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The NanoEnTek FREND™PSA Plus is designed for in vitro DIAGNOSTIC USE ONLY for the quantitative measurement of total Prostate Specific Antigen (PSA) in human serum, Li-heparinized plasma, and K3-EDTA plasma using the FREND™ System. This device is indicated for the serial measurement of total PSA to be used as an aid in the management of patients with prostate cancer.

The FREND™ PSA Plus is a rapid fluorescence immunoassay that measures prostate specific antigen (PSA) in human serum and in lithium heparin and K3-EDTA plasma using the FREND™ system. The FREND™ PSA Plus is intended for use as an aid for prostate cancer management.

The FREND™ PSA Plus Test is a single use fluorescence immunoassay designed to quantify the concentration of total PSA in serum and lithium heparin and K3-EDTA plasma samples. The specimen is added by the operator to the sample inlet with a transfer pipet, allowing the appropriate volume of sample (35 µL) to be delivered into the FREND™ PSA Plus Test Cartridge. The Cartridge is then placed into the FREND™ System, which is programmed to begin analysis once the sample has reacted with the reagents. The reaction and analysis time is approximately 4 minutes. The PSA quantification is based on the amount of fluorescence detected by the FREND™ System at the FREND™ PSA Plus Test Cartridge window. A higher level of fluorescence is indicative of a higher PSA concentration. In other words, the magnitude of the fluorescent signal is directly proportional to the amount of total PSA in the sample.

The total PSA detection range of the FREND™ PSA Plus Test System is 0.08 to 25 ng/mL. Results are determined via a lot-specific calibration curve which is generated by the manufacturer using a six-point calibration determined from values averaged from five replicates at each level. The established curve is uploaded to the FREND™ via the PSA Plus Code-chip and is valid until the lot expiration date. The established curve is saved in the code-chip and valid until the expiration date of the test cartridge lot.

The FREND™ PSA Plus Test cartridge is a disposable plastic device that houses the reagents and contains a port or opening (inlet) where the sample is applied. Once the sample is applied, it will mix with the reagents and travel towards the detection area via capillary action.

The FREND™ System is a portable, automated FREND™ cartridge reader. The FREND™ System is based on quantitative immunoassay technology capable of quantifying single or multiple analytes by measuring laser-induced fluorescence in a single-use disposable reagent cartridge. The FREND™ cartridge utilizes micro-fluidics lateral flow technology where the analyte of interest in the sample forms immune complexes while moving through the fluidics pathway in the cartridge. The concentration of the analyte of interest in an unknown sample is calculated using the ratio of the fluorescent intensity of the test zone and the reference zone.

FREND™ System is a bench top fluorescence reader containing a touchscreen user interface. The System has a slot that accepts the sample loaded FREND™ PSA Plus Test Cartridge, and is programmed to analyze the Test when the sample has fully reacted with the on-board in cartridge reagents. Results of the test are displayed on the screen and can be printed on an optional printer.

The FREND™ System software controls the graphical user interface, communication with hardware, database management and data analysis. The software also controls the functions of the mechanical components including the motor, laser, printer control and acquisition of data from the sensor. The user can set the time and date and enter patient ID through the graphic user interface. The user cannot make any changes to the software.

The FREND™ PSA Plus includes the following in the kit:

• 25 FREND™ PSA Plus cartridges
• · 30 Disposable pipette tips
• 1 FREND™ PSA Plus Code Chip
• 1 FREND™ PSA Plus Package Insert

The FREND™ System (previously cleared in K124056, K131928, K152422, K153577, and K162754) is not provided with the kit but is required for the use of the FREND™ PSA Plus test cartridge.

Here's a breakdown of the requested information regarding the acceptance criteria and study for the NanoEnTek FREND™ PSA Plus device:

The provided text describes a 510(k) submission for a modified version of the FREND™ PSA Plus, comparing it to its predicate device (the previously cleared FREND™ PSA Plus assay, K124056). Therefore, the "acceptance criteria" are implicitly the performance of the predicate device, and the "study" aims to demonstrate that the modified device's performance is substantially equivalent to this predicate.

1. Table of Acceptance Criteria and Reported Device Performance

For the purpose of this analysis, the "acceptance criteria" are based on the performance of the predicate device (FREND™ PSA Plus, K124056), and the "reported device performance" refers to the modified FREND™ PSA Plus.

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

• Test Set Sample Size:

  • Precision/Reproducibility: 4 clinical samples, assayed in replicates of two, two times per day for twenty days (implies 4 samples * 2 replicates * 2 times/day * 20 days = 320 measurements per lot for within-lot precision, across 3 lots).
  • Multi-site Precision: 3 samples (C, D, E), N=25 for each sample at each of 3 sites (3 samples * 25 runs/sample/site * 3 sites = 225 runs for within-laboratory, and 75 for each sample for overall reproducibility).
  • Linearity: Samples tested in quadruplicate or quintuplicate per dilution level across a range of 0.05 ~ 25.53 ng/mL. (Exact number of unique samples or total measurements not specified, but multiple dilutions were used.)
  • High Dose Hook Effect: One concentrated sample of purified PSA antigen, neat and on dilution.
  • Interference: Two PSA levels (1ng/mL and 4ng/mL) tested with various interferents/cross-reactants. Data presented as average %Recovery.
  • Sample Volume Comparison: 64 serum samples.
  • Matrix Comparison: 40 sample pairs (serum, lithium heparin plasma, K3-EDTA plasma aliquots for each patient).
  • Method Comparison (vs. FDA Approved Assay): 207 samples.
  • Clinical Studies (Serial Monitoring): 194 determinations (each representing a point-to-point change in tPSA concentration compared to clinical status). Longitudinal samples from patients.

• Data Provenance:

  • The primary analytical performance studies (Precision/Reproducibility, Linearity, LoD, LoQ, High Dose Hook Effect, Analytical Specificity, Sample Volume Comparison, Matrix Comparison) were performed at the NanoEnTek, Inc. facility (manufacturer's site) in Korea.
  • The Multi-site precision study was performed at three different sites. (Locations not specified beyond 'different sites').
  • The Method Comparison with an FDA-approved assay (ARCHITECT total PSA) was done in a CLIA-certified laboratory testing facility (CentraState Medical Center).
  • The Clinical Studies (Serial Monitoring) involved patients with prostate cancer. The sample collection was described as "longitudinally from patients previously diagnosed with prostate cancer and treated in a variety of ways over the clinical course of their disease". The geographical origin of these patients/samples is not specified but given the manufacturer's location, samples from Korea or other Asian countries are possible, as well as potentially US samples if the CLIA lab was involved in recruitment. These were retrospective samples in the sense that they were "previously diagnosed" and "collected longitudinally."

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

• Analytical Studies: For most analytical studies (Precision, Linearity, LoD, Hook Effect, Interference, Method Comparisons), the "ground truth" is typically established by established reference methods, spiked samples with known concentrations, or comparison to a cleared predicate device or gold standard assay. It doesn't inherently involve human "experts" in the same way clinical image reviews would.
• Clinical Studies (Serial Monitoring): The "clinical status" (NED, Responding, Stable, Progression) used as ground truth for serial monitoring was determined for the patients based on "other laboratory tests, patient interviews, physical examinations, and imaging studies of a variety of types." This implies a clinical review by attending physicians or a clinical team. The number and qualifications of these specific clinicians/experts are not specified in the provided text.

4. Adjudication Method for the Test Set

• Not applicable in the context of this type of IVD device submission. Adjudication methods like "2+1" (two readers agree, third is tie-breaker) are typically used for subjective assessments, such as reviewing medical images where there can be inter-reader variability. For quantitative invitro diagnostic tests like PSA measurement, the result is a numerical value, and the comparison is statistical against a reference or clinical outcome.

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

• No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is primarily applicable to diagnostic imaging devices, especially those incorporating AI, where the performance of human readers with and without AI assistance is evaluated. The FREND™ PSA Plus is an in vitro diagnostic (IVD) immunoassay, not an imaging device, and does not involve AI assistance for human readers in its direct use.

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

• Yes, this is effectively a standalone device. The FREND™ PSA Plus assay, run on the FREND™ System, provides a quantitative result for total PSA. While an operator loads the sample, the system itself interprets the fluorescent signal and calculates the PSA concentration. There isn't a human "in-the-loop" who re-interprets or modifies the assay's output based on their own judgment in the way that an AI-assisted diagnostic imaging system might require. Its performance is evaluated entirely on its independent ability to measure PSA accurately and consistently.

7. The Type of Ground Truth Used

• Analytical Studies:
  • Traceability: WHO International Standard Prostate Specific Antigen (90:10) NIBSC code: 96/670.
  • Linearity, LoD, LoQ: Spiked samples with known concentrations or dilutions of highly concentrated samples.
  • Method Comparison: Comparison to the predicate device (FREND™ PSA Plus, K124056) and an FDA-approved commercial assay (Abbott ARCHITECT total PSA assay) as external reference methods.
• Clinical Studies (Serial Monitoring):
  • Clinical Status: A composite judgment based on patient outcomes data and expert clinical assessment, including "other laboratory tests, patient interviews, physical examinations, and imaging studies of a variety of types." This represents a form of clinical diagnosis/outcome.

8. The Sample Size for the Training Set

• Not applicable / Not explicitly specified as a "training set" in the context of machine learning. This device is a fluorescence immunoassay, not a machine learning or AI-based diagnostic tool that would typically have a distinct "training set" for an algorithm. All samples mentioned in the performance characteristics section (precision, linearity, method comparison, clinical evaluation) would be considered part of the overall analytical and clinical validation, not segregated into typical ML training/test sets. The lot-specific calibration curve used for quantification is generated by the manufacturer using a six-point calibration from five replicates at each level, but this is a traditional calibration process, not an AI training set.

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

• Not applicable. As explained above, there isn't a "training set" in the machine learning sense for this device. The closest equivalent is the process of generating the lot-specific calibration curve, which uses known concentrations of PSA standards (traced to WHO International Standard) that are measured multiple times to establish the relationship between fluorescence signal and PSA concentration.

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The FREND™ Testosterone test is a fluorescent nanoparticle immunoassay designed for in vitro quantitative measurement of total testosterone in human serum and plasma (K3-EDTA and lithium heparin). Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in males, hirsutisim (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

The FREND™ Testosterone microfluidic flow cartridge is designed for use in the FREND™ System fluorescent immunoassay reader. The FREND™ Testosterone Test System is intended for use in clinical laboratories. For in vitro diagnostic use only. The test is not intended for use in point-of-care settings.

The FREND™ Testosterone is a rapid fluorescence immunoassay that measures testosterone levels in human serum and plasma using the FREND™ system.

The FREND™ Testosterone test is a single-use rapid "competitive" immunoassay utilizing fluorescent nanoparticle in microfluidic flow to capture and quantify total testosterone levels in human serum and plasma (KgEDTA and lithium-heparin) specimens using the FREND™ system. The FREND™ Testosterone Test is a two-step competitive immunoassay with gold micro-particles labeled with mouse monoclonal antitestosterone antibody, testosterone-biotin labeled with fluorescence nanoparticles and fluorescence detection by the FREND™ System.

The FREND™ Testosterone test utilizes microfluidic technology and detects immunecomplexes bound to testosterone. In Step 1, a 70 µL patient sample is first incubated for 5 minutes at 98.6 °F (37 °C) in the Testosterone Gold Antibody pretreatment tube, where the sample interacts with a proprietary mix of a pretreatment solution. In Step 2, the Test Cartridge is placed on the warming platform of the heating block and 35 µL of the mixture from Step 1 is manually loaded into the inlet of the cartridge. The cartridge remains on the warming platform for 30 seconds, while the sample hydrates the testosterone-biotin fluorescent bead conjugate and migrates along the test strip. During migration the bound testosterone in the sample and the testosterone-biotin fluorescent bead conjugates compete to form antigen-antibody complexes in the test zone. Unbound testosterone-biotin fluorescent conjugates flow through and bind to the antitestosterone antibody that is immobilized on the surface in the reference zone. The cartridge is inserted into the FREND instrument for analysis where fluorescent signals in the test and reference zones are measured, typically within 4 minutes.

Testosterone quantification is based upon the ratio of the intensity of the test and reference zones. The magnitude of the fluorescent ratio is inversely proportional to the amount of testosterone in the sample.

The measuring range of the FREND™ Testosterone Test System is 20 to 1500 ng/dL. Results are determined via a lot-specific calibration curve which is generated by the manufacturer using a six-point calibration determined from values averaged from 5 replicates at each level. The established curve is uploaded to the FREND™ System via the Testosterone Code-chip and is valid until the lot expiration date.

The FREND™ Testosterone test cartridge is a disposable plastic device that houses the reagents and contains a port or opening (inlet) where the sample is applied. Once the sample is applied, it will mix with the reagents and travel towards the detection area via capillary action.

The FREND™ System is a portable, automated FREND™ cartridge reader. The FREND™ System is based on quantitative immunoassay technology capable of quantifying single or multiple analytes by measuring laser-induced fluorescence in a single-use disposable reagent cartridge. The FREND™ cartridge utilizes micro-fluidics lateral flow technology where the analyte of interest in the sample forms immune complexes while moving through the fluidics pathway in the cartridge. The concentration of the analyte of interest in an unknown sample is calculated using the ratio of the fluorescent intensity of the test zone and the reference zone.

The FREND™ System is a bench top fluorescence reader containing a touch screen user interface. The System has a slot that accepts the FREND™ Testosterone Test Cartridge (which contains the reagents and sample), and is programmed to analyze the Test when the sample has fully reacted with the on-board in-cartridge reagents. Results of the test are displayed on the screen and can be printed on an optional printer.

The FREND™ System software controls the graphical user interface, communication with hardware, database manaqement and data analysis. The software also controls the functions of the mechanical components including the motor, laser, printer control and acquisition of data from the sensor. The user can set the time and date and enter patient ID through the graphic user interface. The user cannot make any changes to the software.

The FREND™ Testosterone Test System includes the following in the kit:

• . 20 FREND™ Testosterone cartridges
• 20 Testosterone Gold Antibody Pretreatment Tubes .
• Disposable pipette tips .
• . 1 FREND™ Testosterone Code Chip
• 1 FREND™ Testosterone Package Insert ●

The FREND™ System (previously cleared in K124056 (FREND™ PSA Plus) K131928 (FREND™ TSH), and K152422 (FREND™ Free T4)) is not provided with the kit but is required for the use of the FREND™ Testosterone test cartridge.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for each performance characteristic as clear pass/fail thresholds. Instead, it provides the results of various analytical performance studies. However, the implicit acceptance criterion for most of these studies is typically that the device performs within expected and acceptable analytical limits for a diagnostic test of its type, and that its performance is comparable to the predicate device.

For the purpose of this table, I will infer the performance goals based on industry standards and the presented data.

2. Sample Sizes and Data Provenance (for test set/comparison studies)

• Precision/Reproducibility: Three serum pools were assayed, each in duplicate, twice per day for 20 days (80 total measurements per level).
• Linearity/Assay Reportable Range: Seven levels of serum testosterone were tested in quadruplicate using three reagent lots.
• Detection Limit (LoD): Not specified in terms of sample number, but established according to CLSI EP17-A2 protocol.
• Analytical Specificity (Interference): Not explicitly stated how many samples were used, but testing involved samples spiked with various interferents.
• Analytical Specificity (Cross-Reactivity): Not explicitly stated how many samples were used, but testing involved samples spiked with various cross-reactants.
• Method Comparison with Predicate Device: 157 de-identified leftover samples were used. An additional 2 samples were outside the range of both methods.
  • Data Provenance: The method comparison study was performed in a CLIA-certified laboratory testing facility. The document does not specify the country of origin for the samples directly, but the applicant company is located in Korea, and the US FDA is reviewing the device for the US market. The samples were "de-identified leftover samples," indicating they were retrospective.
• Matrix Comparison: 40 individuals' samples (serum, lithium heparin, and K3EDTA plasma) were used.
• Expected Values/Reference Range: 488 normal, apparently healthy adult male and female individuals.

3. Number of Experts and Qualifications for Ground Truth

This document describes a diagnostic in vitro medical device (an assay for testosterone levels) and does not involve image interpretation or clinical diagnosis by human experts for establishing ground truth as typically seen in AI/CADe devices.

Instead, the "ground truth" for the comparison studies is established by:

• Reference methods/predicate devices (e.g., Abbott ARCHITECT 2nd Generation Testosterone assay).
• Gravimetric preparation for standards/calibrators.
• Protocols and standards like CLSI guidelines for analytical performance.

Therefore, the concept of "number of experts" and "qualifications of those experts" in the context of clinical interpretation of a test set is not directly applicable here. The experts involved would be laboratory scientists and method developers ensuring adherence to CLSI guidelines and proper validation of the reference method.

4. Adjudication Method for the Test Set

Not applicable. For an in vitro diagnostic device measuring a quantitative analyte, adjudication methods like 2+1 or 3+1 consensus are not generally used. The ground truth for method comparison is the result obtained from the predicate device or a recognized reference method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging devices or AI tools that assist human readers in making diagnoses or interpretations. The FREND™ Testosterone Test System is a laboratory assay that provides a quantitative value, not an assistive AI tool for human interpretation.

6. Standalone Performance

Yes, a standalone performance was done for the device itself. All the analytical performance studies (Precision, Linearity, LoD, Analytical Specificity, Stability) and matrix comparison were conducted to assess the performance of the FREND™ Testosterone Test System independently. The method comparison study also shows the device's standalone performance compared to another established device. The device generates a quantitative result directly, rather than assisting a human in an interpretative task.

7. Type of Ground Truth Used

The ground truth used for various performance evaluations includes:

• Reference Method: For method comparison, the Abbott ARCHITECT 2nd Generation Testosterone assay (K120009) was used as the reference method.
• Gravimetric Preparation: For standards/calibrators, the ground truth is established through gravimetric preparation and confirmed by the reference method.
• Expected Values/Spiked Samples: For interference and cross-reactivity studies, known concentrations of analytes and interferents are spiked into samples, creating a known "ground truth" to measure recovery and specificity.
• CLSI Protocols: Adherence to CLSI (Clinical and Laboratory Standards Institute) protocols for various analytical studies (e.g., EP5-A3 for precision, EP6-A for linearity, EP17-A2 for LoD, EP07-A2 for interference/cross-reactivity, EP14-A3 for matrix comparison, C28-A3 for reference intervals) implies that the ground truth is established based on recognized industry standards and best practices for in vitro diagnostic device validation.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithm development because the FREND™ Testosterone Test System is a fluorescent nanoparticle immunoassay. While it uses the "FREND™ System" which includes software and data analysis, it's a fixed algorithm for quantifying a chemical analyte based on fluorescent ratio, not a learning algorithm that requires a traditional training set like a deep learning model.

The "calibration curve" is "generated by the manufacturer using a six-point calibration determined from values averaged from 5 replicates at each level." This is a form of calibration rather than algorithm training.

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

As there is no traditional "training set" in the AI/ML sense, the concept of establishing ground truth for it is not applicable. The device's operational parameters (like the calibration curve) are established by the manufacturer through rigorous calibration using control materials with known testosterone concentrations derived from a six-point calibration curve, averaged from 5 replicates at each level. The standards/calibrators themselves are prepared gravimetrically and confirmed by measurement on the predicate device.

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The FREND™ Free T4 Test System is a rapid indirect competitive immunoassay for the quantitation of free thyroxine (FT4) in human serum and lithium heparinized plasma specimens using the FREND™ Free T4 system. Measurements of free thyroxine (FT4) are used in the diagnosis of thyroid disorders. The FREND™ Free T4 Test System is intended for use in clinical laboratories. For in vitro diagnostic use only. The test is not intended for point-of-care facilities.

The FREND™ Free T4 is a rapid fluorescence immunoassay that measures Free T4 in human serum and in lithium heparinized plasma using the FREND™ Free T4 Test System. The FREND™ Free T4 is a single use fluorescence immunoassay designed to quantify the concentration of free thyroxine in serum and lithium heparinized plasma samples, The FREND™ Free T4 test is a two-step competitive immunoassay with gold nanoparticles labeled with T4-specific monoclonal anti-T4- antibody (mouse), T3-BSA labeled with fluorescent nanoparticles, and fluorescence detection by the FREND™ System. The FREND™ Free T4 Test utilizes microfluidic technology and detects immunecomplexes bound to Free T4. A 70ul Sample is first incubated during Step 1 for five minutes at 37 degrees C in the Free T4 Gold AB Tube with monoclonal anti-T4 antibody conjugated with gold nanoparticles. In Step 2, 35 ul of the mixture from Step 1 is manually loaded into the inlet of the cartridge, where it hydrates a T3-BSA fluorescent bead conjugate and migrates along the test strip. During migration the bound Free T4 in the sample and the fluorescent bead conjugates of T3-BSA compete to form antigenantibody complex in the test zone. Unbound T3-BSA fluorescent conjugates flow through and bind to the anti-T4 antibody that is fixed on the surface in the reference zone. Step 2 takes approximately four minutes after which the fluorescent signals in the test and reference zones are measured. Free T4 quantification is based upon the ratio of the intensity of the test and reference zones. A lower ratio of fluorescence is indicative of a higher Free T4 concentration, in other words, the maqnitude of the fluorescence ratio is inversely proportional to the amount of Free T4 in the sample. The free T4 detection range of the FREND™ Free T4 Test System is 0.4 to 6.0 ng/dL. Results are determined via a lot-specific calibration curve which is generated by the manufacturer using a six-point calibration determined from values averaged from five replicates at each level. The established curve is uploaded to the FREND™ System via the Free T4 Code-chip and is valid until the lot expiration date. The established curve is saved in the code-chip and valid until the expiration date of the test cartridge lot. The FREND™ Free T4 Test cartridge is a disposable plastic device that houses the reagents and contains a port or opening (inlet) where the sample is applied. Once the sample is applied, it will mix with the reagents and travel towards the detection area via capillary action. The FREND™ System is a portable, automated FREND™ cartridge reader. The FREND™ System is based on quantitative immunoassay technology capable of quantifying single or multiple analytes by measuring laser-induced fluorescence in a single-use disposable reagent cartridge. The FREND™ cartridge utilizes micro-fluidics lateral flow technology where the analyte of interest in the sample forms immune complexes while moving through the fluidics pathway in the cartridge. The concentration of the analyte of interest in an unknown sample is calculated using the ratio of the fluorescent intensity of the test zone and the reference zone. The FREND™ System is a bench top fluorescence reader containing a touch screen user interface. The System has a slot that accepts the FREND™ Free T4 Test Cartridge (which contains the reagents and sample), and is programmed to analyze the Test when the sample has fully reacted with the on-board in-cartridge reagents. Results of the test are displayed on the screen and can be printed on an optional printer. The FREND™ System software controls the graphical user interface, communication with hardware, database manaqement and data analysis. The software also controls the functions of the mechanical components including the motor, laser, printer control and acquisition of data from the sensor. The user can set the time and date and enter patient ID through the graphic user interface. The user cannot make any changes to the software.

Here's a summary of the acceptance criteria and study details for the FREND™ Free T4 Test System, based on the provided 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as pass/fail values in many sections, but rather implied by the statistical analyses meeting CLSI guidelines and demonstrating comparability to the predicate device. The performance data is presented against these implicit standards.

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

• Precision Study: 3 serum pools
• Linearity Study: 1 serum base pool diluted to 11 levels
• Interference Studies: Two levels of free T4 for various endogenous substances and pharmaceuticals.
• Cross-Reactivity Study: Two concentrations for various cross-reactants.
• Method Comparison: 358 samples
• Matrix Comparison: 48 paired serum and lithium heparin samples
• Expected Values/Reference Range: 196 normal, apparently healthy adult individuals

The specific country of origin for the test set data is not explicitly stated, but the precision, linearity, interference, and matrix comparison studies were performed at the NanoEnTek laboratory. The method comparison study was performed at a CLIA-certified laboratory testing facility. The clinical samples for the method comparison were evaluated at that CLIA laboratory. The reference range study used samples from 196 normal, apparently healthy adult individuals. The nature of "clinical samples" for the method comparison implies they would be patient samples, and "normal, apparently healthy adult individuals" for the reference range are also patient-like samples. The studies appear to be prospective in nature, as they involve testing the device with specific protocols (e.g., CLSI guidelines).

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

• None stated for the analytical performance studies. The ground truth for analytical studies (precision, linearity, LoD, LoQ, interference, cross-reactivity) is generally based on the inherent properties of the samples and the performance of established reference methods or spiked concentrations.
• For Method Comparison: The ground truth was established by a predicate device, the Abbott ARCHITECT Free T4 Assay. The number of human experts involved in interpreting results from either the predicate device or the FREND™ Free T4 Test System is not specified, as this is a quantitative immunoassay where results are read by a machine.

4. Adjudication Method for the Test Set

Not applicable for this type of quantitative immunoassay performance study. Ground truth is established by reference methods or defined concentrations, not human adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a quantitative immunoassay, not an imaging device requiring human interpretation, so MRMC studies are not relevant.

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

Yes, the studies described are standalone performance studies for the FREND™ Free T4 Test System. The device is intended for use in clinical laboratories, and the results are quantitatively measured by the FREND™ System directly. There is no human-in-the-loop performance evaluation described beyond standard laboratory procedures for operating the instrument and handling samples.

7. The Type of Ground Truth Used

• Analytical Performance:
  • Precision, Linearity, LoD, LoQ, Interference, Cross-reactivity: Ground truth was established by prepared samples with known concentrations, spiking experiments, and measurements against established laboratory protocols and standards (CLSI guidelines).
• Method Comparison: Ground truth was established by the predicate device, the Abbott ARCHITECT Free T4 Assay (K123379). This is a comparison against an existing, legally marketed device.
• Matrix Comparison: Ground truth (or comparative standard) derived from measuring the same analyte in different matrices (serum vs. plasma), with the expectation of comparable results.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/machine learning algorithm. For this immunoassay, the system's "training" involves the manufacturer-generated lot-specific calibration curve (six-point calibration determined from values averaged from five replicates at each level), which is then uploaded to the FREND™ System via a Code-chip.

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

As described above, the "ground truth" for the device's operational curve (its calibration) is established by:

• Internal standards prepared according to CLSI C45-A Measurement of Free Thyroid Hormones.
• Gravimetric methods based on L-Thyroxine (Sigma T1775, Cell culture grade).
• Confirmation of calibrator Free T4 levels by measurement on the ARCHITECT i free T4 assay (K123379).

This process ensures that the device's internal calibration accurately reflects known Free T4 concentrations.

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