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510(k) Data Aggregation
(75 days)
This in vitro diagnostic method is intended to quantitatively measure unconjugated estriol (uE¿) in human serum on the Bayer Immuno 1™ system. Measurements of uE, are used in evaluating fetal well-being by monitoring the level of the hormone derived from fetal-placental circulation.
This diagnostic method is not intended for use on any other system.
This in vitro diagnostic method is intended to quantitatively measure unconjugated estriol in human serum on the Bayer Immuno 1 System.
Here's an analysis of the provided text regarding the Bayer Immuno 1™ Unconjugated Estriol method, focusing on acceptance criteria and study details:
Device: Bayer Immuno 1™ System Unconjugated Estriol Assay
Predicate Device: Diagnostic Products Corporation (DPC) Coat-a-Count® Free Estriol RIA method
1. Acceptance Criteria and Reported Device Performance
The document presents performance data for the Bayer Immuno 1™ uEstriol method and compares it to the predicate DPC Coat-a-Count® Free Estriol RIA method. While explicit acceptance criteria (e.g., "must be less than X," "must be greater than Y") are not formally listed as such in the provided text, the implied acceptance criteria are that the new device's performance is comparable to or better than the predicate device across various metrics, demonstrating substantial equivalence.
Table of Acceptance Criteria (Implied) and Reported Device Performance:
| Performance Metric | Implied Acceptance Criteria (relative to predicate) | Bayer Immuno 1™ uE3 Reported Performance | DPC Coat-a-Count® Free Estriol RIA Reported Performance (Predicate) | Meets Implied Criteria? |
|---|---|---|---|---|
| Precision (within-run) | Comparable or better %CV at various concentration levels. | |||
| - 0.41 ng/mL equiv. | %CV should be similar or lower than predicate. | 3.6% | 9.1% (for 0.74 ng/mL mean) | Yes |
| - 3.60 ng/mL equiv. | %CV should be similar or lower than predicate. | 3.2% | 5.5% (for 2.9 ng/mL mean) | Yes |
| - 6.49 ng/mL equiv. | %CV should be similar or lower than predicate. | 1.5% | 3.8% (for 7.9 ng/mL mean) | Yes |
| - 11.37 ng/mL equiv. | %CV should be similar or lower than predicate. | 2.3% | 3.8% (for 12.2 ng/mL mean) | Yes |
| Precision (total) | Comparable or better %CV at various concentration levels. | |||
| - 0.41 ng/mL equiv. | %CV should be similar or lower than predicate. | 4.9% | 21.2% (for 0.74 ng/mL mean) | Yes |
| - 3.60 ng/mL equiv. | %CV should be similar or lower than predicate. | 3.4% | 9.3% (for 2.90 ng/mL mean) | Yes |
| - 6.49 ng/mL equiv. | %CV should be similar or lower than predicate. | 2.3% | 9.9% (for 7.90 ng/mL mean) | Yes |
| - 11.37 ng/mL equiv. | %CV should be similar or lower than predicate. | 2.7% | 8.0% (for 12.20 ng/mL mean) | Yes |
| Method Comparison | Strong correlation (r close to 1) and linear regression indicating agreement between methods. | |||
| - Regression Equation | (No explicit numerical criterion given, but substantial equivalence implies a strong linear relationship with minimal bias) | y = 0.87x + 0.62 | N/A (predicate is 'x') | Yes (implied) |
| - Correlation Coefficient (r) | Close to 1 (e.g., typically > 0.95 for good agreement). | 0.98 | N/A | Yes |
| - Sy.x | (No explicit numerical criterion, but a low value indicates good fit). | 1.23 | N/A | Yes (implied) |
| Specificity (Cross-reactivity) | Cross-reactivity with common interferents should be low and comparable to the predicate. | |||
| - Estriol-3-sulfate | % Cross-reactivity comparable to predicate. | 1.70% | 0.46% | Comparable* |
| - Estriol-3-(β-D-glucuronide) | % Cross-reactivity comparable to predicate. | 1.60% | 0.26% | Comparable* |
| - Estriol-16-α-(β-D-glucuronide) | % Cross-reactivity comparable to predicate. | 0.05% | 0.66% | Yes |
| - Estradiol | % Cross-reactivity comparable to predicate. | 0.44% | 0.13% | Comparable* |
| - 16a-Hydroxyestrone | Low cross-reactivity. | 7.60% | Not reported | (No direct comparison) |
| - Other compounds | Low or not detected cross-reactivity. | Generally low or not detected | Generally low or not detected | Yes |
*Note on Specificity: For some compounds (e.g., Estriol-3-sulfate, Estriol-3-(β-D-glucuronide), Estradiol), the Bayer Immuno 1™ shows a higher cross-reactivity percentage than the DPC method. However, without explicit acceptance limits, and given that these values are still relatively low (mostly <2%), they are likely considered acceptable in the context of substantial equivalence, particularly if they do not significantly impact the intended use or if the overall profile is favorable. The DPC method did not report 16a-Hydroxyestrone, so direct comparison is not possible for that compound.
2. Sample Size Used for the Test Set and Data Provenance
-
Sample Size for Method Comparison (Regression Equation):
n = 249(samples were compared between Immuno 1 uE3 Assay and DPC Coat-a-Count Free Estriol RIA). -
Sample Size for Precision (within-run & total):
n = 20samples measured over10 daysfor each concentration level. -
Sample Size for Specificity (Cross-Reactants): Cross-reactants were "spiked into Normal Human Serum Pools." The number of individual samples within these pools or the number of pools tested isn't specified, but it implies a controlled experiment using pooled human serum.
-
Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. It presents laboratory performance data. Given it's a submission to the FDA, it would typically be derived from studies conducted in a controlled lab environment, likely from a prospective study design to evaluate the new device. The phrase "Normal Human Serum Pools" suggests controlled sample procurement.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes the performance characteristics of an in vitro diagnostic assay for measuring unconjugated estriol. For such assays, "ground truth" is typically established by:
- Reference Methods: Comparison to a legally marketed predicate device (as done here with the DPC RIA method) is a common way to establish agreement and "truth" in terms of clinical utility relative to existing methods.
- Analytical Standards: Known concentrations of analytes (e.g., purified unconjugated estriol) are used to calibrate the assay and determine its accuracy, linearity, and precision.
Therefore, the concept of "experts establishing ground truth" in the sense of clinical specialists reviewing cases (like radiologists for imaging studies) is not directly applicable here. The "ground truth" in this context is the accuracy and reliability of the measurement itself, validated against established analytical principles and a predicate device.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, especially those involving subjective interpretation of data (e.g., imaging, pathology slides) by multiple human experts.
Since this is an analytical performance study for an in vitro diagnostic assay, there is no adjudication method described or relevant in this context. The comparisons are quantitative measurements between the new device and the predicate device, or between multiple runs of the same device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
MRMC studies are relevant for evaluating the impact of AI systems, particularly in diagnostic imaging or pathology, on the performance of human readers. This document describes an in vitro diagnostic assay for measuring a specific hormone level in serum, which is an automated, quantitative measurement. It does not involve human "readers" interpreting output in a comparative effectiveness setting.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the provided study assesses standalone performance.
The Bayer Immuno 1™ Unconjugated Estriol method is an automated in vitro diagnostic system, meaning it operates as an "algorithm only" (or rather, an automated instrument and reagent system) without human interpretation as part of its core function, other than loading samples and reviewing results. The reported precision, method comparison, and specificity data all represent the standalone analytical performance of the device.
7. The Type of Ground Truth Used
The "ground truth" for this study is established by:
- Comparison to a Legally Marketed Predicate Device: The DPC Coat-a-Count® Free Estriol RIA method served as the reference for method comparison, implying its accepted performance defines the "ground truth" for clinical utility in that context.
- Analytical Standards/Known Concentrations: For precision and specificity, the ground truth is based on known concentrations of unconjugated estriol and other compounds used in spiked samples and controls. This ensures the device accurately measures what it's supposed to measure and doesn't react significantly with other substances.
In essence, the ground truth is analytical accuracy and precision relative to established methods and known chemical standards, rather than expert consensus on a clinical outcome or pathology.
8. The Sample Size for the Training Set
This document describes a pre-market submission for a medical device (an in vitro diagnostic assay). The concept of a "training set" is primarily associated with machine learning or AI models. This device is a traditional analytical instrument system.
Therefore, there is no "training set" in the machine learning sense for this type of device. The system's "training" involves its chemical and mechanical design, calibration procedures using known standards, and validation processes described in the performance studies.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" and associated "ground truth" in the machine learning context does not apply to this traditional in vitro diagnostic assay.
Instead, the device's accuracy and reliability are ensured through:
- Calibration: Using reference materials with defined, known concentrations of unconjugated estriol.
- Quality Control: Regular testing with control samples to ensure the assay is performing within expected parameters.
- Development and Validation: Extensive lab testing during the device's development to optimize its chemical reactions, optical/detection system, and software algorithms to accurately quantify unconjugated estriol. These processes inherently rely on established chemical and physiological principles and analytical standards.
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(30 days)
The DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL EIA assay is intended for the quantitative determination of Unconjugated Estriol in human serum. The measurement of Unconjugated Estriol is used as a diagnostic aid in the diagnosis and treatment of fetoplacental distress.
The DSL Ultra-Sensitive Unconjugated Estriol EIA kit was developed for the quantitative measurement of Unconjugated Estriol in human serum. The ElA format is a competitive binding protein assay. Horseradish peroxidase labelled unconiugated estriol competes with un-labeled Unconjugated Estrict in the serum sample for antibody binding sites. After incubation and washing the wells are incubated with the substrate tetramethylbenzidine (TMB). An acidic stopping solution is then added and the decree of enzymatic turnover of the substrate is determined by dual wavelength absorbance measurement.
This document describes the DSL 10-3700 Ultra-Sensitive Unconjugated Estriol EIA Kit and its equivalence to an existing device, the DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA. However, it does not provide a clear set of acceptance criteria with specific thresholds or present a study comparing the device against those criteria. Instead, it describes a comparative study showing substantial equivalence to a predicate device.
Given the information provided, here's an attempt to answer the questions based on what is available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state pre-defined acceptance criteria with pass/fail thresholds for this specific device. It relies on demonstrating "substantial equivalence" to a predicate device. The performance reported for this equivalence study is:
| Acceptance Criteria (Implicit from Equivalence Study) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Substantial equivalence to DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA (evaluated by linear regression and correlation) | Linear Regression: Y = 0.85(X) - 0.11 |
| Correlation Coefficient (r): 0.93 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: 106 patient samples.
- Data Provenance: The document does not specify the country of origin. It states "patient samples (n = 106) were collected". It does not explicitly state if these were retrospective or prospective, but the wording "were collected and assayed using both methods" suggests they were existing or newly collected samples for the purpose of the comparison, which could be either. The statement "Samples were chosen based on expected Unconjugated Estriol levels so that samples with low, intermediate and high levels would be evaluated" indicates a conscious selection strategy.
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. The "ground truth" in this context is the measurement obtained by the predicate device (DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA), not established by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This study focuses on comparing a new assay to a predicate assay, not on expert adjudication of diagnostic outcomes.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device, and no human reader study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the study described is a standalone performance comparison of the new assay (DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL EIA) against a predicate assay (DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA). Both are laboratory assays and operate without direct human-in-the-loop diagnostic interpretation in the context of this comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the purpose of demonstrating substantial equivalence was the measurement obtained from the predicate device, the DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA.
8. The sample size for the training set
Not applicable in the typical sense of machine learning. This is a biochemical assay, not an AI/ML algorithm that requires training data in the same way. The development and calibration of such assays typically involve internal development samples and validation samples, but not a "training set" as understood in AI/ML. The document does not provide details on such internal development samples.
9. How the ground truth for the training set was established
Not applicable for the reasons stated in point 8.
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(176 days)
The DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA assay is intended for the quantitative determination of Unconjugated Estriol in human serum. The measurement of Unconiugated Estriol is used as a diagnostic aid in the diagnosis and treatment of fetoplacental distress.
The DSL Ultra-Sensitive Unconjugated Estriol RIA kit was developed for the quantitative measurement of Unconjugated Estriol in human serum. The RIA format is a competitive binding protein assav. Radio-labeled Unconjugated Estriol competes with un-labeled Unconjugated Estriol in the serum sample for binding sites on the antibody coated tubes. Separation of free from bound Unconjugated Estriol is achieved by decanting the coated tubes after incubation. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of radio-labeled estriol bound to the antibody is inversely proportional to the concentration of the estricl present in the sample.
This document describes the DSL 3700 ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA Kit. It's a Radioimmunoassay (RIA) kit designed for the quantitative measurement of Unconjugated Estriol in human serum, intended as a diagnostic aid for fetoplacental distress. The submission claims substantial equivalence to the DPC FREE ESTRIOL RIA.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Strong correlation with a predicate device | Correlation coefficient (r) = 0.97 with DPC FREE ESTRIOL RIA |
| Linear relationship between measurements of the two devices | Linear regression equation: Y = 0.58(X) + -0.03 |
| Ability to measure a range of Unconjugated Estriol levels | Patient samples chosen to include low, intermediate, and high levels |
Note: The document doesn't explicitly state "acceptance criteria" but implies them through the equivalence study's design and results.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 126 patient samples.
- Data Provenance: Not explicitly stated, but it's implied to be human serum samples collected for this comparison study. Whether this was retrospective or prospective is not specified. The country of origin is also not mentioned, but given the submitter's address in Texas, USA, it is likely from the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- This information is not provided in the document. The study compares two RIA assays, and the "ground truth" for the comparison is essentially the measurement from the predicate device (DPC FREE ESTRIOL RIA) or the agreement between the two methods, rather than an expert clinical assessment.
4. Adjudication Method for the Test Set
- This information is not applicable or not provided. This study is a method comparison for an in-vitro diagnostic device, not a multi-reader imaging study requiring adjudication of expert interpretations. The comparison is based on quantitative analytical results.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement
- No, an MRMC comparative effectiveness study was not done. This document describes the validation of an in-vitro diagnostic (IVD) test kit, not an imaging device or a system requiring human interpretation as part of its primary function. Therefore, there's no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, in essence, this is a standalone performance study in the context of an IVD. The DSL RIA kit operates as an automated (or semi-automated) laboratory test. Its performance is evaluated based on its analytical output (quantitative measurement of Unconjugated Estriol) compared to a predicate device, without direct human intervention in the "reading" or "interpretation" of the analytical signal in the same way an AI algorithm might augment a radiologist. The human element comes in performing the assay and interpreting the final quantitative result.
7. The Type of Ground Truth Used
- The "ground truth" for this study is the measurement obtained from the predicate device, the DPC FREE ESTRIOL RIA. The intent is to show that the new device's measurements are substantially equivalent and highly correlated with those of an already approved device. It's a comparative analytical ground truth, not pathology, expert consensus, or outcomes data in the traditional sense for diagnostic accuracy.
8. The Sample Size for the Training Set
- This information is not applicable or not provided. RIA kits are laboratory assays based on biochemical reactions and do not typically involve "training sets" in the machine learning sense. The assay's parameters are developed and optimized through laboratory research and development, but not "trained" on a dataset of samples.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no "training set" for an RIA kit in the context of machine learning. The development process for an RIA involves optimizing reagents, incubation times, and other assay parameters to achieve desired performance characteristics.
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