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510(k) Data Aggregation
(94 days)
For in vitro diagnostic use only. VITROS dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma. High Density Lipoprotein (HDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with lower HDL cholesterol concentrations.
For in vitro diagnostic use. VITROS Chemistry Products Calibrator Kit 25 is used to calibrate VITROS Chemistry Systems for the quantitative measurement of HDL cholesterol using VITROS Chemistry Products dHDL Slides.
For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers I and II are assayed controls used to monitor performance on VITROS Chemistry Systems.
The VITROS Chemistry Systems are fully automated clinical chemistry analyzers intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid).
The system is comprised of four main elements:
- The VITROS Chemistry System - instrumentation, which provides automated use of the chemistry reagents.
- The VITROS Chemistry Products MicroSlides range of products, in this case the VITROS Chemistry Products dHDL Slides, VITROS Chemistry Products Calibrator Kit 25 and VITROS Chemistry Products Performance Verifier I and II which are combined by the VITROS Chemistry Systems to perform the VITROS dHDL Slide assay.
- The VITROS Chemistry Products MicroTip range of liquid reagent products that are formulated for use only on the VITROS 5,1 FS Chemistry System.
- Common reagents used by multiple assays on the VITROS Chemistry Systems, in this case VITROS Chemistry Products 7% BSA.
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
The provided document is a 510(k) summary for in-vitro diagnostic devices (VITROS Chemistry Products dHDL Slides, Calibrator Kit 25, and Performance Verifiers I and II) and therefore does not include the detailed acceptance criteria and study information typically found for AI/ML-driven medical devices. The document focuses on demonstrating substantial equivalence to a predicate device.
However, I can extract the information provided regarding the comparison study.
Here's a breakdown of the available information based on your request categories:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the way an AI/ML study would (e.g., target specificity, sensitivity thresholds). Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance is reported as a correlation between the new device and the predicate device.
| Metric (New Device vs. Predicate Device) | Reported Value |
|---|---|
| Linear Regression Coefficient (slope) | 0.953 |
| Linear Regression Intercept | -0.64 mg/dL |
| Correlation Coefficient (r) | 0.996 |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document states that "patient samples" were used, but the specific number is not provided.
- Data Provenance: Not specified (e.g., country of origin).
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this is an in-vitro diagnostic device measuring HDL cholesterol. The "ground truth" would be established by reference methods or comparison to the predicate device, not by expert interpretation of images or other subjective data. No experts for ground truth establishment are mentioned.
4. Adjudication method for the test set:
Not applicable for this type of device. The comparison is between quantitative measurements from two different analytical systems.
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 assay, not an AI-assisted diagnostic tool that would involve human readers interpreting results.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a standalone in-vitro diagnostic assay. Its performance is evaluated intrinsically and through comparison to the predicate device. It operates without human-in-the-loop performance in the interpretative sense of AI.
7. The type of ground truth used:
The "ground truth" for this study is essentially the quantitative measurement of HDL cholesterol obtained from the predicate device, the AHDL Flex® reagent cartridge for use with the Dade Behring Dimension® analyzer. The study aims to show that the new device's measurements are highly correlated with those of the predicate device.
8. The sample size for the training set:
The document describes a comparison study, not a machine learning study with distinct training and test sets in the typical sense. Therefore, "training set" is not applicable in this context. The study utilized patient samples for the correlation analysis.
9. How the ground truth for the training set was established:
Not applicable, as there's no "training set" in the context of an ML model. The comparison is against the predicate device's measurements.
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(19 days)
Vitros Chemistry Products CRP Slides For in vitro diagnostic use only. Vitros Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma. Vitros Chemistry Products Calibrator Kit 7 For in vitro diagnostic use only. Vitros Calibrator Kit 7 is intended for use in the calibration of the Vitros Chemistry Systems for the quantitative measurement of CRP.
The Vitros Chemistry System uses Vitros Slides to perform discrete chemistry tests on body fluid specimens. All reactions necessary for a single quantitative measurement take place within the multilayered analytical element of a Vitros slide. The system is comprised of two main elements: 1. The range of Vitros Chemistry Products (in this case Vitros Chemistry Products CRP Slides and Vitros Chemistry Products Calibrator Kit 7), which are combined on the Vitros Chemistry System to perform the Vitros CRP assay. 2. The Vitros Chemistry System - instrumentation, which provides automated use of the chemistry slides. Vitros 250 and 950 Chemistry Systems were cleared for market by separate 510(k) pre-market notifications (K922072 and K946090, respectively). The Vitros Chemistry System and Calibrators are dedicated specifically for use only with the Vitros Chemistry Products range of products. The Vitros System uses common reagents. The Vitros Chemistry Products Specialty Diluent and Vitros ImmunoWash fluid were cleared by previous 510(k) pre-market notification (K962235 and K942610, respectively).
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the VITROS Chemistry Products CRP Slides:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it demonstrates substantial equivalence to a predicate device. The performance is assessed by comparing key characteristics and showing that the modified device performs similarly or equivalently.
| Device Characteristic | Predicate Device (Current Vitros CRP Slide) | New Device (Modified Vitros CRP Slide) | Equivalence/Performance |
|---|---|---|---|
| Sample Volume | 11 µL | No Change (Implies 11 µL) | Equivalent |
| Wash Volume | 12 µL | No Change (Implies 12 µL) | Equivalent |
| Intended Use | For in vitro diagnostic use only. Vitros CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma. | No Change (Same intended use) | Equivalent |
| Basic Principle | Dry multi-layered slide utilizing reflectance spectrophotometry. | No Change (Same basic principle) | Equivalent |
| Sample Type | Serum, Plasma (lithium heparin, sodium citrate and EDTA) | Serum, Plasma (heparin and EDTA) | Similar, with a slight narrowing of accepted plasma types (sodium citrate explicitly removed from new device description). However, the overall conclusion is still substantial equivalence. |
| Reportable Range (Serum, Plasma) | 0.7 - 11.0 mg/dL (Conv. Units) / 7 - 110 mg/L (SI Units) / 700 - 11000 ug/dL (Alt. Units) | 0.3 - 11.0 mg/dL (Conv. Units) / 3 - 110 mg/L (SI Units) / 300 - 11000 ug/dL (Alt. Units) | Improved lower detection limit (0.3 mg/dL vs 0.7 mg/dL). This is an improvement over the predicate, making it effectively equivalent or better in this aspect, which supports substantial equivalence. The upper limit remains the same. |
| Instrumentation | Vitros 250 and 950 Chemistry Systems | No Change (Same instrumentation) | Equivalent |
| Incubation time and temperature | 7.5 minutes at 37°C | No Change (Same incubation time and temperature) | Equivalent |
| Immobilized phosphorylcholine | 0.07 mg per cm² | No change (Implies 0.07 mg per cm²) | Equivalent |
| Anti-CRP antibody labeled with HRP | 0.0009 units per cm² | 0.0006 units per cm² | Different, however, the study concluded that despite this change, the overall performance (including the improved reportable range) demonstrates substantial equivalence. The implication is that this formulation change does not negatively impact performance but rather contributes to the improved lower detection limit. |
| Calcium chloride | 0.10 mg per cm² | 0.08 mg per cm² | Different, but similar to the anti-CRP antibody, the study concluded that the overall performance is substantially equivalent. |
| Leuco dye | 0.04 mg per cm² | No change (Implies 0.04 mg per cm²) | Equivalent |
Study that Proves the Device Meets Acceptance Criteria:
The study described is an equivalence study designed to show that the "Vitros Chemistry Products CRP Slides (modified)" are substantially equivalent to the "Vitros Chemistry Products CRP Slides (current/predicate)."
- Study Design: The information provided describes a comparison study between the new device and the predicate device. Equivalence was demonstrated by testing manufactured slides with patient and quality control samples.
- Performance Metrics: The implied performance metrics are the various assay characteristics listed in Table 1, particularly the reportable range and the ability to measure CRP values across that range accurately compared to the predicate. The key 'acceptance criteria' is the demonstration of substantial equivalence, which means the device performs at least as well as the legally marketed predicate device, and any differences do not raise new questions of safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size for the test set. It mentions "patient and quality control samples," but no specific numbers are given.
- Data Provenance: Not specified. There is no mention of the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Ground Truth Establishment: For in vitro diagnostic assays like this, the "ground truth" is typically established by comparing results to a reference method or another already cleared device (in this case, the predicate device itself acts as the benchmark for comparison, along with quality control materials that have known values). It's not usually established by human expert consensus in the same way an imaging AI would be.
4. Adjudication Method:
- Adjudication Method: Not applicable in the context of this type of in vitro diagnostic device comparison study. Adjudication methods like 2+1 or 3+1 are relevant for interpreting ambiguous data (e.g., medical images) where human experts might disagree. For quantitative assays, the 'ground truth' is more objective (e.g., a measured concentration).
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:
- MRMC Study: No. This is an in vitro diagnostic device for quantitative measurement of C-reactive protein, not a device requiring human interpretation of medical images. Therefore, MRMC studies and concepts of human readers improving with AI assistance are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, in effect. The device (VITROS Chemistry Products CRP Slides used on the VITROS Chemistry System) is an automated system for measuring CRP concentration. Its performance is inherent to the reagent slides and the instrument, requiring no human interpretation or "human-in-the-loop" decision-making for the actual measurement process once the sample is loaded. The "algorithm" here is the chemical reaction and spectrophotometric measurement process validated by the manufacturer.
7. The Type of Ground Truth Used:
- Type of Ground Truth: For the "modified" device, the ground truth was established by comparison to the predicate device (VITROS Chemistry Products CRP Slides, current slide) using "patient and quality control samples with measured CRP values." Quality control samples typically have known, certified values. Patient samples would have their CRP levels independently measured, presumably by the predicate device or a recognized reference method, to assess correlation and accuracy.
8. The Sample Size for the Training Set:
- Sample Size: The document does not specify a separate "training set." For this type of IVD device, the term "training" is not typically used for algorithm development in the same way it would be for machine learning. Instead, the product development and manufacturing process would involve internal testing and optimization (sometimes referred to as verification and validation activities), but not a distinct "training set" of patient data in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable, as no "training set" is described for algorithm development in the AI sense. The development of the slides (including the modified reagent composition) would have been based on established chemical principles and optimization to achieve desired performance characteristics.
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(19 days)
VITROS Chemistry Products ALB Slides For in vitro diagnostic use only. VITROS ALB Slides quantitatively measure albumin (AL concentration in serum and plasma.
VITROS Calibrator Kit 4 For in vitro diagnostic use only. VITROS Calibrator Kit 4 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.
The VITROS Chemistry System uses Vitros Slides to perform discrete chemistry tests on body fluid specimens. All reactions necessary for a single quantitative measurement take place within the multi-layered analytical element of a Vitros Slide.
The system is comprised of two main elements:
- The VITROS Chemistry Products range of chemistry products (in this case VITROS Chemistry Products ALB Slides, VITROS Chemistry Products Calibrator Kit 4, which are combined by the VITROS Chemistry System to perform the VITROS ALB test.
- The VITROS Chemistry System instrumentation, which provides automated use of the chemistry slides.
The provided document describes a 510(k) premarket notification for a modified in vitro diagnostic device, the VITROS Chemistry Products ALB Slides and VITROS Chemistry Products Calibrator Kit 4. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than outright performance acceptance criteria against a defined standard.
Therefore, the acceptance criteria and study details are primarily presented in terms of comparative equivalence to the predicate device, rather than explicit numerical thresholds.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state numerical acceptance criteria in the typical sense (e.g., sensitivity > X%, specificity > Y%). Instead, the "acceptance criteria" appear to be demonstration of substantial equivalence to the predicate device, particularly through performance with "patient and quality control samples with measured albumin values spanning the assay range."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (VITROS Chemistry Products ALB Slide (current) and VITROS Chemistry Products Calibrator Kit 4) | Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured albumin values spanning the assay range. |
| No significant change in clinical performance despite changes in sample volume (5.5 µL vs 10 µL) and quantity of reactive ingredients (bromcresol green dye: 125.4 µg vs 250 µg). | The information presented in the pre-market notification demonstrates that the performance of the VITROS ALB Slides (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document only generically states "patient and quality control samples." No specific number is provided for the test set.
- Data Provenance: Not specified within the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For in vitro diagnostic devices like this, "ground truth" for albumin measurement is typically established by reference methods or highly accurate laboratory analyzers, not human expert consensus like in image analysis.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. As an in vitro diagnostic device measuring a quantitative biomarker, adjudication by human readers is not relevant. The "ground truth" would be established by laboratory methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers Improve with AI vs without AI Assistance
This information is not applicable and therefore not provided. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or decision support tool involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a standalone measurement system (an automated chemistry analyzer utilizing specific slides and calibrators). The "algorithm" here refers to the chemical reaction and reflectance spectrophotometry, not a machine learning algorithm. The study effectively assesses the standalone performance of this system against the predicate system. The performance is assessed without human interpretation of raw data, beyond operating the instrument and reviewing results.
7. The Type of Ground Truth Used
For this type of in vitro diagnostic device, the ground truth would be established by:
- Reference laboratory methods: Established, highly accurate methods for measuring albumin concentration.
- Predicate device results: As the goal is substantial equivalence, the results from the predicate device often serve as a comparative ground truth for the new device.
- Known concentrations in quality control samples: Quality control materials have certified albumin concentrations.
The document states "patient and quality control samples with measured albumin values." This implies that these samples had their albumin values determined by a reliable method (likely the predicate device or a reference method) to serve as the ground truth for comparison.
8. The Sample Size for the Training Set
This information is not provided and is largely not applicable in the context of this device. This is a chemical assay, not a machine learning model that requires a "training set" in the computational sense. The "training" of such a system involves the development and optimization of the chemical reagents and instrument parameters, which is a different process than data-driven machine learning training.
9. How the Ground Truth for the Training Set was Established
As explained above, the concept of a "training set" and associated "ground truth" in the machine learning sense does not directly apply to this in vitro diagnostic device. The development process would involve extensive experimentation and optimization against known chemical standards and clinical samples, but this is not typically referred to as establishing ground truth for a training set in regulatory submissions for chemical assays.
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(19 days)
VITROS Chemistry Products Mg Slides For in vitro diagnostic use only. VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine.
VITROS Calibrator Kit 1 For in vitro diagnostic use only. VITROS Calibrator Kit 1 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of BUN/ UREA, Ca, CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC.
The VITROS Chemistry System uses Vitros Slides to perform discrete chemistry tests on body fluid specimens. All reactions necessary for a single quantitative measurement take place within the multi-layered analytical element of a Vitros Slide. The system is comprised of two main elements: 1. The VITROS Chemistry Products range of chemistry products (in this case VITROS Chemistry Products Mg Slides, VITROS Chemistry Products Calibrator Kit 1, which are combined by the VITROS Chemistry System to perform the VITROS Mg test. 2. The VITROS Chemistry System - instrumentation, which provides automated use of the chemistry slides.
The provided text describes a 510(k) submission for a modified medical device, the VITROS Chemistry Products Mg Slides and VITROS Chemistry Products Calibrator Kit 1. The submission aims to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state acceptance criteria in the form of specific performance metrics (e.g., accuracy, precision targets). Instead, it relies on demonstrating substantial equivalence to the predicate device. The performance is assessed by comparing the characteristics and overall performance of the modified device to the predicate device.
| Device Characteristic | Acceptance Criteria (Implied: Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Device Model / Name | Equivalence to VITROS Chemistry Products Mg Slide (current) and VITROS Chemistry Products Calibrator Kit 1 | VITROS Chemistry Products Mg Slides (modified) and VITROS Chemistry Products Calibrator Kit 1. |
| Intended Use | No Change from Predicate Device | No Change. For in vitro diagnostic use only. VITROS Mg Slides quantitatively measure Magnesium (MG) concentration use in serum, plasma, and urine. VITROS Calibrator Kit 1 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of BUN/UREA. Ca. CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC. |
| Basic Principle | No Change from Predicate Device | No Change. Dry, multilayered slide utilizing reflectance spectrophotometry. |
| Sample Type | No Change from Predicate Device | No Change. Serum, plasma, urine. |
| Reportable Range (Serum, Plasma) | No Change from Predicate Device | No Change. 0.20 - 10.00 mg/dL. |
| Reportable Range (Urine) | No Change from Predicate Device | No Change. 1.20 - 60.00 mg/dL (after multiplying by a 6X dilution factor). |
| Instrumentation | No Change from Predicate Device | No Change. VITROS 250, 500, 750 and 950 Series Analyzers. |
| Incubation time and temperature | No Change from Predicate Device | No Change. Approximately 5 minutes at 37°C. |
| Sample volume | Demonstrated equivalence despite change from predicate | Modified Device: 5 µL. Predicate Device: 10 µL. While this is a change, the study would have shown that despite this change, the performance (e.g., accuracy, precision) remains equivalent to the predicate. |
| Quantity of Reactive Ingredients per slide (test) | Demonstrated equivalence despite change from predicate | Modified Device: 1,2-bis(o-aminophenoxy)ethane-N,N,N',N'-tetraacetic acid (calcium chelator) 272.1 µg and 1,5-bis(2-hydroxy-3,5-dichlorophenyl)-3-cyanoformazan (dye) 46.19 µg. Predicate Device: 1,2-bis(o-aminophenoxy)ethane-N,N,N',N'-tetraacetic acid (calcium chelator) 542.3 µg and 1,5-bis(2-hydroxy-3,5-dichlorophenyl)-3-cyanoformazan (dye) 92.06 µg. Similar to sample volume, this changes, but overall performance is still shown to be equivalent. |
| Concentrations of Slide Reactive Ingredients per cm-squared | No Change from Predicate Device | No Change. This is a crucial point, suggesting that while the total quantity of reactive ingredients changed due to the reduced sample volume, the concentration per unit area remained the same, implying a consistent reaction environment despite the reduction in overall analyte. |
| Overall Performance | Substantially equivalent to cleared predicate device | "The performance of the VITROS Mg Slides (modified) for use with human serum, plasma, and urine is substantially equivalent to the cleared predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a numerical value. The document mentions "patient and quality control samples."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as using "patient and quality control samples with measured Magnesium values spanning the assay range," implying real-world or simulated clinical samples. It is a retrospective or prospective study as it involves testing the modified device against the predicate using samples. The nature of the study (e.g., in-house validation or multi-site trial) is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and therefore, not provided. For this type of in-vitro diagnostic device (a chemistry assay), the "ground truth" for Magnesium concentration is established by a reference method or a highly accurate, previously validated method, rather than expert consensus on images or clinical assessments. The reference values for calibrators/controls would typically be determined by highly accurate analytical chemistry techniques.
4. Adjudication Method for the Test Set
This information is not applicable and therefore, not provided. Adjudication methods like "2+1" or "3+1" are typically used in studies involving human readers and subjective interpretations (e.g., radiology studies). For a quantitative diagnostic assay, the "adjudication" is inherent in the analytical measurement process and statistical comparison of results with the predicate device or reference method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable and therefore, not provided. An MRMC study is relevant for imaging devices or AI-assisted diagnostic tools where human interpretation is a key component. This device is a quantitative chemistry assay where the output is a numerical concentration, not an image requiring human interpretation or AI assistance in that interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is partially applicable but not explicitly detailed. The device itself is an "algorithm only" in the sense that it is an automated assay system. The study described compares the performance of the modified assay (the "device") to a predicate assay (the "existing device"). There isn't a "human-in-the-loop" component in the direct measurement of Mg concentration by these devices. The study effectively assesses the standalone performance of the modified device against the predicate.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the test set was established by the measured Magnesium values spanning the assay range in both "patient and quality control samples." For quality control samples, the "ground truth" would be pre-assigned target values based on established reference methods. For patient samples, the "ground truth" would likely be values obtained from a comparative method or the predicate device itself, assuming it's considered a highly accurate reference in this context for demonstrating equivalence. It's essentially reference analytics or comparative method data.
8. The Sample Size for the Training Set
This information is not applicable and therefore, not provided. This device is a chemistry assay, not a machine learning or AI model that requires a "training set" in the traditional sense. The development of the assay (e.g., optimizing reagent concentrations) would involve experimental data, but this is distinct from an AI model's training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for a chemistry assay in the context of AI. The "ground truth" for the experimental data used during the development and optimization of the assay would have been established through standard analytical chemistry techniques and reference methods to determine accurate concentrations for various samples.
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