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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 Audit® MicroControls™ Linearity DROP LQ Blood Glucose is intended to simulate human patient samples for use as assayed quality control material, determining linearity, calibration, and the verification of reportable range for the glucose analyte.

The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is for In Vitro Diagnostic use only.

The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is an in-vitro diagnostic device consisting of sets of 5 levels of liquid, linearity material and additives in human based serum. The product contains the following analyte: glucose. 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.

Here's a breakdown of the acceptance criteria and study information for the Audit® MicroControls™ Linearity DROP LQ Blood Glucose device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides acceptance criteria for stability claims rather than performance metrics like sensitivity or specificity.

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

• The document mentions that multiple measurements were taken for the analyte at each level during value assignment and stability studies. However, specific sample sizes for a "test set" (e.g., number of unique samples or runs for a formal validation study) are not explicitly provided.
• Data Provenance: The studies were conducted internally by Aalto Scientific, Ltd. The data is retrospective for the completed accelerated stability study and real-time open vial stability, and prospective for the ongoing real-time shelf-life study. The country of origin of the data is not explicitly stated but can be inferred as the USA, where Aalto Scientific, Ltd. is located.

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

• This information is not applicable in the context of this device. The device is a quality control material used to verify the linearity, calibration, and reportable range of blood glucose measurement systems. The "ground truth" for this type of device is established through analytical value assignment based on measurements performed on a reference instrument, not through human expert interpretation of results.
• The document states: "Analyte value assignment for Level A through Level E was performed on Roche Cobas for the blood glucose analyte using the corresponding reagent. The analyte was measured multiple times. The mean value of the analyte was used to establish a target concentration value at each level."

4. Adjudication Method for the Test Set

• Not applicable. As the device is a quality control material and "ground truth" is established through analytical measurement, there is no human-based adjudication process for a test set in the conventional sense. The "adjudication" is inherent in the analytical measurement and statistical determination of mean values.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices (e.g., imaging AI) where human readers are making diagnoses. The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is a quality control material for analytical instruments, not an interpretative device.

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

• Not applicable. This device is a control material, not an algorithm. Therefore, "standalone performance" in the context of an algorithm's accuracy without human intervention is not relevant. Its performance is measured by its stability and its ability to produce expected values when analyzed by a blood glucose measurement system.

7. The Type of Ground Truth Used

• The ground truth (or target values) for the device's glucose levels was established through analytical measurement on a reference instrument (Roche Cobas c501) with multiple measurements and calculation of the mean value. This is essentially an instrument-based reference value rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Not explicitly stated and not directly applicable as this is a physical control material, not an AI/ML algorithm. The concept of a "training set" is typically used for machine learning models. For this device, the equivalent would be the data used for the "value assignment" to establish its target concentrations. The document mentions "The analyte was measured multiple times" for value assignment, but a specific number is not given.

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

• As explained in Point 7, the "ground truth" (target values) for the device's five levels (A-E) was established through repeated analytical measurements of the glucose analyte on a Roche Cobas c501 instrument. The mean of these multiple measurements was used to define the target concentration value for each level. Raw materials are subject to internal quality control.

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The Linearity LQ Cystatin-C 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 Cystatin-C analyte.

The Linearity LQ Cystatin-C is for In Vitro Diagnostic use only.

The Audit® MicroControls™ Linearity LQ Cystatin-C product is an in-vitro diagnostic device consisting of one set of five levels of liquid, linearity/QC material. For the set there are five levels labeled A, B, C, D and E. The set contains 1ml for each level. The set contains the Cystatin-C analyte and additives in human and bovine based serum. 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.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document is a 510(k) Premarket Notification for a Linearity LQ Cystatin-C quality control material (device). The goal of the submission is to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes a quality control material used for linearity, calibration verification, and reportable range for a specific analyte (Cystatin-C). It's not a diagnostic device with a "test set" in the traditional sense of patient data.

• Test Set Description: The "test set" here refers to the actual device (Linearity LQ Cystatin-C) which comes in five levels (A, B, C, D, E) of a liquid material. Each level contains 1ml.
• Sample Size:
  • For stability studies: Vials from two lots of finished product were used for real-time stability (stored at 2-8℃ and -80℃). Measurements were taken at two different time points. The analyte values from these vials were tested in duplicate.
  • For value assignment: The Cystatin-C analyte was measured multiple times.
• Data Provenance: The document does not specify the country of origin of the data. The studies were conducted by Aalto Scientific, Ltd., located in Carlsbad, CA. These are prospective studies performed to characterize the device's stability and assigned values.

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

This type of device (quality control material) does not typically involve human "experts" establishing a ground truth for a test set in the way a diagnostic algorithm for medical images would. Instead, the ground truth (target concentration values) is established through technical laboratory measurements.

• Number of Experts: Not applicable.
• Qualifications: Not applicable. The "ground truth" (target values) is established through analytical testing methods on a specific instrument.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is not a diagnostic device where patient cases are reviewed and adjudicated. The "ground truth" (target analyte concentrations) for the quality control material is inherent to its formulation and confirmed through laboratory measurements.

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 a quality control material, not an AI-powered diagnostic device, and therefore no MRMC study was conducted or relevant.

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

Not applicable. This is a laboratory quality control material, not an algorithm or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used for this device, the Audit® MicroControls™ Linearity LQ Cystatin-C, is analytical reference measurement. Specifically:

• Analyte Value Assignment: "The mean value of the Cystatin-C analyte was used to establish target concentration value at each level." This refers to the measured concentration on a reference instrument (Beckman Immage) using a specific reagent.
• Stability: Measured values at different time points and storage conditions are compared against initial or expected values established through analytical testing.

8. The Sample Size for the Training Set

Not applicable. This is a quality control material, not a machine learning algorithm, and therefore does not have a "training set."

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

Not applicable. As there is no training set for this type of device, the concept of establishing ground truth for it does not apply.

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