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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™ PSA Plus as performed on the FREND™ system, is a quantitative in vitro diagnostic test which measures total Prostate Specific Antigen (PSA) in human serum and plasma. The NanoEnTek FREND™ PSA Plus is designed for in vitro DIAGNOSTIC USE ONL Y for the quantitative measurement of total Prostate Specific Antigen (PSA) in human serum, heparinized plasma, and EDTA plasma using the FREND™ System. This device is indicated for the serial measurement of total PSA in serum, heparinized plasma and EDTA plasma to be used as an aid in the management of patients with prostate cancer.

The FREND™ PSA Plus is indicated for use in clinical laboratories upon prescription by the attending physician as an aid to clinicians in managing patients with prostate cancer.

The information provided from this test may supplement decision-making and should only be used in conjunction with routine monitoring by a physician and the use of other diagnostic procedures. Because of the variability in the effects of various medications used in the treatment of prostate cancer, clinicians should use professional judgment in the interpretation of PSA results as an indicator of disease status.

The FREND™ PSA Plus is a rapid fluorescence immunoassay that measures prostate specific antigen (PSA) in human serum and in lithium heparin and 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 EDTA plasma samples. The specimen is added by the operator to the sample inlet with a transfer pipet, allowing the appropriate volume of sample (30 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 6 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 FREND™ System is a bench top fluorescence reader containing a touchscreen user interface. The System has a slot that accepts the FREND™ PSA Plus 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 through the RS232C interface.

Here's a summary of the acceptance criteria and study findings for the FREND™ PSA Plus on the FREND™ system, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

| Performance Metric | Acceptance Criteria (Stated or Implied) | Total (Total CV%) | |
| Site-to-Site Value) | 3.50% | 1.57% | 1.67% | 3.47% | 1.61% | 2.06% | |
| Inter-cartridge | 18.45% | 6.81% | 7.94% | 20.03% | 6.17% | 7.49% | |
| Total (Total CV%) | 20.87% | 7.74% | 10.79% | 21.22% | 7.69% | 9.81% | |

Note: The document explicitly states "acceptance criteria" for some tests (e.g., dilution linearity, spiked recovery, interference) but for others (e.g., imprecision, method comparison), it describes the results and concludes they are "acceptable" or "compared well," implying that the performance met internal thresholds comparable to predicate devices.

2. Sample Sizes and Data Provenance

• Clinical Samples: 1219 evaluable clinical serum samples.
  • Provenance: Prospectively collected stored samples were utilized for the clinical study. No specific country of origin is explicitly stated, but NanoEnTek is a Korean company with a CRO (DOCRO, Inc.) in the US, and testing was done at both NanoEnTek facilities and CLIA licensed facilities in the US.
• Precision (Analytical):
  • Intra-assay/inter-assay/complex imprecision: Three clinical samples (0.186, 2.757, 16.625 ng/mL) assayed in duplicates twice a day for 20 days using a single lot cartridge (total 80 measurements per sample).
  • Multi-Site, Multi-Lot Imprecision: Four replicates each of Material A, B, C and two replicates of QC 1, 2, 3 were evaluated in two runs performed for five days at each of three geographically diverse sites. This yielded a total of 40 results on each material per site, and 120 total replicates for each material across all sites.
• Dilution Linearity & Recovery: A serum pool with elevated PSA (34 ng/mL) was diluted to seven levels, plus neat and zero samples. Each level was tested in 6 replicates.
• Spiked Recovery: A serum pool from females (tPSA < 0.01 ng/mL) was spiked with 3 known PSA levels. Samples were assayed before and after spiking (number of replicates not explicitly stated, but table shows 3 replicates per spike level).
• Analytical Sensitivity (LOD/LOQ): 5 blank samples and 5 low PSA concentration samples were tested in 12 replicates each.
• High Dose Hook Effect: A concentrated sample of purified PSA antigen tested neat and on dilution (number of replicates not specified).
• Interfering Substances and Assay Specificity: Not explicitly stated, but samples were tested according to CLSI protocol EP7-A.
• Method Comparison:
  • Prostate cancer samples: Single point samples (n = 85) and earliest sample from serially monitored subjects (n = 75), for a total of 160 samples (tPSA < 25 ng/mL).
  • Serially Monitored Subjects: 75 subjects undergoing serial monitoring for prostate cancer. A total of 236 point-to-point determinations for each assay.
• Sample Matrix Comparison Study: 36 matched sets (serum, lithium heparin, EDTA plasma, sodium citrate) were collected, aliquoted, frozen, and run.
• Reagent Stability Studies: Three different lots of cartridges were tested over 15 months at three-month intervals using five standard specimens.

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

The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with X years of experience) for establishing the ground truth for the test set in the clinical performance section.

• For the serial monitoring study, "Disease status for the patients was determined by the physician. This Disease Status was used to determine Progression or No Progression from a clinical perspective." This implies a medical professional established the clinical ground truth. The nature of this determination included "other laboratory tests, patient interviews, physical examinations, and imaging studies of a variety of types."

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for the clinical test set. The clinical status for serially monitored patients was determined by "the physician" and was used as the ground truth.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an in vitro diagnostic assay, not an imaging device or AI-assisted diagnostic tool that would typically involve human readers interpreting cases with and without AI assistance. The clinical study compares the device's performance to a predicate device and clinical status, but not the improvement of human reader performance.

6. Standalone (Algorithm Only) Performance

Yes, numerous standalone performance studies were done. The FREND™ PSA Plus is an automated immunoassay system, and its analytical and clinical performance is its standalone performance. The entire "Performance Data Summary - Analytical Testing" and "Performance Data Summary - Clinical Testing" sections detail the standalone performance of the assay and system without human intervention in the measurement process (though human input is required to operate the system and interpret results in a clinical context).

7. Type of Ground Truth Used

• Analytical Studies:
  • Precision, Dilution Linearity, Spiked Recovery, Sensitivity, Hook Effect, Interference: Ground truth was based on known concentrations of PSA, characterized reference materials, or clinically established levels of interfering substances. For example, for dilution linearity, the "Expected Value" was the ground truth based on known dilutions. For spiked recovery, the "Concentration Added" was the ground truth.
• Clinical Studies:
  • Disease Cohorts (Normal, Benign, Malignant): Ground truth was based on patient diagnoses (e.g., "Benign prostate disease," "Prostate Cancer") established through clinical assessment (including other diagnostic tests and potentially pathology results, though not explicitly detailed for this specific aspect).
  • Serial Monitoring: Ground truth for "Progression" or "No Progression" was based on "the clinical status of the patients as measured by other laboratory tests, patient interviews, physical examinations, and imaging studies of a variety of types." This is essentially patient outcomes data/clinical diagnosis as determined by a physician.

8. Sample Size for the Training Set

The document does not explicitly describe a separate "training set" for an algorithm in the way that would typically be detailed for an AI/ML device. This device is an immunoassay, and its performance characteristics (like linearity, precision, etc.) are established through traditional analytical and clinical validation studies, rather than machine learning model training on a distinct dataset. The "development" and "optimization" of the assay would typically involve internal samples and experiments, but these are not referred to as a "training set" in the context of this 510(k) submission.

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

Since a "training set" for an AI/ML algorithm is not described, the method for establishing its ground truth is not applicable/provided. The analytical and clinical performance data presented here are for the validation and verification of the device's performance against established metrology principles and clinical outcomes.

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The TPSA method for the Dimension® clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure total prostate specific antigen (PSA) in human serum and plasma:

• as an aid in the detection of prostate cancer when used in conjunction with digital rectal 1. exam (DRE) in men 50 years or older. Prostate biopsy is required for diagnosis of cancer
• as an aid in management (monitoring) of prostate cancer patients. 2.

The TPSA Flex® reagent cartridge with the labeling revision referenced in this submission is substantially equivalent in intended use, principle and performance to the current Dade Behring Total Prostate Specific Antigen assay (P000021/S2). Both assays are in vitro immunoassays with intended uses for the measurement of Prostate Specific Antigen in serum and plasma. There are no formulation or design changes associated with this labeling change. The two products are identical and use the same manufacturing processes.

This 510(k) submission (K031343) is for a labeling change to the TPSA Flex® Reagent Cartridge, not a new device or a design change. Therefore, it primarily focuses on demonstrating that the revised labeling does not alter the substantial equivalence of the device to its predicate. As a result, the document does not contain the typical detailed performance study information that would be present for a novel device or a device with significant design modifications.

Here's a breakdown based on the provided text, highlighting what is not applicable or not provided for this specific type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in this submission. The submission states: "There are no formulation or design changes associated with this labeling change. The two products are identical and use the same manufacturing processes." The core of the acceptance criteria here is "substantial equivalence" based on the absence of change impacting performance, rather than new performance data against specific metrics.

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

Not provided. Since there are no new performance studies involving a test set, this information is not relevant to this submission. The device itself (TPSA Flex® Reagent Cartridge) was previously approved (P000021/S2); performance data for that original approval would have been submitted at that time.

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

Not applicable. No new test set requiring expert ground truth was evaluated in this submission.

4. Adjudication method for the test set

Not applicable. No new test set requiring adjudication was evaluated in this submission.

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 in vitro diagnostic reagent cartridge for measuring PSA, not an AI-assisted diagnostic tool.

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

Not applicable. This device is an in vitro diagnostic reagent cartridge, not an algorithm.

7. The type of ground truth used

Not applicable. No new performance studies requiring a ground truth were conducted for this submission.

8. The sample size for the training set

Not applicable. This submission is for a labeling change to an existing device, not for the development or training of an algorithm.

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

Not applicable.

Summary of the Study and Acceptance Criteria for K031343:

Acceptance Criteria for K031343 (Labeling Change):

The primary acceptance criterion for this 510(k) submission was to demonstrate substantial equivalence to the predicate device (Dade Behring TPSA Flex® reagent cartridge, P000021/S2) despite a revision to the labeling. This means proving that the change in labeling would not alter the fundamental safety or effectiveness of the device.

Reported Device Performance (as per this submission):

The substance of this submission is that there is no change in device performance because there is no underlying change to the device itself.

• Intended Use: Identical to the predicate.
• Principle: Identical to the predicate.
• Performance: Identical to the predicate, as "there are no formulation or design changes associated with this labeling change. The two products are identical and use the same manufacturing processes."

Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is the comparison document itself, which asserts and provides justification for the substantial equivalence.

• Evidence Presented: The submitter highlighted that the proposed change was solely a labeling revision related to the availability of a specific calibrator (removing reference to TPSA Calibrator, RC459, which would no longer be available for sale, and now having approval for the Free PSA product).
• Key Argument: The core of the argument is that the two previously referenced calibrators (RC 459 and RC 452) had the "same formulation but different packaging and labeling." The decision to keep them separate was based on a prior FDA request related to the Free PSA Flex® product, which has now received approval. Therefore, consolidating the calibrator instruction in the Total PSA Flex® insert by removing RC459 is deemed a change without impact on performance.
• Conclusion: The submitter concludes, and the FDA concurs, that "The revised PSA Flex® reagent cartridge is substantially equivalent in principle and performance to the current PSA Flex® reagent cartridge."

In essence, for this specific 510(k) for a labeling change, the "study" is the explicit declaration and justification provided by the manufacturer that the device itself remains unchanged and thus its performance remains identical to the already-approved predicate device. Performance data from the original approval (P000021/S2) would implicitly support the underlying performance characteristics of the unchanged device.

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The Bayer ADVIA® IMS PSA assay is an in vitro diagnostic device intended to quantitatively measure prostate specific antigen (PSA) in human serum. This assay is indicated for the measurement of serum PSA as an aid in management (monitoring) of prostate cancer patients. PSA values obtained using the Bayer ADVIA IMS assay method must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined.

Not Found

The provided text describes the acceptance criteria and the study for the Bayer ADVIA® IMS PSA assay.

Here's the information extracted and organized as requested:

Acceptance Criteria and Device Performance for Bayer ADVIA® IMS PSA Assay

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in a table format, but rather reports performance characteristics. Based on the data presented and common analytical testing standards, the implicit acceptance criteria are inferred to be comparable or superior to the predicate device (Immuno 1 PSA Assay).

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

• Correlation Studies (Test Set):

  • N=54 serum samples (0.37-79.70 ng/mL)
  • N=44 serum samples (0.07-62.93 ng/mL)

• Imprecision Study: Six calibrator levels and commercial controls were tested. The exact number of individual samples (replicates for each level) is not specified but implied to be sufficient for robust CV calculation.

• Interfering Substances Study: Serum pool with PSA concentration of 4.0 ng/mL was spiked. Specific number of samples beyond "serum pool" is not detailed.

• Recovery Study: Four samples were used, each with several dilutions (5 dilution points per sample).

• Data Provenance: Not explicitly stated (e.g., country of origin, specific clinical sites). The study type is retrospective as it involves analyzing existing serum samples and comparing the new assay results to those obtained from a predicate device.

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 involve human expert interpretation for establishing ground truth in the same way as imaging or pathology studies. The "ground truth" for the test set is established by the measurements from the predicate device (Immuno 1 PSA Assay), which is itself a legally marketed and presumably validated diagnostic tool. Therefore:

• Number of experts: Not applicable in the context of interpretation.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

Not applicable. The ground truth for comparative studies of quantitative assays is typically the result from the established predicate method, not a consensus of human interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic assay, not an imaging or AI-assisted diagnostic tool that involves human readers interpreting cases.

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

Yes, the studies presented (Imprecision, Correlation, Interfering Substances, Recovery, Analytical Range, Minimum Detectable Concentration) are all standalone performance evaluations of the ADVIA IMS PSA assay system. There is no human intervention in the measurement process once the sample is loaded and the assay runs. The results are quantitative values generated directly by the device.

7. The type of ground truth used

The primary ground truth used for performance validation is:

• Predicate Device Measurements: For correlation studies, the results obtained from the Immuno 1 PSA Assay on the same samples serve as the comparison (reference) "ground truth" for the new ADVIA IMS assay.
• Known Concentrations/Spikes: For imprecision, recovery, and interfering substance studies, known concentrations of PSA or spiked substances are used as the "ground truth" against which the device's measurements are evaluated.

8. The sample size for the training set

This document does not describe a "training set" in the context of machine learning or AI models. For an immunoassay, the concept of a training set is not directly applicable. The assay is developed and optimized during its R&D phase, and the studies presented here are for validation.

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

Not applicable, as there is no mention of a training set for an AI model in this document. The "ground truth" for developing an immunoassay would be established through a combination of chemical principles, antibody specificity, detection methods, and extensive optimization using known calibrators and reference materials.

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The Bayer ADVIA® IMS cPSA assay is an in vitro diagnostic device intended to quantitatively measure complexed prostate specific antigen (cPSA) in human serum. This assay is indicated for the measurement of serum complexed PSA as an aid in management (monitoring) of prostate cancer patients. Complexed PSA values obtained using the Bayer ADVIA IMS assay method must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined.

Prostate Specific Antigen (PSA) is a secretory product of the epithelial cells of human prostatic tissue, whether normal, benign, or malignant. The tissue specificity of PSA makes it a sensitive and specific tumor marker as an aid in management (monitoring) prostate cancer patients and disease progression following surgery or other therapies. PSA in serum exists in several forms including free, uncomplexed PSA and PSA complexed to several protease inhibitors including a-2-macroglobulin, a-1antichymotrypsin (ACT), and a-1-antitrypsin. It should be noted that there are no existing commercial methods that can recognize PSA bound to α-2-macroglobulin. However, it has been demonstrated that the proportion of PSA complexed with ACT increases as a function of the total PSA concentration, and that the majority of immunoreactive PSA in cancer patients is in complex with ACT. The Bayer cPSA Assay uses a monoclonal antibody for capture which recognizes both free and complexed PSA, but which, when bound to free PSA, precludes the binding of other antibodies specific for the free form of PSA. The inclusion of a second, unlabelled monoclonal antibody which is specific for free PSA prevents the binding of free PSA in the cPSA assay and allows measurement of only PSA which is complexed with ACT. cPSA can be used as a single test alternative to free and total PSA in management of patients with CaP.

Here's a summary of the acceptance criteria and study details for the Bayer ADVIA® IMS cPSA assay, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Imprecision: Not explicitly stated as a test set, but the evaluation involved six calibrator levels and commercial controls, with 10 runs performed. Total replicates = 40. Data provenance not specified, likely internal laboratory data.
   • Correlation: Forty-five (45) serum samples and ninety-eight (98) serum samples were used in two separate correlation studies. The values ranged from 0.03 to 69.69 ng/mL and 0.14 to 86.28 ng/mL, respectively. Data provenance not specified, likely internal laboratory data (e.g., from a clinical laboratory or research setting).
   • Serial Monitoring: Two longitudinal patient samples were used. Data provenance not specified but are described as "serial patient monitoring studies."
   • Interfering Substances: A serum pool with a cPSA concentration of about 3.7 ng/mL was used, spiked with various interfering substances.
   • Recovery: Not stated as a specific test set size, but multiple dilutions were evaluated for several "samples" (at least 4 distinct samples with 5 dilutions each).

2. 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 measuring a biomarker. The "ground truth" for its performance is typically established through analytical studies comparing its measurements to a reference method (in this case, the predicate Immuno 1 cPSA Assay) and assessing its precision, linearity, and interference.
   • There is no mention of "experts" in the sense of clinical reviewers or adjudicators for establishing ground truth as one would find in imaging or clinical diagnostic studies. The ground truth refers to the analyte concentration as measured by a established comparator or derived from known standards.

3. Adjudication method for the test set:

   • Not applicable. This is an analytical performance study for an IVD assay, not a study requiring clinical adjudication of patient outcomes or interpretations. The comparison is against the predicate device's measured values.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is an IVD assay, not an AI-powered diagnostic imaging or interpretation tool that involves human readers.

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

   • Yes, the performance data presented (imprecision, correlation, interfering substances, recovery, analytical range, minimum detectable concentration) are all derived from the standalone performance of the ADVIA IMS cPSA assay. The device itself is an automated laboratory analyzer.

6. The type of ground truth used:

   • The primary ground truth for the correlation study was the measurements obtained from the predicate device, Immuno 1 cPSA Assay. This establishes substantial equivalence.
   • For imprecision, the ground truth relates to the consistency of measurements of known calibrators and controls.
   • For interfering substances and recovery, the ground truth relates to expected concentrations after spiking or dilution, and the observed values are compared to these.

7. The sample size for the training set:

   • Not applicable in the context of this 510(k) submission. This is an IVD assay, not a machine learning or AI algorithm that requires a "training set" in the traditional sense. The assay is based on established immunodiagnostic principles. Any internal development or optimization of the assay would have been done prior to this submission, but it's not described in terms of a "training set" like an AI model.

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

   • Not applicable, as there is no "training set" for an AI or machine learning model described here. This device relies on chemical and immunological reactions, with calibration performed using known standards.

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