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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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For in vitro diagnostic use only. VITROS Chemistry Products TIBC Kit with VITROS Chemistry Products Fe Slides quantitatively measures total iron-binding capacity (TIBC) in serum. The iron binding capacity is useful in the differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning.

VITROS Chemistry Products Calibrator Kit 4 is used to calibrate VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.

The VITROS TIBC assay is performed using the VITROS Chemistry Products TIBC Kit, VITROS Chemistry Products Fe Slides, and the VITROS Chemistry Products Calibrator Kit 4 on VITROS Chemistry Systems.

The VITROS TIBC Kit consists of VITROS TIBC Columns (containing alumina) and VITROS Iron Saturating Reagent.

Total iron-binding capacity is determined by pretreating a sample using the method of Starr. Excess iron citrate reagent is added to the sample to saturate all available apotransferrin sites. After an incubation period of five minutes, the treated sample is applied to an alumina column where iron that is not bound to transferrin is adsorbed.

The transferrin-bound iron contained in the eluate represents the total iron-binding capacity of the sample.

A drop of eluate is deposited on the VITROS Fe Slide and is evenly distributed by the spreading layer to the underlying layers. After the addition of the eluate, the slide is incubated at 37℃. Two reflection density measurements at 600 nm are made at approximately one and five minutes. The difference in reflection density is proportional to the iron concentration in the sample.

Once a calibration has been performed for each slide lot, total iron binding capacity in unknown samples can be determined using the softwareresident two-point rate math model and the change in reflectance calculated for each unknown test slide.

VITROS Calibrator Kit 4 contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from processed bovine serum and bovine serum albumin to which organic analytes, inorganic salts, electrolytes, stabilizers, and preservatives have been added. The diluents are prepared from processed water. Once reconstituted, the standards are used to calibrate VITROS Chemistry Systems for the quantitative measurement of total iron binding capacity in serum. Calibration of the VITROS TIBC assay requires the use of three of the four levels (bottles 1, 3 and 4). For in vitro diagnostic use only.

This prompt describes a 510(k) summary for an in vitro diagnostic device, specifically the VITROS Chemistry Products TIBC Kit and Calibrator Kit 4. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results in the typical format of an AI/ML device study.

Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be directly extracted from the provided text. These concepts are primarily relevant to clinical validation studies for AI/ML-driven medical devices, which this document is not.

The provided document describes a chemistry assay, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as number of experts, adjudication method, MRMC studies, effect size with AI, standalone performance, training set data, etc.) are not applicable in this context.

However, I can extract information related to the device's performance characteristics and how its equivalence to a predicate device was demonstrated.

Here's the information that can be extracted and how it relates (or doesn't relate) to your request:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative sense for this submission. Instead, it demonstrates "substantial equivalence" to a predicate device by comparing various device characteristics. The "reported device performance" is essentially the modified device's characteristics, assumed to be acceptable because they are substantially equivalent to a legally marketed device.

Study Proving Substantial Equivalence:

The document states: "Equivalence was demonstrated using manufactured reagents along with quality control fluids, proficiency samples and human serum samples with measured TIBC values spanning the assay range." This is the core of the "study" for this type of submission.

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

• Sample Size for Test Set: The document mentions "human serum samples with measured TIBC values spanning the assay range," but does not provide a specific number for the sample size.
• Data Provenance: The provenance is "human serum samples." The country of origin and whether they are retrospective or prospective is not specified. Given the context of a 510(k) summary for an in-vitro diagnostic, these are typically clinical samples, likely from a diverse population or at least representative of the target user base (e.g., US patients if for US market), but this is not explicitly stated. It is implicitly retrospective as the samples would have been collected prior to the study.

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

This question is not applicable. For a chemistry assay measuring TIBC, the "ground truth" is established by a reference method or validated laboratory procedure, not by a panel of human experts in the way it is for image-based AI/ML devices. The predicate device's performance, and traceability to SRM 937 via NCCLS approved standard methods, serves as the benchmark.

4. Adjudication method

Not applicable for a chemistry assay.

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 an in vitro diagnostic chemistry assay, not an AI-assisted diagnostic tool requiring human interpretation.

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

Not applicable. This is a standalone chemistry assay, meaning it provides a quantitative result directly, rather than an "algorithm" augmenting human performance. Its performance is inherent to the assay itself.

7. The type of ground truth used

The "ground truth" for this type of assay is derived from:

• Comparison to the predicate device's performance.
• Traceability to SRM 937 (Standard Reference Material) via NCCLS approved standard methods (H17-A2 for the modified device, H17-P3 for the predicate). This essentially means the accuracy is tied to recognized international standards for iron measurement.
• "Measured TIBC values spanning the assay range" implies these values were determined by a reference method.

8. The sample size for the training set

Not applicable. This is a chemistry assay that does not usually involve a "training set" in the machine learning sense. The assay method is developed and validated through chemical principles and analytical studies, not statistical learning from a dataset.

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

Not applicable for the reasons stated above.

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Dimension Vista™ Albumin (ALB) Flex® reagent cartridge: The ALB method is an in vitro diagnostic test for the quantitative measurement of albumin in human serum and plasma on the Dimension Vista™ System. Measurements obtained by this device are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Dimension Vista™ Aspartate amino transferase (AST) Flex® reagent cartridge: The AST method is an in vitro diagnostic test for the quantitative measurement of aspartate aminotransferase in human serum and plasma on the Dimension Vista™ System. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

Dimension Vista™ Carbamazepine (CRBM) Flex® reagent cartridge: The CRBM method is an in vitro diagnostic test for the quantitative measurement of carbamazepine in human serum and plasma on the Dimension Vista™ System. Carbamazepine measurements may be used in the diagnosis and treatment of carbamazepine overdose and in therapeutic drug monitoring. Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to ensure appropriate therapy.

Dimension Vista™ Alanine amino transferase (ALT) Flex® reagent cartridge: The ALT method is an in vitro diagnostic test for the quantitative measurement of alanine aminotransferase in human serum and plasma on the Dimension Vista™ System. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g. viral hepatitis and cirrhosis) and heart diseases.

Dimension Vista™ Total Iron-binding capacity (TIBC) Flex® reagent cartridge: The TIBC method is an in vitro diagnostic test for the quantitative measurement of total iron binding capacity in human serum and plasma on the Dimension Vista™ System. Measurements of total iron binding capacity are used in the diagnosis and treatment of iron deficiency anemia and chronic inflammatory disorders.

Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K 051087).

This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system.

The ALB, AST, CRBM, ALT, and TIBC reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.

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

Acceptance Criteria and Device Performance

The provided document describes a 510(k) submission for several reagent cartridges for the Dimension Vista™ system. The primary goal of this submission is to demonstrate substantial equivalence to existing predicate devices (Flex® reagent cartridges used on Dimension® clinical chemistry systems) due to a packaging modification. Therefore, the "acceptance criteria" are implicitly tied to the performance of the predicate devices.

The document states: "Comparative testing described in the protocol included in this submission demonstrates equivalent performance." And in the conclusion: "Comparative testing also demonstrates substantially equivalent performance."

While explicit numerical acceptance criteria are not provided in the publicly available summary, the general acceptance criteria for this type of submission would be that the performance of the new device (Dimension Vista™ Flex® reagent cartridges) must be comparable or equivalent to the predicate device (Dimension® Flex® reagent cartridges). This comparison typically involves analytical performance characteristics such as:

• Accuracy: How close the measured values are to the true values.
• Precision: The reproducibility of measurements.
• Linearity/Measuring Range: The range over which the device accurately measures the analyte.
• Interferences: The effect of other substances on the measurement.
• Method Comparison: Correlation with the predicate device.

Since the submission states the reagents are the same, and only the packaging is modified for use on a different (but related) instrument, the expectation is that the analytical performance should remain unchanged or within acceptable variations for clinical use.

Table of Acceptance Criteria and Reported Device Performance (Inferred):

Study Information:

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

   • Sample Size: Not explicitly stated in the provided summary. The document mentions "Comparative testing described in the protocol included in this submission," but doesn't detail the sample sizes for comparison studies.
   • Data Provenance: Not explicitly stated. For in-vitro diagnostic devices, testing typically involves human serum and plasma samples, likely collected in a clinical laboratory setting. Whether it was retrospective or prospective is not mentioned, but validation studies for IVDs often involve prospective sample collection or the use of archived samples.

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

   • Not applicable as this is an in-vitro diagnostic test. Ground truth for such devices is established by the analytical performance against a reference method or validated calibrators, not by expert consensus in the way image analysis or clinical diagnosis might be.

3. Adjudication method for the test set:

   • Not applicable for an in-vitro diagnostic test. Results are quantitative measurements against established analytical standards.

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:

   • No. This is an in-vitro diagnostic device (reagent cartridge for laboratory analysis), not an AI-assisted diagnostic imaging or clinical decision support tool that involves "human readers."

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

   • Yes, this is an inherent aspect of an in-vitro diagnostic device. The "algorithm" here is the chemical assay and instrument processing. The performance reported (e.g., accuracy, precision) is the standalone performance of the device without human interpretation of the primary data, beyond standard laboratory quality control and result reporting.

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

   • For in-vitro diagnostic devices, the "ground truth" for analytical performance studies is typically established by:
     • Reference Methods: Highly accurate and precise methods (e.g., gas chromatography-mass spectrometry for drugs, isotope dilution mass spectrometry for certain analytes) considered the gold standard.
     • Validated Calibrators/Controls: Materials with known, assigned values traceable to reference standards.
     • Clinical Diagnosis/Patient Outcome: For clinical utility, but analytical performance uses the above.
   • The document implies that the ground truth for comparison was the established performance of the legally marketed predicate devices, which would have been validated against such reference methods or standards.

7. The sample size for the training set:

   • Not explicitly stated. For reagent development, a "training set" in the context of machine learning isn't directly applicable. Instead, reagent formulations are optimized through R&D, and their performance is characterized using various samples (e.g., quality control materials, patient samples) during that development phase. The "study" described here is for validation, not training or development.

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

   • As noted above, a "training set" linked to a ground truth in the machine learning sense isn't directly relevant here. However, the development of the original reagents (predicate devices) would have involved extensive analytical characterization against reference methods and clinical samples to establish their performance specifications and clinical utility. The current submission leverages the established ground truth of these existing reagents.

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For in vitro diagnostic use only. VITROS Chemistry Products dTIBC Reagent is used to quantitatively measure total iron-binding capacity (TIBC) in human serum. The iron binding capacity is useful in the differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning.

For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.

For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers are assayed controls intended for use in monitoring performance on VITROS Chemistry Systems.

The VITROS Chemistry Products dTIBC Reagent is a dual chambered package containing ready-to-use liquid reagents. Reagent 1, an acidic buffer containing ferric ions bound to chromazurol B (iron-binding dye) is added to the sample. The acidic pH releases iron from transferrin and the released iron binds to the excess chromazurol B. Reagent 2, a neutral buffer is added, shifting the pH, which results in increased affinity of transferrin for iron. Serum transferrin rapidly extracts iron from the dye-iron complex. The decrease in absorbance of the colored dye-iron complex is directly proportional to the total iron-binding capacity of the sample and is measured spectrophotometrically at 660 nm. Once a calibration has been performed, the TIBC concentration in each unknown sample can be determined using the I TDO collection curve and the measured absorbance obtained in the assay of the sample. The VITROS Chemistry Products Calibrator Kit 29 is a two level standard used to calibrate VITRÓS 5,1 FS Chemistry Systems for the quantitative measurement of total iron binding capacity (TIBC). VITROS Calibrator Kit 29 level 1 is an aqueous solution containing processed bovine serum albumin, and preservative. VITROS Calibrator Kit 29 level 2 is a lyophilate containing processed human serum, proteins, enzymes, organic compounds, electrolytes, immunoglobulins, inorganic compounds, hormones, and metals. The VITROS Chemistry Products FS Reconstitution Diluent is processed water used to reconstitute the VITROS Calibrator Kit 29 level 2. The VITROS Chemistry Products Performance Verifiers I and II are lyophilized materials prepared from processed human serum to which enzymes, electrolytes, stabilizers, preservatives, and other organic analytes have been added. The lypohilate is reconstituted using diluent manufactured from processed water to which inorganic salts have been added. These are assayed quality control materials are used to monitor the performance of the VITROS dTIBC assay on the VITROS 5,1 FS System. The VITROS dTIBC assay utilizes VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline), a common reagent that is used by multiple assays on the VITROS 5,1 FS System. This is a dual chambered package containing two ready-to-use liquid diluents. Diluent 1 (Saline) is prepared from processed water to which inorganic salt has been added. Diluent 2 (BSA) is prepared from processed water to which bovine serum albumin, inorganic salts and preservatives have been added. The VITROS 5,1 FS Chemistry System is a clinical chemistry instrument that provides automated use of the VITROS Chemistry Products MicroTip® and MicroSlides® range of products.

The provided document, K052867, describes a premarket notification for the VITROS Chemistry Products dTIBC Reagent, Calibrator Kit 29, and Performance Verifiers I & II. This submission focuses on establishing substantial equivalence to previously cleared predicate devices, rather than outlining specific, quantitative acceptance criteria for device performance and detailed study results that would typically be found in a more comprehensive clinical trial report.

Therefore, much of the requested information, such as detailed quantitative acceptance criteria with specific thresholds, sample sizes for test sets, expert qualifications for ground truth, adjudication methods, multi-reader multi-case studies, and explicit standalone performance, is not present in this 510(k) summary. The document highlights the comparison to predicate devices to demonstrate equivalence, rather than providing a detailed performance study against pre-defined acceptance criteria.

However, based on the provided text, I can infer and summarize the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a pass/fail format with specific numerical thresholds for performance metrics. Instead, it demonstrates "substantial equivalence" based on correlation studies and bench testing for various assay characteristics.

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

• Test Set Sample Size: Not explicitly stated. The text mentions "patient samples" were used for equivalence testing.
• Data Provenance: Not specified regarding country of origin 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

• This information is not applicable and not provided. For this type of in vitro diagnostic device (quantitative assay), the "ground truth" is typically established by the reference method or the predicate device's established performance, not by expert interpretation of images or other subjective assessments.

4. Adjudication method for the test set

• This information is not applicable and not provided for this type of in vitro diagnostic device.

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 an in vitro diagnostic assay, not an AI-powered image analysis or diagnostic aid for human readers.

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

• The device is a standalone in vitro diagnostic assay. Its performance is measured directly, not in conjunction with a human operator making interpretive decisions based on the assay's output. The output (a quantitative TIBC value) is directly reported.

7. The type of ground truth used

• The "ground truth" for demonstrating substantial equivalence was the performance of the predicate device (Dade Behring Total Iron Binding Capacity (IBCT) Flex® assay on the Dimension® clinical chemistry systems). The new device's measurements were compared against the predicate's measurements on the same samples.

8. The sample size for the training set

• This information is not applicable and not provided. This device is a chemical reagent-based assay, not an AI/machine learning algorithm requiring a "training set" in the conventional sense.

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

• This information is not applicable and not provided, as there is no "training set" for this type of device.

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The Sentinel UIBC Liquid (Unsaturated Iron Binding Capacity) assay is intended to measure the unsaturated iron-binding capacity in serum and plasma. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. CFR 862.1415

The Sentinel UIBC 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. Serum is added to an alkaline buffer/reductant solution containing a known concentration of iron to saturate the available binding sites on transferrin. The iron that remains free after transferrin saturation is reduced to a ferrous state and then complexed by Ferene-S to form a stable complex, of which the color intensity is measured at 580-600nm. UIBC is therefore determined by subtracting the quantity of unbound iron from the total added quantity.

The document describes the Sentinel UIBC Liquid device and its comparison to a predicate device. Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria." However, it presents a method comparison study as evidence of performance. The implicit acceptance criterion for substantial equivalence is a strong correlation with the predicate device.

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

• Sample Size for Test Set: 60 serum samples
• Data Provenance: Not explicitly stated, but it's a clinical evaluation of human serum samples, likely prospective for the purpose of the 510(k) submission. No country of origin is mentioned.

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

This type of information is not applicable and not provided in the document. For in vitro diagnostic devices like the Sentinel UIBC Liquid, "ground truth" is typically established by the results from a legally marketed predicate device, not by expert consensus in the same way it would be for image-based diagnostic AI.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for this type of device is the measurement from the predicate device, not a subjective assessment 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

Not applicable. This document describes an in vitro diagnostic device for laboratory analysis, 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 is an in vitro diagnostic assay, meaning its performance is inherently standalone (algorithm/reagent only). The method comparison study is effectively a standalone performance evaluation against a gold standard (the predicate device).

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

The ground truth for the performance evaluation was the results obtained from the predicate device (Roche UIBC). For this type of IVD, the predicate device's performance is considered the established method against which the new device is compared for substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The device's performance is based on chemical principles and reagent formulations.

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

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

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An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum and plasma. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

Not Found

The retrieved document is a 510(k) premarket notification letter from the FDA regarding the Olympus Unsaturated Iron Binding Capacity device. This type of document does not typically contain the detailed technical study information requested, such as specific acceptance criteria, performance data, sample sizes for test and training sets, ground truth establishment, or details about expert involvement and adjudication.

The letter primarily focuses on:

• Confirming the review of the premarket notification.
• Determining substantial equivalence to a predicate device.
• Stating the device's regulation number, regulation name, and regulatory class.
• Specifying the "Indications for Use" for the device, which is to measure iron-binding capacity in serum and plasma for the diagnosis and treatment of anemia.

Therefore, I cannot extract the requested information from the provided text.

To answer your questions, one would need access to the actual 510(k) submission document or supporting studies that detail the device's performance validation.

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The "Wiener lab. Fer-Color Transferrina" iron-binding capacity test system is a quantitative in vitro diagnostics device intended to measure iron-binding capacity in serum or plasma. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

End point method.
Transferrin or specific iron carrier protein is assayed through its physiologic activity of binding Fe (III) (TIBC) at a pH higher than 7.2 in which transferrin is saturated in the presence of excess Fe (III). The remaining unbound Fe (III) is totally removed by coprecipitation with magnesium carbonate. After centrifugation, iron in the supernatant is determined as follows: iron bound to transferrin is released and colorimetrically measured according to Fer-Color procedure.
Such measurement proceeds as follows: iron is released from its specific carrier protein (transferrin) in a pH 4.5 acetate buffer, and in presence of a reducing agent (ascorbic acid). Then it reacts with color reagent, pyridyl bis-phenyl triazine sulfonate (ferrozine) producing a colored complex measured at 570 nm.

The provided document is a 510(k) premarket notification for a medical device called "WIENER LAB FER-COLOR TRANSFERRINA", which is a photometric method for Total-Iron Binding Capacity determination. The document indicates that this device is substantially equivalent to a predicate device, the RANDOX TOTAL-IRON BINDING CAPACITY / IRON test system. However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation reports or performance studies.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway, rather than detailing a study against predefined acceptance criteria for novel claims.

Here's a breakdown of why the information isn't available in the provided text:

• Acceptance Criteria and Reported Device Performance: This information is not present. A 510(k) summary primarily focuses on comparing the new device to a predicate device to demonstrate substantial equivalence, not on establishing performance against specific acceptance criteria through a dedicated study with quantified results.
• Sample Size and Data Provenance: Not mentioned for any test set. The document does not describe a performance study with a distinct test set.
• Number of Experts and Qualifications: Not applicable as no expert-based ground truth establishment is described.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not mentioned. This type of study is more common for imaging or diagnostic devices where human interpretation plays a significant role. The device is a laboratory assay.
• Standalone Performance Study: A standalone performance study against explicit acceptance criteria with quantitative results is not detailed in this 510(k) summary. The comparison is between the new device and a predicate device.
• Type of Ground Truth Used: Not described. For laboratory assays, ground truth often involves reference methods or established clinical diagnoses, which are not outlined here as part of a formal study.
• Sample Size for Training Set: Not mentioned. The device appears to be a reagent-based assay, not a machine learning algorithm that would typically require a training set.
• How Ground Truth for Training Set was Established: Not applicable.

The document primarily states:

• Device Name: WIENER LAB FER-COLOR TRANSFERRINA
• Intended Use: Quantitative determination of Total Iron binding capacity in human serum and plasma. Used in the diagnosis and treatment of anemia.
• Predicate Device: RANDOX TOTAL-IRON BINDING CAPACITY / IRON test system.
• Equivalencies and Differences: A table comparing the intended use, test principle, reagents, and expected values between the new device and the predicate. The expected values for the Wiener Lab device are stated as 250 - 400 µg/dl. The RANDOX device states 46.0 - 69.5 µmol/l (259 - 388 µg/dl). This comparison serves as the basis for claiming substantial equivalence, implying that similar performance is expected.

To answer your request, a detailed performance study report with specific acceptance criteria and detailed statistical analysis would be required, which is beyond the scope of this 510(k) summary.

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The ADVIA IMS Unsaturated Iron Binding Capacity (UIBC) assay is an in vitro diagnostic device intended to measure iron binding capacity in human serum and dlagmostly are new inding capacity are used in the diagnosis and treatment of anemias.

Not Found

The provided document describes a 510(k) summary for a new in vitro diagnostic device, the ADVIA® IMS™ Unsaturated Iron Binding Capacity (UIBC) method. The summary focuses on demonstrating substantial equivalence to a predicate device, the Technicon CHEM 1. Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state formal "acceptance criteria" in terms of predefined success thresholds (e.g., "CV must be

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The Olympus AU5400 Clinical Chemistry Analyzer is a fully automated photometric analyzer intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay.

The Olympus AU5400 Clinical Chemistry Analyzer is a fully automated photometric analyzer.

While the provided document is a 510(k) clearance letter for the Olympus AU5400 Clinical Chemistry Analyzer, it does not contain the detailed performance study results, acceptance criteria, or ground truth information typically found in the actual 510(k) submission or a scientific publication.

The letter confirms that the device has been found substantially equivalent to predicate devices, meaning it is considered safe and effective for its indicated use. However, it does not explicitly state the specific performance metrics (like sensitivity, specificity, accuracy), the thresholds for acceptance of those metrics, or the specifics of the validation study.

Therefore, I cannot populate all the requested fields from the given text. I can only infer some information based on the nature of a 510(k) submission for a clinical chemistry analyzer.

Here's what I can convey based on the provided document and general understanding of 510(k) submissions for similar devices:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in the provided letter. For a clinical chemistry analyzer, acceptance criteria would typically involve demonstrating analytical performance similar to or better than a predicate device across various parameters, including:

  • Accuracy: Agreement with a reference method.
  • Precision (Reproducibility & Repeatability): Consistency of results.
  • Linearity: Accuracy across the analytical measurement range.
  • Detection Limits: Lowest concentration that can be reliably measured.
  • Interference: Lack of significant impact from common interfering substances.
  • Carry-over: Minimal contamination between samples.
  • Stability: Reagent and calibration stability.
  • Correlation: Strong correlation with predicate device or reference method.

• Reported Device Performance: Not explicitly stated in the provided letter. The 510(k) submission would have contained data supporting these performance characteristics, demonstrating that the device meets the established acceptance criteria. The FDA's clearance implies that this evidence was found satisfactory.

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

• Sample Size: Not specified in the provided letter. For a clinical chemistry analyzer, test sets would include a variety of patient samples (normal, abnormal) and spiked samples to assess different analytical aspects.
• Data Provenance: Not specified in the provided letter. Typically, clinical chemistry analyzer validation involves prospective collection of patient samples, often from multiple sites to ensure representativeness, as well as characterization of control materials.

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

• Experts and Qualifications: Not specified in the provided letter. For clinical chemistry analyzers, "ground truth" for analytical performance is typically established through:
  • Reference interval studies: Involving a statistically significant number of healthy individuals.
  • Comparison studies: Against a recognized reference method or a legally marketed predicate device, where the predicate device's results serve as the comparison standard.
  • Control materials and calibrators: With known, certified values.
  • Analytical experts (e.g., clinical chemists, laboratory directors) would be involved in designing and overseeing these studies, and interpreting the results.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable in the traditional sense for analytical performance of a clinical chemistry analyzer. Adjudication methods (like 2+1, 3+1) are typically used for subjective interpretations, such as image analysis or pathology review, where expert opinion is directly establishing "ground truth." For an automated analyzer, the output is quantitative, and performance is assessed against established analytical standards or comparison methods.

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

• MRMC Study: Not applicable. MRMC studies are used to evaluate human reader performance, often with AI assistance, for tasks involving interpretation (e.g., radiology). The Olympus AU5400 is an automated clinical chemistry analyzer that produces quantitative results, not an AI-assisted diagnostic imaging tool with human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: As an automated analyzer, the device's performance is inherently "standalone" in generating the quantitative results. The entire 510(k) submission would be focused on demonstrating this standalone analytical performance. However, there's no "algorithm only without human-in-the-loop" contrast needed, as the device's function is to perform the chemical analysis automatically.

7. The Type of Ground Truth Used

• Ground Truth Type: For a clinical chemistry analyzer, the "ground truth" is typically established through:
  • Reference methods: Highly accurate and validated analytical methods.
  • Certified reference materials/calibrators: Materials with known, traceable analyte concentrations.
  • Comparison to a legally marketed predicate device: Demonstrating equivalent performance to a device already on the market.
  • Pathology/Outcomes data: Would generally not be the primary "ground truth" for the analytical performance of the analyzer itself, though the results generated by the analyzer would be used in conjunction with such data for clinical decision-making.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable in the conventional machine learning sense. This device is a traditional analytical instrument, not a machine learning or AI model that requires a "training set" to learn its function. Its operational parameters are determined by its design, engineering tolerances, and chemical principles, not by training on a dataset.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" for a traditional clinical chemistry analyzer. The device's calibration involves using calibrator materials with known concentrations, but this is part of routine operation and quality control, not "training" in the ML sense.

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