Search Results

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.

Ask a specific question about this device

The Linearity FD Unsaturated Iron Binding Capacity 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 unsaturated iron binding capacity.

Linearity FD Unsaturated Iron Binding Capacity is for In Vitro Diagnostic use only.

Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity product is an in-vitro diagnostic device consisting of five levels of freeze dried, linearity/QC material, containing additives in human serum. There are five levels labeled A,B,C,D and E which contain 1ml for each level.

The provided document is a 510(k) premarket notification decision letter from the FDA for the Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain a detailed study proving the device meets acceptance criteria in the way typically expected for a diagnostic or AI-driven medical device.

The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (K130157 Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set) based on similar intended use and technical characteristics. It mentions performance data related to stability and value assignment, but not clinical performance with respect to patient outcomes or comparison against a diagnostic gold standard in a traditional clinical study.

Here's an attempt to extract and organize the information based on your request, with significant caveats that much of the requested information (especially for AI/ML device performance) is not present in this type of regulatory submission for a quality control material:

Device Name: Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity

Device Type: Assayed Quality Control Material for Unsaturated Iron Binding Capacity (UIBC)

Intended Use: To simulate human patient samples for use in determining linearity, calibration verification, and the verification of reportable range for unsaturated iron binding capacity. For In Vitro Diagnostic use only.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this device (a quality control material), the "acceptance criteria" and "device performance" are primarily related to its stability and its ability to provide target values within a specified range, demonstrating linearity. This is not a diagnostic device with performance metrics like sensitivity, specificity, or AUC.

Information Not Applicable or Not Provided in this Document:

The following points are typically relevant for AI/ML-driven diagnostic devices or clinical studies, which are not the subject of this 510(k) for a quality control material. Therefore, the requested information is either not applicable or not provided in this submission.

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

• Not applicable for a QC material in this context. The "test sets" would refer to analytical samples used for stability and value assignment, not patient data for diagnostic evaluation. The document mentions "samples are taken at four different time points" for real-time stability and "each analyte was measured multiple times" for value assignment.
• Data Provenance: The studies were conducted internally by Aalto Scientific, Ltd. (Carlsbad, CA, USA).

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)

• Not applicable. "Ground truth" in the clinical diagnostic sense is not established for a quality control material. The "truth" here relates to the analytical value determined by the reference method (Hitachi P-Modular) and the stability performance compared to a baseline.

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

• Not applicable. No expert adjudication process is described for this type of analytical validation.

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 not an AI/ML device or a diagnostic device requiring human interpretation.

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

• Not applicable. This is a quality control material, not an algorithm.

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

• The "ground truth" for the performance of this quality control material is its analytical value as determined by a reference laboratory instrument (Hitachi P-Modular) and its demonstrated stability over time according to pre-defined internal acceptance criteria. It is an analytical "truth," not a clinical "ground truth."

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set." The measurements for stability and value assignment are based on multiple replicates as described in the methodology.

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

• Not applicable. (See point 8).

Ask a specific question about this device

The Linearity LQ Special Diabetes 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: fructosamine, insulin, and C-peptide.

Linearity LQ Special Diabetes is for In Vitro Diagnostic use only.

The Audit® MicroControls™ Linearity LQ Special Diabetes product is an in-vitro diagnostic device consisting of five levels of liquid, linearity/QC material, containing Fructosamine, Insulin, C-peptide and additives in human serum. There are five levels labeled A, B, C, D and E which contain 2ml 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 describes the 510(k) summary for the Audit® MicroControls™ Linearity LQ Special Diabetes device. This device is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration verification, and the verification of the reportable range for fructosamine, insulin, and C-peptide.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on the stability (shelf life and open vial stability) and value assignment (expected range) as performance criteria.

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

• Sample Size:
  • Shelf Life - Real Time Stability: Vials from two lots of finished product. Samples taken at 9 months, 18 months, and 19 months.
  • Value Assignment/Linearity: Implicitly, the "five levels labeled A, B, C, D and E" of the device itself are the samples for which values are assigned. Each analyte was "measured multiple times" at each level.
• Data Provenance: Not explicitly stated regarding country of origin, but the company is Aalto Scientific, Ltd. in Carlsbad, CA. The context is a 510(k) submission to the US FDA. The studies appear to be prospective as they involve accelerated and real-time stability studies with samples taken over time.

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

This information is not provided in the document. The "ground truth" for value assignment seems to be established internally by Aalto Scientific, Ltd. through multiple measurements on specific analytical instruments (Roche Modular P and Roche Cobas e411). There is no mention of external experts or their qualifications for establishing these values.

4. Adjudication Method for the Test Set:

This information is not provided. The value assignment appears to be based on "mean value of the analyte," indicating an averaging approach rather than an adjudication among multiple independent assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic quality control material, not a diagnostic imaging or AI-driven interpretative device that would typically involve human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.

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

Yes, in essence. The performance data presented (stability and value assignment) describes the intrinsic characteristics of the linearity material itself when measured on laboratory instruments. This is analogous to a "standalone" assessment of the material's properties without human interpretative intervention beyond operating the instruments and recording results. The device's "performance" is its ability to maintain its target values and linearity, which is assessed directly by analytical measurements.

7. The Type of Ground Truth Used:

The ground truth used for value assignment and stability assessment appears to be analytical measurements obtained from established, FDA-approved methods on specific laboratory instruments (Roche Modular P for Fructosamine, Roche Cobas e411 for Insulin and C-peptide). For stability, the "Day0 vials" serve as the baseline ground truth reference for comparison with real-time samples.

8. The Sample Size for the Training Set:

This information is not applicable as this device is a quality control material and not an AI/ML algorithm that requires a "training set." The materials used for "value assignment" and "stability studies" are the product itself across different levels and time points.

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

This information is not applicable for the same reason as above. There is no training set for this type of device. The ground truth for the device's characteristics (analyte concentrations at each level) is established by multiple analytical measurements on a specified instrument, and the mean value is used.

Ask a specific question about this device

The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains: Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin. These five levels demonstrate a linear relationship to each other for their respective analytes. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification of reportable range for Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin.

The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for these analytes. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set should not be used for calibration or standardization of the Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin assays. The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is "For In Vitro Diagnostic Use Only".

The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is an in-vitro diagnostic device consisting of five levels of Lyophilized linearity material containing Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin and additives in human serum. There are five vials labeled A, B, C, D, and E, and contain 5 mL for each level.

Materials of human origin used in the manufacture of this linearity set has been tested using FDA approved methods and 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® MicroCV™ Therapeutic Drug (TDM) Linearity Set, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criterion for the Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is the demonstration of linearity.

Note: The document explicitly states: "If the five-point linear regression value is greater than 0.90 and if the plots are linear then the products demonstrate linearity." This phrasing indicates these are the conditions for acceptance and that the device met these conditions.

Study Details

This device is an in-vitro diagnostic quality control material, not an AI or imaging device, so many of the requested categories (like MRMC studies, experts for ground truth, adjudication methods, or separate training/test sets for an algorithm) are not applicable in the typical sense. The study focused on demonstrating the linearity of the control material and its stability.

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

   • Sample Size: Each analyte was measured 5 times (5 separate vials) at each of the five levels (A through E).
   • Data Provenance: Not explicitly stated, but implies internal testing by Aalto Scientific, Ltd. The information available does not indicate country of origin for the data (beyond the company location being Carlsbad, CA) or whether it was retrospective or prospective in the context of human patient data. It is a prospective analytical study performed on the device itself.

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

   • Not applicable as this is a linearity control material. The "ground truth" (target concentration values) was established through repeated measurements on specified instruments (Abbott Axsym and Roche Hitachi 911) using specific reagents. This involves highly trained laboratory personnel but not "experts" in the sense of clinical interpretation for an AI device.

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

   • Not applicable. The data generation was quantitative measurement. The mean value of five measurements was used to establish the target concentration, which is a statistical method, not an adjudication process.

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 not an AI or imaging device with human readers.

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

   • Not applicable. This is a physical quality control material, not an algorithm.

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

   • The "ground truth" for each level's concentration was established by mean concentration values from 5 replicate measurements performed on specified laboratory instruments (Abbott Axsym and Roche Hitachi 911) using appropriate reagents. This is effectively an instrument-derived quantitative reference value.

7. The sample size for the training set:

   • Not applicable as there is no "training set" in the context of an algorithm.

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

   • Not applicable.

Ask a specific question about this device

The Audit® MicroCV™ Vitamin D Linearity Set is an assayed quality control material consisting of five levels of human and equine based serum. Each level contains Vitamin D. These five levels demonstrate a linear relationship to each other for Vitamin D. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Vitamin D.

The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for Vitamin D. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroCV™ Vitamin D Linearity Set should not be used for calibration or standardization of the Vitamin D assay. The Audit® MicroCV™ Vitamin D Linearity Set is "For In Vitro Diagnostic Use Only".

The Audit® MicroCV™ Vitamin D Linearity Set is an assayed quality control material consisting of five levels of human and equine based serum, with each level containing Vitamin D. It is used to confirm the proper calibration, linear operating range, and reportable range of Vitamin D. Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E.

{
  "1": {
    "title": "Acceptance Criteria and Reported Device Performance for Audit® MicroCV™ Vitamin D Linearity Set",
    "table": {
      "headers": [
        "Vitamin D (ng/mL)",
        "Level A",
        "Level B",
        "Level C",
        "Level D",
        "Level E"
      ],
      "rows": [
        [
          "Target value",
          "20.18",
          "46.57",
          "77.68",
          "107.32",
          "135.72"
        ],
        [
          "Target Range",
          "17.15-23.21",
          "39.58-53.55",
          "66.03-89.33",
          "91.22-123.42",
          "115.36-156.08"
        ]
      ]
    },
    "notes": "The provided document specifically details the 'Expected Values' for the Audit® MicroCV™ Vitamin D Linearity Set. These expected values and their target ranges serve as the reported device performance and implicitly, the acceptance criteria for the linearity of the Vitamin D measurements across the five levels (A-E) on the Advia Centaur instrument using Siemens Reagent. The product is intended to demonstrate a linear relationship between these levels."
  },
  "2": "The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions that stability studies and value assignments were performed and that 'All supporting data is retained on file at Aalto Scientific, Ltd.'",
  "3": "The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications.",
  "4": "The document does not specify an adjudication method for the test set.",
  "5": "A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a quality control material, not an AI-assisted diagnostic tool for human readers.",
  "6": "A standalone performance study was not explicitly described as 'algorithm only without human-in-the-loop performance'. The context is a quality control material for an instrument, not a standalone algorithm in the typical AI sense.",
  "7": "The type of 'ground truth' for the expected values appears to be established through 'Value assignment' performed by the manufacturer, implying internal testing and validation against established laboratory methods or reference materials. It's described as 'Expected Values' determined for the Audit® MicroCV™ Vitamin D Linearity Set, suggesting a form of expert consensus or manufacturer-defined reference values for the particular instrument/reagent combination.",
  "8": "The document does not specify the sample size for the training set.",
  "9": "The document does not detail how the ground truth for a training set (if applicable) was established. The focus is on establishing expected values and stability for the quality control material itself."
}

Ask a specific question about this device

The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains Beta- Hydroxybutyric Acid. These five levels demonstrate a linear relationship to each other for Beta-Hydroxybutyric Acid. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Beta- Hydroxybutyric Acid.

The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for Beta-Hydroxybutyric Acid. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroCV™ Beta- Hydroxybutyric Acid Linearity Set should not be used for calibration or standardization of the Beta- Hydroxybutyric Acid assay. The Audit® MicroCV™ Beta- Hydroxybutyric Acid Linearity Set is "For In Vitro Diagnostic Use Only".

The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum, with each level containing Beta-Hydroxybutyric Acid. It is used to confirm the proper calibration, linear operating range, and reportable range of Beta-Hydroxybutyric Acid. Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E.

The provided document is a 510(k) Summary for a medical device (Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set), which describes the device's intended use, performance data, and comparison to a predicate device. It is a regulatory submission, not a study report that details the methodology and results of a device's performance against specific acceptance criteria in the manner requested.

Therefore, many of the specific details for acceptance criteria and the study that proves the device meets them, especially those pertaining to clinical performance with human readers, ground truth establishment for AI models, and comparative effectiveness studies, cannot be extracted directly from this document. This document is focused on the analytical performance of a quality control material rather than the clinical performance of a diagnostic device.

However, I can extract the information relevant to the analytical performance as described in the document.

Here's an analysis based on the provided text:

Device: Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set

Device Type: Assayed quality control material for Beta-Hydroxybutyric Acid.

Purpose: To confirm proper calibration, linear operating range, and reportable range of Beta-Hydroxybutyric Acid assays.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides "Product claims" based on stability studies and expected values. These claims serve as the performance characteristics. Explicit "acceptance criteria" for linearity or other analytical parameters are not detailed in this summary, but the "Target Range" for expected values implicitly reflects acceptable performance for value assignment.

Note: The document states, "When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides." This indicates that the "Target Range" is a guide for expected values, and laboratories would define their specific acceptance criteria based on their analytical system.

Regarding the study that proves the device meets acceptance criteria:

The document refers to "Stability studies" and "Value assignment" studies. These are analytical studies, not clinical studies.

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

• Test Set Sample Size: Not explicitly stated. The document mentions "five levels of human based serum" for the linearity set. For stability studies, the number of samples or experimental replicates is not provided.
• Data Provenance: Not explicitly stated for the test data (e.g., country of origin). The material itself is "human based serum." The studies were performed by Aalto Scientific, Ltd. in Carlsbad, CA, US, suggesting the data originates there.
• Retrospective/Prospective: Not specified, but stability studies typically involve prospective real-time testing, while value assignment could be either.

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

• This is not applicable as the device is a quality control material for analytical assays, not a diagnostic device requiring expert interpretation of clinical data. The "ground truth" here is the assigned analytical value of Beta-Hydroxybutyric Acid.

4. Adjudication method for the test set

• Not applicable for this type of analytical device. Ground truth for value assignment is established through laboratory methods, not expert 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

• Not applicable. This device is a linearity set for an analytical instrument, 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 not an algorithm or AI.

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

• The ground truth for the expected values of Beta-Hydroxybutyric Acid in the linearity set samples is established through analytical testing/value assignment using quantitative assays on an indicated analyzer (e.g., "P-Modular Instrument, Roche Reagent" is mentioned for the values). This involves precise laboratory measurements.

8. The sample size for the training set

• Not applicable as this is not an algorithm/AI model that requires training data. The "training" for this product would be the manufacturing and quality control processes to ensure consistency.

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

• Not applicable as this is not an algorithm/AI model. The "ground truth" for the manufactured product's components and values would be established through standard analytical chemistry and manufacturing quality control procedures.

Summary of Limitations Based on Document Content:

The provided 510(k) summary focuses on the analytical performance and stability of a quality control material. It does not contain information about clinical studies, diagnostic accuracy, human reader performance, AI algorithms, or "ground truth" established by clinical experts, which are typical expectations for the detailed questions provided. The data presented is intended to demonstrate the material's suitability for its stated purpose in verifying the performance of Beta-Hydroxybutyric Acid assays.

Ask a specific question about this device

Audit® MicroLQ™ Spinal Fluid Control is a quality control material intended for monitoring the precision of laboratory testing procedures.

When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroLQ™ Spinal Fluid is for In Vitro Diagnostic use only.

The Audit® MicroLQ™ Spinal Fluid is a human based, liquid set of QC material. Each level of the set contains Chloride, Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Lactate, Lactate Dehydogenase (LD), Microalbumin, Microprotein, and Sodium analytes. It is used to confirm the proper calibration of Chloride, Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Lactate, Lactate Dehydogenase (LD), Microalbumin, Microprotein, and Sodium

The provided document is a 510(k) premarket notification for a medical device called "Audit® MicroLQ™ Spinal Fluid." This document describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the kind of detailed study information (acceptance criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for AI/algorithm-based devices) that your request outlines.

The "studies" mentioned in the document are limited to stability studies performed to determine the shelf life of the quality control material. This is a very different type of study from those typically conducted for AI/algorithm-based diagnostic devices.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and study design as laid out in your prompt because this information is not present in the provided text. The document is for a quality control material for laboratory testing, not an AI or algorithm-based diagnostic device.

Here's a breakdown of why the information is missing based on the provided text:

1. Acceptance Criteria and Reported Device Performance (Table): Not applicable in the context of stability studies for a QC material. The "device performance" here is its stability, detailed below.

   • Acceptance Criteria (Implicit - based on product claims):
     • Shelf Life: Two years, when stored unopened at 2 – 8º C.
     • Open Vial: 30 days, when stored at 2 – 8º C.
   • Reported Device Performance:
     • The document states "Stability studies have been performed to determine the shelf life for the Audit® MicroLQ™ Spinal Fluid Set. All supporting data is retained on file at Aalto Scientific. Ltd. Product claims are as follows:
       • Shelf Life: Two years, when stored unopened at 2 - 8º C.
       • Open Vial: 30 days, when stored at 2 - 8º C."
     • It also notes: "Real time studies are ongoing to support the shelf life of this product."

2. Sample Size used for the test set and data provenance: Not relevant for a stability study of a QC material. There is no "test set" in the context of evaluating an algorithm's performance on patient data.

   • The document states that "All supporting data is retained on file at Aalto Scientific. Ltd." but doesn't detail the sample size or specific methodology of the stability studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Stability studies do not involve expert interpretation for ground truth.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this type of study is for evaluating human performance with and without AI assistance, which is not relevant for a quality control material.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this device is a quality control material, not an algorithm.

7. The type of ground truth used: For stability studies, the "ground truth" would be the known concentration of analytes in the QC material over time, measured by analytical methods, not expert consensus, pathology, or outcomes data. The document does not specify how this ground truth was measured or established in detail.

8. The sample size for the training set: Not applicable. This device is not an AI/algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a quality control material used to monitor the precision of laboratory tests, not an AI-powered diagnostic device. Therefore, the specific types of studies, acceptance criteria, and ground truth methodologies requested are not relevant or present in this context.

Ask a specific question about this device

The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is assayed quality control material consisting of two sets of five levels of aqueous buffer. Each level of Set 1 contains the following analytes: Phosphorous, Urea Nitrogen, Uric Acid. Each level of Set 2 contains the following analytes: Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin, These five levels of each set demonstrate a linear relationship to each other for their respective analytes, reagents and instruments.

The product is intended for use with quantitative assays on the indicated analyzer specified in the labeling. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is "For In Vitro Diagnostic Use Only".

The Audit® MicroCV™ Urine/Fluids Chemistry Linearity is a aqueous buffer based, lyophilized, two five level sets of QC material, with each level of the first set containing Phosphorous, Urea Nitrogen, Uric Acid.and the second set containing Amylase, Calcium, Chloride, Creatinine, Glucose, Magnesium, Microalbumin, Microprotein, Potassium, Sodium. It is used to confirm the proper calibration, linear operating range, and reportable range of Phosphorous, Urea Nitrogen, Uric Acid, Amylase, Calcium, Chloride, Creatinine, Glucose, Magnesium, Microalbumin, Microprotein, Potassium, Sodium Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E.

The provided text describes a 510(k) premarket notification for a medical device called "Audit® MicroCV™ Urine/Fluids Chemistry Linearity". This device is a quality control material used to confirm the proper calibration, linear operating range, and reportable range of various analytes in urine and fluid chemistry.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission claims substantial equivalence to a predicate device (Audit® MicroCV™ General Chemistry Linearity Set (K042318)). The performance criteria are primarily focused on stability and linearity, demonstrating that the new device performs similarly to the predicate.

Note: The acceptance criteria for the new device are implicitly met by demonstrating substantial equivalence to the predicate device. The performance data provided are the reported characteristics of the new device itself, which are compared to those of the predicate. The key "proof" is that these characteristics are considered acceptable, given the similarity to the predicate, even if the new device has different analytes or matrix type (which is discussed in the context of substantial equivalence).

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

The document states: "Stability studies have been performed to determine the reconstituted stability and shelf life for the Audit® MicroCV™ Urine/Fluids Chemistry Linearity Set. All supporting data is retained on file at Aalto Scientific, Ltd."

• Sample Size: Not explicitly stated in the provided text.
• Data Provenance: The studies were conducted by Aalto Scientific, Ltd. (the manufacturer). The text does not specify the country of origin for the data or whether it was retrospective or prospective, though "real time studies are ongoing" for shelf life, indicating a prospective component for that aspect.

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

This type of information is generally not applicable to the validation of a chemistry linearity quality control material. The "ground truth" for linearity sets is established through analytical methods and statistical analysis, not expert interpretation of images or patient data. The manufacturer would establish the expected linear relationship of the analyte concentrations within the different levels of the control material through precise preparation and analytical testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of ambiguous data (e.g., medical images) to establish a consensus ground truth. For a chemistry linearity control, the "ground truth" is determined by the meticulously prepared concentrations and subsequent analytical 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 device is a quality control material for chemistry analyzers, not an AI-powered diagnostic tool requiring human interpretation. Therefore, MRMC studies and the concept of AI assistance for human readers are irrelevant in this context.

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

Not applicable. This is not an algorithm or an AI product. It is a physical chemical solution used to calibrate and verify the linearity of laboratory instruments.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device is the analytically determined concentrations and the designed linear relationship among the different levels of the control material. The manufacturer would have precisely formulated each level to have specific, known concentrations of the analytes, creating an expected linear progression. The performance study verifies that both the stability and the linearity of these known concentrations are maintained over time and storage conditions with analytical testing.

8. The Sample Size for the Training Set

Not applicable. As a quality control material, there is no "training set" in the context of machine learning or AI. The product is manufactured to a specific formulation and then tested to demonstrate its characteristics.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

Audit® MicroCV™ T-Uptake Calibration/Verification Set consists of five levels of human and bovine albumin based serum containing T-Uptake. The Audit® MicroCV™ T-Uptake Calibration/Verification Set is a quality control material intended for use in the quantitative verification of calibration and reportable range of the Roche T-uptake Assay when performed on the P-Modular Analyzer When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroCV™ T-Uptake Calibration/Verification is for In Vitro Diagnostic use only.

The Audit® MicroCV™ T-Uptake Calibration/Verification is a human and bovine albumin based, liquid set of QC material. Each level of the set contains T-Uptake analyte. It is used to confirm the proper calibration, linear operating range, and reportable range of T-Uptake. Level A is near the lower limit level and Level E has concentrations near the upper limit of P-Modular analyzer. Levels B, C, and D are prepared in a manner such that an equal distance exists between each consecutive level.

The provided document describes the Aalto Scientific, Ltd. Audit® MicroCV™ T-Uptake Calibration/Verification Set, a quality control material intended for use in the quantitative verification of calibration and reportable range of the Roche T-uptake Assay when performed on the P-Modular Analyzer.

However, the document focuses on demonstrating substantial equivalence to a predicate device rather than presenting acceptance criteria and a detailed study proving the device meets those criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly provide a table of acceptance criteria for the "Audit® MicroCV™ T-Uptake Calibration/Verification Set" itself in terms of performance metrics like accuracy, precision, or detection limits. Instead, it focuses on the equivalence of its characteristics to a predicate device and stability claims.

The closest we get to "performance" are the stability claims.

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

The document mentions "Stability studies have been performed" but does not specify the sample size used for these studies. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not applicable to this type of device and study. The device is a quality control material, and its performance is assessed through analytical stability, not through expert-reviewed ground truth on patient samples.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no mention of expert review or adjudication in the context of this device's testing.

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 where human readers evaluate cases with and without AI assistance. This device is a quality control material, not an interpretive diagnostic tool.

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

No, a standalone algorithm performance study was not done. The device itself is a physical quality control material, not an algorithm. Its performance is related to its stability and ability to verify calibration, not an algorithm's output.

7. The Type of Ground Truth Used:

For the stability studies, the "ground truth" would be the expected concentration values of T-Uptake in the quality control material at different time points, as determined by a reference method or validated assay. The document implies that measurement against these established values forms the basis of the stability assessment.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a quality control material, not a machine learning algorithm. Therefore, there is no "training set."

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

This information is not applicable as there is no training set.

Summary of the Study and "Acceptance" for K112143:

The document primarily focuses on demonstrating substantial equivalence to the predicate device, Audit® MicroCV™ Immunoassay Linearity Set (K062668), based on comparable technical characteristics and intended use.

The study that supports the device's claims is stability testing, which aimed to determine the shelf life and open-bottle stability of the Audit® MicroCV™ T-Uptake Calibration/Verification Set.

• Study Design: Implied to be real-time stability studies.
• "Acceptance Criteria" for Stability: The primary "acceptance criteria" presented are the defined stability periods:
  • Open Bottle: 10 days at 2 - 8° C.
  • Shelf Life: Two Years (unopened) at 2 - 8° C.
• "Study Results" (Reported Performance): The document states that "All supporting data is retained on file at Aalto Scientific, Ltd." and explicitly claims the "Product claims are as follows" with the listed stability periods. This indicates that the conducted stability studies demonstrated performance meeting these stated claims.
• Data Detail: The submission states that supporting data for stability is "retained on file." No specific raw data, statistical analysis, or detailed breakdown of the stability study's methodology (e.g., number of batches tested, frequency of testing, acceptance criteria for allowable drift) is provided in this summary.

In essence, the "study" is the internal stability testing, and the "acceptance criteria" are the target stability durations. The declared performance indicates these criteria were met, leading to the substantial equivalence determination by the FDA.

Ask a specific question about this device

Audit® MicroLQ™ Serum Protein Control is an assayed, ready-to-use liquid, bi-level, human serum -based control for use with assays designed to quantitate: Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III, Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin. It is intended to simulate human patient samples for the purpose of monitoring the precision of laboratory testing procedures for Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III, Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin assays. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The product is intended for use with quantitative assays on the Beckman Immage 800. The Audit® MicroLQ™ Serum Protein Control is for In Vitro Diagnostic use only.

The Audit® MicroLQ™ Serum Protein Control is a human based, liquid set of QC material. Each level of the set contains Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III, Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin analytes. It is used to confirm the proper calibration of Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III. Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin.

The provided document describes the Audit® MicroLQ™ Serum Protein Control, which is a quality control material, not a device that generates diagnostic results. Therefore, the typical acceptance criteria and study designs for diagnostic devices (like sensitivity, specificity, agreement with ground truth, comparative effectiveness with human readers, etc.) are not applicable in this context.

Instead, the performance data presented is focused on the stability of the control material.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a "test set" in the traditional sense. The data relates to the stability of the control material itself. The document states "All supporting data is retained on file at Aalto Scientific, Ltd."
• Data Provenance: The studies were performed by Aalto Scientific, Ltd., located in Carlsbad, CA, USA. This indicates the data is likely retrospective for initial claims and "real-time studies are ongoing" for further support.

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

This is not applicable as the device is a control material, not a diagnostic device requiring expert interpretation for ground truth establishment. The "truth" for a control material would be its manufacturing specifications and its demonstrated stability.

4. Adjudication Method for the Test Set

Not applicable for a control material stability study.

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 not an AI-powered diagnostic device.

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

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of this control material is its chemical stability and its ability to maintain its assayed values over time under specified storage conditions. This is established through analytical testing of the control material itself at various time points and conditions.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable.

Ask a specific question about this device