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Luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free progesterone (a female hormone) in saliva. Measurements obtained by this device may be used in the diagnosis and treatment of disorders of the ovaries and can be used as an aid for confirmation of ovulation.

Luminescence immunoassay (LIA) based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labeled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After addition of the luminescence substrate solution the intensity of the luminescence measured is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.

IBL Progesterone LIA - Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the performance characteristics of the IBL Progesterone LIA. The acceptance criteria for these characteristics are not explicitly stated as distinct thresholds in the document, but rather the reported performance values themselves serve as the demonstration of the device's capability. For this analysis, we will interpret the reported performance as meeting the implicit acceptance criteria for a device of this type.

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The IBL Progesterone ELISA test kit is intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.

Not Found

This document is a 510(k) clearance letter from the FDA for a Progesterone ELISA Test Kit. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Thus, I cannot answer questions 1-9 based on the provided text.

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VITROS Progesterone Reagent Pack - For the in vitro quantitative measurement of progesterone in human serum and plasma (EDTA or heparin) in the diagnosis and treatment of disorders of the ovaries or placenta VITROS Progesterone Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of progesterone in human serum or plasma in the diagnosis and treatment of disorders of the ovaries or placenta

Not Found

The provided text details the FDA clearance of "VITROS Immunodiagnostic Products Progesterone Reagent Pack" and "VITROS Immunodiagnostic Products Progesterone Calibrators" but does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed metrics requested in your prompt.

The document is an FDA 510(k) clearance letter, which confirms the substantial equivalence of the device to a legally marketed predicate device. It does not typically include the detailed performance data or study results.

Therefore, I cannot fulfill your request with the provided input. To answer your questions, I would need a different document, such as a summary of safety and effectiveness (SSE) or the full 510(k) submission, which would contain the performance study details.

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OPUS Progesterone is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of progesterone in human serum or heparanized plasma. OPUS Progesterone is intended for use with the OPUS analyzers.

OPUS Progesterone is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of progesterone in serum or heparanized plasma, used in the diagnosis and treatment of disorders of the ovaries or placenta. OPUS Progesterone is intended for use with the OPUS analyzers.

OPUS Progesterone is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of progesterone in human serum or heparanized plasma.

Here's an analysis of the provided 510(k) notification, focusing on the acceptance criteria and the study details:

Device: OPUS® Progesterone Test System

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The provided document does not explicitly state pre-defined acceptance criteria values for each performance metric. The "Acceptance Criteria" column above is based on typical industry standards and expectations for immunoassay performance for such devices at the time of submission (mid-1990s). The reported device performance generally falls within these commonly accepted ranges, suggesting the device met the implicit or expected criteria for clearance.

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

• Precision (Intra-assay): 3 levels of control material, 20 replicates each.
• Precision (Inter-assay): 3 levels of control material, duplicate assays over 5 days (totaling 20 replicates).
• Accuracy by Recovery: 5 different levels of Progesterone spiked into previously assayed human serum, assayed in duplicate.
• Accuracy by Correlation: 83 serum samples.
• Data Provenance: The document does not explicitly state the country of origin. It indicates human serum and heparanized plasma were used as sample matrices. The study appears to be prospective in the sense that the samples were analyzed using the OPUS system for the purpose of demonstrating performance. It's unclear if the samples themselves were collected prospectively or retrospectively from a larger bank.

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 (immunoassay for quantitative measurement of a biomarker) typically does not rely on expert review of images or clinical cases for ground truth. Instead, the ground truth for performance characteristics like accuracy and precision is established through:

• Reference materials/standards: For precision, control materials with known concentrations are used.
• Spiked samples with known analyte concentrations: For recovery studies, a known amount of progesterone is added to a sample, and the device's ability to measure that addition is assessed.
• Comparison to a legally marketed predicate device: For accuracy by correlation, the predicate device (DPC Coat-a-Count® Progesterone) serves as the "truth" or reference method against which the new device's measurements are compared.

Therefore, the concept of "experts establishing ground truth" in the way it applies to image-based diagnostics is not directly relevant here.

4. Adjudication Method for the Test Set

Not applicable for this type of IVD performance study. Adjudication (e.g., 2+1, 3+1) is typically used in clinical studies or image-based diagnostic evaluations where multiple reviewers resolve discrepancies in interpretations.

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 for measuring progesterone levels. It does not involve human readers interpreting AI outputs or images.

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

Yes, the performance studies described (Precision, Accuracy by Recovery, Accuracy by Correlation) are all standalone performance studies for the OPUS Progesterone system. The device itself is an automated system designed for quantitative measurement. Human intervention is limited to sample loading, running the assay, and interpreting the reported numerical result, not in the direct "performance" of the measurement itself or its internal analytical process.

7. The Type of Ground Truth Used

• Precision: Established using control materials with known reference ranges.
• Accuracy by Recovery: Established by spiking samples with known quantities of progesterone.
• Accuracy by Correlation: Established by comparison to a legally marketed predicate device (DPC Coat-a-Count® Progesterone), which serves as the reference method or "truth" for comparative purposes.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI models, as this is an immunoassay device. Immunoassays are based on biochemical reactions and calibrated using a calibrator system, not typically "trained" in the AI sense.

• Calibrator System: The OPUS Progesterone uses a six-point calibrator system. This calibrator system is crucial for establishing the standard curve against which unknown samples are measured. While not a "training set" in the ML sense, these calibrators are fundamental to the device's ability to provide quantitative results.

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

Given that this is an immunoassay and not an AI/ML device, the concept of "ground truth for the training set" doesn't directly apply. Instead, the "ground truth" for the calibrator system (used to establish the standard curve) would be based on:

• Highly purified progesterone standards: The concentrations of progesterone in the calibrator materials would be precisely determined using gravimetric methods or other highly accurate analytical techniques, often traceable to international reference standards.
• Manufacturing QC: The calibrators would be manufactured and verified for their specified concentrations and stability according to strict quality control procedures.

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Immunoassay for the in vitro quantitative determination of progesterone in human serum and plasma.

Competition principle. Total duration of assay: 18 minutes (37 °C). · Ist incubation (9 min.): 50 uL sample - in the presence of a progesterone-derivative labeled with a ruthenium complex(65 uL)** are incubated with Danazol to release progesterone. After addition of biotinylated polyclonal ·2nd incubation (9 min.): progesterone-specific antibodies (50 uL) and streptavidin-coated microparticles (50 uL), progesterone from the sample competes with the labeled progesterone derivative for the antibody binding sites. At the same time the entire complex becomes bound to the solid phase via interaction of biotin and streptavidin. The proportion of labeled progesterone derivative bound to the solid phase is inversely proportional to the progesterone content of the sample. · The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame). ·Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code. **Tris(2,2'-bipyridy))ruthenium(II) complex (Ru(bpy)2+3)

Here's an analysis of the provided text, focusing on acceptance criteria and the study data:

The document is a 510(k) Summary for the Boehringer Mannheim Elecsys® Progesterone Assay, comparing it to a predicate device, the Enzymun® Progesterone Assay. It focuses on demonstrating substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that the document doesn't explicitly state "acceptance criteria" in the format of pass/fail thresholds against which the new device is being judged. Instead, it presents performance characteristics of both the new device (Elecsys® Progesterone Assay) and the predicate device (Enzymun® Progesterone Assay) to demonstrate substantial equivalence. The implication is that if the Elecsys® performance is comparable to or better than the predicate, it meets the unstated "acceptance criteria" for equivalence.

Therefore, the table below presents the performance characteristics as reported for both devices. The "Acceptance Criteria" column is derived from the performance of the predicate device, assuming the new device must achieve comparable or better results.

Observations from the table:

• The Elecsys® Progesterone Assay generally shows significantly better precision (lower %CV) at all levels compared to the predicate device.
• The Lower Detection Limit of the Elecsys® assay is much lower, indicating improved sensitivity.
• The Linearity Range of the Elecsys® assay is much wider, indicating a broader measurable range.
• The Method Comparison shows a strong correlation for both devices to the same predicate, with the Elecsys® having a slightly lower 'r' value but also a lower 'SEE' (Standard Error of Estimate) when compared to the Enzymun Test® Progesterone, suggesting good agreement.
• The Interfering Substances data shows some instances where the documented tolerance for the Elecsys® is lower than the predicate (Bilirubin, Hemoglobin, Biotin), while for Lipemia, it is higher. This might require specific clinical considerations.

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

• Sample Size for Test Set:
  • Precision (Within-Run & Total %CV): For each of the "Low", "Mid", and "High" levels, N=60 samples were used for both the Elecsys® and Enzymun® assays.
  • Method Comparison:
    • Elecsys® Progesterone: N=53 samples
    • Enzymun® Progesterone: N=48 samples
• Data Provenance: The document does not explicitly state the country of origin. It is a 510(k) submission to the FDA, so it typically implies data relevant to US market requirements. The data type is retrospective, as sample collections and analyses would have occurred prior to the submission date.

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

• This document is for an in vitro diagnostic (IVD) assay. The concept of "ground truth" established by human experts (like radiologists for imaging) is not directly applicable here.
• For IVDs, the "ground truth" is typically established by reference methods or highly accurate laboratory measurements. In this case, the Elecsys® assay's standardization is mentioned to be against "Enzymun® Progesterone," and the predicate's standardization is stated as "ID-GC/MS" (Isotope Dilution Gas Chromatography/Mass Spectrometry), which is a highly accurate reference method for quantitative measurements.

4. Adjudication Method for the Test Set

• Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments, such as reviewing medical images or clinical outcomes.
• For an IVD assay measuring an analyte quantitatively, adjudication is not performed in the same manner. The "adjudication" is inherent in the analytical process itself, with quality control, calibration, and comparison to established reference methods (like ID-GC/MS for the predicate). Data points that fall outside expected ranges might be flagged and re-tested, but there isn't an expert panel adjudicating results in the sense of clinical decision-making.

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

• No, an MRMC comparative effectiveness study was not done. This document pertains to an in vitro diagnostic (IVD) quantitative assay, not an AI-assisted diagnostic tool that involves human "readers" interpreting results. Therefore, the concept of human reader improvement with/without AI assistance does not apply.

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

• This is an in vitro diagnostic assay, essentially a "standalone algorithm" in its function. It provides a quantitative measurement of progesterone. The "performance" characteristics detailed (precision, linearity, detection limit, method comparison) are its standalone performance.
• However, it's not an "AI algorithm" in the modern sense. It's an automated immunoassay system that delivers a result based on chemical reactions and instrumental measurements. Human interaction is primarily for sample loading, running controls, and interpreting the quantitative result within a clinical context, not for interpreting the raw data to derive the result itself.

7. The Type of Ground Truth Used

• For the Elecsys® Progesterone Assay, the "ground truth" for its performance comparison appears to be the Enzymun-Test® Progesterone Assay (the predicate). The method comparison section ("Vs Enzymun-Test® Progesterone") explicitly states this.
• For the Enzymun® Progesterone Assay (the predicate), its standardization is indicated as ID-GC/MS (Isotope Dilution Gas Chromatography/Mass Spectrometry), which is widely considered a highly accurate and precise reference method for quantitative analytical measurements, serving as a robust "ground truth" in analytical chemistry.

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" in the context of machine learning or AI. This is a traditional immunoassay.
• The "calibration curve" is generated by "2-point calibration and a master curve provided via the reagent bar code." This calibration process uses specific calibrator materials, not necessarily what would be termed a "training set" in an AI/ML context. The number of samples for generating a master curve is not specified but would be conducted by the manufacturer.

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

• As a traditional immunoassay, there isn't a "training set" with ground truth in the AI/ML sense.
• The concept of "ground truth" for calibration materials would relate to their certified concentration values, which are typically established through highly accurate reference methods (e.g., gravimetry, titrimetry, or methods like ID-GC/MS) performed by qualified analytical chemists at the manufacturer.

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The VIDAS Progesterone (PRG) assay is intended for use with a Vitek ImmunoDiagnostic Assay Systems (VIDAS) as an automated enzyme-linked fluorescent immunoassay (ELFA) for the quantit determination of progesterone in serum or plasma. The VIDAS Progesterone assay is intended for us an aid in the diagnosis and treatment of disorders of the overies and placenta.

The VIDAS Progesterone (PRG) assay is an enzyme-linked fluorescent immunoassay (ELFA) that is performed in an automated VIDAS instrument. All assay temperature are controlled by the instrument. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR), serves as a solid phase for the assay as well as a pipetting device. At the time of manufacture, the SPR is coated with mouse anti-progesterone antibodies. Reagents for the assay are located in the sealed Reagent Strips. The sample is transferred into the well containing a progesterone derivative conjugated with alkaline phosphatase. Wash steps remove unbound conjugate. A fluorescent substrate, 4-methylumbellifory! phosphate, is cycled through the SPR and flouresences. The intensity of fluorescence is measured by the optical scanner in the instrument; it is inversely proportional to the progesterone concentration present in the sample.

Here's an analysis of the provided text regarding the acceptance criteria and study for the VIDAS Progesterone (PRG) Assay:

Acceptance Criteria and Device Performance for VIDAS Progesterone (PRG) Assay

Based on the provided 510(k) summary, the acceptance criteria are implicitly derived from the non-clinical and clinical study summaries. The device's reported performance is directly stated.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the clinical test set used for correlation, sensitivity, or calibration studies.

The provenance of the data (e.g., country of origin, retrospective or prospective) is not mentioned in the provided summary.

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

This information is not applicable in the context of this diagnostic assay. For assays like the VIDAS Progesterone test, the "ground truth" for the test set is typically established by comparative analysis with a well-established predicate device or reference method, not by expert interpretation of images or clinical data. The DPC Coat-A-Count Progesterone assay served as the predicate device against which the VIDAS assay was compared.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1, 3+1) is not applicable here. Adjudication methods are typically used in clinical trials or studies involving human readers and subjective interpretations (e.g., radiology studies) to resolve discrepancies among experts. For quantitative assays like this, the comparison is directly between the result of the new device and the result of the predicate/reference method.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are used to evaluate the performance of human readers, sometimes with and without AI assistance, typically in medical imaging. This document describes a diagnostic assay, not an imaging device that would involve human readers interpreting AI outputs.

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

The performance detailed in this summary is effectively standalone performance. The VIDAS Progesterone assay is an automated Enzyme-Linked Fluorescent Immunoassay (ELFA) performed entirely by the VIDAS instrument. While a human initiates the test and interprets the numerical result, the "performance" of the device itself (accuracy, precision, sensitivity, etc.) is measured based on the automated output. There isn't a "human-in-the-loop" component that actively modifies the assay's output during the measurement process.

7. The Type of Ground Truth Used

The primary ground truth used for the clinical validation was comparison with a legally marketed predicate device, specifically the DPC Coat-A-Count Progesterone assay. This serves as the reference standard against which the new device's performance (correlation) is measured. The limit of detection and precision studies also use controlled samples with known progesterone concentrations.

8. The Sample Size for the Training Set

The document does not provide information on a "training set" in the context of machine learning or AI models. This device is a biochemical assay, not a software algorithm that undergoes a training phase with a distinct dataset. The development and optimization of such assays involve method development and validation, but not typically a "training set" as defined in AI/ML contexts.

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

As discussed in point 8, there is no explicit "training set" mentioned or implied for this biochemical assay in the context of AI/ML. The "ground truth" for the development and optimization of the assay's reagents and methodology would have been established through standard chemical and biological assay development practices, using reference materials and established analytical techniques.

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for the quantitative determination of progesterone in human serum and plasma (heparin or EDTA).

AxSYM Progesterone is a microparticle enzyme immunoassay for the quantitative determination of progesterone in human serum and plasma (heparin or EDTA). AxSYM Progesterone is calibrated with Abbott calibrators and Abbott controls are used for verification of the calibration and to monitor the performance of the Abbott AxSYM System.

This document is a 510(k) summary for a diagnostic test, not an AI device. Therefore, many of the requested categories (e.g., number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission. The summary focuses on demonstrating substantial equivalence to a predicate device for an in-vitro diagnostic (IVD) assay.

Here's the information that can be extracted, with explanations for the inapplicable sections:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document implies these as acceptance criteria through the reported correlation analysis. In 510(k) submissions for IVDs based on substantial equivalence, the "acceptance criteria" are generally that the new device performs comparably to the predicate device across relevant performance characteristics (e.g., accuracy, precision, dynamic range, analytical sensitivity, analytical specificity). The correlation analysis directly addresses accuracy relative to the predicate.

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

• Sample Size for Test Set: 209 specimens
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This is typical for older 510(k) summaries which often focused on the statistical results rather than detailed demographic or collection information for the samples.

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

• Not Applicable. This is an in-vitro diagnostic test for a biomarker (progesterone). The "ground truth" for the test set is established by the measurements from the predicate device (Diagnostics Products Corporation Coat-A-Count® Progesterone assay), which itself is assumed to be an accurate measurement of progesterone. There are no human "experts" establishing ground truth in the sense of image interpretation or clinical diagnosis for this type of device.

4. Adjudication method for the test set

• Not Applicable. See point 3. The comparison is directly between the new device's readings and the predicate device's readings. There is no adjudication process involving human review of discrepancies.

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

• Not Applicable. This is not an AI device or an imaging device requiring human reader interpretation. It is an automated immunoassay for a biomarker.

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

• Yes, by definition. This is an automated in-vitro diagnostic assay. Its performance is evaluated intrinsically through its ability to accurately measure progesterone. There isn't a "human-in-the-loop" component in the direct operation or result generation of the assay itself, beyond an operator running the instrument. The comparison is between two automated assay systems.

7. The type of ground truth used

• Predicate Device Measurement: The "ground truth" for the performance study (correlation analysis) was the quantitative determination of progesterone in the same specimens by the Diagnostics Products Corporation Coat-A-Count® Progesterone assay.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. It's a chemical immunoassay system. The system is "calibrated" using Abbott calibrators, but this is a different concept than training an AI model.

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

• Not Applicable. See point 8. The "calibration" is performed using known concentration standards (Abbott calibrators), not a "training set" with established ground truth labels in the AI context.

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