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The Audit® MicroControls™ Linearity FD Tumor Markers II is intended to simulate human patient samples for use as assayed quality control material, determining linearity, callbration verification of reportable range for the HE4 and HER2 analytes.

The Audit® MicroControlsTM Linearity FD Tumor Markers II is for In Vitro Diagnostic use only.

The Audit® MicroControls™ Linearity FD Tumor Markers II is an in-vitro diagnostic device consisting of sets of 5 levels of freeze-dried, linearity material and additives in human based serum. The product contains the following analytes: HE4 and HER2. Each set consists of 5 levels labeled Level A, B, C, D and E. Each level has a fill size of 1ml. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.

This document describes the Audit® MicroControls™ Linearity FD Tumor Markers II, an in-vitro diagnostic device. The provided text, however, focuses on the substantial equivalence review for a regulatory submission (510(k)) and details the device's characteristics, intended use, and performance data from stability studies. It does not present a study designed to prove the device meets specific acceptance criteria in terms of diagnostic accuracy or clinical effectiveness, as it is a quality control material.

The "acceptance criteria" discussed here relate to the stability and value assignment of the control material, not to diagnostic performance metrics like sensitivity or specificity for a medical imaging device. The "performance" refers to the stability of the control material and its ability to provide target values.

Therefore, many of the requested points are not applicable to this type of device and submission. I will address the relevant points based on the provided text.

Acceptance Criteria and Reported Device Performance

As this device is a quality control material, the acceptance criteria relate to its stability and the establishment of target values for its analytes (HE4 and HER2).

Additional Information based on request:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Test Set Sample Size: Not explicitly stated in terms of number of distinct samples for the stability studies or value assignment. The studies involved analyzing "vials representative of the entire lot" and "multiple times" for value assignment.
   • Data Provenance: The studies were conducted by Aalto Scientific, Ltd. in Eatonton, GA, USA. The data would be considered prospective for the stability studies. The origin of the human serum matrix is not specified beyond "human serum."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not Applicable. The "ground truth" for this device refers to the assigned target values and stability characteristics of the quality control material itself, determined through laboratory measurements, not human expert interpretation of clinical data.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not Applicable. This is not a study requiring adjudication of diagnostic interpretations. The value assignment was based on "mean value" from "multiple measurements" using specific laboratory analyzers and reagents.

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 a quality control material, not an AI diagnostic device that assists human readers.

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

   • Not Applicable. This is a quality control material. However, the performance assessment of the control material (stability, value assignment) is done in a "standalone" laboratory setting by measuring it on specified clinical chemistry analyzers.

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

   • The "ground truth" for this quality control material is the assigned target concentration values for HE4 and HER2 established through repeated measurements on specific reference instruments (Siemens Centaur XP for HER2 and Roche Cobas e411 for HE4) using their corresponding reagents. This is a form of analytical reference measurement.

7. The sample size for the training set

   • Not Applicable. This device is a quality control material and does not use a "training set" in the context of an AI/machine learning algorithm. The "value assignment" uses multiple measurements on specific instruments to determine the target values for each level.

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

   • Not Applicable. As there is no training set, this question is not relevant. However, the target values for the control material were established by measuring each analyte multiple times on the specified analyzers, and the mean value was used as the target concentration. "All supporting data is retained on file at Aalto Scientific, Ltd." (Page 6).

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The Linearity FD Tumor Markers II is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration, and the verification of reportable range for the following analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), Prostate-specific antigen-total (PSA), Carbonic Anhydrase-125 (CA-125), Carbonic Anhydrase 19-9 (CA19-9), Carbonic Anhydrase 27-29 (CA27-29)(BR), free-PSA (fPSA), and Carbonic Anhydrase 15-3 (CA15-3).

The Linearity FD Tumor Markers II is for In Vitro Diagnostic use only.

The Audit® MicroControls™ Linearity FD Tumor Markers II product is an in-vitro diagnostic device consisting of two sets of five levels of liquid, linearity/QC material. Set 1 contains the analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), Prostate-specific antigentotal (PSA), Carbonic Anhydrase-125 (CA-125), Carbonic Anhydrase 19-9 (CA19-9), and Carbonic Anhydrase 27-29 (CA27-29) (BR) and additives in human serum. Set 2 contains the analytes: free-PSA (fPSA), and Carbonic Anhydrase 15-3 (CA15-3) and additives in human serum and bovine serum. For each set there are five levels labeled A, B, C, D and E. Both sets contain 1ml for each level. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.

This document is a 510(k) summary for the Audit® MicroControls™ Linearity FD Tumor Markers II, a quality control material. It describes the device's intended use and compares it to a predicate device (K082717 Audit® MicroCV™ Tumor Markers Linearity Set). The primary focus of the performance data section is on stability studies and value assignment, not diagnostic accuracy or comparative effectiveness with human readers.

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

1. A table of acceptance criteria and the reported device performance

The document outlines acceptance criteria for stability (shelf life and reconstituted vial stability) and expected value ranges for various analytes.

Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: The document does not specify a "test set" in the context of diagnostic accuracy. The performance data focuses on stability and value assignment of the quality control material itself.
  • For accelerated stability, it mentions "All supporting data is retained on file at Aalto Scientific, Ltd." but doesn't quantify the number of samples or lots.
  • For real-time stability, it states "Vials from two lots of finished product are stored at 2-8℃ (real time vials) and -80℃ (Dayl vials). Samples are taken at two different time points."
  • For value assignment, it mentions each analyte was "measured multiple times" on specific instruments (Siemens Advia Centaur and Abbott Architect i1000SR).
• Data Provenance: The studies were conducted by Aalto Scientific, Ltd., located in Carlsbad, CA, USA. The data would therefore be considered prospective as it relates to the manufacturing and testing of their product. The matrix for the product uses "Human Based Serum and bovine based serum," but this refers to the components of the QC material itself, not patient samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to this document. The device is a quality control material, not a diagnostic device that requires expert interpretation of results for ground truth. The "ground truth" for the QC material is its assigned target values based on measurements by calibrated instruments and established reference methods (implied through the use of specific analyzers and reagents).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. There is no "test set" in the context of diagnostic performance requiring adjudication.

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

This section is not applicable. The device is a quality control material, not an AI-assisted diagnostic tool.

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

This section is not applicable. The device is a quality control material, not an algorithm. What might be considered "standalone performance" for this device is its ability to maintain its assigned values over time (stability) and the accuracy of its initial value assignments, which are demonstrated through the described studies.

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

For this quality control material, the "ground truth" is established through:

• Reference Instrument Measurement: Analytes were measured multiple times on specific, high-precision clinical chemistry analyzers (Siemens Advia Centaur and Abbott Architect i1000SR) using corresponding reagents. These instruments themselves are calibrated against established reference standards.
• Mean Value Calculation: The mean value of multiple measurements for each analyte at each level was used to establish the "target concentration value."

8. The sample size for the training set

This section is not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the conventional sense. The development of the QC material involves formulation and initial testing, but not machine learning training.

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

This section is not applicable for the same reasons as point 8.

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