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FSH Menopausal Test is a rapid Step The One chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine to aid in the detection of the onset of menopause. The test utilizes a combination of antibodies including mouse monoclonal anti-FSH antibodies and goat polyclonal anti-mouse antibodies to selectively detect elevated levels of FSH. This device is intended for both professional and lay person use.

One Step FSH Menopausal Test is a rapid chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine. The test utilizes a combination of antibodies including mouse monoclonal anti-FSH antibodies and goat polyclonal anti-mouse antibodies to selectively detect elevated levels of FSH.

Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) summary for the "One Step FSH Menopausal Test":

A. Acceptance Criteria and Reported Device Performance

The acceptance criteria for diagnostic tests often involve measures like sensitivity, specificity, and accuracy, especially when comparing to a reference method or clinical endpoint. While the specific numerical acceptance criteria established by the manufacturer are not explicitly detailed in this FDA letter (which typically focuses on substantial equivalence), the provided data implies a performance standard for "positive agreement" and "negative agreement" in comparison to a predicate device or clinical reference.

Note: The FDA 510(k) summary usually provides the specific acceptance criteria. This document indicates the device is "substantially equivalent," meaning its performance is comparable to a legally marketed predicate device, implicitly meeting accepted performance standards for its intended use.

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

The provided document does not explicitly state the specific sample size used for the test set in a clinical study to validate these performance metrics. The agreement percentages (Positive Agreement, Negative Agreement, Overall Agreement) are listed, but the accompanying sample sizes for "Professional Use" and "Lay Use" are not present in this excerpt.

• Data Provenance: Not specified in this document. It does not mention the country of origin of the data or whether the study was retrospective or prospective.

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

This information is not available in the provided document. For an FSH Menopausal Test, the "ground truth" for elevated FSH levels would likely be established by a laboratory assay (e.g., ELISA) for quantitative FSH levels, interpreted by a qualified medical professional (e.g., endocrinologist, gynecologist). The document doesn't detail the involvement of experts in establishing the ground truth or their qualifications.

D. Adjudication Method for the Test Set

This information is not available in the provided document. Adjudication methods (e.g., 2+1, 3+1) are typically used in imaging or subjective interpretation studies. For a diagnostic test like this, the ground truth is usually established by a reference method (e.g., quantitative laboratory FSH measurement), making multi-reader adjudication less relevant in the same way.

E. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, which typically evaluates how AI assistance impacts human reader performance, is not applicable to a single-use, qualitative in-vitro diagnostic test like the One Step FSH Menopausal Test. This device is not an AI-assisted interpretation tool.

F. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, in essence. This device inherently operates as a "standalone" test. The "performance" figures provided (Positive Agreement, Negative Agreement, Overall Agreement) reflect the device's ability to accurately detect FSH in urine samples, without human intervention in the detection process itself. The "Lay Use" section specifically evaluates its performance when interpreted by non-professionals, which is a key aspect of its standalone functionality for over-the-counter use.

G. The Type of Ground Truth Used

The ground truth used for performance evaluation is indicated by "Clinical Reference" and "Negative Reference" / "Positive Reference." This strongly suggests that the device's results were compared against an established clinical reference method for FSH levels (likely a quantitative laboratory assay) to determine true positive and true negative cases.

H. The Sample Size for the Training Set

This information is not available in the provided document. For a traditional in-vitro diagnostic test, there isn't a "training set" in the machine learning sense. The device's components (antibodies, reagents) are developed and optimized through research and development, but the sample sizes involved in that development process are distinct from the clinical validation (test set) discussed above.

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

Not applicable in the machine learning sense. The "ground truth" for the development of such a test would involve confirming the specificity and sensitivity of the antibodies and reagents against known concentrations of FSH, using established laboratory standards and methods. This is part of the product development and quality control process, rather than a "training set" in AI/ML terminology.

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The Moments Menopause Check is an in-vitro diagnostic screen for the detection of FSH (follicle stimulating hormone) in urine. Change in FSH levels may be associated with changes in menopause. This kit provides a preliminary screening result. This kit is intended for over-the-counter sales.

Immunoassay for the qualitative detection of FSH in urine.

Here's an analysis of the provided information regarding the Moments Menopause Check (Model 9113), focusing on its acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance for Moments Menopause Check (Model 9113)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not explicitly state the sample size used for the clinical sample correlation study or the blind labeled spiked study.
• Data Provenance: The studies used "clinical specimens." The country of origin for the data is not specified, but the manufacturer is Phamatech, located in San Diego, California, USA. The studies appear to be prospective, as they were conducted to evaluate the performance of the Moments Menopause Check.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the performance studies.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study being performed to assess how much human readers improve with AI vs. without AI assistance. This device is a rapid, qualitative immunoassay for over-the-counter use, and such a study design is generally not applicable to this type of diagnostic.

6. Standalone Performance Study

A standalone performance study was performed. The "clinical sample correlation study" and "blind labeled spiked study" evaluated the device's performance (qualitative detection of FSH in urine) independently. The "consumer study" also assessed the device in a standalone context, focusing on user interpretation.

7. Type of Ground Truth Used

• Clinical Sample Correlation Study: The ground truth for this study was likely established by the "predicate devices" to which the Moments Menopause Check was compared. This implies a comparison to existing, legally marketed FSH tests which themselves have established accuracy.
• Blind Labeled Spiked Study: For this study, the ground truth would have been based on known, controlled concentrations of FSH that were "spiked" into samples, allowing for a direct assessment of the device's ability to detect FSH at the specified threshold (25 mIU/ml).
• Consumer Study: The ground truth for the consumer interpretation was likely derived from the objective results of the FSH test (e.g., whether FSH was actually present at the detectable level) and then compared to the consumer's visual interpretation.

8. Sample Size for the Training Set

The document does not provide information about a training set since this is a chemical test (immunoassay) and not a machine learning or AI-based device. Therefore, the concept of a "training set" as understood in AI/ML is not applicable here. The device's performance is based on its inherent chemical properties and design.

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

As mentioned above, the concept of a training set and its ground truth is not applicable to this device, which relies on immunoassay technology rather than machine learning.

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FSH Menopause Predictor Test is a qualitative, one-step, midstream assay for the detection of Follicle Stimulating Hormone (FSH) in urine to be used as an aid in predicting menopause. The FSH Menopause Predictor Test is intended for over-the-counter use by the lay consumer.

The FSH Menopause Predictor Test is a midstream test used for the qualitative measurement of FSH and the detection of Follicle Stimulating Hormone in a woman's urine as an aid in predicting menopause. The FSH predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. FSH Menopause Predictor is an over-the-counter (OTC) device and may be sold under various private labels.

Here's a breakdown of the acceptance criteria and study details for the ACON Laboratories Inc. FSH Menopause Predictor Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 70 females.
• Data Provenance: The study was a prospective clinical trial as participants conducted tests at home according to instructions, and urine samples were collected for testing by a study coordinator. The location of the study (e.g., country of origin) is not explicitly stated in the provided text.

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

• The ground truth in this study was established using a substantially equivalent product (InstaCheck®) and the ACON FSH Menopause Predictor Test used by a trained lab tech.
• The text refers to a "trained Lab Tech," implying a professional with specific training in operating such devices. No further details on the qualifications (e.g., years of experience, specific certifications) are provided for this "trained Lab Tech."

4. Adjudication Method for the Test Set

• The text describes a comparison study rather than an adjudication process for a single ground truth. The "adjudication" was effectively done by comparing the results of the ACON FSH Menopause Predictor Test (both consumer-used and lab tech-used) against the InstaCheck® device. The data obtained from both devices were recorded as "Negative or Positive" without mention of an adjudication panel resolving discrepancies between the devices.

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

• No, a traditional MRMC comparative effectiveness study was not done in the context of comparing human readers with and without AI assistance. This device is a diagnostic test kit, not an AI-powered diagnostic imaging tool that would typically involve radiologists or other human readers interpreting complex images.
• However, the study does compare performance between the "trained Lab Tech" and the "consumer" using the ACON device, which could be seen as a form of multi-user comparison, albeit without an AI component. There is no "effect size of how much human readers improve with AI vs without AI assistance" as AI assistance is not part of this device.

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

• Yes, a standalone performance was done in the sense that the ACON FSH Menopause Predictor Test (when operated by a trained lab tech) was evaluated for its accuracy against the InstaCheck® product. This represents the device's inherent performance under controlled conditions. The "consumer" arm of the study also represents a standalone performance of the device in the hands of its intended user.

7. The Type of Ground Truth Used

• The ground truth used was comparative performance against a legally marketed predicate device (InstaCheck®) and the device itself when operated by a trained professional. While not explicitly "pathology" or "outcomes data" in the traditional sense, the InstaCheck® device serves as an established clinical reference for FSH levels in this context. The study also uses the ACON device operated by a trained professional as a reference for assessing consumer performance.

8. The Sample Size for the Training Set

• The provided text does not specify a training set sample size. This is likely because the FSH Menopause Predictor Test is a chemical-based in vitro diagnostic, not a machine learning or AI-driven device that requires a separate training set for algorithm development. The performance data presented are from a clinical trial (test set) designed to validate the device's performance.

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

• As there's no mention of a training set in the context of AI or machine learning for this device, a separate ground truth establishment method for a training set is not applicable based on the provided information. The device's mechanism is based on antibody-antigen reactions, not on learned patterns from a large dataset.

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The Moments Menopause Check is an in-vitro diagnostic screen for the detection of FSH (follicle stimulating hormone) in urine. Change in FSH levels may be associated with stages in menopause. This kit provides a preliminary result for the detection/presence of FSH in urine. It is intended for over-the-counter sales.

Immunoassay for the qualitative detection FSH (follicle stimulating hormone) in urine. The Moments Menopause Check, like many commercially available FSH screening test kits, qualitatively measures the presence of FSH by visual color sandwich one step immunoassay technology.

Here's a summary of the acceptance criteria and study details for the Moments Menopause Check device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The exact sample sizes for the clinical sample correlation study and the consumer study are not explicitly stated in the provided text.

• Data Provenance: The text indicates "Laboratory studies, using clinical specimens" and "A consumer study was also performed." This implies that the data was collected from human participants, likely in a prospective manner for the consumer study, and potentially retrospective or prospective for the clinical sample correlation study, though this is not specified. The country of origin is not mentioned, but the manufacturer is based in San Diego, California, USA, suggesting the studies likely originated there.

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

• Clinical Sample Correlation Study: The "predicate devices" were used as the comparison for establishing ground truth. The expertise involved in generating results from the predicate devices is not specified, but it's implied that these are established, commercially available tests.
• Consumer Study: The ground truth for the consumer study's accuracy (97%) is not explicitly described in terms of "experts." It refers to the device's accuracy in the hands of lay users, suggesting the "truth" against which their results were compared was likely derived from the established laboratory methods (predicate devices) on the same samples, although this is inferred.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated in the provided text for either study.

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

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The studies focus on comparing the device to predicate devices and assessing accuracy with lay users, not on how human readers' performance improves with or without AI assistance. The device itself is a qualitative immunoassay, not an AI-assisted diagnostic.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance was done. The "clinical sample correlation study" and the "consumer study" directly assess the performance of the Moments Menopause Check device itself (the "algorithm" in this context refers to the device's inherent detection mechanism) without explicit human-in-the-loop assistance influencing the detection mechanism itself, beyond the user performing the test.

7. Type of Ground Truth Used

• Clinical Sample Correlation Study: The ground truth was established by comparison to predicate devices. This implies the results from established, commercially available FSH screening test kits were considered the "truth."
• Consumer Study: The ground truth for the accuracy assessment against the lay user's results was likely established by laboratory methods (predicate devices) on the same samples, though this is not explicitly stated.

8. Sample Size for the Training Set

The provided text does not mention a training set or its sample size. This type of immunoassay device typically does not involve a "training set" in the machine learning sense. Performance is established through validation studies.

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

As no training set is mentioned for this type of device, this question is not applicable.

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EarlyDETECT MENOPAUSE TEST is a qualitative rapid membrane immunoassay for the in vitro diagnostic detection of follicle stimulating hormone (FSH) in human urine as a confirmation of hormone changes related to the symptoms associated with the stages of menopause. This device is intended for professional and Over the Counter (OTC) use.

Rapid Membrane ImmunoAssay

The provided document is a 510(k) premarket notification letter from the FDA for the EarlyDETECT® MENOPAUSE TEST. This document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can, therefore, be marketed subject to general controls provisions. It specifies the device name, regulation number, regulation name, and product code, along with its intended use as a qualitative rapid membrane immunoassay for in vitro diagnostic detection of follicle-stimulating hormone (FSH) in human urine for confirming hormone changes related to menopause, intended for professional and Over-The-Counter (OTC) use.

Therefore, I cannot provide the requested information based on the text provided. A separate submission, often referred to as the 510(k) summary or the full 510(k) submission, would typically contain such detailed study information.

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The quantitative determination of follicle stimulating hormone (FSH) concentration in human serum and plasma by a microplate enzymeimmunoassay.Measurements of follicle-stimulating hormone are used in the diagnosis of pituitary gland and gonadotropin disorders.

Monobind Inc., registration number 2020726, plans to introduce Into commercial distribution an enzymeimmunoassay (ELISA) kit for the determination of folliclestimulating hormone (FSH) in human serum and plasma.

The Monobind ELISA method is based on two-site immunoassay (sandwich) technology utilizing the streptavidin-blotin reaction to effect separation. Upon mixing monoclonal blotinylated anti-FSH antibody, the enzyme-labeled anti-FSH antibody and a serum containing the native antigen (FSH), reaction results between the native antigen (FSH) and the antibodies, without competition or steric hindrance, to form a soluble sandwich complex. Simultaneously, the complex is deposited to the well through the high affinity reaction of streptavidin and biotinylated antibody. After incubation is complete, decantation or aspiration separates the bound fraction. The enzyme activity on the well Is directly proportional to the native antigen (FSH) concentration. By utilizing several different serum references of known antigen values, a dose response curve can be generated from which the antigen concentration of an unknown can be ascertained.

The provided document describes the Monobind Inc. Follicle-stimulating hormone (FSH) ELISA kit and its submission for 510(k) clearance. The focus of the acceptance criteria and study is on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Linear Regression: The relationship between the new device and the predicate device should be linear, allowing for predictable conversion or direct comparison, expressed as y = mx + b.

Mean Values: The mean values of the new device should be comparable to the predicate device, indicating a similar central tendency in measurements. | Correlation Coefficient: 0.994, indicating very good method agreement.

Linear Regression Equation: y = 0.93(x) - 1.5, showing a strong linear relationship.

Mean Values: Predicate device (ICMA) mean = 21.0 mIU/ml; New device (ELISA) mean = 18.0 mIU/ml. |
| Analytical Recovery | Average Recovery Rate: When exogenous FSH is added to human serum specimens, the device should accurately recover the added amount, reflecting minimal interference or loss. | Average recovery of 99.9% when exogenous added FSH was introduced into human serum specimens. |
| Linearity (Dilution Studies) | Average Linearity: When specimens with varying FSH concentrations are diluted and compared to the dose response curve, the device should maintain accurate and proportional readings, demonstrating linearity across its measurement range. | Average linearity of 93.8% when specimens were diluted and compared to the dose response curve. |

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a clinical comparison study (sometimes referred to as a method comparison study) specifically designed to demonstrate substantial equivalence to the predicate device, the Ciba Corning ACS 180 chemiluminescence (ICMA) test.

2. Sample Size and Data Provenance:

• Sample Size for Test Set: 128 specimens.
• Data Provenance: The document does not explicitly state the country of origin. However, the manufacturer is Monobind Inc., located in Costa Mesa, CA (USA), and the submission is to the FDA. It is highly probable the data is from the USA. The study used specimens "from low to elevated populations," indicating a range of clinical samples.
• Retrospective or Prospective: Not explicitly stated, but clinical comparison studies for 510(k) submissions are typically prospective or involve retrospectively collected samples that are then prospectively tested with both devices. The phrase "clinical comparison... using 128 specimens" suggests these were real-world samples tested with both methods.

3. Number of Experts and Qualifications:

Not applicable for this type of device and study. The ground truth itself is established by the predicate device's measurement, not by expert consensus on visual assessment or interpretation. For an in vitro diagnostic (IVD) device like an ELISA kit, the "ground truth" for the comparison study is the result from the established, legally marketed predicate device.

4. Adjudication Method:

Not applicable. This is a quantitative measurement device comparison, not an interpretation task requiring adjudication. The "ground truth" is the numerical result from the predicate device.

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

Not applicable. This is an in vitro diagnostic (IVD) device that provides a quantitative measurement of a biomarker in a sample, not an imaging or diagnostic interpretation device where human readers are involved. Therefore, there is no "human reader" component to improve in this context.

6. Standalone Performance:

Yes, a standalone performance study was done in the sense that the Monobind ELISA kit generated its own quantitative results independent of human interpretation. The study then compared these standalone results to those of the predicate device. The performance characteristics reported (mean values, recovery, linearity) are standalone performance metrics of the Monobind ELISA.

7. Type of Ground Truth Used:

The ground truth for the comparison was the measurement obtained from the legally marketed predicate device, the Ciba Corning ACS 180 chemiluminescence (ICMA) test. This is an accepted method for demonstrating substantial equivalence for IVDs.

8. Sample Size for the Training Set:

The document does not explicitly mention a "training set" in the context of an algorithm or machine learning. For an ELISA kit, "training" might refer to assay development and optimization rather than a separate dataset for an algorithm. The reported 128 specimens were used for the clinical comparison/validation study. There is no indication of a separate training set for a machine learning model.

9. How the Ground Truth for the Training Set was Established:

As there is no explicit mention of a "training set" for an algorithm, this question is not directly applicable. If one considers the process of developing and optimizing the ELISA kit itself (which could be loosely termed "training" for a traditional assay), the "ground truth" would be established by various biochemical and analytical methods to ensure the assay accurately detected and quantified FSH in reference materials and spiked samples. This would precede the formal clinical comparison study.

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The AquaLite® FSH Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® FSH assay) is intended to be used in clinical laboratories for the quantitative determination of human FSH in sera and plasma. The AquaLite® FSH assay is for in vitro diagnostic use.

The AquaLite® FSH Bioluminescent Immunoassay Kit uses a polyclonal anti-FSH antibody that is pre-coated onto polystyrene tubes (solid phase). Samples (serum or plasma) and appropriate calibrators or controls, are pipetted (25 µL) into the pre-coated tubes. Anti-FSH Conjugate (150 uL) is then added to the tubes. The conjugate uses the photoprotein. AquaLite® (recombinant aequorin; Patent Nos. 5, 422, 266 and 5, 486, 455) which is covalently linked to an anti-FSH monoclonal antibody. FSH in the sample simultaneously combines with polyclonal antibody on the solid phase and conjugate antibody to form an immune complex or "sandwich" bound to the solid phase. Complex formation is complete after a 60-minute incubation period at room temperature (18°C to 25°C) on a standard orbital shaker. The tubes are then washed to remove unbound conjugate. The washed tubes are placed in a luminometer that is capable of reading a triggered, flash-type reaction in 12 x 75 mm tubes. An injected calcium trigger solution causes AquaLite® to oxide its self-contained luciferin molecule. This reaction produces a flash of light at 469 nm. which is measured by the luminometer. The intensity of the light is directly proportional to the concentration of the FSH in the sample. To calculate results, the light intensity (in relative light units, RLU) of the FSH calibrators is plotted against FSH concentration (in International Units per liter. IU/L) to vield a calibration curve. This curve is used to relate the light intensity generated from the samples and controls to FSH concentration in IU/L.

The information provided is for an in vitro diagnostic test (AquaLite® FSH Bioluminescent Immunoassay (BIA) Kit), not a medical device in the typical sense of AI-powered systems analyzed for clinical improvement. Therefore, many of the requested fields, particularly those related to AI, multi-reader multi-case studies, and ground truth established by expert consensus or pathology, are not applicable.

However, I can extract and present the acceptance criteria and the study results for the performance characteristics of this immunoassay as an analogy to the requested format.

Here’s an interpretation of the provided 510(k) summary into the requested structure:

Acceptance Criteria and Device Performance for SeaLite Sciences, Inc. AquaLite® FSH

1. Table of Acceptance Criteria and Reported Device Performance

*Note on Inter-assay precision: The table formatting for inter-assay precision is corrupted in the input document, but the provided %CV values indicate similar low variability to intra-assay (7.52%, 6.39%, and 4.049%).

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

• Sensitivity: 20 replicates of a zero-level calibrator.
• Specificity: Not explicitly stated as a "test set" in terms of patient samples. Tested using aliquots of WHO/NIBSC preparations of purified hormones.
• Precision (Intra-assay): N = 10 per solution for each of three FSH levels (total 30 samples).
• Precision (Inter-assay): N = 20 per solution (2 replicates x 10 assays) for three FSH levels (total 60 samples).
• Method Comparison: N = 92 patient samples.
• Linearity and Nonparallelism: 5 human serum samples.
• Spike and Recovery: 8 normal human serum samples.
• Recovery in Serum and Plasma: Blood samples from 2 normal subjects, processed into 6 different sample types each.
• Effect of Common Interferents: Pooled normal male human serum.

Data Provenance: The studies were conducted at SeaLite Sciences, Inc. The samples appear to be clinical samples (patient samples, human serum), but the specific country of origin is not explicitly stated, although WHO/NIBSC (London, England) reference materials were used for specificity. The data is retrospective in the sense that the experiments were conducted and then analyzed, but not in the context of analyzing pre-existing patient data for an algorithm.

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 immunoassay, and the "ground truth" for the test set (e.g., FSH concentration, absence of interferents, hormone specificity) is established by the known characteristics of the samples or the reference measurements, not by expert interpretation.

4. Adjudication method for the test set

Not applicable. As an immunoassay, the results are quantitative measurements, not subjective evaluations 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 immunoassay, not an AI-powered diagnostic system involving human readers.

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

Yes, in so far as an immunoassay can be considered "standalone." The device (AquaLite® FSH assay) provides quantitative results directly from the sample without human interpretation of complex images or signals requiring an 'algorithm' in the AI sense. Its performance characteristics (sensitivity, specificity, precision, etc.) are measured as direct outputs of the device.

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

The "ground truth" for this immunoassay is primarily based on:

• Known concentrations/compositions of reference materials: For sensitivity (zero calibrator), specificity (purified hormones), linearity (dilution of samples with known FSH), spike-and-recovery (known amount of spiked FSH).
• Reference standard methods/devices: For method comparison (comparison to a "commercially available kit").
• Biological realism: For assessing recovery in different matrices (serum/plasma) and the effect of interferents.

8. The sample size for the training set

Not applicable. This is a biochemical assay, not an machine learning algorithm that requires a discrete training set. The assay's parameters (e.g., antibody concentrations, incubation times) are developed through R&D, but not in the same way an AI model is "trained."

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

Not applicable (see point 8). The assay's performance is optimized through traditional experimental design and chemical/biological principles during its development phase.

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Immunoassay for the in vitro quantitative determination of human follicle stimulating hormone in human serum and plasma.

Sandwich principle. Total duration of assay: 18 minutes.
• 1st incubation (9 min.): 40 µL of sample, a biotinylated monoclonal FSH-specific antibody (80 µL) and a monoclonal FSH-specific antibody labeled with a ruthenium complex (50 µL)** react to form a sandwich complex.
•2nd incubation (9 min.): after addition of streptavidin-coated microparticles (30 µL), the complex becomes bound to the solid phase via interaction of biotin and streptavidin.
**Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)) 2+ 3
•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.

Here's an analysis of the provided text regarding the Elecsys® FSH Assay, focusing on acceptance criteria and study details.

This document describes a medical device, specifically an in vitro diagnostic (IVD) device. For IVDs, "acceptance criteria" often refer to performance characteristics that demonstrate the device is substantially equivalent to a predicate device and performs reliably. "Device performance" is typically reported through various analytical and sometimes clinical studies.

It's important to note that the provided text is a 510(k) summary, which is a submission to the FDA. It summarizes the information and doesn't always contain the full detail of the underlying studies.

Acceptance Criteria and Reported Device Performance

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