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The Quantitative Determination of Prolactin Hormone Concentration in Human Serum by a Microplate Immunoenzymometric assay. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or the hypothalamus portion of the brain.

Monobind Inc., registration number 2020726, plans to introduce into commercial distribution an enzymelmmunoassay (IEMA) kit for the determination of prolactin (PRL) in human serum. The proprietary name is Prolactin (PRL) ELISA and the usual name is PRL IEMA. This device classification name is - prolactin test system - product code CFT (per 21 CRF section 862.1625). 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-PRL antibody, the enzyme-labeled anti-PRL antibody and a serum containing the native antigen (PRL), reaction results between the native antigen (PRL) 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 (PRL) 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 text describes the Monobind Inc. Prolactin (PRL) ELISA device and its substantial equivalence to a predicate device. It does not describe an AI medical device, but rather an immunoassay kit for measuring prolactin levels. Therefore, several of the requested categories for AI device studies are not applicable.

Here's the information extracted and organized as best as possible given the provided text:

Device Name: Prolactin (PRL) ELISA (Monobind Inc.)

Device Type: Enzyme immunoassay (IEMA) kit for the quantitative determination of prolactin (PRL) in human serum.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific threshold values. Instead, it describes performance characteristics and compares them to a predicate device to demonstrate substantial equivalence.

2. Sample Size and Data Provenance

• Sample Size for Test Set: 86 specimens
• Data Provenance: Not explicitly stated, but the specimens were sourced from "normal (including pregnancy) and disease states' populations." The country of origin is not mentioned. The study appears to be retrospective, using existing specimens for comparison against the predicate device.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This is an immunoassay kit, not an image-based AI device requiring expert interpretation for ground truth. The "ground truth" for the test set was the measured PRL concentration as determined by the predicate device (Ciba Corning ACS 180 chemiluminescence test).

4. Adjudication Method

Not applicable. There was no adjudication method described as it's an immunoassay comparison study, not an expert panel review.

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

Not applicable. This is not an AI device, and no MRMC study was performed.

6. Standalone Performance (Algorithm Only)

Not applicable. This is an immunoassay kit, not an AI algorithm. The performance described is the standalone performance of the kit itself in comparison to a predicate device.

7. Type of Ground Truth Used

The ground truth for the comparison study was the prolactin (PRL) concentration as determined by the predicate device, the Ciba Corning ACS 180 chemiluminescence (ICMA) test.

8. Sample Size for Training Set

The document does not mention a separate "training set." The 86 specimens were used for the clinical comparison study to demonstrate substantial equivalence against the predicate device. For an immunoassay, the "training" equivalent would be the development and calibration of the assay itself, which is not detailed in terms of sample size for that specific process.

9. How Ground Truth for Training Set Was Established

Not applicable. As this is not an AI device, there isn't a "training set" in the sense of data used to train a model. The assay itself is based on established immunoassay principles and utilizes "several different serum references of known antigen values" to generate a dose-response curve for quantification. These "known antigen values" would have been established through prior reference methods, but the specifics are not detailed here.

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

The AquaLite® Prolactin Bioluminescent Immunoassay Kit uses a mixture of mouse monoclonal and rabbit polyclonal with anti-prolactin activity that is pre-coated onto polystyrene tubes (solid phase). Samples (serum or plasma), or appropriate calibrators or controls, are pipetted (25 uL) into the pre-coated tubes. Anti-prolactin conjugate consisting of mouse monoclonal antibody covalently linked to AquaLite® (150µL) is then added to the tubes. The conjugate uses the photoprotein, AquaLite® (recombinant aequorin: U.S. Patent Nos. 5,422,266 and 5,486,455) which is covalently linked to an anti-prolactin polyclonal antibody. Prolactin 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° 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 twosecond 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 prolactin in the sample. To calculate results, the luminometer uses a cubic spline curve fit applied to a logit-log transformation of the light intensity (in relative light units, RLU) of the prolactin calibrators versus prolactin concentration (in ng/mL).

Note: Samples that generate signals greater than the signal from the highest calibrator are off-scale. These samples must be diluted and re-assayed. Remember to multiply the results from diluted samples by the dilution factor used.

Here's a breakdown of the acceptance criteria and study details for the SeaLite Sciences, Inc. AquaLite® Prolactin Bioluminescent Immunoassay (BIA) Kit:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sensitivity: 20 replicates of the zero-level calibrator. Data provenance is internal to SeaLite Sciences, Inc.
• Specificity: Not explicitly stated how many aliquots or how many times each substance was tested, but they were supplied by the World Health Organization's National Institute for Biological Standards and Control (London, England).
• Precision (Intra-assay): N = 20 per concentration level for tri-level commercial controls. Data provenance is internal to SeaLite Sciences, Inc.
• Precision (Inter-assay): N = 2 x 10 = 20 (duplicate assays across 10 sets of calibration values) for tri-level commercial controls. Data provenance is internal to SeaLite Sciences, Inc.
• Method Comparison: N = 100 patient samples. Data provenance is internal to SeaLite Sciences, Inc., as these were patient samples previously assayed by another method. This would be considered retrospective in the context of the AquaLite Prolactin study.
• Linearity and Nonparallelism: Three human serum samples, each diluted at 4 levels, assayed in duplicate. Data provenance is internal to SeaLite Sciences, Inc.
• Spike and Recovery: Five normal male human serum samples. Data provenance is internal to SeaLite Sciences, Inc.
• Recovery in Serum and Plasma: Blood samples from 4 normal subjects, prepared into various matrices. Data provenance is internal to SeaLite Sciences, Inc.

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

This device is an in vitro diagnostic (IVD) assay for measuring prolactin levels. The "ground truth" for such assays is typically established by:

• Reference materials: For specificity, WHO/NIBSC standards were used.
• Known concentrations: For sensitivity, linearity, spike and recovery, and precision, predefined calibrators, controls, or spiked samples with known prolactin concentrations were used.
• Comparison to a legally marketed predicate device: For method comparison, the results were compared to a "commercially available automated chemiluminescent immunoassay."

Therefore, the concept of "experts establishing ground truth for a test set" as one might find in image analysis (e.g., radiologists reviewing images) does not directly apply here. Instead, it relies on the chemical and biological properties of the assay and comparison to established and validated reference methods/materials.

4. Adjudication Method for the Test Set

Not applicable. As this is an IVD assay measuring an analyte, there isn't a subjective "adjudication" process in the way there would be for image interpretation by multiple human readers. The results are quantitative measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is not an AI-assisted diagnostic device or an imaging study that involves human readers interpreting cases. It is a standalone in vitro diagnostic assay.

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies presented are all standalone performance evaluations of the AquaLite® Prolactin assay itself. The device is designed to quantitatively determine prolactin levels without direct human interpretation of the results beyond reading the numerical output.

7. The Type of Ground Truth Used

• Known concentrations: For sensitivity, linearity, spike and recovery, and precision, the ground truth was based on samples with experimentally determined or certified prolactin concentrations (e.g., calibrators, commercial controls, spiked samples).
• Reference materials: For specificity, internationally recognized reference preparations from the World Health Organization's National Institute for Biological Standards and Control (WHO/NIBSC) were used.
• Predicate device comparison: For method comparison, a "commercially available automated chemiluminescent immunoassay" was used as a reference for patient sample measurements.

8. The Sample Size for the Training Set

Not applicable. This is a traditional immunoassay, not a machine learning or AI-based device that requires a "training set" in the computational sense. The "training" of the assay refers to its chemical and biological formulation and optimization during development, before the performance studies presented here.

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

Not applicable. See point 8.

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

Sandwich principle. Total duration of assay: 18 minutes (37 °C).
• 1st incubation (9 min.): 10µL of sample, a biotinylated monoclonal prolactin- specific antibody (75 µL), and a monoclonal prolactin-specific antibody labeled with a ruthenium complex (75 µL)** react to form a sandwich complex.
•2nd incubation (9 min.): after addition of streptavidin-coated microparticles (40 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.

The provided text describes the Elecsys® Prolactin Assay, an immunoassay for the quantitative determination of human prolactin. The document is a 510(k) premarket notification summary, aiming to establish substantial equivalence to a predicate device, the Enzymun® Prolactin Assay.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a set of predefined thresholds that the device must meet for approval. Instead, it presents various performance characteristics and compares them to the predicate device. The implied acceptance is that the new device's performance is comparable to or better than the predicate.

Given the comparative nature, I will present the performance metrics shown for the new device (Elecsys® Prolactin Assay) and the predicate device (Enzymun® Prolactin Assay) for comparison. The "acceptance criteria" here is implicitly that the Elecsys® Prolactin Assay performs acceptably in these categories, and its performance is at least equivalent to the predicate.

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

• Precision Test Set (N):

  • Elecsys® Prolactin Assay: 60 samples at each level (Low, Mid, High), totaling 180 measurements for precision.
  • Enzymun® Prolactin Assay (Predicate): 119 samples at Low and Mid levels, 120 at High level, totaling 358 measurements for precision.

• Method Comparison Test Set (N):

  • Elecsys® Prolactin Assay vs. Enzymun-Test® Prolactin: 99 samples (for both Least Squares and Passing/Bablok).

• Interfering Substances & Specificity: The sample sizes for these tests are not explicitly stated as 'N' values for each substance but rather as the tested levels at which no interference or cross-reactivity was observed. These are likely conducted using controlled spiked samples rather than a large clinical cohort.

• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of these in-vitro diagnostic studies, they are typically prospective laboratory-based studies using controlled samples and clinical specimens.

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

This type of in-vitro diagnostic device (immunoassay) does not typically rely on human expert review (e.g., radiologists, pathologists) to establish "ground truth" in the same way an imaging AI device would.

• Ground Truth Determination: For assays like this, the "ground truth" for method comparison and performance evaluation is generally the results from a well-established, validated reference method (like the predicate device in this case, or a recognized gold standard). Precision, linearity, and interference are evaluated based on analytical measurements against known values (e.g., spiked samples, reference materials).
• Experts: While laboratory experts (e.g., clinical chemists, medical technologists) are involved in performing and validating such tests, they are not "establishing ground truth" through their interpretation in the context of this summary. Their role is to execute the assays and interpret the analytical data according to established protocols.

4. Adjudication Method for the Test Set

Not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are common in scenarios where human interpretation (e.g., reading medical images) contributes to establishing a ground truth that might be subjective or require consensus. For an immunoassay, the results are quantitative measurements, and the "truth" is either the chemical standard or the result from a validated reference method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable.

• This device is an automated in-vitro diagnostic assay. It does not involve "human readers" interpreting output in the same way an imaging AI would.
• There is no "AI assistance" component in the context of human interpretation for this device. The device provides a quantitative measurement.

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

Yes, the performance characteristics presented (precision, linearity, detection limit, method comparison, interference, specificity) are inherently standalone performance of the Elecsys® Prolactin Assay system (reagents plus instrument). It operates as an automated system producing quantitative results without human interpretive input for the measurement itself. Human-in-the-loop aspects would involve a clinician interpreting the result in the context of a patient's overall health, but not in the measurement process itself.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device's evaluation primarily relies on:

• Analytical Standards/Reference Materials: For parameters like precision, linearity, and detection limit, the "ground truth" is based on the known concentrations of prolactin in control samples or reference materials.
• Reference Method (Predicate Device): For method comparison, the results from the predicate Enzymun-Test® Prolactin Assay serve as a reference ("ground truth") to demonstrate comparable performance.
• Spiked Samples: For interference and specificity studies, the "ground truth" involves known concentrations of interfering substances or related hormones added to samples, and results are checked against expected prolactin values.

8. The Sample Size for the Training Set

The document does not explicitly mention "training set" or "validation set" in the context of machine learning, because this is not an AI/ML device. The described assays are chemical/immunological systems.

However, if we interpret "training set" as the data used to initially develop, optimize reagents, and establish preliminary assay parameters, that information is not provided in this 510(k) summary. These summaries typically focus on the final validation studies.

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

Not applicable, as this is not an AI/ML device with a "training set" that requires ground truth establishment in the described manner. The "ground truth" for the development and optimization of such assays would involve rigorous analytical chemistry techniques, established reference methods, and internal validation steps guided by scientific principles and regulatory requirements for in-vitro diagnostics.

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