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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

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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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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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 < X%"). Instead, it presents performance data for the new device and the predicate device, implying that equivalence (or superior performance) to the predicate serves as the de facto acceptance benchmark for substantial equivalence.

Summary of Reported Device Performance:

• Imprecision: The ADVIA IMS showed lower Total CV% at higher UIBC levels (157 ug/dL and 537 ug/dL) compared to the CHEM 1 at comparable levels, indicating better precision. At the lower level, direct comparison is difficult due to different predicate concentration.
• Correlation (vs. CHEM 1): Very high correlation (R=0.997) and a low standard error of the estimate (Syx = 7.86 ug/dL) suggest strong agreement between ADVIA IMS and CHEM 1.
• Correlation (Plasma vs Serum): Excellent correlation (R=0.999) and low Syx (3.04 ug/dL) between plasma and serum samples on the ADVIA IMS, indicating that either sample type can be used.
• Interfering Substances: Bilirubin had a relatively small effect (-5% to -10%), but lipids (Triglycerides) showed a significant negative effect (-69%), which would require a cautionary note in the labeling.
• Analytical Range: 30 to 560 ug/dL is provided.

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

• Correlation (vs. Predicate):
  • Sample Size: 58 Serum samples
  • Data Provenance: Not explicitly stated (e.g., country of origin). It is retrospective as it compares the new device with an existing predicate using collected samples.
• Correlation (Serum vs Plasma):
  • Sample Size: 50 samples (presumably collected concurrently to compare serum and plasma from the same individuals)
  • Data Provenance: Not explicitly stated. Likely prospective for this specific comparison.
• Imprecision: Not specified, but typically involves repeated measurements of control samples or patient pools over several days.
• Interfering Substances: Not explicitly stated per substance, but involves specific concentrations of interferents added to samples.

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

This document describes the performance of an in vitro diagnostic (IVD) device that measures a specific analyte (UIBC) in a sample. The "ground truth" for such devices is established by reference methods or validated predicate devices, not by expert interpretation of images or other qualitative data. Therefore:

• Number of experts: Not applicable.
• Qualifications of those experts: Not applicable.

4. Adjudication method for the test set

Not applicable, as the "ground truth" is determined by quantitative measurements from validated methods/devices rather than human interpretation 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 is an IVD device for laboratory measurement, not an AI-assisted diagnostic imaging or interpretation system involving human readers.

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

Yes, the studies presented (Imprecision, Correlation, Interfering Substances, Analytical Range) represent the standalone performance of the ADVIA IMS device. This device functions as a laboratory analyzer, providing quantitative results directly from the sample without human intervention in the measurement process itself. The user interprets the numerical output.

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

The ground truth for this type of IVD device is based on recognized reference methods or the performance of a legally marketed predicate device.

• For the correlation study, the Technicon CHEM 1 (the predicate device) served as the reference for comparison of UIBC values.
• For imprecision, the "ground truth" is the true analytical variability inherent in the method when measuring known concentrations.
• For interfering substances, the "ground truth" is the UIBC concentration of samples without the interferent added.

8. The sample size for the training set

Not applicable for this type of IVD device. This device is based on chemical reactions and optical detection, not machine learning or artificial intelligence that requires a "training set."

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

Not applicable, as no "training set" is used for this type of IVD device.

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The Total Iron Binding Capacity (IBCT) Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure total iron binding capacity in human serum and plasma. Measurements of total iron binding capacity are used in the diagnosis and treatment of iron deficiency anemia and chronic inflammatory disorders.

The IBCT method for the Dimension® clinical chemistry system is a fully automated assay in which serum or plasma is mixed with a ferric iron solution, to saturate all available iron-binding sites of transferrin in the sample. Under non-acidic conditions (pH 8.6), only unbound, excess saturating iron is available to be reduced to ferrous iron by ascorbic acid and to form a blue complex with Ferene®. Subsequent addition of acid (final pH of 4.5) releases the iron bound to transferrin; this additional iron is reduced to ferrous iron by ascorbic acid and forms an increased amount of blue complex with Ferene®. The increase in absorbance upon shifting from pH 8.6 to pH 4.5, measured using a bicromatic (600,700 nm) endpoint technique, is proportional to the concentration of transferrin-bound iron, and thus to the iron binding capacity (total) of the serum or plasma sample.

The provided document is a 510(k) summary for the "Total Iron Binding Capacity (IBCT) Flex® reagent cartridge". It describes a device that measures total iron binding capacity in human serum and plasma and compares its performance to a predicate device.

Here's an analysis based on the provided text to answer your questions:

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and the Reported Device Performance:

Note: The document does not explicitly state pre-defined acceptance criteria values for the correlation coefficient, slope, or intercept. However, for a device to be considered "substantially equivalent" to a predicate, these values would implicitly need to fall within an acceptable range, with 0.971 for correlation generally indicating strong agreement.

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

• Sample Size for Test Set: 137 clinical patient samples.
• Data Provenance: Not explicitly stated, but given it refers to "clinical patient samples," it is implied to be from patient populations. It does not mention country of origin or whether it's retrospective or prospective.

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

• Not applicable for this type of device and study. The "ground truth" in this context is the quantitative measurement provided by the predicate device (Dimension® Total Iron Binding Capacity (TIBC) Flex® reagent cartridge). Expert consensus is not used to establish the reference values for these types of clinical chemistry assays.

4. Adjudication method for the test set:

• Not applicable. This is a quantitative comparison study between two diagnostic devices, not a study involving human interpretation 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:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is a performance comparison of an in-vitro diagnostic device against a predicate device, not an AI-assisted human reader study.

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

• Yes, this study represents a standalone performance comparison. The IBCT Flex® reagent cartridge, when used with the Dimension® clinical chemistry system, operates as an automated assay without human intervention in the measurement process itself, similar to the predicate device. The performance data presented (correlation, slope, intercept) indicates its direct measurement capabilities.

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

• The "ground truth" was established by the predicate device, the Dimension® Total Iron Binding Capacity (TIBC) Flex® reagent cartridge (K864230). The study performed a split sample comparison, meaning both the investigational device and the predicate device measured the same clinical patient samples, and the predicate's results served as the reference for comparison.

8. The sample size for the training set:

• Not applicable. This is a comparison study for an in-vitro diagnostic reagent cartridge, not a machine learning or AI algorithm that requires a "training set." The device is a chemical reagent-based assay.

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

• Not applicable, as this device does not involve a training set.

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The Total Iron Binding Capacity (TIBC) reagents, product No. FE109-01, FE109-02 and The Total Iron Binding Capacity (TIDO) reagones processor seni-automated, quantitative determination of TIBC in serum, or plasma.

Not Found

This document is a 510(k) clearance letter from the FDA for a Total Iron Binding Capacity (TIBC) device. It confirms the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain the detailed study information required to answer your questions regarding acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment. The document is primarily an FDA regulatory approval letter and an "Indications For Use" statement.

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

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The total iron reagents: Buffer, pH 4.5 (R1), product No. FE109-01 and Color reagent, product No. FE109-02 are intended for use in the automated, quantitative determination of Total Iron in serum, or plasma.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the "TOTAL IRON" device. It acknowledges that the device is substantially equivalent to legally marketed predicate devices for the "automated, quantitative determination of Total Iron in serum, or plasma."

However, this letter does not contain any information regarding specific acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment. It is a regulatory approval document based on substantial equivalence, not a detailed scientific study report.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and device performance, or describe the study details using the provided input. This document only states the intended use and regulatory classification.

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