solutions, patient results and operator performance for quality assurance.

This device is not intended to provide any diagnosis on patient results. The health care provider has the ability to visually confirm that the results on the Accu-Chek HQ display match the results on the monitor display. This inherent redundancy provides a method for the health care provider to confirm all data that is being logged by the Accu-Chek HQ system.

The provided text describes a 510(k) summary for the Accu-Chek HQ System, a data management unit for blood glucose and quality control tests. However, the document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria.

Instead, the document focuses on:

• Device Description: What the Accu-Chek HQ System is and what it does (collects, stores, transfers information, generates reports).
• Intended Use: How the device is meant to be used (automating record-keeping associated with blood glucose and quality control tests, in conjunction with an Accu-Chek monitor).
• Comparison to a Predicate Device: A table comparing the Accu-Chek HQ System to the AccuData Glucose Test Station, highlighting similarities and differences in functionality and intended use.
• Regulatory Information: The FDA's review and determination of substantial equivalence (K983047).

Crucially, the document explicitly states: "This device is not intended to provide any diagnosis on patient results." and "The health care provider has the ability to visually confirm that the results on the Accu-Chek HQ display match the results on the monitor display. This inherent redundancy provides a method for the health care provider to confirm all data that is being logged by the Accu-Chek HQ system." This indicates that the device's primary function is data management and record-keeping, and its performance is not evaluated in terms of diagnostic accuracy or clinical outcomes.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them because this information is not present in the provided text. The document describes a "data processing module for clinical use" where the "performance" is more about data accuracy and transfer, rather than a clinical diagnostic performance that would typically have specific sensitivity/specificity, accuracy, etc. acceptance criteria and a corresponding study.

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The Elecsys® CalCheck IgE is intended for use in periodic verification of the calibration of the Elecsys IgE assay.

The Elecsys CalCheck IgE is manufactured using a human serum matrix, human IgE, stabilizers, and preservatives. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels.

The provided text is a 510(k) summary for the "Elecsys CalCheck IgE" device, which is a calibration verification material. This type of device does not typically involve the complex clinical studies or AI performance metrics requested in the prompt. Therefore, several of the requested categories are not applicable or cannot be extracted from this document.

Here's an attempt to answer the questions based on the provided text, while noting limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The Elecsys® CalCheck IgE was evaluated for value assignment and stability." However, specific quantitative acceptance criteria or detailed performance data for "value assignment" and "stability" are not provided in this 510(k) summary. These would typically be found in a more detailed study report or in the submission itself, not necessarily summarized in the public 510(k) summary.

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

This information is not available in the provided 510(k) summary. For a calibration verification material, the "test set" would refer to the samples used during the validation of the material's properties (value assignment, stability). The document does not specify the number of samples or their origin (country, retrospective/prospective).

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

This is not applicable for a calibration verification material. Ground truth in this context would likely refer to the assigned values of the IgE concentrations, which are determined through a manufacturing and assay process, not by expert interpretation.

4. Adjudication Method for the Test Set

This is not applicable for a calibration verification material. Adjudication typically refers to resolving discrepancies in expert interpretations, which isn't relevant here.

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

This is not applicable. An MRMC study assesses the performance of human readers, with or without AI assistance, on diagnostic tasks. The "Elecsys CalCheck IgE" is a calibration material, not a diagnostic imaging or interpretive device that human readers would use in this way.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable. The device is a physical calibration material, not an algorithm.

7. The Type of Ground Truth Used

For a calibration verification material, the "ground truth" would be the assigned target values for the IgE concentrations within the CalCheck IgE material. These values are established through the manufacturing process and metrology, not typically through expert consensus, pathology, or outcomes data in the way these terms are used for diagnostic devices.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this device as it is not an AI/ML algorithm.

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

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

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The Preciset® Serum Proteins calibrator is intended to be used in the calibration of immunoturbidimetric assays on the BM/Hitachi systems.

The Preciset® Serum Proteins consists of multi-level calibrators based on human serum. The concentrations of the components have been adjusted to ensure optimal calibration of the following immunoturbidimetric assays: Tina-quant® IgA, Tina-quant® IgG, Tina-quant® IgM, Tina-quant® C3, and Tina-quant® C4, Transferrin, and C-Reactive Protein (CRP).

The provided text is a 510(k) summary for the Preciset® Serum Proteins calibrator. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria, device performance studies to meet such criteria, sample sizes, expert involvement, or ground truth establishment.

The document focuses on the regulatory submission process for a calibrator, which is a device used to establish calibration curves for quantitative determinations. The "performance" in this context refers to the stated values of constituent analytes in the calibrator, not a diagnostic accuracy performance as might be seen for devices like imaging AI. Therefore, most of the requested information is not applicable or not present in this type of submission.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in terms of performance metrics like sensitivity, specificity, or clinical accuracy. For calibrators, acceptance criteria would typically revolve around the accuracy and stability of the assigned analyte values, and their ability to produce valid calibration curves on specified instruments. This document does not include these specific criteria or the studies that demonstrate compliance.
• Reported Device Performance: The "performance" for a calibrator is presented as the representative constituent analyte levels used in the calibrator, which are listed in the table below. This is not performance as in diagnostic accuracy, but rather the intrinsic property of the calibrator.

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

• Not Applicable / Not Provided: This document does not describe performance studies involving "test sets" in the context of diagnostic accuracy. The data provenance is not mentioned.

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

• Not Applicable / Not Provided: This information is not relevant for a calibrator's regulatory submission, as there's no "ground truth" to establish through expert consensus as there would be for a diagnostic tool. The values for the calibrator analytes are determined through established analytical methods.

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

• Not Applicable / Not Provided: This is not relevant for a calibrator.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable: This is a calibrator, 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 a calibrator, not an algorithm.

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

• Not Applicable / Not Provided: For a calibrator, the "ground truth" for the analyte concentrations is established through rigorous analytical measurement processes and metrological traceability, not through clinical expert consensus, pathology, or outcomes data. The specific methods used to assign values are not detailed in this summary.

8. The sample size for the training set

• Not Applicable: This device is a calibrator, not an algorithm that requires a training set.

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

• Not Applicable: This device is a calibrator, not an algorithm that requires a training set.

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The Boehringer Mannheim Elecsys® CalCheck™ Troponin T is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Troponin T assay.

Elecsys CalCheck Troponin T calibration verification solutions comprise three levels - low, mid. and high - each with a defined Troponin T concentration. The low solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.

The Elecsys CalCheck Troponin T is intended for use in periodic verification of the calibration of the Elecsys Troponin T assay.

The Boehringer Mannheim Elecsys CalCheck Troponin T is manufactured using bovine serum albumin, human recombinant Troponin T, stabilizers, and preservatives. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels.

The provided text describes the 510(k) summary for the "Elecsys CalCheck Troponin T" device. This device is a calibration verification material, not a diagnostic device that measures patient samples. Therefore, the acceptance criteria and study details are focused on the performance of the calibration material itself (value assignment and stability), rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC which are typical for devices that provide patient results.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document is a 510(k) summary which focuses on demonstrating substantial equivalence to a predicate device. It states that the device "was evaluated for value assignment and stability." However, it does not explicitly list quantitative acceptance criteria for these evaluations or the specific results obtained. This level of detail is often found in the full 510(k) submission, not typically in the publicly available summary. For a calibration verification material, typical acceptance criteria would involve:

• Value Assignment: The measured values for each level (low, mid, high) must fall within a predefined range of the assigned target values. This range is usually determined by precision goals and clinical requirements for the assay being calibrated.
• Stability: The assigned values must remain within predefined acceptable limits over a specified period (e.g., shelf-life, open-vial stability) under various storage conditions (e.g., refrigerated, room temperature). Changes within these limits are usually compared to initial assigned values.

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

The document does not specify a "test set" in the context of diagnostic performance on patient data. For a calibration verification material, the "test set" would refer to the lots or units of the Elecsys CalCheck Troponin T that were manufactured and evaluated.

• Sample size: Not specified. The summary states that the material "was evaluated for value assignment and stability," implying that a sufficient number of product lots or units were tested, but no concrete numbers are given.
• Data Provenance: Not applicable in the traditional sense of patient data. The evaluations would have been conducted internally by Boehringer Mannheim Corporation, likely in their manufacturing and R&D facilities. The country of origin for the data is therefore the USA, where Boehringer Mannheim Corporation is listed. The study would be prospective in the sense of manufacturing and testing new lots of the CalCheck material.

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

This concept is not applicable for a calibration verification material. "Ground truth" for this type of device relates to the accurately assigned concentrations of Troponin T within the calibration solutions.

• Establishing Ground Truth: The "ground truth" (i.e., the target concentration values for each level – low, mid, high) would be established through highly controlled analytical methods and reference materials, often involving a hierarchical traceability chain to international standards. This process typically involves:
  • Using reference measurement procedures (RMPs) or highly accurate, validated methods.
  • Comparing against certified reference materials (CRMs).
  • Multiple measurements by skilled analytical chemists or laboratory professionals.
• The document does not detail the specific number or qualifications of individuals involved in the value assignment process, as it is a standard laboratory procedure for reference material production.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations of diagnostic images or data in clinical studies. For a calibration material, discrepancies in value assignment would be resolved through re-analysis, investigation of analytical errors, or use of a reference method.

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

No, an MRMC study was not done. MRMC studies are used to evaluate the impact of a diagnostic device (especially imaging AI) on human reader performance. The Elecsys CalCheck Troponin T is a calibration material, not a diagnostic device.

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

Yes, in a sense. The "performance characteristics" evaluated (value assignment and stability) represent the standalone performance of the calibration material itself, independent of human interpretation of a diagnostic result. The device's output (its assigned value) is assessed directly through analytical methods.

7. The Type of Ground Truth Used

The ground truth used for this calibration verification material would be assigned values derived from:

• Reference materials: Highly pure human recombinant Troponin T.
• Analytical methods: Precisely measured concentrations using validated laboratory techniques, traceable to higher-order reference measurement procedures or international standards where available.
• Formulation specifications: The material is manufactured by "appropriately spiking" the analyte to achieve specific concentrations.

It is not based on expert consensus, pathology, or outcomes data, as those relate to diagnostic findings in patients.

8. The Sample Size for the Training Set

Not applicable. The Elecsys CalCheck Troponin T is a chemical reagent product, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of algorithm development.

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

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

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For the in vitro quantitative determination of troponin T in human serum and plasma.

The specificity and sensitivity of troponin T measurements aid in both the early and late diagnosis of AMI. Troponin T elevations have also been measured in patients with the clinical diagnosis of unstable angina due to the sensitivity of troponin T for detecting minor myocardial damage.

The determination of cTnT in serum is an important component in the diagnosis of myocardial ischemia, e.g. AMI and myocarditis, as well as in monitoring the course of unstable angina pectoris and assessing the associated risk.

The Boehringer Mannheim Elecsys ® Troponin T STAT test is based on a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined via a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code.

This document describes the Boehringer Mannheim Elecsys® Troponin T STAT Test, an immunoassay for the quantitative determination of troponin T in human serum and plasma, used in the diagnosis of myocardial ischemia.

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

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

The provided text does not explicitly state specific acceptance criteria or provide a table summarizing device performance metrics against such criteria. It mentions "Specific data on the performance of the test have been incorporated into the draft labeling in Attachment 5," but this attachment is not included in the provided excerpts.

The document primarily focuses on establishing substantial equivalence to a predicate device, the Boehringer Mannheim Elecsys® Troponin T test (cleared by FDA in K961500), rather than detailing performance specifications and meeting predefined acceptance thresholds for this particular iteration of the device.

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 mentions "Comparative studies on 770 patients confirm the prognostic utility of cTnT." This appears to be the sample size for a clinical study related to the prognostic utility of cTnT, which supports the "Indications for Use." However, it's not explicitly stated if this 'test set' was for the modified device's performance validation against specific acceptance criteria, or if it refers to general clinical evidence for Troponin T as a biomarker.

• Sample Size (for prognostic utility): 770 patients.
• Data Provenance: Not specified regarding country of origin.
• Retrospective or Prospective: Not specified.

It's important to note that this is for the prognostic utility of cTnT, not necessarily the performance characteristics (e.g., accuracy, precision) of the device itself. The actual performance data for the device is referenced as being in "Attachment 5," which is not provided.

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 information is not provided in the given text.

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

This information is not provided in the given text.

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 device is an in vitro diagnostic (IVD) immunoassay; it is not an AI-assisted diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not conducted.

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

This device is an in vitro diagnostic immunoassay. Its performance is inherently standalone in the sense that the test produces quantitative results directly. There is no "human-in-the-loop" component in the interpretation of the raw quantitative troponin T value produced by the instrument and reagent, although a clinician interprets the clinical significance of that value.

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

For the "Comparison to the Predicate Device," the ground truth implicitly is the performance of the predicate device. For the "Indications for Use" and the prognostic utility cited ("Comparative studies on 770 patients confirm the prognostic utility of cTnT"), the ground truth would likely be clinical outcomes data related to cardiac events and patient prognosis. However, the exact methodology for establishing specific ground truth for the device's analytical performance (e.g., accuracy, precision) is not described in the provided text, other than through comparison to the predicate.

8. The sample size for the training set

The concept of a "training set" as understood in machine learning (ML) or AI is not applicable to this traditional immunoassay device. Immunoassays do not have training sets in this sense. They are developed based on chemical and biological principles, and their performance is validated through analytical and clinical studies.

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

As noted above, the concept of a "training set" is not applicable to this type of device.

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The Roche Diagnostics, Boehringer Mannheim Inorganic Phosphorus reagent is intended for use for the quantitative in vitro determination of phosphorus in human serum, plasma and urine with automated clinical chemistry analyzers.

According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1580, a Phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Endpoint method with sample blanking.

Inorganic phosphate forms an ammonium phosphomolybdate complex with ammonium molybdate in the presence of sulfuric acid. The complex is determined photometrically in the ultraviolet region (340 nm).

The provided text describes the 510(k) summary for the Roche Diagnostics, Boehringer Mannheim Inorganic Phosphorus Reagent. This submission seeks substantial equivalence to an existing device, focusing on extended claims for specimen collection, reportable range (urine), imprecision, and method comparison (urine).

Here's an analysis of the provided information concerning acceptance criteria and the study:

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

The document describes the changes and similarities to the predicate device but does not explicitly state specific acceptance criteria (e.g., performance targets, accuracy thresholds) or provide a table directly comparing acceptance criteria with reported device performance for the extended claims.

However, it implicitly refers to performance characteristics for the extended claims. The "Limitations - Interferences" section provides some performance details related to interference, which could be considered partial performance data, though not directly tied to explicit acceptance criteria:

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

The provided text does not specify the sample size used for the test set for any of the performance characteristics or the data provenance (country of origin, retrospective/prospective nature). It only states that specific data on the performance of the system has been incorporated into the draft labeling in Section V and that data related to extended claims is described in Section VI. These sections are not included in the provided document.

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 information is not applicable to this type of in vitro diagnostic device (reagent for chemical analysis). Ground truth for chemical assays is typically established through reference methods and calibrated instruments, not expert human interpretation.

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

This information is not applicable to this type of in vitro diagnostic device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective human interpretation (e.g., medical imaging, pathology).

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 information is not applicable to this type of in vitro diagnostic device. MRMC studies and concepts of human reader improvement with AI assistance are relevant to AI-based diagnostic tools that assist human interpreters (e.g., radiologists, pathologists). This device is a chemical reagent.

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

This information is not applicable in the context of an AI algorithm. For this chemical reagent, "standalone performance" refers to the performance of the reagent on an automated clinical chemistry analyzer without manual human intervention in the measurement process, which is inherent to its intended use with "automated clinical chemistry analyzers." However, the document does not explicitly detail the standalone performance study protocol or results beyond general statements about "performance characteristics."

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

For this type of chemical reagent, the ground truth for performance evaluation (e.g., accuracy, precision) would typically be established using:

• Reference materials/calibrators: Samples with known, validated concentrations of inorganic phosphorus.
• Reference methods: Established, highly accurate analytical methods considered the gold standard for measuring inorganic phosphorus.

The document does not explicitly state the type of ground truth used, but these are the standard practices for verifying the performance of such devices.

8. The sample size for the training set:

This information is not applicable because the device is a chemical reagent, not an AI or machine learning algorithm that requires a "training set."

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

This information is not applicable as there is no "training set" for this chemical reagent.

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The Preciset® Serum Proteins calibrator is intended to be used in the calibration of immunoturbidimetric assays on the BM/Hitachi systems.

The Preciset® Serum Proteins consists of multi-level calibrators based on human serum. The concentrations of the components have been adjusted to ensure optimal calibration of the following immunoturbidimetric assays: Tina-quant® IgA, Tina-quant® IgG, Tina-quant® IgM, Tina-quant ® C3, and Tina-quant ® C4.

The provided 510(k) summary for the "Preciset® Serum Proteins" calibrator focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its performance against specific acceptance criteria. This type of submission, common for calibrators and certain other IVDs, often relies on comparing the new device's formulation and intended use to an already cleared predicate.

Therefore, many of the requested details about acceptance criteria, clinical studies, and ground truth establishment are not applicable to this 510(k) submission.

Here's a breakdown of the available information in relation to your request:

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

• Acceptance Criteria: Not explicitly stated as formal performance acceptance criteria (e.g., accuracy, precision targets). The core "acceptance criteria" for a calibrator in this context is its ability to accurately calibrate the specified immunoturbidimetric assays. This is implied by its composition and comparison to the predicate.
• Reported Device Performance: Instead of performance metrics, the document provides the representative constituent levels for each analyte (IgG, IgA, IgM, C3, C4) at different "levels" (1 through 5, or 4 for C3 and C4). These levels are what the calibrator is designed to provide for calibration, not a measure of its performance against a gold standard. The fact that the device was cleared implies that these levels were deemed appropriate for its intended use.

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

• N/A. This document does not describe a clinical performance study using a test set of patient samples. The device is a calibrator, and its evaluation typically involves analytical studies (e.g., accuracy of manufactured concentrations, stability) rather than clinical studies on patient samples.

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

• N/A. No test set requiring expert ground truth is described. The "ground truth" for the calibrator's constituent levels would be established through accredited reference materials and methods, as indicated by the "Reference Material: RPPHS" in the table.

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

• N/A. No test set or adjudication method is described.

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

• N/A. This device is a chemical calibrator, not an AI-assisted diagnostic tool.

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

• N/A. This is not an algorithm-based device.

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

• The "ground truth" for the calibrator's constituent levels is based on Reference Material (RPPHS). This indicates that the concentrations of the analytes (IgG, IgA, IgM, C3, C4) in the calibrator were determined and traced to a recognized reference standard (Reference Preparation for Human Serum Proteins). This is a common and appropriate method for establishing the "truth" for calibrator values.

8. The sample size for the training set

• N/A. This device does not use a training set in the context of machine learning or AI.

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

• N/A. As above, no training set in the context of machine learning. The "ground truth" for the calibrator's composition is linked to Reference Material (RPPHS).

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For the quantitative in vitro determination of IgE in human serum and plasma on automated clinical chemistry analyzers. IgE determinations are used as an aid in the diagnosis of allergic diseases.

The Boehringer Mannheim Tina-quant ® IgE test is based on the principle of immunological agglutination with enhanced of the reaction by latex.

The provided text describes the Boehringer Mannheim Tina-quant® IgE Test, comparing it to a predicate device (Behring N IgE Test) to establish substantial equivalence. However, the document does not contain details about specific acceptance criteria and a study that proves the device meets those criteria in the format requested.

The text focuses on:

• Device Description and Intended Use: For quantitative in vitro determination of IgE in human serum and plasma as an aid in diagnosing allergic diseases.
• Comparison to Predicate Device: Highlighting similarities in intended use, indications, sample type, assay principle, and standardization, while noting differences in measurement approach, instrument, and reagent formulation.
• Regulatory Substantial Equivalence: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

1. A table of acceptance criteria and the reported device performance: The document only states "Performance characteristics: The performance of the Boehringer Mannheim Tina-quant ® IgE Test is substantially equivalent to other products device (cont.) in commercial distribution intended for similar use." It does not provide specific performance metrics or acceptance criteria thresholds.
2. Sample size used for the test set and the data provenance: No information on test sets or their characteristics is given.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as there's no mention of a diagnostic study with ground truth establishment.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable, as this is an in-vitro diagnostic device and such a study is not described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is a lab test, not an AI algorithm.
7. The type of ground truth used: Not applicable, no diagnostic study details are provided.
8. The sample size for the training set: Not applicable, no training set details are provided.
9. How the ground truth for the training set was established: Not applicable.

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Immunoassay for the in vitro quantitative determination of Prostate-Specific Antigen in human serum and plasma. The Elecsys PSA assay is further indicated for serial measurement of PSA to aid in the management of cancer patients.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

The Elecsys® test principle is based on sandwich principle. Total duration of assay: 18 minutes (37° C).
• 1st incubation (9 minutes): Sample (20 µL), a biotinylated monoclonal PSA-specific antibody (70 µL), and a monoclonal PSA-specific antibody labeled with a ruthenium complex (70 µL) react to form a sandwich complex.
• 2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (40 µL), the entire complex is bound to the solid phase via interaction of biotin and streptavidin.
·The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame).
•Results are determined via a calibration curve which is instrument-generated by 2-point calibration and a master curve provided via the reagent bar code.

Here's an analysis of the provided text regarding the Elecsys® PSA assay, structured to address your specific questions.

It's important to note that this document is a 510(k) summary for a diagnostic assay (a lab test), not a medical imaging device or an AI-powered system in the modern sense. Therefore, some of your questions, particularly those related to imaging, AI performance, human readers, and ground truth establishment for AI, are not directly applicable or addressable by this type of submission. This summary focuses on the analytical performance of the assay itself compared to a predicate assay.

Acceptance Criteria and Study Details for Elecsys® PSA Assay

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" for each performance characteristic in a formalized table. Instead, it presents performance data for the new device (Elecsys PSA, 2nd Gen) and the predicate device (Elecsys PSA, 1st Gen) side-by-side, implying that the new device's performance should be comparable or improved relative to the predicate to establish substantial equivalence.

Based on the "Performance Characteristics" section, here's a table summarizing the reported device performance and implicitly accepted levels (by showing equivalence to the predicate):

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

• Precision: For each level (HS1, HS2, HS3, PC-TM1, PC-TM2), the sample size (N) was 60. The submission does not specify the country of origin or whether the data was retrospective or prospective. Given the nature of a lab assay performance study, these are typically prospective laboratory testing results.
• Method Comparison: The sample size (N) for the method comparison study was 108. No information on data provenance (country, retrospective/prospective) is provided.

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

This question is not applicable to this submission. For an in vitro diagnostic (IVD) assay like Elecsys® PSA, "ground truth" for the test set is established by the reference measurement procedure (i.e., the predicate device or a recognized reference method) or by the known concentrations of calibrators/controls used for analytical performance studies like precision and linearity. There are no "experts" in the sense of human readers/adjudicators for interpreting results in this context; performance is based on analytical measurements.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 refer to human expert consensus for interpreting images or clinical data, which is not relevant for an analytical assay.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This is an in vitro diagnostic assay, not an AI-powered medical imaging or decision support system that involves human readers.

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

Not applicable in the usual sense of an "algorithm" as an AI. This is an automated immunoassay system. The "standalone" performance is what is presented in the Precision, Sensitivity, Linearity, and Hook Effect sections, as it describes the analytical performance of the instrument/reagent system without human interpretation beyond pipetting and loading. The "algorithm" here refers to the instrument's calibration and calculation of results from the chemiluminescent signal.

7. The Type of Ground Truth Used

For the Elecsys® PSA assay, the "ground truth" for the performance studies would be:

• For Precision: The known target concentrations of the quality control samples (HS1, HS2, HS3, PC-TM1, PC-TM2).
• For Sensitivity/Linearity: The gravimetrically or otherwise accurately prepared concentrations of PSA in dilution series.
• For Method Comparison: The results obtained from the predicate device (Elecsys PSA, 1st Gen) on the same samples.
• For Hook Effect: Samples with extremely high, known concentrations of PSA.

8. The Sample Size for the Training Set

Not applicable in the context of machine learning. This is an IVD assay, not an AI algorithm that undergoes a "training phase" on a dataset. The assay involves chemical reactions and signal detection, with a calibration curve set up using internal calibrators.

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

Not applicable. As explained above, there isn't a "training set" in the AI sense. Calibration curves, which are analogous to a "trained model" for converting signal to concentration, are established using known concentrations of PSA calibrators provided with the reagent kit.

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