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Proov test is intended for the detection of pregnanediol glucuronide (PdG, the major urine metabolite of progesterone) in urine and can be used as an aid for confirmation of ovulation.

The Proov Test is intended for measuring pregnanediol glucuronide (PdG) in first morning urine during the luteal phase of the monthly female reproductive cvcle. The Proov Test is a disposable lateral flow test strip, consisting of a test area and control area. The urine sample is applied to the strip by dipping. The sample moves by lateral flow into the test area, and then the control area. The test area has PdG-specific reagents impregnated on it to detect the present of PdG in the urine. The control area has antibodies impregnated to be used as internal control for proper assay function. The test strip is intended for use outside the body (in vitro diagnostic use) and provides qualitative results with a single red line indicating a positive result for PdG and two red lines indicating a negative result for PdG in urine. Women can use Proov Test at multiple times during their menstrual cycle to confirm ovulation.

The provided document is a 510(k) Premarket Notification from the U.S. FDA for the Proov Test, a device intended for the detection of pregnanediol glucuronide (PdG) in urine as an aid for confirmation of ovulation. The document details the analytical and clinical studies conducted to demonstrate the device's performance characteristics.

Here’s a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria & Reported Device Performance

The document doesn't explicitly present a formal "acceptance criteria" table with pre-defined performance thresholds alongside the results. However, the performance studies implicitly define the expected outcomes for the device to be considered acceptable. I will infer the acceptance criteria from the context of "good performance" for this type of diagnostic test.

• 0 ug/mL (100% below cutoff): 0 positive / 90 negative (100% correctly negative)
• 2.5 ug/mL (50% below cutoff): 0 positive / 90 negative (100% correctly negative)
• 3.75 ug/mL (25% below cutoff): 0 positive / 90 negative (100% correctly negative)
• 5 ug/mL (Cut-Off): 41 positive / 49 negative (Mix of results as expected at cutoff)
• 6.25 ug/mL (25% above cutoff): 90 positive / 0 negative (100% correctly positive)
• 7.5 ug/mL (50% above cutoff): 90 positive / 0 negative (100% correctly positive)
  Conclusion: Cut-off value of 5 ug/mL is verified. |
  | Detection Limit | Clearly defined and consistently detected. | 5 ug/mL PdG (verified by precision study above) |
  | Interference/Cross Reactivity | No significant interference from common substances at physiological/pathological concentrations. | No interference observed from 20 tested substances (e.g., LH, HCG, Progesterone, glucose, acetaminophen, etc.) at specified concentrations. |
  | Effect of Urine Specific Gravity & pH | Consistent results across a range of normal urine specific gravity and pH values. | All positive samples above cutoff remained positive, and all negative samples remained negative across pH 4.25-9 and specific gravity 1.000-1.025. |
  | Hook Effect | No hook effect observed at high analyte concentrations. | No hook effect observed up to 1 mg/mL PdG. |
  | Comparison to Reference Method (Clinical Correlation) | High concordance with a validated reference method (EIA procedure). Minor discordances, particularly near the cutoff, are expected. | Comparison Study (94 urine samples):
• Viewer A: 90.4% concordance (85/94 matched ELISA classification)
• Viewer B: 92.6% concordance (87/94 matched ELISA classification)
• Viewer C: 95.7% concordance (90/94 matched ELISA classification)
  Discordant results primarily near the ELISA cutoff (e.g., ELISA 4.4 ug/mL read positive by Viewer A, ELISA 5.2 ug/mL read negative by Viewers B & C). |
  | Lay User Performance (Ability to read and interpret) | High percentage of lay users correctly identify positive/negative results and find instructions easy to understand. | Lay User Study (101 lay persons; 121 total samples):
• 100% correct interpretation for all tested concentrations (1.25, 2.5, 3.75 ug/mL negative; 6.25, 7.5, 8.75 ug/mL positive). (Actual number of correct interpretations: 121 of 121 samples).
• 92% of lay users indicated instructions were "easy" or "very easy". |

2. Sample Sizes and Data Provenance

• Test Set (Analytical & Clinical):
  • Precision Studies: 90 replicates per PdG concentration (total 540 replicates in the table).
  • Interference/Cross Reactivity: Samples (negative male urine and spiked male urine) tested with three batches of the device for each of the 20 substances. Specific number of samples not explicitly stated beyond "samples."
  • Specific Gravity & pH: "Negative urine samples" and "urine spiked with PdG 25% above cut-off levels" tested with three batches of the device. Specific number of samples not explicitly stated.
  • Hook Effect: "Negative urine samples were spiked with PdG at concentrations of ranging from 50 ug/ml to 1 mg/ml." Tested with three lots. Specific number of samples not explicitly stated.
  • Comparison Studies: 94 urine samples collected from "apparently healthy female individuals."
  • Lay User Study: 101 lay persons; 121 blind-labeled samples (each participant received 1 or 2 samples).
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective in nature, as they involve testing samples (either prepared or collected) with the device and assessing performance.

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

• Analytical Ground Truth (e.g., for precision, interference): Established by the study design (known concentrations of spiked PdG, known interfering substances). No external "experts" were used to establish this ground truth in the sense of clinical interpretation.
• Comparison Study Ground Truth: A "validated PDG EIA procedure" was used as the reference method (ground truth) for the 94 urine samples. No information is provided regarding the qualifications of the personnel who performed the EIA procedure or established its "validity."
• Lay User Study Ground Truth: The ground truth for the lay user study was the known spiked concentration of PdG in the simulated urine samples (e.g., 1.25 ug/mL was negative, 6.25 ug/mL was positive).

4. Adjudication Method for the Test Set

• Comparison Study: The Proov Test results were read by "three different technicians." It does not explicitly state an adjudication method (e.g., 2+1, majority vote) among these technicians to arrive at a single "Proov Test result" for comparison. The table shows separate results for Viewer A, Viewer B, and Viewer C, implying individual readings were recorded and compared to the ELISA. Discordant results are listed individually for each viewer.
• Lay User Study: Lay users read their own results. The "correctness" was determined by comparison to the known spiked concentrations. No "adjudication" between lay users occurred; their individual reading accuracy was assessed.

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

• No, a formal MRMC study was not described in the typical sense of comparing human readers with AI assistance vs. without AI assistance.
• The comparison study involved three technicians reading the Proov test, and their individual results were compared to a reference method (ELISA). This is a multi-reader study for the device interpretation, but it does not evaluate the improvement of human readers using AI, as the Proov Test itself is a rapid diagnostic kit, not an AI-powered diagnostic.
• The Lay User study also involved multiple readers (the lay persons), but it focused on their ability to interpret the device without any assistance (AI or otherwise) beyond the package insert.

6. Standalone Performance (Algorithm Only)

• Not applicable. The Proov Test is a visually read lateral flow assay, not an algorithm or AI-driven device. Its performance is inherent to the chemical reactions on the strip and how it presents results for human interpretation. Therefore, there is no "algorithm only" performance to describe.

7. Type of Ground Truth Used

• Analytical Studies: Ground truth was established by known concentrations of PdG in samples (spiked male urine or simulated urine) and the presence/absence of specific interferents.
• Comparison Study: Ground truth was established by a validated PDG EIA procedure, used as a reference method for the collected urine samples.
• Lay User Study: Ground truth was established by known spiked concentrations of PdG in prepared simulated urine samples.

8. Sample Size for the Training Set

• Not applicable. This is a diagnostic kit, not a machine learning or AI model that requires a "training set" in the computational sense. The device's performance is based on its chemical and biological components.

9. How Ground Truth for the Training Set Was Established

• Not applicable, as there is no "training set" for this type of device. The "training" for the device's development would be analogous to traditional R&D and validation processes for chemical assays, where performance is optimized based on laboratory testing and analytical validation, not by training an algorithm on a dataset with established ground truth.

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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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VITROS Progesterone Reagent Pack
For in vitro diagnostic use only.
The Vitros Progesterone Reagent Pack quantitatively measures progesterone concentration in human serum and plasma.

VITROS Progesterone Calibrators
For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of progesterone in human serum and plasma (EDTA or heparin).

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.

The system is comprised of three main elements:

1. The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Progesterone Reagent Pack, VITROS Immunodiagnostic Products Progesterone Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Progesterone assay).
2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) premarket notification (K962919/S1).
3. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

This submission describes the VITROS Immunodiagnostic Products Progesterone Reagent Pack and VITROS Immunodiagnostic Products Progesterone Calibrators (modified), which is a progesterone assay. The device is intended for in vitro diagnostic use to quantitatively measure progesterone concentration in human serum and plasma. The study presented aims to demonstrate substantial equivalence to a legally marketed predicate device (VITROS Immunodiagnostic Products Progesterone Reagent Pack and VITROS Immunodiagnostic Products Progesterone Calibrators).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details a comparison of assay characteristics between the predicate and the new device. It does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it focuses on substantial equivalence based on comparable characteristics.

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). The submission focuses on comparing the modified device's characteristics to a predicate device, rather than providing detailed clinical study results with a test set.

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 device for quantitative measurement, and the ground truth would typically be established by established reference methods or primary analytical measurements, not by expert interpretation in the same way imaging or diagnostic algorithms are validated. The document does not mention the use of experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment is based on analytical performance and comparison to a predicate, not on subjective interpretations 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

Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting results.

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

The device itself is a standalone immunoassay system. The document implies that the performance of the VITROS Progesterone assay (modified) was evaluated on its own analytical capabilities to demonstrate substantial equivalence to the predicate. There is no mention of human interaction beyond the operation of the instrument.

7. The Type of Ground Truth Used

The ground truth for this type of in vitro diagnostic device would typically be established through highly accurate and precise analytical reference methods, or by comparing agreement with the predicate device's established performance, rather than pathology, outcomes data, or expert consensus in an observational or interpretive sense. The document states that "the information presented in the pre-market notification demonstrates that the performance of the VITROS Progesterone assay (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device." This implies that the 'ground truth' or benchmark for performance comparison is the predicate device's established performance using recognized analytical methods.

8. The Sample Size for the Training Set

The document does not provide details on a "training set" in the context of machine learning. This device is an immunoassay, not an AI/ML-based algorithm that typically requires a training set. The development of such assays involves analytical validation, linearity studies, precision, accuracy, and interference studies, but these do not fall under the conventional definition of a "training set" for AI.

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

Not applicable, as this device does not utilize a "training set" in the AI/ML sense. The "ground truth" for developing and validating immunoassay performance would be derived from rigorous analytical testing using known concentrations of analytes, reference materials, and comparison with established methods.

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VITROS Progesterone Reagent Pack For in vitro diagnostic use only. The Vitros Progesterone Reagent Pack quantitatively measures progesterone concentration in human serum and plasma.

VITROS Progesterone Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Progesterone in human serum and plasma (EDTA or heparin).

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:

1. The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Progesterone Reagent Pack, VITROS Immunodiagnostic Products Progesterone Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Progesterone assay.
2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) premarket notification (K962919).
3. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

The provided text describes a 510(k) submission for a modified VITROS Immunodiagnostic Products Progesterone Reagent Pack and Calibrators. This type of submission demonstrates substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical study with acceptance criteria in the same way a novel device might. Therefore, many of the requested categories are not directly applicable or are addressed by demonstrating equivalence to the predicate.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The document states that "Equivalence was demonstrated using manufactured reagents along with patient samples with measured Progesterone values spanning the assay range." This implies that the 'acceptance criteria' for this submission was demonstrating substantial equivalence in assay characteristics and performance (accuracy, precision, linearity, etc.) to the predicate device.

The study presented focuses on comparing the modified device's assay characteristics to the predicate device. The performance is "reported" through this comparison, asserting clinical equivalence.

Table 1: List of Assay Characteristics: Comparison to Predicate Device (from the document)

The document concludes "the performance of the VITROS Progesterone assay (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device." This is the reported device performance and the key criterion for 510(k) clearance.

Study Information

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Sample Size: The document only states "patient samples with measured Progesterone values spanning the assay range." It does not specify the exact number of patient samples used in the equivalence study.
   • Data Provenance: Not specified.
   • Retrospective or Prospective: Not specified, but typically, for 510(k) in-vitro diagnostic submissions, comparative studies often use banked (retrospective) samples or newly collected (prospective) samples run in parallel. The text does not provide this detail.

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

   • Not applicable in this context. For an in-vitro diagnostic assay that measures a biomarker, the "ground truth" is typically the measured value itself, often derived from a reference method or the predicate device, not expert consensus in the way it would be for image analysis or clinical diagnosis. The study here compares the modified device's measurements to the predicate device's measurements, not to an expert-established ground truth.

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

   • Not applicable. This concept applies to studies where multiple readers or experts assess a case and their opinions need to be reconciled, such as in imaging studies. For an in-vitro diagnostic assay, the measurement itself is the output.

4. 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/imaging device and does not involve human readers interpreting results. It is an in-vitro diagnostic assay.

5. 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 biochemically (how well it measures progesterone), not as an algorithm-only or human-in-the-loop system in the AI sense. The study effectively acts as a standalone performance evaluation compared to the predicate.

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

   • The "ground truth" in this context is the measured progesterone values obtained from the predicate device or potentially a recognized reference method, to which the modified device's measurements are compared to demonstrate substantial equivalence.

7. The sample size for the training set:

   • This concept is typically for machine learning or AI models. For an in-vitro diagnostic assay, there isn't a "training set" in the same sense. The development of the assay's reagents and calibration curves would involve internal validation and optimization, but the document doesn't detail the number of samples used during that specific development phase. The submission focuses on the final product's performance for equivalence.

8. How the ground truth for the training set was established:

   • As there is no "training set" in the AI sense, this is not applicable. The assay's performance characteristics (e.g., linearity, precision, accuracy) are established through analytical studies using reference materials, spiked samples, and patient samples with known or well-characterized progesterone levels.

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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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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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