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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.

• Real-Time Stability: Ongoing studies, but "product is determined to meet its predicted shelf life if the % difference of the real-time mean values compared to the Day0 mean value is within the acceptance criteria." (indicating current data supports predicted shelf life)
  Claimed Shelf Life: 24 months, when stored unopened at 2-8°C. |
  | Reconstituted Vial Stability | Not explicitly stated as a numerical criterion, but implied "within acceptance criteria." | - Accelerated + Real-Time Stability: Met acceptance criteria.
  Claimed Reconstituted Vial Stability: 30 days when stored tightly capped at 2-8°C. |
  | Value Assignment / Linearity | Target ranges for each of the five levels (calculated as +/-15% of the target mean values). | Individual analyte values for Level A through Level E were measured multiple times on a Hitachi P-Modular analyzer. The mean value of UIBC was used to establish target values.
  Reported Target Values and Ranges (µg/dL):
• Level A: Target 75.7 (Range 64.4-87.1)
• Level B: Target 185.5 (Range 157.7-213.4)
• Level C: Target 297.3 (Range 252.7-341.9)
• Level D: Target 403.7 (Range 343.2-464.3)
• Level E: Target 525.1 (Range 446.3-603.8) |
  | AMR (Analytical Measuring Range) | Not explicitly stated as an "acceptance criterion" but reported as a characteristic. | Unsaturated Iron Binding Capacity: 10-500 µg/dL. This range encompasses the target values of the linearity levels. |

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).

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The ACE Direct Total Iron-Binding Capacity (TIBC) Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Alera Clinical Chemistry System. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE Total Iron Reagent is intended for the quantitative determination of iron in serum using the ACE Alera Clinical Chemistry System. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE LDH-L Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the ACE Alera Clinical Chemistry System. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction and tumors of the lung or kidneys. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

In the ACE Direct Total Iron-Binding Capacity (TIBC) Reagent assay, Direct TIBC Color Reagent, an acidic buffer containing an iron-binding dye and ferric chloride, is added to the serum sample. The low pH of Direct TIBC Color Reagent releases iron from transferrin. The iron then forms a colored complex with the dye. The colored complex at the end of the first step represents both the serum iron and excess iron already present in Direct TIBC Color Reagent. Direct TIBC Buffer, a neutral buffer, is then added, shifting the pH and resulting in a large increase in the affinity of transferrin for iron. The serum transferrin rapidly binds the iron by abstracting it from the dye-iron complex. The observed decrease in absorbance of the colored dye-iron complex is directly proportional to the total iron-binding capacity of the serum sample. The absorbance is measured at 647 nm.

In the ACE Total Iron Reagent assay, transferrin-bound iron in serum is released at an acidic pH and reduced from ferric to ferrous ions. These ions react with ferrozine to form a violet colored complex, which is measured bichromatically at 554 nm/692 nm. The intensity of color produced is directly proportional to the serum iron concentration.

In the ACE LDH-L Reagent assay, lactate dehydrogenase catalyzes the conversion of L-lactate to pyruvate. Nicotinamide adenine dinucleotide (NAD+) acts as an acceptor for the hydrogen ions released from the L-lactate and is converted to reduced nicotinamide adenine dinucleotide (NADH). NADH absorbs strongly at 340 nm whereas NAD+ does not. Therefore, the rate of conversion of NAD+ to NADH can be determined by monitoring the increase in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from NAD+ to NADH is directly proportional to the lactate dehydrogenase activity in the sample.

The provided document describes in vitro diagnostic (IVD) reagents (ACE Direct Total Iron-Binding Capacity (TIBC) Reagent, ACE Total Iron Reagent, and ACE LDH-L Reagent) for use on the ACE Alera Clinical Chemistry System. The acceptance criteria and performance data presented relate to the analytical performance of these reagents/systems, specifically their ability to accurately and precisely measure analytes in serum samples.

Crucially, this is not a study about an AI/ML powered medical device. Therefore, many of the typical acceptance criteria and study aspects requested in your prompt regarding AI/ML (e.g., ground truth established by experts, multi-reader multi-case studies, human-in-the-loop performance, training/test set sample sizes for AI, adjudication methods) are not applicable to this type of device and submission.

The "study" described here is a series of analytical performance tests (linearity, precision, method comparison, detection limits, interference) to demonstrate that the new device (ACE Alera system with these reagents) performs comparably to the predicate device (ACE Clinical Chemistry System with the same reagents) and meets established analytical performance specifications for clinical chemistry assays.

Here's a breakdown of the relevant information from the document in the format you requested, with an explanation of why certain AI/ML-centric points are not applicable:

Device: ACE Direct Total Iron-Binding Capacity (TIBC) Reagent, ACE Total Iron Reagent, ACE LDH-L Reagent (for use on ACE Alera Clinical Chemistry System)

1. Table of acceptance criteria and reported device performance:

Since the document does not explicitly present "acceptance criteria" alongside "reported performance" in a single table, I will infer the acceptance criteria from the context of method comparison, linearity, and precision studies, which are standard for IVD device validation, often aiming for performance comparable to predicate devices or within clinically acceptable limits. The reported performance is directly extracted from the tables provided.

Interference:
The acceptance criterion for interference studies in IVD assays is typically that the interferent, up to a specified concentration, does not cause a "significant interference" (e.g., a bias exceeding a defined clinical or analytical threshold). The document lists the concentrations at which no significant interference was observed.

Precision (POL - Point of Care/Physician Office Lab):
Similar to in-house precision, specific %CV or SD limits would be the acceptance criteria. The data shows results from 3 POLs compared to in-house.

Method Comparison (POLs vs. In-House (ACE Alera (x) vs. POL ACE Alera (y))):
Similar to the in-house method comparison, the acceptance criteria are for slopes to be near 1, intercepts near 0, and high correlation coefficients (e.g., >0.99), indicating consistent performance across different lab environments.

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

• Sample Sizes for analytical performance studies (Test Set):

  • Method Comparison:
    • TIBC: 50 samples
    • Iron: 48 samples
    • LDH-L: 58 (in-house comparison) / 51 (POL comparison) samples
  • Linearity: The number of samples/levels for linearity is not explicitly stated as 'n', but standard practice involves multiple levels (typically 5-7) prepared from diluted/spiked samples.
  • Precision: Standard runs (e.g., 2 runs per day for 20 days for total precision, with replicates per run for within-run precision) would involve a substantial number of measurements (e.g., 20 days x 2 runs/day x 2 replicates/run = 80 measurements per level). The POL precision data shows n=20, likely referring to 20 days of testing.
  • Interference: The number of samples used for interference studies is not explicitly stated.

• Data Provenance: "In-House" and "POL" (Physician Office Laboratories). The specific country of origin is not explicitly stated, but given the company's location (New Jersey, USA) and FDA 510(k) submission, it's highly likely to be United States. The studies are prospective analytical validation studies, meaning the data was collected specifically to demonstrate the performance of the device.

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

Not applicable. This is an in vitro diagnostic (IVD) chemistry analyzer and reagent system. "Ground truth" for IVD analytical performance is established by reference methods, certified reference materials, or highly accurate comparative methods, not by human expert consensus or radiologists. The performance is assessed against quantitative values, not qualitative interpretations requiring expert review.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., imaging studies where radiologists disagree). For analytical performance of a chemistry analyzer, the "ground truth" is typically the quantitative value obtained from a reference method or the predicate device, and differences are assessed statistically (e.g., bias, correlation).

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. MRMC studies are specific to evaluating the impact of a device on human readers' performance, typically in diagnostic imaging with AI assistance. This device is an automated chemistry analyzer, not an AI-assisted diagnostic imaging tool. There are no human "readers" in the context of this device's operation.

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

Yes, in essence. The performance data provided (linearity, precision, detection limits, interference, method comparison) represents the "standalone" analytical performance of the automated chemistry system (ACE Alera with the new reagents) in measuring the target analytes in patient samples. There isn't an "algorithm only" in the AI sense, but the chemical reactions and photometric measurements are entirely automated by the device. The data shown is the raw analytical output.

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

The "ground truth" for these analytical studies is primarily:

• Highly characterized samples: For linearity, samples with known, precise concentrations (often prepared by dilution of high-concentration materials or spiking low-concentration materials).
• Comparative method/Predicate device: For method comparison, the results generated by the predicate device (ACE Clinical Chemistry System) are treated as the reference or comparative method against which the new ACE Alera system's results are compared. This is a common and accepted "ground truth" for chemical analyzers seeking substantial equivalence.
• Reference materials/controls: For precision and detection limits, control materials with established target values are used.

8. The sample size for the training set:

Not applicable. This is a traditional IVD device (chemical reagents and analyzer), not an AI/ML device that requires a "training set" in the context of machine learning model development. The reagents perform chemical reactions, and the analyzer reads photometric changes; it does not "learn" from data.

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

Not applicable, as there is no training set in the AI/ML sense for this device.

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The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative determination of constituents in blood and other fluids.

The ACE TIBC Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Axcel Clinical Chemistry System. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Serum Iron Reagent is intended for the quantitative determination of iron concentration in serum using the ACE Axcel Clinical Chemistry System. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Lipase Reagent is intended for the quantitative determination of lipase activity in serum using the ACE Axcel Clinical Chemistry System. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.

In the ACE Direct Total Iron-Binding Capacity (TIBC) Reagent assay, Direct TIBC Color Reagent, an acidic buffer containing an iron-binding dye and ferric chloride, is added to the serum sample. The low pH of Direct TIBC Color Reagent releases iron from transferrin. The iron then forms a colored complex with the dye. The colored complex at the end of the first step represents both the serum iron and excess iron already present in Direct TIBC Color Reagent. Direct TIBC Buffer, a neutral buffer, is then added, shifting the pH and resulting in a large increase in the affinity of transferrin for iron. The serum transferrin rapidly binds the iron by abstracting it from the dye-iron complex. The observed decrease in absorbance of the colored dye-iron complex is directly proportional to the total iron-binding capacity of the serum sample. The absorbance is measured at 647 nm.

In the ACE Serum Iron Reagent assay, transferrin-bound iron in serum is released at an acidic pH and reduced from ferric to ferrous ions. These ions react with ferrozine to form a violet colored complex, which is measured bichromatically at 554 nm/692 nm. The intensity of color produced is directly proportional to the serum iron concentration.

In the ACE Lipase Reagent Assay, serum lipase acts on a natural substrate, 1,2-diglyceride, to liberate 2-monoglyceride. This is hydrolyzed by monoglyceride lipase (a highly specific enzyme for monoglyceride) into glycerol and free fatty acid. Glycerol kinase acts on glycerol to form glycerol-3-phosphate, which is in turn acted on by glycerol-3-phosphate oxidase to generate hydrogen peroxide. Peroxidase converts the hydrogen peroxide, 4-Aminoantipyrine and TOOS (N-ethyl-N-(2-hydroxy-3-sulfopropyl)-m-toluidine) into a quinine dye. The rate of formation of the dye, determined bichromatically at an absorbance of 573 nm/692 nm, is proportional to the lipase activity in the sample.

Here's a breakdown of the acceptance criteria and study information for the ACE Direct Total Iron-Binding Capacity (TIBC) Reagent, ACE Serum Iron Reagent, and ACE Lipase Reagent, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Within-run CV: 0.9% to 2.2%
• Total CV: 2.0% to 3.3%
  POL Sites:
• Within-run CV: 0.9% to 3.4%
• Total CV: 0.9% to 4.1% |
  | Accuracy (Correlation to Predicate) | High correlation coefficient, low standard error, slope near 1, intercept near 0 when compared to predicate device. | Lab (109 samples):
• Correlation Coefficient: 0.9950
• Standard Error Estimate: 9.1
• Confidence Interval Slope: 0.961 to 0.998
• Confidence Interval Intercept: -9.2 to 4.3
  POL Sites:
• Correlation Coefficients: 0.9902 to 0.9987
• Standard Error Estimates: 6.1 to 11.2
• Confidence Interval Slopes: 0.923 to 1.006
• Confidence Interval Intercepts: -8.2 to 19.4 |
  | Detection Limit | Low enough to be clinically useful. | 42.21 µg/dL |
  | ACE Serum Iron Reagent |
  | Precision | Low within-run and total CV for various Serum Iron levels. | Lab Testing:
• Within-run CV: 1.2% to 5.2%
• Total CV: 1.3% to 5.4%
  POL Sites:
• Within-run CV: 1.2% to 4.1%
• Total CV: 1.2% to 4.2% |
  | Accuracy (Correlation to Predicate) | High correlation coefficient, low standard error, slope near 1, intercept near 0 when compared to predicate device. | Lab (130 samples):
• Correlation Coefficient: 0.9995
• Standard Error Estimate: 3.3
• Confidence Interval Slope: 1.000 to 1.012
• Confidence Interval Intercept: -2.7 to -1.0
  POL Sites:
• Correlation Coefficients: 0.9992 to 0.9998
• Standard Error Estimates: 6.1 to 11.2
• Confidence Interval Slopes: 0.997 to 1.041
• Confidence Interval Intercepts: -2.7 to 9.2 |
  | Detection Limit | Low enough to be clinically useful. | 5.08 µg/dL |
  | ACE Lipase Reagent |
  | Precision | Low within-run and total CV for various lipase levels. | Lab Testing:
• Within-run CV: 1.1% to 6.5%
• Total CV: 6.0% to 10.7%
  POL Sites:
• Within-run CV: "to 7.3%" (lower bound not specified)
• Total CV: 1.9% to 7.3% |
  | Accuracy (Correlation to Predicate) | High correlation coefficient, low standard error, slope near 1, intercept near 0 when compared to predicate device. | Lab (107 samples):
• Correlation Coefficient: 0.9980
• Standard Error Estimate: 9.06
• Confidence Interval Slope: 0.970 to 0.994
• Confidence Interval Intercept: 1.97 to 5.97
  POL Sites:
• Correlation Coefficients: 0.9993 to 0.9997
• Standard Error Estimates: 4.44 to 7.89
• Confidence Interval Slopes: 1.002 to 1.047
• Confidence Interval Intercepts: -4.74 to 3.41 |
  | Detection Limit | Low enough to be clinically useful. | 10.63 U/L |

Note: The acceptance criteria are "implied" because the document primarily presents the results of the performance data without explicitly stating the pre-defined target values or ranges that were aimed for. However, the context of a 510(k) submission requires demonstrating substantial equivalence, meaning the performance should be comparable to the predicate device. Therefore, the reported data, particularly the high correlation coefficients, slopes near 1, and intercepts near 0 for accuracy, indicate that these outcomes met whatever internal acceptance criteria were set for demonstrating equivalency. For precision, low CVs are generally accepted as good performance.

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

• ACE Direct Total Iron-Binding Capacity (TIBC) Reagent:

  • Sample Size:
    • Accuracy (correlation study): 109 samples
    • Precision (lab): 4 TIBC levels tested for 22 days.
    • Precision (POL sites): 3 separate POL sites, testing over 5 days (number of samples not specified, but likely multiple runs per site per day).
  • Data Provenance: Not explicitly stated, but the testing occurred at "Physician Office Laboratory (POL) sites" and an unnamed central lab. It is not specified if the data is retrospective or prospective, nor the country of origin.

• ACE Serum Iron Reagent:

  • Sample Size:
    • Accuracy (correlation study): 130 samples
    • Precision (lab): 4 Serum Iron levels tested for 22 days.
    • Precision (POL sites): 3 separate POL sites, testing over 5 days (number of samples not specified).
  • Data Provenance: Not explicitly stated, but testing occurred at "Physician Office Laboratory (POL) sites" and an unnamed central lab. Retrospective or prospective nature and country of origin are not specified.

• ACE Lipase Reagent:

  • Sample Size:
    • Accuracy (correlation study): 107 samples
    • Precision (lab): 3 lipase levels tested for 22 days.
    • Precision (POL sites): 3 separate POL sites, testing over 5 days (number of samples not specified).
  • Data Provenance: Not explicitly stated, but testing occurred at "Physician Office Laboratory (POL) sites" and an unnamed central lab. Retrospective or prospective nature and country of origin are not specified.

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 given text. The ground truth for these types of in vitro diagnostic tests is typically established by measurements from a reference method or a predicate device. The text indicates that the "Alfa Wassermann ACE Clinical Chemistry System" was used as the comparator (predicate device) (referred to as 'x' in the regression analyses).

4. Adjudication Method for the Test Set

This information is not applicable and therefore, not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation, such as by human readers of medical images, to resolve discrepancies in diagnoses. These clinical chemistry devices produce quantitative numerical results, which are then compared statistically to a reference method or predicate device, rather than adjudicated.

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 information is not applicable as the described devices are in vitro diagnostic clinical chemistry reagents and an automated system (ACE Axcel Clinical Chemistry System), not AI-assisted imaging or diagnostic tools designed for human readers to interpret. Therefore, an MRMC study and effects on human reader performance are not relevant to this submission.

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

Yes, the studies described are standalone performance studies of the device and reagents. The ACE Axcel Clinical Chemistry System is an "automated, discrete, bench-top, random access analyzer." The performance data presented (precision, accuracy, detection limit) are measurements of the system's ability to quantitatively determine analytes directly, without a human interpretation step that would introduce a "human-in-the-loop" component in the result generation itself. The results quantify the device's inherent measurement capabilities.

7. The Type of Ground Truth Used

The ground truth for these studies was established by comparison to a legally marketed predicate device, the "Alfa Wassermann ACE Clinical Chemistry System" (specifically, the ACE Reagents K000781, K944911 run on the K931786 system). This is a common method for demonstrating substantial equivalence for in vitro diagnostic devices in 510(k) submissions. The new device's measurements (y) were correlated against the predicate device's measurements (x).

8. The Sample Size for the Training Set

This information is not provided and is generally not applicable in the context of these types of in vitro diagnostic submissions for clinical chemistry reagents and analyzers. The device described does not employ a machine learning algorithm that requires a "training set" in the conventional sense. The "training" of such a device primarily involves rigorous internal calibration procedures and validation during its development and manufacturing, which are distinct from the concept of a "training set" for AI/ML models.

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

As explained in point 8, the concept of a "training set" requiring ground truth establishment in this manner is not applicable to this type of device and submission. The device's operational parameters are set through design, engineering, and calibration processes, not machine learning model training.

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The ATAC Serum Calibrator is intended for use with the ATAC Clinical Systems to establish points of reference that are used in the determination of albumin, calcium, cholesterol, creatinine, direct bilirubin, glucose, iron, magnesium, phosphorus, total bilirubin, total protein, triglycerides, urea and uric acid in human specimens.

Not Found

The provided text is related to the FDA's 510(k) premarket notification for the ATAC Serum Calibrator. It outlines the regulatory approval for this device, which is intended for use with ATAC Clinical Systems to establish reference points for various analytes in human specimens.

However, the provided text does not contain any information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert involvement. It is primarily a regulatory approval letter and an "Indications for Use" statement.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the detailed questions about the study from the given input.

To answer your questions, I would need a document that describes the verification and validation studies performed for the ATAC Serum Calibrator, including:

• Specific performance metrics (e.g., accuracy, precision, linearity).
• The acceptance criteria for each metric.
• The results of the studies demonstrating that these criteria were met.
• Details about the study design, sample characteristics, and how ground truth was established.

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The EasyRA DBIL Reagent is for the in vitro measurement of Direct Billirubin in serum specimens of adults on the Medica EasyRA analyzer. Bilirubin measwements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block, EasyRA Bilirubin-Total Reagent The EasyRA TBIL Reagent is for the in vitro measurement of Total Bilirubin in serum specimens of adults on the Medica EasyRA analyzer. Bilirubin measwements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. The EasyRA Phosphorus Reagent is for the in vitro measurement of phosphorus in serum on the Medica EasyRA analyzer. Phosphorus measurements are used in the diagnosis and treatment of parathyroid gland, kidney diseases, and vitamin D imbalance. The EasyRA Iron Reagent is for the in vitro measurement of iron in serum on the Medica EasyRA analyzer. Iron measurements are used in the diagnosis and treatment of iron deficiency anemia, hemochromatosis, and chronic renal disease. The EasyRA Magnesium Reagent is for the in vitro measurement of phosphorus in serum on the Medica EasyRA analyzer. Magnesium measurements are used in the diagnosis and treatment of: Hypermagnesemia occuring during renal failure, acute diabetic acidosis, dehydration or in Addison's disease. Hypomagnesemia observed in cases of chronic alcoholism, malabsorption, acute pancreatitis and kidney disorders.

Not Found

I am sorry, but the provided text only contains a 510(k) clearance letter from the FDA for several EasyRA reagents. It does not include acceptance criteria, performance data from a study, or details about the methodology of such a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication, MRMC study, or training set information).

Therefore, I cannot provide the requested information based on the input.

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The Iron method for the Dimension Vista ™ system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma. Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.

The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension Vista TM system.

The Dimension Vista™ IRON Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight well cartridge for use on the Dade Behring Dimension Vista ™ system for the quantitative determination of iron in serum and plasma.

The Dimension Vista™ Iron Calibrator is an aqueous solution of iron wire dissolved in a dilute solution of HCl. The kit contains three glass screw top vials, 1.0 mL each, of the Calibrator A (1075 ug/dL).

Here's an analysis of the acceptance criteria and study information for the Dimension Vista™ IRON Flex® reagent cartridge and Calibrator, based on the provided document:

This document is a 510(k) summary for an in vitro diagnostic device and its calibrator. For such devices, acceptance criteria typically relate to performance characteristics like precision, accuracy (comparison to a predicate device or reference method), linearity, and interference. The study described is primarily a comparative study to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria for performance metrics. Instead, it states that "The performance testing according to the verification and validation test protocols demonstrate that the Dimension Vista™ IRON Flex® reagent cartridge is substantially equivalent to the designated predicate device."

However, the comparison table between the device and predicate for the reagent cartridge (Section I.3) highlights similarities in performance-related parameters which imply the new device is expected to meet similar performance standards to the predicate. The stated "Assay Range: 0 to 1,000 µg/dL" is a key performance metric.

For the calibrator, similar qualitative substantial equivalence is claimed without specific quantitative acceptance criteria or performance metrics beyond its intended use for calibrating the IRON method.

Therefore, a table cannot be fully generated with explicit acceptance criteria as they are not quantitatively stated in the document. However, we can infer performance characteristics from the comparison to the predicate.

Inferred Performance Characteristics (from comparison to predicate):

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

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 generally refers to "performance testing according to the verification and validation test protocols." The guidance documents referenced (e.g., NCCLS EP7-A for interference, EP5-A2 for precision, EP09-A2 for method comparison) suggest standardized sample sizes and methodologies for specific tests, but the actual numbers used in this specific submission are not provided.

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

Not applicable for this type of in vitro diagnostic device (IVD). Ground truth for IVDs like this is established through comparison to a well-characterized predicate device or reference methods, not human expert interpretation of images or clinical cases.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are relevant for studies where human interpretation or diagnostic decisions are being evaluated, such as in imaging studies. For an IVD measuring a chemical analyte, the "ground truth" is determined by the reference method or predicate device's measurement, not by expert consensus or 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. MRMC studies are used to evaluate human reader performance, often with or without AI assistance, in diagnostic imaging or similar fields. This document concerns an in vitro diagnostic reagent cartridge for measuring an analyte, not an AI-assisted diagnostic tool for human readers.

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

This device is a standalone instrument-based measurement system. Its performance is evaluated intrinsically through analytical studies (precision, accuracy, linearity, interference) against established analytical methods and a predicate device. The performance is the "algorithm only" in the sense that it is the device's ability to accurately measure iron without human interpretation beyond operating the instrument and reading the numerical result.

7. The Type of Ground Truth Used

For the Dimension Vista™ IRON Flex® reagent cartridge, the primary type of "ground truth" or reference for establishing performance and substantial equivalence is:

• Comparison to a legally marketed predicate device: Dimension® Iron Flex® reagent cartridge (K060264).
• Reference materials/methods: The device's standardization is traceable to NIST SRM 937 (National Institute of Standards and Technology - Standard Reference Material), which serves as a highly accurate reference for iron concentration.
• Established analytical principles: The method adapts direct iron assays using Ferene® chromophore, a recognized chemical principle for iron measurement.

For the Dimension Vista™ IRON Calibrator, the ground truth for its value and performance is primarily NIST SRM 937 traceability and its ability to properly calibrate the iron method on the Dimension Vista™ system, aligning with the predicate calibrator.

8. The Sample Size for the Training Set

Not applicable. This device is an in vitro diagnostic reagent and calibrator kit. It does not use machine learning or AI that requires a "training set" in the conventional sense. Its performance is based on chemical reactions and optical measurements, with an analytical curve (likely established through instrument calibration and validation runs, not machine learning) guiding its quantitative output.

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

Not applicable, as there is no "training set" in the context of machine learning for this device. The accuracy of measurements is established via traceability to NIST SRM 937 and comparison to the predicate device, following established laboratory quality control and validation procedures.

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The Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator is an in vitro diagnostic product for the calibration of the Total Iron Binding Capacity (TIBC) method on the Dimension Vista™ system.

The Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator is a liquid, bovine albumin based product containing human transferrin. The kit consists of 3 vials, each containing 1.0 mL.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator.

Please note: The provided text is a 510(k) summary for a calibrator, not a diagnostic device that performs interpretations. Therefore, many of the typical questions for AI/diagnostic device studies (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types like pathology/outcomes data) are not applicable in this context. The document focuses on demonstrating **substantial equivalence** to a predicate device, primarily through comparison of their characteristics and intended use.

Acceptance Criteria and Device Performance

For a calibrator like the Dimension Vista™ TIBC Calibrator, the "acceptance criteria" isn't typically phrased in terms of sensitivity, specificity, or accuracy against a disease state. Instead, acceptance is based on demonstrating that its performance is equivalent to a legally marketed predicate device for its intended use (calibration). The "reported device performance" is implicitly shown through the comparison table and the conclusion of substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance

Given this context, the "acceptance criteria" can be inferred as matching the key characteristics and performance expectations of the predicate device for calibrator functionality.

Study Information (Based on Available Text):

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

   • Not Applicable. This is a 510(k) submission for a calibrator, not a diagnostic device evaluating patient samples. The "test set" would refer to internal validation of the calibrator's performance against expected values, but details on sample size or provenance for such internal testing are not provided in this summary. The focus is on comparison to a predicate.

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. There is no "ground truth" derived from expert consensus on patient data described for this calibrator submission. The ground truth for a calibrator relates to its chemical composition and its ability to produce expected instrument responses, which is typically validated through internal quality control and comparison to a primary standard (NIST Iron Standard SRM 937).

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

   • Not Applicable. No adjudication method for a "test set" of patient data is relevant here.

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-assisted diagnostic device.

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

   • Not Applicable. This is not an algorithm or AI device.

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

   • The "ground truth" for the calibrator's value is established by its primary standard: NIST Iron Standard SRM 937. This refers to a standard reference material from the National Institute of Standards and Technology, which provides a highly accurate and certified concentration of iron. The calibrator's assigned values are traceable to this primary standard.

7. The sample size for the training set

   • Not Applicable. This is a calibrator, not a machine learning device that requires a training set.

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

   • Not Applicable. No training set is used.

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The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension® clinical chemistry system.

The IRON calibrator is an aqueous solution of iron wire dissolved in a dilute solution of HCl. The kit consists of 6 ampules, two at each of three levels.

Here's an analysis of the provided text regarding the Dimension® Iron Calibrator and its performance:

1. Acceptance Criteria and Reported Device Performance

The document describes the stability and traceability of the Dimension® Iron Calibrator (IRON Cal - DC 85). However, the specific quantitative acceptance criteria for performance (e.g., recovery percentages, maximum allowable drift) are not explicitly stated in a table format within the provided text. The document focuses on the methods used to assess stability and traceability, rather than specific results against pre-defined thresholds.

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: For stability studies, "three lots of product" were used. For traceability and value assignment, it mentions "six working Iron Standard Solutions of NIST SRM 937" for assigning values, and the comparison of "new calibrator lot" against "Reference Lot" and "Control Calibrator Lot." The number of individual samples or measurements within these lots/solutions is not specified.
• Data Provenance: The data is generated internally by Dade Behring Inc. (the applicant). It is prospective data, as it describes studies conducted to support the device's claims (e.g., 13 months of real-time stability testing). The country of origin of the data is implicitly the United States, where Dade Behring Inc. is located.

3. Number of Experts and Qualifications for Ground Truth

The provided summary does not mention any human experts being used to establish ground truth for the performance studies of this calibrator device. The ground truth for a calibrator is typically established through a highly controlled and standardized reference material.

4. Adjudication Method for the Test Set

Since no human experts are mentioned for establishing ground truth, there is no adjudication method described or applicable in this context.

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

An MRMC study is not applicable to this device. This is an in vitro diagnostic calibrator, not a diagnostic imaging device or an AI algorithm intended to assist human readers. Therefore, no comparison of human readers with or without AI assistance was performed.

6. Standalone Performance Study

Yes, the studies described, particularly the stability studies and the traceability/value assignment studies, can be considered standalone performance studies for the calibrator device itself. These studies evaluate the calibrator's inherent properties (stability over time, accuracy of assigned values against a gold standard) independent of a human operator's interpretation. The calibrator's function is to provide a known reference point for the Dimension® clinical chemistry system, so its "performance" is evaluated on its ability to maintain that reference.

7. Type of Ground Truth Used

The primary ground truth used for this calibrator is NIST SRM 937 (National Institute of Standards and Technology - Standard Reference Material). This is a highly certified and recognized reference material, considered a "gold standard" for iron concentration.

8. Sample Size for the Training Set

This document describes a calibrator, not a machine learning model. Therefore, the concept of a "training set" in the context of AI or algorithms is not applicable. The calibrator itself does not learn from data; its values are assigned based on comparisons to a reference standard.

9. How Ground Truth for the Training Set Was Established

As explained above, there is no "training set" in the AI/machine learning sense for this device. The values of the calibrator are established through direct comparison and standardization against the NIST SRM 937, which is intrinsically the ground truth for iron concentration. The process involves:

• Preparing six working Iron Standard Solutions from NIST SRM 937.
• Assigning values to new lots of the calibrator by recovering these reference solutions.
• Ensuring acceptable recovery against the NIST SRM 937 (Reference Lot) and an approved Control Calibrator Lot.

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The IRON method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma. Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.

The Dimension® IRON Flex® reagent cartridge (DF85) is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight well cartridge for use on the Dade Behring Dimension® clinical chemistry system for the quantitative determination of iron in serum and plasma.

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

Acceptance Criteria and Device Performance

Within-lab Standard Deviation (%CV):
Plasma pool: 0.7%
Serum pool 1: 0.6%
Serum pool 2: 1.1%
Serum pool 3: 0.8%
BioRad Lyphochek® control Level 1: 0.7%
BioRad Lyphochek® control Level 2: 1.9%
BioRad Lyphochek® Anemia control Level 1: 1.9%
Reduced Sample Volume Serum pool 1: 0.9%
Reduced Sample Volume Serum pool 2: 1.1%
Reduced Sample Volume Serum pool 3: 0.8%
Reduced Sample Volume BioRad Lyphochek® Anemia control Level 1: 1.9%
Reduced Sample Volume BioRad Multiqual® control Level 3: 0.9% |
| Linearity/Assay Reportable Range | Correlation coefficient of 0.999, slope of 0.999, and intercept of 0.178. Assay range claim: 5.0 µg/dL to 1000 µg/dL. | Correlation Coefficient: 0.999
Slope: 0.999
Intercept: 0.178
Assay Range Claim: 5.0 µg/dL to 1000 µg/dL |
| Detection Limit (Analytical Sensitivity) | Ability to distinguish iron from zero. | Analytical Sensitivity: 5 µg/dL [0.9 µmol/L] |
| Analytical Specificity (Interference) | Systematic inaccuracies (bias) due to interfering substances

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The RDI Direct TIBC Calibrator Set is intended for medical purposes for use with the RDI Direct TIBC Kit to establish points of reference that are used in the quantitative determination of Total Iron-Binding Capacity (TIBC) in human serum.

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves whether the Direct TIBC Calibrator Set meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, but not specific performance study details, acceptance criteria, or performance data.

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