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510(k) Data Aggregation
(73 days)
High Sensitivity Cardiac C-Reactive Protein (CCRP) reagent, when used in conjunction with IMMAGE® 800 Immunochemistry Systems and Calibrator 5 Plus, is intended for the quantitative determination of C-Reactive protein in human serum or plasma by rate turbidimetry.
Measurement of C-Reactive protein (CRP) aids in evaluation of stress, trauma, infection, inflammation, surgery, and associated diseases. Cardiac CRP assays are indicated for use as an aid in the identification and stratification of individuals at risk for future cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, CRP may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndrome.
CAL 5 Plus (Calibrator 5 Plus), when used in conjunction with Beckman Coulter reagents, is intended for use on IMMAGE® Immunochemistry Systems for the calibration of Anti-Streptolysin O (ASO), C-Reactive Protein (CRP) and Rheumatoid Factor (RF).
High Sensitivity Cardiac C-Reactive Protein (CCRP) reagent is intended for the quantitative determination of C-Reactive protein in human serum or plasma by rate turbidimetry. The IMMAGE® 800 Immunochemistry Systems CCRP reagent is based on the highly sensitive Near Infrared Particle Immunoassay rate methodology. An anti-CRP antibody-coated particle binds to CRP in the patient sample resulting in the formation of insoluble aggregates causing turbidity. The rate of aggregate formation is directly proportional to the concentration of CRP in the sample.
CAL 5 Plus (Calibrator 5 Plus) is a frozen liquid serum matrix intended for use on IMMAGE® Immunochemistry Systems for the calibration of Anti-Streptolysin O (ASO), C-Reactive Protein (CRP) and Rheumatoid Factor (RF).
Here's a breakdown of the acceptance criteria and study information for the Immage® 800 Immunochemistry Systems High Sensitivity Cardiac C-Reactive Protein (CCRP) Reagent, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative format for method comparison, linearity, or imprecision (e.g., "slope must be between X and Y"). However, it presents the results of these studies, and the FDA's decision to grant substantial equivalence implies that these results met their internal criteria for acceptance.
For the purpose of this analysis, I will infer the implicit acceptance criteria from the context of standard analytical performance requirements for diagnostic devices and the successful outcome of the 510(k) submission.
| Performance Characteristic | Acceptance Criteria (Inferred) | Reported Device Performance (Immage® High Sensitivity Cardiac CCRP Reagent) |
|---|---|---|
| Method Comparison | ||
| Slope (vs. Predicate) | Close to 1.0 | 0.965 (0.2 to 60 mg/L) |
| 1.013 (0.2 to 10 mg/L) | ||
| Intercept (vs. Predicate) | Close to 0 | 0.334 (0.2 to 60 mg/L) |
| -0.026 (0.2 to 10 mg/L) | ||
| R (Correlation Coefficient) | Close to 1.0 | 0.9962 (0.2 to 60 mg/L) |
| 0.9939 (0.2 to 10 mg/L) | ||
| Imprecision (Within-Run) | %CV typically |
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(70 days)
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(120 days)
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(82 days)
The IMMAGE® Immunochemistry System Ferritin (FER) Reagent, when used in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Beckman Coulter Ferritin Calibrator, is intended for the quantitative determination of ferritin in human serum by turbidimetric immunoassay.
Beckman Coulter Ferritin Calibrator, when used in conjunction with Ferritin reagent, is intended for use on IMMAGE® Immunochemistry Systems for the calibration of ferritin.
The IMMAGE® Immunochemistry System Ferritin (FER) Reagent and Fentiin Calibrator are designed for optimal performance on the IMMAGE® Immunochemistry Systems. They are intended for the quantitative determination of Ferritin in serum.
Here's an analysis of the acceptance criteria and study detailed in the provided text, formatted as requested:
Acceptance Criteria and Device Performance
The document describes the IMMAGE® Immunochemistry System Ferritin (FER) Reagent and Calibrator. The core of the study reported is a comparison to a predicate device and an evaluation of the device's imprecision. The acceptance criteria are implicitly defined by the reported performance and the finding of "substantial equivalence" to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance | Study Type |
|---|---|---|
| Method Comparison: | ||
| Slope close to 1 | 1.059 | Comparison to Predicate (IMx Ferritin) |
| Intercept close to 0 | -6.5 ng/mL | Comparison to Predicate (IMx Ferritin) |
| Correlation coefficient (r) ≥ 0.98 | 0.987 | Comparison to Predicate (IMx Ferritin) |
| Imprecision (within-run): | ||
| Level 1: ≤ 4.4% C.V. | 4.4% C.V. (S.D. 2.4 ng/mL at 53.5 ng/mL Mean) | Imprecision Study |
| Level 2: ≤ 3.0% C.V. | 3.0% C.V. (S.D. 5.3 ng/mL at 172.0 ng/mL Mean) | Imprecision Study |
| Level 3: ≤ 2.6% C.V. | 2.6% C.V. (S.D. 10.5 ng/mL at 397.0 ng/mL Mean) | Imprecision Study |
| Imprecision (total): | ||
| Level 1: ≤ 5.5% C.V. | 5.5% C.V. (S.D. 2.9 ng/mL at 53.5 ng/mL Mean) | Imprecision Study |
| Level 2: ≤ 4.1% C.V. | 4.1% C.V. (S.D. 7.1 ng/mL at 172.0 ng/mL Mean) | Imprecision Study |
| Level 3: ≤ 3.1% C.V. | 3.1% C.V. (S.D. 12.4 ng/mL at 397.0 ng/mL Mean) | Imprecision Study |
Note: The acceptance criteria are inferred from the reported "good" performance metrics that led to substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
-
Method Comparison Study:
- Sample Size (n): 116 serum samples
- Data Provenance: Not explicitly stated, but clinical samples (serum) would typically be from a patient population. It is not specified if they were retrospective or prospective, nor the country of origin.
-
Imprecision Study:
- Sample Size (N): 80 replicates for each of the three levels (240 total measurements).
- Data Provenance: Not explicitly stated, but these would be internal laboratory samples or controls.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of in-vitro diagnostic device does not typically rely on "experts" in the same way an imaging or pathology device would for establishing ground truth.
- For the method comparison study, the "ground truth" for the test set was effectively the measurements obtained from the predicate device (Abbott IMx® Ferritin). Therefore, the "experts" were the established and validated methodology of the predicate device.
- For the imprecision study, the "ground truth" refers to the true concentration of ferritin in the control samples used. This would be established through robust analytical methods, often by the control manufacturer, and not by individual human experts in a consensus manner.
4. Adjudication Method for the Test Set
Not applicable for this type of in-vitro diagnostic device study. The comparison is quantitative to an existing method or to established control values, not subject to human expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is an automated immunoassay system for quantitative determination of ferritin, not an AI-assisted diagnostic tool that involves human interpretation of varied cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, the studies reported (method comparison and imprecision) represent standalone performance of the IMMAGE® Immunochemistry System Ferritin Reagent. The system performs the quantitative determination of ferritin automatically without human interpretive input for each measurement. Human involvement is in operating the system, loading samples, and interpreting the final quantitative results output by the machine.
7. The Type of Ground Truth Used
- For the method comparison study: The ground truth was the quantitative results obtained from the predicate device, the Abbott IMx® Ferritin system. This is a form of "reference method" ground truth.
- For the imprecision study: The ground truth was the known or assigned concentration values of control materials at different ferritin levels.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" in the context of machine learning or AI. This is a traditional immunoassay system, not an AI-based device that undergoes a training phase with a specific dataset. The closest analogue would be the calibration process, which uses the IMMAGE® Immunochemistry System Ferritin Calibrator according to its instructions.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of AI/machine learning for this device. For the calibrators, the "ground truth" (assigned values) would be established by the manufacturer through rigorous analytical methods, often traceable to an international reference standard (e.g., WHO Standard as mentioned for the IMMAGE System FER Calibrator).
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(22 days)
The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Calibrator 2, is intended for the quantitative determination of human Beta-2-Microglobulin in serum or plasma by rate nephelometry.
The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent is designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of beta-2-microglobulin in serum or plasma.
Here's a breakdown of the acceptance criteria and the study information for the Beckman Coulter IMMAGE® Immunochemistry System Beta-2-Microglobulin Reagent, based on the provided text:
Acceptance Criteria and Device Performance
The provided document does not explicitly state "acceptance criteria" in a table format with pass/fail thresholds. Instead, it presents performance data for a method comparison study and an imprecision study to demonstrate substantial equivalence to a predicate device. The implied acceptance is that the device performs comparably to the predicate device and exhibits acceptable imprecision for its intended use.
Here's a table summarizing the reported device performance, with the understanding that these are the results that presumably met the underlying (unspecified) acceptance criteria for substantial equivalence:
| Performance Metric | Reported Device Performance (IMMAGE B2MX Reagent) | Implied Acceptance Criteria (relative to Predicate) |
|---|---|---|
| Method Comparison (vs. Array 360 Beta-2-Microglobulin) | Linear regression should demonstrate high correlation and agreement. | |
| Slope | 0.979 | Close to 1.0 |
| Intercept (mg/dL) | -0.017 | Close to 0.0 |
| Correlation Coefficient (r) | 0.996 | Close to 1.0 (indicating strong correlation) |
| Imprecision (Within-Run) | CV should be within clinically acceptable limits, and comparable to industry standards/predicate performance. | |
| Level 1 (0.10 mg/dL) | 10.0 %C.V. | Acceptable for low concentrations |
| Level 2 (1.84 mg/dL) | 2.3 %C.V. | Low %C.V. |
| Level 3 (3.19 mg/dL) | 1.9 %C.V. | Low %C.V. |
| Imprecision (Total) | CV should be within clinically acceptable limits, and comparable to industry standards/predicate performance. | |
| Level 1 (0.10 mg/dL) | 10.0 %C.V. | Acceptable for low concentrations |
| Level 2 (1.84 mg/dL) | 2.6 %C.V. | Low %C.V. |
| Level 3 (3.19 mg/dL) | 2.2 %C.V. | Low %C.V. |
Study Details
The provided document describes two main studies: a method comparison study and an imprecision study.
2. Sample Size and Data Provenance
- Test Set Sample Size (Method Comparison): 111 samples (for serum analytes)
- Data Provenance: Not explicitly stated, but clinical laboratory device studies for FDA submission typically use samples from a clinical population. The document does not specify country of origin or whether samples were retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. For this type of in vitro diagnostic device (IVD) studying an analyte's quantitative determination, ground truth is established by a reference method (the predicate device in this case) and traceable calibrators, not by expert interpretation.
4. Adjudication Method
- Not Applicable. No human interpretation or adjudication process is mentioned, as the study is a quantitative comparison of analytical methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is not relevant for this type of IVD, which quantifies a biomarker. MRMC studies are typically used for imaging diagnostics or other modalities requiring human interpretation.
6. Standalone Performance (Algorithm Only)
- Yes. The studies present the analytical performance of the IMMAGE® Immunochemistry System Beta-2-Microglobulin Reagent as a standalone system. The results (slope, intercept, correlation, imprecision) directly reflect the algorithm's (reagent and instrument's) ability to measure the analyte without human interpretation in the results generation process.
7. Type of Ground Truth Used (Test Set)
- Reference Method / Predicate Device Output. The "ground truth" for the method comparison study was the results obtained from the predicate device, the Beckman Array® Beta-2-Microglobulin (B2M) on the Array 360 system.
8. Sample Size for Training Set
- Not explicitly stated/Not applicable in the same way as AI/ML. For IVD assay development, there isn't a "training set" in the machine learning sense. Instead, development involves experiments to optimize reagent formulation, calibration curves, and instrument parameters, which effectively "train" the assay to measure accurately. The document does not provide details on the number of samples used during this development/optimization phase.
9. How Ground Truth for Training Set Was Established
- Not applicable in the same way as AI/ML. For IVD assays, the "ground truth" during development is established through the use of characterized reference materials, calibrators with known concentrations, and comparison to established reference methods or primary standards, ensuring traceability and accuracy. The document does not detail this process but it is standard for IVD development.
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(57 days)
The IMMAGE® Immunochemistry System Digoxin (DIG) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and IMMAGE® Immunochemistry Systems Drug Calibrator 2, is intended for the quantitative determination of digoxin in human serum or plasma by turbidimetric immunoassay.
The IMMAGE® Immunochemistry Systems Drug Calibrator 2, used in conjunction with IMMAGE® Digoxin reagent, is intended for use on Beckman Coulter's IMMAGE® Immunochemistry Systems for the calibration of digoxin test systems.
The IMMAGE® Immunochemistry System Digoxin (DIG) Reagent is designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of Digoxin in serum and plasma.
Here's a breakdown of the acceptance criteria and the study details for the Beckman Coulter IMMAGE® Immunochemistry System Digoxin (DIG) Reagent, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" as a set of predefined thresholds that the device had to meet to be approved. Instead, it presents "performance data" which demonstrates substantial equivalence to a predicate device. For the purpose of this request, I will infer the "acceptance criteria" from typical requirements for such devices, focusing on linearity/correlation and precision, and then list the reported performance.
| Performance Metric | Inferred Acceptance Criteria (Typical for such devices) | Reported Device Performance (IMMAGE® DIG Reagent) |
|---|---|---|
| Method Comparison (Correlation with Predicate) | ||
| Slope | Close to 1.0 (e.g., 0.95 - 1.05) | 1.051 |
| Intercept (ng/mL) | Close to 0.0 (e.g., ± 0.15) | 0.13 ng/mL |
| Correlation Coefficient (r) | ≥ 0.97 (indicating strong linear correlation) | 0.993 |
| Imprecision (CV%) | ||
| Within-Run Imprecision (Level 1) | ≤ 10% | 7.2 %C.V. |
| Within-Run Imprecision (Level 2) | ≤ 5% | 2.6 %C.V. |
| Within-Run Imprecision (Level 3) | ≤ 5% | 2.7 %C.V. |
| Total Imprecision (Level 1) | ≤ 10% | 7.4 %C.V. |
| Total Imprecision (Level 2) | ≤ 5% | 2.8 %C.V. |
| Total Imprecision (Level 3) | ≤ 5% | 3.0 %C.V. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Method Comparison: 113 samples (presumably human serum)
- Imprecision: 80 measurements per level (3 levels tested, so 240 measurements in total).
- Data Provenance: Not explicitly stated (e.g., country of origin). However, given it's a 510(k) submission to the US FDA, it likely involves data from studies conducted in the US or regions adhering to similar regulatory standards. The samples are referred to as "serum," implying human biological samples.
- Retrospective or Prospective: Not explicitly stated, but method comparison and imprecision studies are typically conducted prospectively with available samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of in-vitro diagnostic (IVD) device does not typically rely on "experts" to establish a ground truth in the way medical imaging or clinical diagnostic devices might. Instead, the "ground truth" for method comparison is the measurement obtained from the predicate device, and for imprecision, it's the statistical analysis of repeated measurements of known control samples.
Therefore, this section is not applicable in the traditional sense for this type of device and study. The predicate device (Abbott TDx Digoxin II) serves as the "reference method" for comparison.
4. Adjudication Method for the Test Set
This is not applicable for this type of IVD device and study. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in subjective diagnostic tasks where multiple human readers interpret data (e.g., radiology, pathology). Here, results are quantitative measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This device is an in-vitro diagnostic (IVD) immunoassay system that provides quantitative measurements of digoxin in serum/plasma. It is not an AI-powered diagnostic tool for human readers, nor does it have a human-in-the-loop component for interpretation that would warrant an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The performance data presented ("Method Comparison Study Results" and "Estimated IMMAGE System Digoxin (DIG) Reagent Imprecision") represents the standalone performance of the IMMAGE® Immunochemistry System Digoxin (DIG) Reagent itself. It measures the device's ability to quantitatively determine digoxin levels without any human interpretive intervention.
7. The Type of Ground Truth Used
- For Method Comparison: The "ground truth" was established by the predicate device, the Abbott TDx Digoxin II. The IMMAGE® DIG Reagent's measurements were compared against the measurements obtained from this established, legally marketed device.
- For Imprecision: The "ground truth" was derived from control samples with known or well-characterized digoxin concentrations. The imprecision study assesses the device's reproducibility and precision when repeatedly measuring these controls.
8. The Sample Size for the Training Set
The document does not provide any information about a "training set" sample size. For an immunoassay reagent, the development process (which might involve optimization or "training" of assay parameters) is typically based on laboratory experiments and analytical validation rather than a distinct "training set" of patient samples in the way machine learning algorithms are trained. The data presented here is for analytical performance validation.
9. How the Ground Truth for the Training Set was Established
As no "training set" is described for this type of device, this point is not applicable. The ground truth for the analytical validation (test set) was established by comparison with a predicate device and characterized control samples, as described in point 7.
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(35 days)
The IMMAGE Immunochemistry System C-reactive protein (CRP) reagent, in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Calibrator 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry.
The IMMAGE Immunochemistry System C-Reactive Protein (CRP) reagent, in conjunction with Calibrator 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE® Immunochemistry System.
Here's an analysis of the provided text regarding the acceptance criteria and study for the IMMAGE® Immunochemistry System C-Reactive Protein (CRP) Reagent:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for method comparison, stability, linearity, or imprecision. Instead, it indicates that the provided data "supports a finding of substantial equivalence to chemistry test systems already in commercial distribution." The reported performance data for imprecision is presented below:
| Performance Metric | Acceptance Criteria (Not explicitly stated with thresholds, but implied to be comparable to predicate) | Reported Device Performance (IMMAGE System CRP Reagent) |
|---|---|---|
| Within-Run Imprecision | (Implied to be acceptable for substantial equivalence) | |
| Level 1 | Mean: 0.35 mg/dL, SD: 0.039 mg/dL, %CV: 11.1 | |
| Level 2 | Mean: 4.95 mg/dL, SD: 0.129 mg/dL, %CV: 2.6 | |
| Level 3 | Mean: 6.69 mg/dL, SD: 0.236 mg/dL, %CV: 3.5 | |
| Total Imprecision | (Implied to be acceptable for substantial equivalence) | |
| Level 1 | Mean: 0.35 mg/dL, SD: 0.043 mg/dL, %CV: 12.1 | |
| Level 2 | Mean: 4.95 mg/dL, SD: 0.149 mg/dL, %CV: 3.0 | |
| Level 3 | Mean: 6.69 mg/dL, SD: 0.266 mg/dL, %CV: 4.0 | |
| Method Comparison | (Implied to show substantial equivalence to predicate) | (Results are mentioned as part of the study but not detailed in this section.) |
| Stability | (Implied to be acceptable for substantial equivalence, with 30 days once opened) | (Results are mentioned as part of the study but not detailed in this section.) |
| Linearity | (Implied to be acceptable for substantial equivalence) | (Results are mentioned as part of the study but not detailed in this section.) |
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Test Set:
- For the imprecision study, N=80 samples were used at each of the three levels (Level 1, Level 2, Level 3) for both within-run and total imprecision calculations.
- The sample size for the method comparison, stability, and linearity studies is not explicitly stated in the provided text.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is a submission to the FDA in the US by Beckman Coulter, Inc., based in California, so it's likely the studies were conducted in the US, but this is not explicitly stated.
3. Number of Experts and Qualifications for Ground Truth
- This device is an in-vitro diagnostic (IVD) reagent for quantitative determination of a biomarker (C-reactive protein). The "ground truth" for such devices typically refers to the true concentration of the analyte in a sample. Expert consensus or human interpretation (like radiologists) is not relevant in this context.
- The ground truth would have been established through a reference method or validated assays/calibrators, often with traceable standards. The document does not specify how the ground truth was established for the samples used in the imprecision, linearity, or method comparison studies. It mentions the use of "Calibrator 5 Plus" in the intended use, implying a calibrated system.
4. Adjudication Method for the Test Set
- Adjudication methods (e.g., 2+1) are usually relevant for studies involving human interpretation or subjective assessments, often in areas like imaging.
- For an IVD device like the CRP reagent, the "adjudication method" as typically understood in human-read studies is not applicable. The measurement is quantitative and objective, based on the instrument's reading.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or is not applicable here. This type of study involves multiple human readers assessing cases (e.g., medical images) to evaluate the impact of an AI algorithm on their performance.
- The IMMAGE® Immunochemistry System CRP Reagent is an automated laboratory assay that quantifies a biomarker. It does not involve human readers interpreting cases in the same way an imaging AI might. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device.
6. Standalone (Algorithm-Only) Performance Study
- Yes, the performance data presented (imprecision, method comparison, stability, linearity) represents the standalone performance of the IMMAGE® Immunochemistry System CRP Reagent in conjunction with the IMMAGE® Immunochemistry System.
- This refers to the performance of the device itself (reagent + instrument) without human intervention in the result generation beyond operating the instrument according to instructions.
7. Type of Ground Truth Used
- The document does not explicitly state the specific type of ground truth used for the performance studies.
- For quantitative IVD assays, ground truth is typically established through:
- Reference materials/calibrators: Samples with known, validated concentrations of the analyte.
- Validated reference methods: Using a method considered the gold standard for measuring CRP.
- Comparative methods: Often, a well-established predicate device's results are used as the comparative "truth" or reference for evaluating substantial equivalence, as indicated in the "Method Comparison Study Results" section.
8. Sample Size for the Training Set
- The IMMAGE® Immunochemistry System CRP Reagent is a diagnostic reagent, likely based on well-established nephelometric principles and antibody-antigen reactions. It does not employ machine learning or artificial intelligence that would require a "training set" in the computational sense.
- Therefore, there is no training set sample size mentioned or applicable in the context of this device.
9. How Ground Truth for the Training Set Was Established
- As concluded in point 8, there is no "training set" for this type of chemical reagent and its associated measurement system.
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(21 days)
The IMMAGE Immunochemistry System Valproic Acid (VPA) Reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of valproic acid in human serum or plasma by rate nephelometric inhibition immunoassay.
The IMMAGE Immunochemistry System VPA Reagent in conjunction with Beckman Drug Calibrator 1, is intended for use in the quantitative determination of valproic acid in human serum or plasma on Beckman Coulter's IMMAGE Immunochemistry Systems.
The provided text describes the IMMAGE® Immunochemistry System Valproic Acid (VPA) Reagent and outlines the performance data used to demonstrate its safety and effectiveness. However, it does not explicitly state "acceptance criteria" in a quantitative manner or provide a detailed study report that proves the device meets specific, pre-defined acceptance criteria with quantifiable results.
The document primarily focuses on demonstrating "substantial equivalence" to a predicate device through method comparison, stability, and imprecision experiments, as required for a 510(k) submission. While performance data is presented, it's not structured as a direct comparison against a set of stated acceptance criteria.
Therefore, the following response will extract the available performance data and highlight the limitations in directly answering all parts of your request based on the provided text.
Here's the analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" against which the device's performance is measured. Instead, it presents performance data (Method Comparison and Imprecision) that are implicitly compared against the performance of the predicate device (Abbott TDx Valproic Acid Reagent) to demonstrate substantial equivalence.
Table: Available Performance Data (No Explicit Acceptance Criteria)
| Performance Metric | Reported Device Performance (IMMAGE VPA Reagent) |
|---|---|
| Method Comparison | Data for "Method Comparison Study Results IMMAGE Valproic Acid (VPA) Reagent" is present but the formatting and content in the provided text is unreadable/corrupt (e.g., "American Car Call (11) Lampulanes...", "P. RAKERAE . Illust . Pres . busaneses ."). Therefore, specific values cannot be extracted. It states "Equivalence is demonstrated through method comparison..." implying favorable results against the predicate. |
| Imprecision | Data for "Estimated Imprecision" is present but the formatting and content in the provided text is unreadable/corrupt (e.g., "IN ANDRIGAL COLLER I SULLER BE...", "TEELLISELVIDE"). Values are noted under "Control . NE Automore and" and "evel". For example, "evel 3" shows "1 . 1 . 11 . 1 . 1 . 1 . 1 . 1". Therefore, specific values cannot be extracted. |
| Stability | "Equivalence is demonstrated through... stability... experiments." No specific data or acceptance criteria are provided in the extract. |
| Intended Use | Quantitative determination of valproic acid in human serum or plasma by rate nephelometric inhibition immunoassay. |
2. Sample Size Used for the Test Set and Data Provenance
Due to the unreadable nature of the "Method Comparison Study Results" and "Estimated Imprecision" sections, specific sample sizes for these test sets cannot be determined from the provided text.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies are implied to be internal validation studies conducted by Beckman Coulter, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For an immunochemistry system that quantifies a substance in blood, the "ground truth" would typically be established by a reference method or a highly accurate gold standard assay, not by human expert interpretation.
4. Adjudication Method for the Test Set
This information is not applicable as the ground truth for this type of device is established by quantitative laboratory methods, not by expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
This information is not applicable. The device is an immunochemistry system for quantitative determination of valproic acid, not an AI-assisted diagnostic imaging or interpretation tool involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is described as an "Immunochemistry System Valproic Acid (VPA) Reagent" for use on the "IMMAGE® Immunochemistry Systems." This implies a standalone diagnostic test performed by the instrument. There is no mention of human interpretation being part of the primary assay result generation process. Therefore, the standalone performance is what is being reported (though specific values for method comparison and imprecision are unreadable).
7. The Type of Ground Truth Used
The ground truth for this type of quantitative assay would typically be established by:
- Reference Method: Comparison against a widely accepted and highly accurate reference method (e.g., Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS) for drug levels).
- Predicate Device Comparison: As stated in the document, "Equivalence is demonstrated through method comparison, stability, and imprecision experiments," implicitly using the TDx® Valproic Acid (VPA) from Abbott Laboratories as a comparative "gold standard" or predicate for performance evaluation.
The document explicitly mentions a "Method Comparison Study" against the predicate device, suggesting the predicate device's results served as the comparative 'truth' in the context of demonstrating substantial equivalence.
8. The Sample Size for the Training Set
This information is not provided in the document. For a traditional immunoassay system, there isn't a "training set" in the machine learning sense. The assay is developed and validated through laboratory experiments, calibration, and QC procedures.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the machine learning context for this device, this question is not applicable. The 'ground truth' for the development and validation of such a system would involve precise preparation of known concentration samples and characterization of reagents and system performance through a rigorous analytical chemistry process. Calibration is performed using "Beckman Drug Calibrator 1," which would have its concentrations established by a trusted reference method.
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(74 days)
The IMMAGE Immunochemistry System AlphaMacroglobulin (AMG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human alpha macroglobulin by rate nephelometry. Measurement of alpha_macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.
The IMMAGE Immunochemistry System AMG Reagent, in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of Alpha-Macroglobulin concentrations on Beckman's IMMAGE Immunochemistry System.
This is an in vitro diagnostic device, not an AI/ML device. Therefore, the questions related to AI/ML device studies, such as the use of experts for ground truth, adjudication methods, MRMC studies, and training set information, are not applicable.
Here's a breakdown of the available information:
Acceptance Criteria and Device Performance
The submission primarily focuses on establishing "substantial equivalence" to a predicate device, as opposed to defining explicit performance acceptance criteria with numerical targets. Equivalence is demonstrated through "method comparison, stability, and imprecision experiments."
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document does not explicitly state numerical acceptance criteria. Instead, it refers to the demonstration of "substantial equivalence" through method comparison, stability, and imprecision experiments. Therefore, the "Reported Device Performance" is inferred from the results presented as part of demonstrating this equivalence, rather than direct numerical comparisons to pre-defined thresholds.
| Performance Area | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Comparison | Substantial equivalence to predicate device (Beckman Alpha₂-Macroglobulin (AMG)) | Data presented supports substantial equivalence (detailed results not explicitly provided in extract, but stated as sufficient). |
| Stability | Acceptable stability over time | Stability study results presented (detailed results not explicitly provided in extract, but stated as sufficient). |
| Imprecision | Acceptable level of measurement variability | Imprecision study results presented (detailed results not explicitly provided in extract, but stated as sufficient). |
2. Sample Size and Data Provenance for Test Set
- Sample Size for Test Set: Not explicitly stated in the provided text for method comparison, stability, or imprecision studies. The tables showing "Method Comparison Study Results," "Stability Study Results," and "Estimated Imprecision" are largely corrupted and do not provide clear numerical data on sample sizes.
- Data Provenance: Not explicitly stated. Given that it's a Beckman Instruments submission, it's likely internal company data, but the geographical origin or whether it's retrospective or prospective is not mentioned.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This is an in vitro diagnostic device measuring a quantitative analyte, not an AI/ML device requiring expert interpretation for ground truth establishment. The "ground truth" for such devices typically refers to the true concentration of the analyte, often determined by reference methods or gravimetric preparation of calibrators/controls.
4. Adjudication Method
- Not Applicable. As this is an in vitro diagnostic device measuring a quantitative analyte, an adjudication method (like 2+1 or 3+1 used for expert consensus in image interpretation) is not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This is an in vitro diagnostic device, not an AI/ML system that assists human readers. Therefore, an MRMC study is not relevant.
6. Standalone Performance Study (Algorithm Only)
- Yes, in spirit. The performance data presented (method comparison, stability, imprecision) assesses the "algorithm only" in the sense that it measures the performance of the IMMAGE Immunochemistry System AMG Reagent as a standalone diagnostic assay on the IMMAGE system, without human interpretive input that would be common in AI/ML clinical decision support. The device is intended for quantitative determination by rate nephelometry, which is an automated process.
7. Type of Ground Truth Used
- For Method Comparison: The ground truth is established by the predicate device (Beckman Alpha₂-Macroglobulin (AMG) using the Array System) or another established method against which the new device's results are compared.
- For Stability and Imprecision: The ground truth is typically the known concentration of the analyte in control materials or patient samples, or the expected measurement derived from robust, repetitive testing.
8. Sample Size for Training Set
- Not Applicable. This is an in vitro diagnostic device with reagents and a defined measurement principle (rate nephelometry), not a machine learning algorithm that requires a "training set" in the AI/ML sense. Data is used for characterization, calibration, and validation rather than training a model.
9. How Ground Truth for Training Set Was Established
- Not Applicable. See reasoning for "Sample Size for Training Set."
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(54 days)
The IMMAGE Immunochemistry System Antithrombin III (AT3) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human Antithrombin III by rate nephelometry.
The IMMAGE Immunochemistry System AT3 Reagent, in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of Antithrombin III concentrations on Beckman's IMMAGE Immunochemistry System.
The provided document describes the IMMAGE™ Immunochemistry System Antithrombin III (AT3) Reagent. The acceptance criteria and supporting study details are summarized below.
1. Table of Acceptance Criteria and Reported Device Performance
The document implicitly uses the performance of the predicate device (Array System Antithrombin III (AT3) Reagent) as the acceptance criteria for the IMMAGE System AT3 Reagent. The key performance metrics evaluated are method comparison (correlation with the predicate), stability, and imprecision.
| Acceptance Criteria Category | Specific Metric | Predicate Performance (Implicit Acceptance) | Reported Device Performance (IMMAGE AT3 Reagent) |
|---|---|---|---|
| Method Comparison | Correlation (r) | High correlation with established methods | 0.996 (vs. Array 360 System AT3 Reagent) |
| Slope | Close to 1.0 | 1.088 | |
| Intercept | Close to 0.0 | -0.10 | |
| Stability | Shelf-life | Established, reliable shelf-life | 24 months shelf-life |
| Open Container Stability | Established, reliable open container stability | 14 day open container stability | |
| Calibration Stability | Established, reliable calibration stability | 14 day calibration stability | |
| Imprecision | Within-Run Imprecision | Low imprecision | "Estimated Imprecision" (details not provided in table, but study was done) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: N = 136 for the method comparison study.
- Data Provenance: The document does not explicitly state the country of origin. It is a retrospective study as it compares the new device's results to an existing, commercially available predicate device using collected samples. The "plasma" sample type is mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This device is an in-vitro diagnostic (IVD) for quantitative determination of Antithrombin III. The "ground truth" for such devices is typically established through direct measurement on samples where the analyte concentration is known or determined by a well-established, often reference, method.
- Number of Experts: Not applicable in the context of expert consensus for image review or clinical diagnosis. The ground truth for the method comparison was established by the predicate device (Array 360 System AT3 Reagent), which itself is a laboratory instrument.
- Qualifications of Experts: Not applicable. The "ground truth" here is the measurement from the predicate device.
4. Adjudication Method for the Test Set
The concept of an adjudication method (e.g., 2+1, 3+1) is typically relevant for studies where human interpretation of medical images or clinical data is involved and discrepancies between readers need to be resolved. For an IVD device like the IMMAGE AT3 Reagent, the "adjudication" is essentially the statistical comparison of the new device's output against the predicate device's output. There is no mention of a human adjudication process for resolving discordant results between the IMMAGE system and the Array system; rather, a statistical correlation (regression analysis) is performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is not applicable for this device. MRMC studies are designed to assess diagnostic performance with and without AI assistance for human readers, typically in image interpretation. The IMMAGE AT3 Reagent is an automated in-vitro diagnostic system that quantifies a biomarker, not an imaging device or an AI assistant for human interpretation.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study
- Was a standalone study done? Yes. The performance data presented (method comparison, stability, imprecision) appears to be for the IMMAGE AT3 Reagent operating as a standalone system (algorithm only) without direct human-in-the-loop diagnostic interpretation that would alter its output. The system measures Antithrombin III concentrations, and its accuracy is assessed against a predicate device.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the performance evaluation (method comparison) was established by the results obtained from a legally marketed predicate device: the Array 360 System AT3 Reagent. This is a form of "reference method" in the context of IVD devices for quantitative analytes.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI algorithm development. This device, being an immunochemistry system, likely relies on established biochemical reaction principles and calibration curves rather than machine learning algorithms trained on large datasets. Therefore:
- Sample Size for Training Set: Not applicable or not specified, as the device doesn't appear to be based on an AI/ML model requiring a training set in the conventional sense. Its performance is validated through analytical studies (method comparison, stability, imprecision).
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" with ground truth in the AI/ML context doesn't appear to apply directly to this device. The system's operation is based on rate nephelometry and calibrated using a specific calibrator (Beckman Calibrator 2). The establishment of the calibrator values would involve a separate, rigorous process, likely traceable to a reference standard, but this is distinct from establishing ground truth for an AI training set.
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