Search Results

Binding assay for the in vitro quantitative determination of folate in erythrocytes (red blood cells, RBC). Folate measurements are used in the diagnosis and treatment of anemia. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

Elecsys Folate III is a binding assay that makes use of a competitive test principle using a ruthenium labeled folate-binding assay.
Elecsys Folate III is a binding assay for the in vitro quantitative determination of folate in erythrocytes (red blood cells, RBC). Folate measurements are used in the diagnosis and treatment of anemia. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
Whole blood treated with anticoagulants (heparin or EDTA) is mixed with ascorbic acid solution and incubated for approximately 90 minutes at 20-25 °C. Lysis of the erythrocytes takes place, with liberation and stabilization of the intracellular folate. The resulting hemolysate sample is then used for subsequent measurement.
Results are determined via a calibration curve, which is instrument-specifically generated by 2point calibration, and a master curve provided via the cobas link.

Here's a summary of the acceptance criteria and study details for the Elecsys Folate III device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Precision (Repeatability & Intermediate Precision): Not explicitly stated, but typically involves multiple replicates over several days/runs with multiple instruments. Specific sample types are "Hemolysate 1" to "Hemolysate 5".
• Lot-to-lot Reproducibility: "three reagent lots" were used.
• Analytical Sensitivity (LoB, LoD, LoQ): Not explicitly stated, but determined according to CLSI EP17-A2, which involves specific numbers of blank and low-concentration samples.
• Linearity and Dilution: "At least seven concentrations using hemolysate samples" for linearity. Dilution study used "high concentration hemolysate samples".
• Endogenous Interferences: Not explicitly stated, but "various endogenous substances" were evaluated.
• Analytical Specificity/Cross-Reactivity: Not explicitly stated.
• Exogenous Interferences: "17 commonly and 1 specially used pharmaceutical" compounds.
• Sample Matrix Comparison: "Whole blood samples were drawn into Na-Heparin and K3-EDTA tubes." (Number not specified).
• Method Comparison to Predicate: 119 samples with concentrations between 132 and 618 ng/mL.
• Reagent Stability (On-board), Lot Calibration Stability, On-board Calibration Stability: Tested on "one cobas e 801 analyzer".

Data Provenance: The document states "NON-CLINICAL PERFORMANCE EVALUATION" and refers to CLSI (Clinical and Laboratory Standards Institute) guidelines, which are standard for in-vitro diagnostic device performance studies. The data is internal to Roche Diagnostics, a company with global operations. The specific country of origin for the studies is not stated, but given the submission is to the U.S. FDA, the studies are expected to meet international and U.S. regulatory standards. These are retrospective studies in the context of device development and validation.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This device is an in-vitro diagnostic (IVD) assay that produces quantitative measurements of folate. It does not involve human interpretation of images or other subjective data. Therefore, the "ground truth" for its performance is established by reference methods, calibrated standards, and accurate measurement principles, rather than human expert consensus. No human experts were used to establish ground truth in the way one would for an AI imaging device.

4. Adjudication Method (Test Set)

Not applicable, as this is an IVD device producing quantitative results, not an AI imaging device requiring expert adjudication.

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

Not applicable. This is an in-vitro diagnostic device, not an AI device assisting human readers with interpreting cases.

6. Standalone (Algorithm Only) Performance

Yes, the studies described are standalone performance evaluations of the Elecsys Folate III assay (the "algorithm" in a broad sense for an IVD) without human intervention in the measurement process. The device performs the quantitative determination of folate using its defined binding assay and electrochemiluminescence immunoassay (ECLIA) method.

7. Type of Ground Truth Used

The ground truth for evaluating the Elecsys Folate III's performance is established through:

• Reference materials/standards: For analytical sensitivity (LoB, LoD, LoQ) and linearity, where known concentrations are used.
• Performance against a predicate method: For method comparison, the results are compared to a previously cleared, established method (Elecsys Folate RBC).
• CLSI guidelines: Adherence to established scientific and statistical methodologies for validating assay performance, implying well-defined benchmarks for accuracy, precision, and interference.

8. Sample Size for the Training Set

Not explicitly stated. For an IVD like the Elecsys Folate III, a traditional "training set" as understood in machine learning is not directly applicable. The "training" for such a system would involve the development and optimization of the reagent formulations, assay parameters, and calibration curve algorithms, using various samples and experiments during the research and development phase. However, a specific training set size with corresponding ground truths is not documented in the same way as an AI algorithm.

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

As above, a formal "training set ground truth" isn't directly applicable in the machine learning sense. The "ground truth" during the development and optimization (analogous to training) would have been established through:

• Known concentrations: Using purified folate standards or spiked samples.
• Reference methods: Comparing early-stage assay performance against established, often more labor-intensive or gold-standard methods for folate determination.
• Clinical correlation: (Though "clinical testing" is marked Not Applicable for this 510(k), early development might involve correlation with clinical status or outcomes).
• Statistical optimization: Adjusting reagent ratios, incubation times, and instrument settings to achieve optimal analytical performance characteristics (sensitivity, specificity, precision, linearity) based on these known values and reference method comparisons.

Ask a specific question about this device

Binding assay for the in vitro quantitative determination of folate in human serum. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Folic acid measurements are used in the diagnosis and treatment of anemias.

The Folate III Assay employs a competitive test principle using natural folate binding protein (FBP) specific for folate. Folate in the sample competes with the added folate (labeled with biotin) for the binding sites on FBP (labeled with a ruthenium complex). Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve (5-point-calibration) provided with the reagent bar code.

Roche Diagnostics' Elecsys Folate III Assay is a quantitative in vitro diagnostic device designed for measuring folate levels in human serum, primarily for the diagnosis and treatment of anemias. The following outlines its acceptance criteria and the studies performed to demonstrate its performance.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Elecsys Folate III Assay are primarily established through comparison to a predicate device, the Roche Elecsys Folate III (K082340). The device demonstrates comparable or improved analytical performance characteristics.

Ask a specific question about this device

(1) Elecsys Folate RBC Assay: Binding assay for the in vitro quantitative determination of folate erythrocytes (red blood cells, RBCs). The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Measurements obtained by this assay are used in the diagnosis and treatment of anemias.
(2) Elecsys Folate RBC CalSet: The Elecsys Folate RBC CalSet is used for calibrating the quantitative Elecsys Folate RBC assay on the Elecsys and cobas e immunoassay analyzers.
(3) Elecsys Folate RBC CalCheck: Elecsys Folate RBC CalCheck is used for the verification of the calibration established by the Elecsys Folate RBC reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use.

(1) The Elecsys Folate RBC assay employs a competitive test principle using natural folate binding protein specific for folate. Manually prepared hemolysate samples are used with this assay. Folate in the sample competes with the added folate (labeled with biotin) for the binding sites on folate binding protein (labeled with ruthenium complex). Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode encoded on the reagent packaging.
(2) The Elecsys Folate RBC CalSet is a lyophilized product consisting of human serum with folate in two concentration ranges. During manufacture, the analyte is spiked into the matrix. This calibrator is used to calibrate the Elecsys Folate RBC assay.
(3) The Elecsys Folate RBC CalCheck is a lyophilized product consisting of a hemolysate with folic acid. During manufacture, the analyte is spiked into the matrix. This solution is used to verify the calibration established with the Elecsys Folate RBC CalSet.

The provided text describes the Elecsys Folate RBC Test System, but it is a device for in vitro quantitative determination of folate in red blood cells and not an AI or imaging device. Therefore, many of the requested categories related to AI performance, such as MRMC studies, ground truth establishment by experts for image data, or training/test set sample sizes for AI models, are not applicable.

However, I can extract information related to the device's analytical performance and the studies conducted to demonstrate its substantial equivalence to a predicate device, focusing on the available information.

Here's the breakdown based on the provided text, adapted for a non-AI diagnostic device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in a table format. Instead, the submission demonstrates substantial equivalence by comparing the performance characteristics of the new Elecsys Folate RBC Assay to the predicate device (Elecsys RBC Folate III Assay) in a feature-by-feature comparison. The reported performance of the new device is shown alongside the predicate's performance. The "acceptance criteria" here are implicitly the predicate device's performance, as the goal is to show substantial equivalence.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a substantial equivalence comparison study against a legally marketed predicate device, the Elecsys RBC Folate III Test System (K082340). This type of study demonstrates that the new device is as safe and effective as the predicate device by showing that it has similar technological characteristics and performance.

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

The document does not explicitly state a single "test set" sample size in the way an AI model validation might. Instead, it details various analytical performance studies with different "samples" for each attribute:

• Precision (Repeatability & Intermediate Precision): Tested on multiple "Hemolysate" or "Sample" controls at different concentration levels. For each level, measurements were taken to determine SD and CV. The exact number of replicates or runs is not specified in the summary but is typically substantial for precision studies (e.g., multiple runs over several days).
• Analytical Sensitivity (LoB, LoD, LoQ): Determined using analytical methods, likely involving dilutions of folate-containing samples. The specific sample count for these determinations is not provided.
• Interferences: Tested using various interfering substances and pharmaceuticals. The number of samples/donors tested for each interference is not specified, but typically involves spiking known concentrations into samples and assessing recovery.
• Expected Values: Determined from a "Whole Blood Folate (from hemolysate sample)" study and an "RBC Folate (folate in erythrocyte fraction)" study. The sample size for these population studies is not provided in the summary.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. For in vitro diagnostic device submissions, such data is typically generated in a controlled laboratory setting (prospective) and may involve samples from different geographical regions, but this is not specified here.

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

Not applicable. This is not an AI/imaging device where expert consensus is used to establish ground truth for a test set. This device quantifies a biomarker (folate in RBCs). The "ground truth" for its analytical performance is established through reference methods and internal validation procedures, not human interpretation or adjudication by experts.

4. Adjudication Method for the Test Set

Not applicable. As this device measures a quantitative biomarker, there is no "adjudication" in the sense of resolving discrepancies in human interpretation or labeling. Analytical performance is typically verified against established laboratory standards and reference methods.

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 device used for interpretation or diagnosis by human readers, so an MRMC study is irrelevant.

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

This is a standalone device performance study. The Elecsys Folate RBC Test System performs the quantitative measurement of folate in RBCs automatically on immunoassay analyzers (Elecsys and cobas e platforms) without human-in-the-loop interpretative performance. The performance metrics (measuring range, sensitivity, precision, interference) are all measures of the algorithm and system's analytical capability.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance relies on analytical reference methods and established laboratory principles. For example:

• For analytical sensitivity (LoB, LoD, LoQ): Determined using standard statistical methods and known concentrations of analyte.
• For precision: Assessed by running replicate measurements on control samples.
• For accuracy/comparison to predicate: The predicate device itself (Elecsys RBC Folate III Assay) serves as the "reference" for demonstrating substantial equivalence. The traceability of the new device is stated as "Reference method is Folate III (Application on the E2010)", meaning its measurements are compared to the predicate's measurements. The predicate's traceability is to the "Elecsys Folate II assay."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set." The system's underlying principles are based on known biochemistry (competitive binding assay using folate binding protein) and not data-driven learning from a training set.

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

Not applicable, as there is no training set for this type of in vitro diagnostic device.

Ask a specific question about this device

The Elecsys Folate III CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers.

The Elecsys Folate III CalCheck 5 is a lyophilized product consisting of Folate in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

The provided 510(k) summary (K094053) describes a device called "Elecsys Folate III CalCheck 5," which is an assayed control for use in calibration verification and verification of the assay range for the Elecsys Folate III reagent on immunoassay analyzers. This type of device is a quality control material and as such, the submission does not involve clinical studies with human participants, expert ground truth, or multi-reader multi-case studies, which are typically associated with diagnostic or AI-powered medical devices. The acceptance criteria and performance data for this device relate to its analytical accuracy and precision in controlling an in vitro diagnostic assay.

Therefore, many of the requested categories are not applicable or cannot be extracted from this specific document, as they pertain to clinical efficacy studies rather than analytical performance of a control solution.

Here's an analysis based on the available information:

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

The provided 510(k) summary does not contain a table of explicit acceptance criteria or reported device performance in the format typically seen for a new diagnostic device. For an assayed control, acceptance criteria would typically involve demonstrating that the control material consistently yields expected values within a defined range when run on the target assay. The submission primarily focuses on establishing substantial equivalence to a predicate device.

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 directly in the context of a quality control material. The "test set" for an assayed control would typically involve rigorous analytical testing in a laboratory setting to confirm its assigned values and stability. The 510(k) summary does not detail the size or provenance of such analytical testing data.

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. Ground truth, in the sense of expert clinical diagnosis, is not relevant for an assayed control material. The "ground truth" for a control material is its assigned concentration, which is determined through a robust analytical process by the manufacturer, not by clinical experts.

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

Not applicable. Adjudication methods are used in clinical studies to resolve discrepancies among expert readers, which is not relevant for an assayed control.

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 device is a quality control material, not a diagnostic device involving human readers or AI assistance.

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

Not applicable. This device is an assayed control, not an algorithm.

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

Not applicable in the clinical sense. For a quality control material, the "ground truth" is typically the assigned value of the analyte (Folate in this case) within the control, which is established by the manufacturer through precise analytical methods and verified against reference materials or methods. The 510(k) summary doesn't detail this process.

8. The sample size for the training set

Not applicable. This device is a quality control material, not a machine learning algorithm that requires a training set.

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

Not applicable. As above, this is not an algorithm requiring a training set.

Summary of the K094053 Submission:

The K094053 submission for the Elecsys Folate III CalCheck 5 is for an assayed control used to verify the performance of an in vitro diagnostic assay (Elecsys Folate III reagent). As such, the focus of the submission is on demonstrating its analytical performance and substantial equivalence to a predicate device (Elecsys HCG+β CalCheck 5 (K092168)). The 510(k) summary describes the device as a lyophilized product consisting of Folate in a human serum matrix, with analyte spiked in at desired concentrations.

For devices of this nature, "acceptance criteria" and "study data" would typically refer to:

• Accuracy: The ability of the control to yield results within a specified range relative to its assigned value.
• Precision (Repeatability and Reproducibility): The consistency of results when the control is run multiple times, by different operators, or on different instruments.
• Stability: The ability of the control to maintain its assigned values over its shelf life and during storage.
• Matrix Equivalence: Ensuring the control matrix behaves similarly to patient samples in the assay.

These analytical performance characteristics would be demonstrated through internal validation studies by Roche Diagnostics. However, the provided 510(k) summary document itself does not include the detailed analytical study report, raw data, or a explicit table of acceptance criteria and results for the Elecsys Folate III CalCheck 5. Such details are typically found in the full 510(k) submission, but are not always part of the publicly available summary. The summary focuses on the administrative details, device description, and intended use to establish substantial equivalence.

Ask a specific question about this device

(1) Elecsys Folate III: Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Measurements obtained by these devices are used in the diagnosis and treatment of anemias. For in vitro diagnostic use.

(2) Elecsys RBC Folate Hemolyzing Reagent: Elecsys RBC Folate Hemolyzing Reagent is used together with the Elecsys Folate III assay for the quantitative determination of folate in erthrocytes (RBC (red blood cell) folate). Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Measurements obtained by these devices are used in the diagnosis and treatment of anemias.

(3) Elecsys Folate III CalSet: Elecsys Folate III CalSet is used for calibrating the quantitative Elecsys Folate III assay on the Elecsys and cobas e immunoassay analyzers.

(4) Elecsys Folate III CalCheck: Elecsys Folate III CalCheck is used for the verification of the calibration established by the Elecsys Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers.

(5) Elecsys PreciControl Anemia: Elecsys PreciControl Anemia is used for the quality control of specified Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.

(1) The Elecsys Folate III assay employs a competitive test principle using natural folate binding protein (FBP) specific for folate. Folate in the sample competes with the added folate (labeled with biotin) for the binding sites on FBP (labeled with ruthenium complex). Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.

(2) The Elecsys RBC Folate Hemolyzing Reagent is a 0.2% ascorbic acid solution with which whole blood treated with anticoagulants (heparin or EDTA) is diluted. After incubation the erythrocytes are lysed and intracellular folate is liberated and stabilized. The hemolysate is then used as a prediluted sample for subsequent measurement in the Elecsys Folate III assay.

(3) The Elecsys Folate III CalSet is a lyophilized product consisting of human serum with folic acid in two concentration ranges. During manufacture, the analyte is spiked into the matrix. This calibrator is used to calibrate the Elecsys Folate III assay.

(4) Elecsys Folate III CalCheck is a lyophilized product consisting of human serum with folic acid. During manufacture, the analyte is spiked into the matrix. This solution is used to verify the calibration established with the Elecsys Folate III CalSet.

(5) The Elecsys PreciControl Anemia is a lyophilized control serum based on human serum matrix in three concentration ranges. The controls are used for monitoring the accuracy and precision of the Elecsys Ferritin, Folate III, and Vitamin B12 immunoassays.

The Elecsys Folate III Test System, including Elecsys Folate III, Elecsys RBC Folate Hemolyzing Reagent, Elecsys Folate III CalSet, Elecsys Folate III CalCheck, and Elecsys PreciControl Anemia, is designed for the in vitro quantitative determination of folate in human serum, plasma, and erythrocytes. This system is intended for use in the diagnosis and treatment of anemias on Elecsys and cobas e immunoassay analyzers.

The acceptance criteria for the Elecsys Folate III and Elecsys RBC Folate Hemolyzing Reagent assays were established through comparison studies against their respective predicate devices (Elecsys Folate II Assay and Elecsys RBC Folate Hemolyzing Reagent (K051292)). The primary method for proving the device meets these criteria is through Method Comparison studies using Passing-Bablok and Linear Regression analysis.

Here's the breakdown of the acceptance criteria and performance:

Ask a specific question about this device

Binding assay for the in vitro quantitative determination of folate in human serum. Measurements obtained by this devices are used in the diagnosis and treatment of anemias. The binding assay is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.

The Elecsys Folate II Assay employs a competitive test principle. In the first step, bound folate in the sample is released from endogenous folate binding proteins through incubation with pretreatment reagents. In the second step, ruthenium labeled folate binding protein complexes with the sample. In the third step, after the addition of streptavidin-coated microparticles and folate labeled with biotin, the unbound sites of the ruthenium labeled folate binding protein become occupied, with formation of a ruthenium labeled folate binding protein-folate biotin complex. The complex becomes bound to the solid phase. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode, unbound substances are removed. Voltage is applied to the electrode inducing chemiluminescent emission which is measured by a photomultiplier. Results are determined using 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.

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets these criteria in the way typically expected for complex medical devices like AI algorithms or imaging analysis tools. This document is a 510(k) summary for an immunoassay, which is a laboratory test.

The document focuses on demonstrating substantial equivalence to a predicate device, rather than outlining stringent acceptance criteria and performance against them. Information provided mainly compares the new device to a previous version and confirms its intended use and technical specifications.

Therefore, many of the requested points cannot be directly answered from the provided text. However, I will extract relevant information where available and note when information is not present.

Acceptance Criteria and Device Performance for Elecsys® Folate II Immunoassay

The provided document is a 510(k) summary for an in vitro diagnostic immunoassay. Its primary purpose is to demonstrate substantial equivalence to a legally marketed predicate device, not to detail the specific performance metrics and acceptance criteria in the same way one would for a novel AI device or imaging system. Therefore, an explicit table of acceptance criteria with reported device performance is not present in this format.

The "performance" in this context is demonstrated through similarities to the predicate device and the continuation of the intended use. The key aspects highlighted are the measuring range and expected values, which are consistent with the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

   Note: The document does not provide a formal table of acceptance criteria with corresponding performance data for the specific changes in the modified device. Instead, it details that the modified device has the "Same" performance characteristics as the predicate device (K031756) for several key attributes. The main change noted in performance is the stability of the opened reagent on the analyzer.

   Characteristic	Predicate Device (K031756) Performance	Modified Device Performance (Elecsys® Folate II)	Implicit "Acceptance Criteria" (by equivalence)
   Intended Use	Quantitative determination of folate in human serum, for Elecsys 2010 and MODULAR ANALYTICS E170.	Same	Must meet the same intended use.
   Indications for Use	Diagnosis and treatment of anemias of gastrointestinal malabsorption.	Diagnosis and treatment of anemias.	Must indicate use in diagnosis/treatment of anemias. (Slight broadening in modified device)
   Test Principle	Competitive chemiluminescence	Same	Must be competitive chemiluminescence.
   Sample Type	Serum	Same	Must use serum.
   Expected Values	3.1-17.5 ng/ml	Same	Must fall within 3.1-17.5 ng/ml.
   Measuring Range	0.600-20.00 ng/ml	Same	Must be 0.600-20.00 ng/ml.
   Traceability	Standardized against Elecsys Folate (itself against a commercial radiobinding assay).	Standardized against Elecsys Folate.	Must maintain traceability to Elecsys Folate.
   Stability (Opened)	At 2-8°C for 12 weeks; On E170/2010 for 6 weeks.	At 2-8°C for 12 weeks; On E170/2010 for 1 week.	Must demonstrate specified stability (note change).

   (The "Acceptance Criteria" column is inferred from the declaration of "Same" or the stated values for the predicate device, as the submission relies on substantial equivalence.)

2. Sample size used for the test set and the data provenance:
   The document does not specify a separate "test set" or its sample size. The substantial equivalence is largely based on the device's formulation, method, and a slight modification in stability on one analyzer, implying that comprehensive re-testing on a new clinical sample set was not the primary focus of this specific 510(k) submission. 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:
   Not applicable. This is an immunoassay, and "ground truth" for clinical performance is typically established by comparison to reference methods or clinical outcomes, not expert consensus on individual "cases." The performance is inherent to the chemical reactions and detection system.

4. Adjudication method for the test set:
   Not applicable. No "test set" requiring adjudication by experts 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:
   Not applicable. This is an immunoassay, not an imaging or AI-assisted diagnostic device that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is an immunoassay, which is a standalone measurement device without a human-in-the-loop component in its analytical operation.

7. The type of ground truth used:
   For an immunoassay, ground truth is established through analytical validation comparing results to known standards, reference methods, and correlation with clinical conditions. The document mentions traceability to "Elecsys Folate which was itself standardized against a commercially available radiobinding folate assay" for both the predicate and modified device. This implies the "ground truth" for standardization is established by comparison to a recognized, validated method for folate measurement.

8. The sample size for the training set:
   Not applicable. This is an immunoassay, not a machine learning or AI device that uses "training sets" in the conventional sense.

9. How the ground truth for the training set was established:
   Not applicable. As above, this is an immunoassay. The device's performance is based on its chemical and physical principles, not on learning from a training set. Standardization against a reference method serves a similar function to establishing accuracy, but it's not a "training set" in the AI context.

Ask a specific question about this device

For use in the verification of the calibration established by the Elecsys Folate II reagent on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.

The Elecsys Folate II CalCheck II is a set of calibration verification solutions comprised of three levels, each with defined folate levels.

This is a 510(k) premarket notification for a calibration verification material, not a device that requires performance metrics like accuracy, sensitivity, or specificity against clinical data. Therefore, many of the requested elements (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable in the context of this submission.

The "acceptance criteria" for a calibration verification material typically relate to its ability to verify the calibration of an analyzer within expected performance parameters, often demonstrated by comparing its performance to a legally marketed predicate device.

Here's the closest interpretation of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. The performance is assessed by confirming that the new device functions similarly in its intended use as a calibration verification material.

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

• Sample Size for Test Set: Not specified in the provided text. For a calibration verification material, the "test set" would typically involve running the material on the specified immunoassay analyzers multiple times to assess its performance against expected values and ensure it behaves as a control. The text does not provide this specific study detail.
• Data Provenance: Not explicitly stated (e.g., country of origin). The submission is from Roche Diagnostics in Indianapolis, IN, USA. The nature of the device (calibration material) suggests internal validation data.
• Retrospective or Prospective: Not specified. Performance evaluations of calibration materials are typically prospective, as they involve testing the manufactured product.

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

• Experts: Not applicable. For a calibration verification material, the "ground truth" (i.e., the target folate levels) is established during the manufacturing and standardization process of the material itself, not through expert consensus on interpretation.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no diagnostic interpretation involved that would require adjudication.

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

• MRMC Study: No. This is a calibration verification material, not a diagnostic imaging or interpretive device that would benefit from an MRMC study.
• Effect Size of Human Readers Improve with AI vs without AI assistance: Not applicable.

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

• Standalone Performance: Not applicable. This device is a material used as part of a larger immunoassay system; it does not operate as a standalone algorithm.

7. The Type of Ground Truth Used

• Ground Truth Type: For a calibration verification material, the "ground truth" is typically the assigned value (concentration) for each level of the material, established through a rigorous standardization process traceable to primary reference materials or methods. In this case, it's stated that the Elecsys Folate II assay was standardized against the Elecsys Folate assay, which in turn was standardized against a commercially available radiobinding folate assay.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a manufactured material, not a machine learning algorithm that requires a "training set."

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

• Ground Truth for Training Set: Not applicable.

Ask a specific question about this device

Ask a specific question about this device

Binding assay for the in vitro quantitative determination of folate in human serum. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption. The binding assay is intended for use on the Roche Elecsys 2010 and Modular Analytics E170 immunoassay analyzers.

The Elecsys® Folate II Assay employs a competitive test principle using natural folate binding protein (FBP) specific for folate. Folate in the sample competes with the added folate labeled with biotin for the binding sites on the ruthenium labeled FBP-complex.

Here's an analysis of the provided text regarding the Elecsys® Folate II Assay, focusing on acceptance criteria and supporting studies.

Important Note: The provided text is a 510(k) Summary for a laboratory assay (in vitro diagnostic device). This type of device does not typically involve the same type of "acceptance criteria" and "studies" as an AI-powered diagnostic device, especially regarding aspects like "sample size used for the test set," "number of experts," "adjudication method," "MRMC studies," or "standalone performance" in the context of image analysis or algorithm-based diagnostics.

For a laboratory assay, "acceptance criteria" generally refer to performance characteristics like precision, accuracy, linearity, measuring range, interference, and agreement with a predicate device. The "studies" are typically analytical and clinical validation studies demonstrating these characteristics.

Given this context, I will address your questions from the perspective of an in vitro diagnostic device.

Description of Acceptance Criteria and Supporting Study for Elecsys® Folate II Assay

The Elecsys® Folate II Assay is a binding assay for the in vitro quantitative determination of folate in human serum, intended for use on Roche Elecsys 2010 and Modular Analytics E170 immunoassay analyzers. It is used in the diagnosis and treatment of anemias of gastrointestinal malabsorption. The device claims substantial equivalence to the previously marketed Elecsys® Folate Assay (K973674).

1. Table of Acceptance Criteria and Reported Device Performance

For an in vitro diagnostic device like this, "acceptance criteria" and "reported device performance" are often demonstrated through comparison with a predicate device and validation of key analytical specifications. The summary explicitly states a comparison to a predicate device and highlights areas of similarity and difference.

Note: The provided 510(k) summary is highly abbreviated. Detailed acceptance criteria for precision, accuracy, linearity, etc., would typically be found in the full 510(k) submission, not necessarily in the public summary. The change in "Expected Values" is a notable difference that would have required specific clinical validation.

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

The provided 510(k) summary does not specify sample sizes used for performance testing (e.g., precision, accuracy, comparison studies). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

For an In Vitro Diagnostic (IVD) device, studies typically involve:

• Analytical Studies: Using controlled panels, spiked samples, and patient samples to assess precision, accuracy, linearity, limits of detection/quantitation, interference, etc. The "test set" here would refer to the number of samples and replicates used in these analytical studies.
• Clinical Studies (if applicable): Patient samples analyzed and compared to a reference method or clinical outcome, often guided by the change in expected values.

Without the full submission, these details are not available from the given text.

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

This concept is not applicable to an in vitro diagnostic assay like the Elecsys® Folate II. Ground truth for an assay is established by:

• Reference Methods: Highly accurate and precise methods (e.g., LC-MS/MS for folate)
• Expert Diagnosis/Clinical Outcome: For clinical utility, the assay's results would be correlated with the clinical diagnosis of anemia, but "experts to establish ground truth for the test set" (as in image interpretation) doesn't fit here.
• Predicate Device Results: For substantial equivalence, results are often compared to the legally marketed predicate device.

4. Adjudication Method for the Test Set

This concept is not applicable to an in vitro diagnostic assay. Adjudication, like 2+1 or 3+1, is typically used for subjective assessments (e.g., radiology image interpretation) where human readers disagree. For an assay, results are quantitative or qualitative measurements, and disagreement implies a technical issue with the assay or instrumentation, not an interpretation difference requiring adjudication.

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

This concept is not applicable to an in vitro diagnostic assay. MRMC studies are designed to compare the performance of human readers, sometimes with and without AI assistance, especially in radiology or pathology. An IVD assay is a standalone measurement device; there are no "human readers" interpreting its output in a comparative effectiveness study in this manner.

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

The Elecsys® Folate II Assay is a standalone device. It is an immunoassay system where the instrument (Elecsys 2010 or Modular Analytics E170) performs the measurement and provides a quantitative result. The human "in the loop" aspects are sample preparation, loading, and interpretation of the numerical result; the assay itself does not involve an "algorithm" in the sense of AI image analysis. Its performance is always its "standalone" performance.

7. The Type of Ground Truth Used

For an in vitro diagnostic assay, the ground truth is typically established through:

• Reference Measurement Procedures: Highly accurate and precise methods for measuring folate, often involving mass spectrometry or validated chromatographic techniques.
• Comparison to Predicate Device: Demonstration of agreement (correlation, bias) with the legally marketed predicate device.
• Clinical Diagnosis/Outcomes Data: For understanding diagnostic utility, folate levels would be correlated with the clinical diagnosis of folate deficiency anemia and associated clinical outcomes.

The provided summary does not explicitly state which "ground truth" method was predominantly used for the performance studies, but given its role as an IVD, comparison to a reference method and/or the predicate device would be standard.

8. The Sample Size for the Training Set

This concept is not applicable to the Elecsys® Folate II Assay. This device is a chemical immunoassay, not an AI/machine learning algorithm that requires a "training set." Its calibration and validation methods are based on analytical chemistry principles and statistical methods, not machine learning training.

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

This question is not applicable as there is no "training set" for this type of device (see point 8).

Ask a specific question about this device

The Elecsys® Red Blood Cell Folate Lysing Reagent is to be used in combination with the Elecsys® Folate Assay for the quantitation of folate in human red blood cells. The electrochemiluminescence assay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

The Elecsys® test principle is based on the competitive principle. Total duration of assay: 90 +- 15 minutes. Reconstitution Step: Add contents of the ascorbic acid packet to 100 mL distilled or deionized water. Pretreatment Step: By incubating the sample (15 μl) with the folate pretreatment 1 (15 μl) and pretreatment 2 (10 μl), bound folate is liberated into the serum. Proceed to conduct the Elecsys® Folate Assay (K973674) as per insert instructions.

The provided text does not contain detailed acceptance criteria or a study that explicitly proves the device meets specific performance criteria beyond general statements about evaluation of assay precision, demonstration of linearity, and correlation with a predicate device. The document primarily focuses on regulatory approval and equivalence to a predicate device.

However, based on the information provided, we can infer some details related to the study conducted.

Here's an attempt to structure the information based on your request, with significant caveats that much of the detailed information you asked for is not present in the provided text.

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

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Not specified. The context suggests a laboratory assay, so "experts" in the clinical interpretation sense might not be directly applicable for establishing ground truth for the raw assay results themselves, but rather for clinical validation or interpretation of results.

4. Adjudication method for the test set

Not specified.

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

Not applicable. This is an in-vitro diagnostic (IVD) assay, not an AI-assisted diagnostic imaging device requiring human reader comparison.

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

Yes, in a sense. This is an IVD assay. Its performance is evaluated as a standalone system (reagent + analyzer) that produces a quantitative result without a "human-in-the-loop" step in generating the primary measurement. The "study" here refers to the analytical performance of the assay itself.

7. The type of ground truth used

For an IVD assay like this, the "ground truth" for assay performance evaluation is typically established through:

• Reference Methods: Using established, highly accurate analytical methods to determine true folate concentrations in samples.
• Known Concentration Samples: Using samples with accurately known concentrations of the analyte (e.g., spiked samples, certified reference materials).
• Clinical Samples with Clinical Diagnosis: For correlation studies, comparing assay results to a clinical diagnosis (though the document only mentions correlation with the predicate device, not directly with patient outcomes).
• Predicate Device Comparison: The document explicitly mentions "correlation with the predicate device," implying the predicate device's results serve as a comparative "ground truth" or standard.

8. The sample size for the training set

Not applicable in the context of traditional machine learning "training sets" as this is a chemical assay, not an AI algorithm. The assay itself doesn't have a "training set" in that sense. However, the development and optimization of the assay would involve various experiments and sample analyses, but these are not referred to as a "training set."

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

Not applicable.

Ask a specific question about this device