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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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