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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 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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General Chemistries reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.

ABX PENTRA ALP CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma based on a kinetic photometric test using p-Nitrophenylphosphate. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

ABX PENTRA Calcium CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of calcium in human serum and plasma based on a photometric test using orthocresolphtalein complexone. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

ABX PENTRA CO2 RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of carbon dioxide in human serum and plasma based on an enzymatic test using phosphoenolpyruvate (PEP), phosphorenolpyruvate carboxylase (PEPC) and an analog of NADH. Bicarbonate/carbon measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

ABX PENTRA Creatinine CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of creatinine in human serum and plasma based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

ABX PENTRA Iron CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of iron (non-heme) in human serum and plasma based on a photometric test (Ferene method). Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and hemochromatosis.

ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

ABX PENTRA Phosphorus CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of phosphorus in human serum and plasma based on a UV method using phosphomolybdate. Measurement of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

ABX PENTRA Urea CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of urea nitrogen (an end-product of nitrogen metabolism) in human serum and plasma based on an enzymatic UV test using urease and glutamate dehydrogenase. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

ABX PENTRA Uric Acid CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of uric acid in human serum and plasma based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

The ABX PENTRA CO2 Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA CO2 RTU method on Horiba ABX clinical chemistry analyzers as specified on the vial.

The ABX PENTRA CO₂ Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CO2 RTU method as specified in the enclosed annex.

All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.

The ABX PENTRA 400 offers both Closed and Open channels for a multitude of parameters (clinical chemistry, DAT, TDM, plasma protein, hemostasis, optional ISE module).

All reagents described in this submission are for the quantitative in-vitro determination of their respective parameters

Here's a breakdown of the acceptance criteria and study information for the Horiba ABX PENTRA reagents, controls, and calibrators, based on the provided 510(k) summary:

This submission is for multiple reagents, controls, and calibrators for the ABX PENTRA 400 clinical chemistry analyzer. The performance data is presented for each reagent individually. The acceptance criteria and reported performance will be summarized for each reagent as presented in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the reported performance, which demonstrates that the devices "met all acceptance criteria" and are "substantially equivalent" to their respective predicate devices. Specific quantitative acceptance criteria are not explicitly stated as separate targets but are shown by the achieved performance values.

ABX PENTRA ALP CP (Alkaline phosphatase)

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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 Sentinel Iron Liquid is a direct colorimetric in vitro diagnostic assay for the quantitative determination of Iron without deproteinization in human serum and plasma (heparin salts, only).

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.

The Iron Liquid described in this 510(k) submission is composed of reagents and standard, packaged and distributed in the same kit. The device is intended to be sold as an in vitro test for professional use.

The Iron Liquid is a direct colorimetric in vitro diagnostic assay for the quantitative determination of iron without deproteinization in human serum and plasma (heparin salt, only). In a pH 4.0 buffer system, iron is released from transferin to which it is bound, and then quantitatively reduced to a ferrous state. The iron forms with Ferene-S a stable colored complex of which the color intensity is proportional to the amount of iron in the sample. Particular reaction conditions and a specific masking agent eliminate the interference from copper.

The provided document is a 510(k) summary for the Sentinel Iron Liquid, an in vitro diagnostic assay. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria or a detailed study section with performance data that would allow for a comprehensive answer to all parts of your request.

Based on the information available in the document, here's what can be extracted and what cannot:

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

The document mentions "Performance evaluations included sensitivity, intra- and inter-assay precision and method comparison." However, it does not provide a table of specific acceptance criteria (e.g., target precision values, sensitivity thresholds) nor does it report the actual device performance metrics (e.g., measured sensitivity, CVs for precision, regression statistics for method comparison). It only states that these evaluations were performed.

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

The document does not specify the sample size used for the performance evaluations (test set). It also does not mention the country of origin of the data or whether the data was retrospective or prospective.

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 question is not applicable as the device is an in vitro diagnostic assay for quantitative determination of iron. The "ground truth" for such devices is typically established through reference methods or established biochemical standards, not expert interpretations of images or clinical cases. The document does not mention experts being used to establish ground truth.

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

This question is not applicable for this type of in vitro diagnostic device, where ground truth is based on quantitative measurements rather than expert consensus requiring adjudication. The document does not mention any adjudication method.

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 question is not applicable as the device is an in vitro diagnostic assay for quantitative determination of iron, not an AI-assisted diagnostic tool for human readers. The document does not mention an MRMC study or AI assistance.

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

The Sentinel Iron Liquid is a reagent-based assay for quantitative determination of iron. It operates standalone in the sense that it produces a quantitative result; there isn't a "human-in-the-loop performance" in the same way there would be for an image-based AI diagnostic. The comparative study was against a predicate device (IL Test Iron), indicating a standalone performance comparison. The document confirms that "Performance evaluations included sensitivity, intra- and inter-assay precision and method comparison." This implies a standalone evaluation of the device's performance.

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

For an in vitro diagnostic assay like Sentinel Iron Liquid, the "ground truth" would be the true concentration of iron in the samples, likely determined by a precise reference method or by using certified reference materials and calibrators. The document does not explicitly state the specific reference method or approach used to establish the ground truth for the performance evaluations. It only implicitly suggests that the predicate device serves as a comparison for accuracy.

8. The sample size for the training set

The concept of a "training set" is primarily relevant for machine learning or AI models. The Sentinel Iron Liquid is a chemical reagent-based assay. Therefore, there is no training set in the context of an AI model. The document does not refer to a training set.

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

As there is no training set for this type of device, this question is not applicable.

Summary of what is present:

• Intended Use: Quantitative determination of iron in human serum and plasma (heparin salts, only).
• Comparison to Predicate Device: IL Test Iron (Instrumentation Laboratory Company, K972363).
• Performance Evaluations Conducted (but not reported in detail): Sensitivity, intra- and inter-assay precision, and method comparison.
• Conclusion: The performance and safety data support a finding of substantial equivalence to the predicate devices.

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The Vitalab Iron Reagent Kit, which contains both reagent and calibrator, is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of total iron in serum and plasma. Iron results may be used for the diagnosis and treatment of diseases associated with iron metabolism 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.

The Vitalab Iron Reagent Kit and the Vitalab Selectra Analyzer are used as a system for the quantitative determination of total iron in serum and plasma. Iron in the sample is specifically released from transferrin using an acidic buffer. The released iron is then reduced and reacts with a chromogenic indicator. The increase in absorbance at 578 nm is measured photometrically. The increase in absorbance at 578 nm is proportional to the iron concentration of the sample.

The provided text describes the acceptance criteria and study for the Vitalab Iron Reagent Kit and Vitalab Selectra Analyzer, which are used as a system for the quantitative determination of total iron in serum and plasma.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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The ATAC Iron Reagent Kit, which contains both reagent and calibrator, is intended for use with the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of total iron in serum. The ATAC TIBC Column Kit, which is marketed with generic labeling and an ATAC 8000 Application Sheet, is intended for use with the ATAC Iron Reagent Kit and other iron reagents for the quantitative determination of total iron binding capacity in serum.

Total iron results are used for the diagnosis and treatment of diciency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, and characterized by pigmentation of the skin), and chronic renal disease. Total iron binding capacity measurements are used for the diagnosis and treatment of anemia.

This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

The ATAC Iron Reagent measures total serum iron by stripping it from the transferrin in a low pH reagent buffer, oxidizing it to ferric ions and binding it with Ferrozine. The resulting increase in absorbance at 546 nm is proportional to the iron concentration in the sample. The ATAC TIBC Column Kit is used to pretreat serum specimens prior analysis. The iron in the saturating reagent ensures that all available iron binding sites in the serum specimen are saturated with iron. The filtrate is assayed with an iron reagent after removing the unbound iron form the sample mixture by passing it through an alumina column. The maximum amount of iron bound in the specimen is a measure of its transferrin concentration.

The provided document describes the ATAC Iron Reagent Kit and ATAC TIBC Column Kit for quantitative determination of total iron and total iron binding capacity in serum. The study aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study particulars:

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly state pre-defined acceptance criteria, but rather presents performance characteristics of the device and claims substantial equivalence to predicate devices. The "reported device performance" are the results of the effectiveness and precision studies.

ATAC Iron Reagent Kit Performance:

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An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis and chronic renal disease. For the quantitative determination of iron in serum and heparinized plasma. For IN VITRO diagnostic use.

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I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding the "Iron-PC-SL Assay." This document primarily focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

The information requested in your prompt, such as specific acceptance criteria and the details of a study proving the device meets those criteria, including sample sizes, ground truth establishment, MRMC studies, or standalone performance, is not present in this type of regulatory correspondence.

This document confirms the device's classification and its ability to be marketed, but it does not contain the technical study details you are asking for. A typical 510(k) submission would include such studies, but the letter itself is just the FDA's response.

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The "Wiener lab. Fer-Color AA" iron test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, and 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.

End point method. Serum iron is released from its specific carrier protein (transferrin) in a pH 4.5 acetate buffer, and in the presence of a reducing agent (ascorbic acid). Then it reacts with the color reagent, pyridyl bis-phenyl triazine sulfonate (ferrozine) producing a colored complex measured at 570 nm.

The document describes the Wiener Lab. FER-COLOR AA test system, a photometric method for iron determination, and its equivalence to the RANDOX IRON test system for FDA 510(k) clearance.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison between the Wiener Lab. FER-COLOR AA test system and the RANDOX IRON test system, which serves as the predicate device. The "acceptance criteria" are implicitly set by the performance of the predicate device, as the submission aims to demonstrate substantial equivalence.

Note: The acceptance criteria are largely implied by demonstrating performance comparable to the predicate device. For some parameters, the predicate did not specify a value (e.g., minimum detection limit, inter-assay precision), allowing the applicant to establish their own performance and still claim substantial equivalence if reasonable.

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

The document does not explicitly state the sample size used for the test set (i.e., for the precision and comparison studies) or the data provenance (e.g., country of origin, retrospective or prospective nature of the samples). The precision data (intra-assay and inter-assay) refers to "Normal Serum Control" and "Abnormal Serum Control," but the number of samples or runs is not detailed.

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

This information is not provided in the document. For in vitro diagnostic tests like this, ground truth is typically established through analytical methods and reference materials, not expert consensus on interpretations.

4. Adjudication method for the test set

This information is not applicable/provided as the study is a comparison of analytical performance of an in vitro diagnostic device, not a subjective interpretation task 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

An MRMC study was not done. This type of study is relevant for imaging or interpretation devices where human readers are involved. The FER-COLOR AA is an in vitro diagnostic assay, an automated photometric method, and does not involve human readers for interpretation in this context. It is an "algorithm only" device for the measurement of iron concentration.

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

Yes, a standalone performance study was done. The entire submission focuses on the analytical performance of the "WIENER LAB. FER-COLOR AA" test system itself, demonstrating its precision, linearity, and other analytical characteristics in comparison to a predicate device. This is the definition of a standalone study for this type of device.

7. The type of ground truth used

The ground truth for parameters like linearity, minimum detection limit, and expected values would be based on:

• Reference materials/calibrators: For linearity, known concentrations of iron would be used.
• Assigned values: Control materials ("Normal Serum Control," "Abnormal Serum Control") used for precision studies would have assigned target values.
• Clinical studies/population data: "Expected values" are generally derived from studies on healthy populations.

The document does not explicitly state the specific ground truth methodologies in detail but implies these standard practices for IVD assays.

8. The sample size for the training set

This information is not applicable/provided. The FER-COLOR AA is a chemical assay, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its performance is based on chemical reactions and photometric measurement, not a learned model from data.

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

This information is not applicable/provided for the reasons stated in point 8.

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