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The µTASWako AFP-L3 Immunological Test System is an in vitro device that consists of reagents used with the uTASWako i30 Immunoanalyzer to quantitatively measure, by immunochemical techniques, AFP-L3% in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC) in conjunction with other laboratory findings, imaging studies and clinical assessment. Patients with elevated AFP-L3% values (≥ 10%) have been shown to be associated with an increase in the risk of developing HCC within the next 21 months and should be more intensely evaluated for evidence of HCC according to the existing HCC practice guidelines in oncology.

The uTASWako DCP Immunological Test System is an in vitro device that consists of reagents used with the µTASWako i30 Immunoanalyzer to quantitatively measure, by immunochemical techniques, DCP in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC) in conjunction with other laboratory findings, imaging studies, and clinical assessment.

The µTASWako i30 Immunoanalyzer is an in vitro diagnostic automated instrument intended for use to quantitatively measure analytes in clinical chemistry by immunochemical techniques. The uTASWako i30 Immunoanalyzer is indicated for use by healthcare professionals. It is intended for assays cleared or approved for use on this instrument.

The Wako uTASWako AFP-L3 Calibrator Set is designed to be used with the Wako µTASWako AFP-L3 Immunological Test System for the quantitative determination of AFP-L3% in human serum.

The Wako µTASWako AFP-L3 Control L is designed to be used as quality control material for the quantitative determination of AFP-L3% in human serum using the Wako µTASWako AFP-L3 Immunological Test System.

The Wako uTASWako AFP-L3 Control H is designed to be used as quality control material for the quantitative determination of AFP-L3% in human serum using the Wako uTASWako AFP-L3 Immunological Test System.

The Wako µTASWako DCP Calibrator Set is designed to be used with the Wako uTASWako DCP Immunological Test System for the quantitative determination of DCP in human serum.

The Wako µTASWako DCP Control L is designed to be used as a quality control material for the quantitative determination of DCP in human serum using the Wako µTASWako DCP Immunological Test System.

The Wako µTASWako DCP Control H is designed to be used as a quality control material for the quantitative determination of DCP in human serum using the Wako uTASWako DCP Immunological Test System.

The µTASWako i30 Immunoanalyzer System is a fully automated immunoassay system that can perform assays of the uTASWako AFP-L3 and µTASWako DCP Immunological Test Systems. This system automatically conducts sampling, mixing, separation, and fluorescence detection on a microfluidic chip to achieve high sensitivity and accuracy. The instrument contains an automated liquid dispenser, temperature controlled reagent container, chip station, analysis compartment, and sample rack station. The outside panel has a printer and a touch panel with a menu to order measurements and to check the availability for reagent, chip, wash solution, and pure water. A chip is used for each test and is disposable. The instrument is designed to automatically and constantly monitor the reagents, chips, dispensing system and the measurement process so that measurement results are not given when an error occurs.

The system is comprised of the following products:
uTASWako i30
uTASWako AFP-L3, Calibrator Set, Control L and Control H
uTASWako DCP, Calibrator Set, Control L and Control H
Instrument and assay accessories as per labeling

The provided text describes the performance data for the µTASWako i30 Immunoanalyzer System and its associated AFP-L3 and DCP immunological test systems. This is a medical device, and the criteria and studies described relate to analytical performance, not clinical diagnostic accuracy or reader studies with human experts.

1. Table of Acceptance Criteria and Reported Device Performance

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The APOLOWAKO T-CHO is for the quantitative determination on the APOLOWAKO analyzer of total cholesterol in whole blood. The APOLOWAKO HDL-C is for the quantitative determination on the APOLOWAKO analyzer of HDL cholesterol in whole blood. The APOLOWAKO TG is for the quantitative determination on the APOLOWAKO analyzer of triglycerides in whole blood. In conjunction with the above values, the APOLOWAKO analyzer also calculates LDL cholesterol for triglyceride values up to 400 mg/dL and T-CHO/HDL-C ratio.

APOLOWAKO Analyzer is a discrete photometric chemistry analyzer for clinical use in both central laboratories and in point of care sites. The device is intended to duplicate manual analytical procedures by automatically performing various steps such as pipetting, mixing and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in whole blood samples.

The measurements of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol (by calculation for triglyceride values up to 400 mg/dL) when used in conjunction with other biochemical markers and coronary risk factors, is useful in the prediction of CHD/CVD risk and the assessment of CHD/CVD severity.

The APOLOWAKO analyzer is a fully-integrated POC test system that can perform up to six analytical tests per individual sample. The analyzer automatically separates plasma from whole blood for testing. Once the plasma has been separated, it is transferred to a cell on a measurement disk where the chemical reactions take place. The analyzer uses liquid reagents which are packaged into kits. Each kit contains 2 reagent units. Each unit is composed of two enzyme color reagents and a lyophilized calibrator. All of the reagents have a reagent information tag applied to the back of each bottle which controls the reagent parameters and conditions such as, calibration, reagent quantity, shelf-life, and lot number. The instrument contains an automated liquid dispenser, temperature controlled reagent carrousel, analysis compartment, and sample holder. The instrument is designed to automatically and constantly monitor the reagents, dispensing system, measurement disk, and measurement process to ensure that no erroneous results are shown. The APOLOWAKO's lipid panel will include, total cholesterol, HDL cholesterol, LDL cholesterol (by calculation), and triglycerides in tubed venous whole blood. The test system is designed for professional use and consists of a small table top instrument (31 cm wide x 47.5 cm high x 56 cm deep, weight: 25 kg).

The provided text describes the Wako Diagnostics APOLOWAKO Lipid Panel and Analyzer, a point-of-care test system designed for the quantitative determination of total cholesterol, HDL cholesterol, and triglycerides in whole blood, with calculated LDL cholesterol. The device aims for substantial equivalence to the CHOLESTECH LDX system.

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

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

The document doesn't explicitly state "acceptance criteria" in a separate section. Instead, the performance characteristics (imprecision, linearity, interference) of the APOLOWAKO system are compared against or shown to be superior to those of the predicate device (Cholestech LDX) and demonstrate acceptable analytical performance. The substantial equivalence conclusion is based on comparable or better performance characteristics.

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The APOLOWAKO HbA1c and APOLOWAKO Glucose are for the quantitative determination on the APOLOWAKO analyzer of hemoglobin A1c (HbA1c) % and glucose in whole blood samples.

HbA1c- Measurement of % HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus.

Glucose- Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia and pancreatic islet cell carcinoma.

The APOLOWAKO analyzer is a fully-integrated POC test system that can perform up to six analytical tests per individual sample. For the HbA Ic test, whole blood, and not plasma, is used. For all other tests, the analyzer automatically separates plasma from whole blood for testing. Once the plasma has been separated, it is transferred to a cell on a measurement disk where the chemical reactions take place. The analyzer uses liquid reagents which are packaged into kits. Each kit contains 2 reagent units. Each unit is composed of two reagents and a calibrator. All of the reagents have a reagent information tag applied to the back of each bottle which controls the reagent parameters and conditions such as, calibration, reagent quantity, shelf-life, and lot number. The instrument contains an automated liquid dispenser, temperature controlled reagent carrousel, analysis compartment, and sample holder. The instrument is designed to automatically and constantly monitor the reagents, dispensing system, measurement disk, and measurement process to ensure that no erroneous results arc shown. The APOLOWAKO HbA1c and APOLOWAKO Glucose include hemoglobin A1c and glucose test reagents. The test system is designed for professional use and consists of a small table top instrument (31 cm wide x 47.5 cm high x 56 cm deep, weight: 25 kg).

The Wako Diagnostics APOLOWAKO HbA1c and APOLOWAKO Glucose test systems were evaluated for their ability to quantitatively determine hemoglobin A1c (HbA1c) % and glucose in whole blood samples.

1. Table of Acceptance Criteria and Reported Device Performance

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The L-Type Creatinine-M is an in-vitro assay for the quantitative determination of creatinine in serum, plasma, and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

L-Type Creatinine M is a reagent kit for creatinine assay based on the enzymatic method employing creatininase, creatinase, sarcosine oxidase and N-(3-sulfopropyl)-3-methoxy-5-methylaniline (HMMPS) as a new color agent.

Here's a breakdown of the acceptance criteria and study information for the L-Type Creatinine M device, based on the provided text:

Acceptance Criteria and Device Performance

The core of the acceptance criteria for the L-Type Creatinine M device is its substantial equivalence to the predicate device, Wako Creatinine HA. This is demonstrated through similar performance characteristics, particularly in correlation, linearity, and precision.

Study Details

Based on the provided text, the study focuses on analytical performance characteristics rather than clinical evaluation with human subjects.

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

   • Sample Size: Not explicitly stated as a number of individual patient samples. The correlation studies likely involved a range of samples to cover the linearity range. Precision studies used "3 levels of controls" with n=21 for within-run and data collected over 21 days for total precision.
   • Data Provenance: Not specified (e.g., country of origin). The studies appear to be laboratory-based analytical performance evaluations, not involving retrospective or prospective human clinical data in the traditional sense.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is an in vitro diagnostic (IVD) assay where "ground truth" for analytical performance is established through reference methods and reference materials, not expert consensus on human images or clinical outcomes.

3. Adjudication method for the test set: Not applicable. As an IVD assay's analytical performance study, there's no adjudication process as would be found in image-based diagnostic or clinical trial settings.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an IVD assay, not an AI-assisted diagnostic imaging device that involves human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Yes, the entire study describes the standalone analytical performance of the L-Type Creatinine M assay. It is an "algorithm only" in the sense that it's an automated chemical assay without human interpretation of results influencing its fundamental analytical performance.

6. The type of ground truth used:

   • For the correlation studies comparing to the predicate (Creatinine HA), the "ground truth" is essentially the results obtained from the predicate device (Wako Creatinine HA), which is a legally marketed device with established performance.
   • For linearity studies, the ground truth is established by preparing known concentrations of creatinine.
   • For precision studies, the ground truth is the "true" or assigned value of the control materials used.

7. The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set. Its "training" involves the chemical formulation and optimization of the reagents.

8. How the ground truth for the training set was established: Not applicable, as there is no "training set" in the context of device development for this type of IVD, as mentioned above.

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The Wako LBA DCP immunological test system is an in vitro device that consists of reagents and an automated instrument used to quantitatively measure by immunochemical techniques DCP in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma in conjunction with other laboratory findings, imaging studies and clinical assessment.

The Wako LBA DCP immunological test system is an in vitro device that consists of reagents and an automated instrument used to quantitatively measure by immunochemical techniques DCP in human serum. The Wako LBA DCP assay is test kit for the quantitative determination of DCP based on a new method, LBA (Liquid-phase Binding Assay). The method uses a liquid-phase binding reaction between antigen and antibody and separates bound and free forms by column chromatography without a need for a solid phase. LBA DCP can offer fully automatic and highly precise DCP measurement by using an automated analyzer "LiBASys". This reagent consists of anti-DCP monoclonal antibodies and anti-Prothrombin monoclonal antibodies which are used as Fab' molecules and a substrate for fluorophotometric measurement.

Here's a breakdown of the acceptance criteria and study details for the Wako LBA DCP immunological test system, based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided document defines the device's utility in terms of its ability to identify patients at risk of developing HCC. A specific threshold for DCP concentration (≥ 7.5 ng/mL) is used to categorize risk. The primary performance metric presented is the relative risk.

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Determination of serum and plasma bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice.

When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH3, direct bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the direct bilirubin concentration in the sample can be obtained by measuring the adsorbances before and after the vanadate oxidation.

This document is a 510(k) Summary of Safety and Effectiveness for the Wako Direct Bilirubin V assay. It highlights that the device is based on a chemical oxidation method and can determine direct bilirubin concentration in serum and plasma samples. The primary goal of the submission is to add plasma as an approved sample type to an already existing and approved device (Wako's previous Direct Bilirubin assay, 510(k) #970986).

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific performance acceptance criteria in numerical terms (e.g., sensitivity, specificity, accuracy thresholds). Instead, the crucial acceptance criterion for this 510(k) submission is "substantial equivalency" to the previously marketed device (Wako's Direct Bilirubin assay, 510(k) #970986).

The reported device performance is:

• "shows good correlation with conventional methods"
• "practically no interference by coexistent serum and plasma substances"
• "convenient ready-to-use liquid type reagent"

Table of Acceptance Criteria and Reported Device Performance:

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

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the submission adds the use of plasma as a sample to the previously cleared device. Therefore, any testing related to substantial equivalence for plasma samples would have been conducted, but the specific details are not included in this summary.

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

This submission describes an in vitro diagnostic (IVD) assay for measuring bilirubin, not an imaging device or one requiring expert interpretation of results for ground truth establishment. Therefore, the concept of "experts used to establish ground truth" as it applies to, for example, radiologists interpreting images, is not applicable here. The "ground truth" for chemical assays typically relies on established reference methods, calibrated standards, and a comparison to a predicate device.

4. Adjudication Method for the Test Set

Given that this is an IVD assay and not an imaging or interpretative device, an "adjudication method" in the sense of multiple experts resolving discrepancies is not applicable. Assay results are quantitative measurements, and accuracy is typically assessed against reference methods or the performance of a predicate device.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable for this type of in vitro diagnostic assay. MRMC studies are typically used to evaluate the diagnostic performance of human readers, often with and without AI assistance, in interpreting medical images or other complex data. This device is an automated chemical assay.

6. Standalone Performance Study

The information provided within this summary does not explicitly describe a separate "standalone" study in the way it might be for an AI algorithm. However, the 510(k) submission itself implicitly represents a standalone performance evaluation by comparing its performance to predicate devices (the previous Wako Direct Bilirubin assay) and conventional methods. The core of a 510(k) relies on demonstrating that the new device is "substantially equivalent" in performance to a legally marketed predicate device. This inherently means its performance was evaluated independently to make that claim.

7. Type of Ground Truth Used

The ground truth for chemical assays like this is typically established through:

• Comparison to established, validated reference methods: The summary mentions "good correlation with conventional methods," indicating such comparisons were likely part of the underlying studies.
• Calibrated standards: Assays are typically validated against precisely known concentrations of the analyte (bilirubin in this case).
• Performance of the predicate device: The primary ground truth for this specific submission is the performance of the legally marketed predicate device (Wako's previous Direct Bilirubin assay, 510(k) #970986), against which "substantial equivalency" is claimed.

8. Sample Size for the Training Set

The concept of a "training set" with a specified sample size is primarily relevant to machine learning or AI algorithms. This device is a chemical reagent-based assay. Therefore, a "training set" in the machine learning sense is not applicable. The development of such assays involves extensive R&D, formulation optimization, and analytical validation.

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

As noted above, a "training set" in the context of AI is not applicable for this chemical assay. The validation of the assay's chemical principles and performance would have involved laboratory studies using known bilirubin concentrations, spiked samples, and clinical samples analyzed by reference methods and the predicate device to ensure accuracy, precision, and linearity.

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Indication of serum and plasma bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice.

Wako Total Bilirubin V is based on a chemical oxidation method, utilizing vanadate as an oxidating agent, shows good correlation with conventional methods, practically no interference by coexistent serum and plasma substances, and is convenient ready-to-use liquid type reagent. When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH3, total bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the total bilirubin concentration in the sample can be obtained by measuring the adsorbances before and after the vanadate oxidation.

This submission is for a reagent, the Wako Total Bilirubin V assay, and thus the acceptance criteria and study design are related to the analytical performance of the assay rather than a diagnostic device that requires expert consensus or advanced imaging.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the Wako Total Bilirubin V assay. Instead, it relies on demonstrating "substantial equivalency" to a previously marketed device (510(K) # 970985).

The reported device performance, in terms of meeting implicit acceptance criteria, is based on the following:

• Substantial Equivalency: The key claim is that "The safety and effectiveness of the Wako Total Bilirubin V assay is demonstrated by its substantial equivalency to our previous Total Bilirubin assay (510(K) # 970985)."
• Correlation with Conventional Methods: The device "[Wako Total Bilirubin V] shows good correlation with conventional methods."
• Interference by Coexistent Serum and Plasma Substances: It demonstrates "practically no interference by coexistent serum and plasma substances."
• Convenience and Stability: It is also "convenient ready-to-use liquid type reagent."

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

Study Details

Given the nature of the submission (510(k) for an in vitro diagnostic reagent, primarily adding a sample type), the study described is an analytical validation comparing the new device to a predicate and conventional methods. It is not a clinical study involving human readers or extensive ground truth establishment in the way a diagnostic imaging device would be studied.

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

   • Sample Size: Not explicitly stated in the provided text.
   • Data Provenance: Not explicitly stated, but typical for such submissions would be laboratory-based analytical studies using human serum and plasma samples. It does not specify country of origin or whether it's retrospective or prospective, but these are generally prospective analytical studies for IVD reagents.

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

   • Not applicable in the sense of expert human interpretation of images/data. The "ground truth" (or reference values) would be established by the "conventional methods" mentioned (diazo coupling, bilirubin oxidase enzymatic method) which are laboratory-based chemical analyses, often performed by trained medical technologists or clinical chemists. No specific number or qualifications of individual "experts" are provided as this is a chemical assay validation.

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

   • Not applicable. This is an analytical performance study of a chemical reagent, not a diagnostic interpretation study requiring adjudication of expert opinions.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is not an AI-assisted diagnostic device, nor is it a study involving human readers.

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

   • This is inherently a "standalone" device in the sense that it is a chemical reagent that performs its function without a human-in-the-loop interpretative step once the sample is added. However, the term "standalone" usually refers to AI algorithms. In the context of IVDs, this refers to the assay's analytical performance on its own. The description implies such a standalone analytical validation was performed.

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

   • The "ground truth" for bilirubin measurement is established through reference laboratory methods, specifically the "conventional methods" like the diazo coupling method and the bilirubin oxidase enzymatic method, which are well-established chemical assays for bilirubin quantification.

7. The sample size for the training set:

   • Not applicable. This is a chemical reagent, not a machine learning algorithm that requires a "training set."

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

   • Not applicable. (See #7).

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The Wako AFP-L3% assay is intended as a risk assessment test for the development of hepatocellular carcinoma (HCC) in patients with chronic liver diseases (CLD). Elevated AFPL3% values (≥ 10%) have been shown to be associated with a seven-fold increase in the risk of developing HCC within the next 21 months. Patients with elevated serum AFPL3% should be more intensely evaluated for evidence of HCC according to the existing HCC practice guidelines in oncology.

The Wako AFP-L3% device consists of reagent 1 (LCA and anion 1-conjugated anti-AFP mouse monoclonal antibody), reagent 2 (horseradish peroxidase (POD)labeled anti-AFP mouse monoclonal antibody and anion 2 conjugated anti-AFP mouse monoclonal antibody, substrate 1 (4 acetamidophenol in 2-propanol) and substrate 2 (hydrogen peroxide) and a column. Reagent 1, reagent 2 and the column are ready-to-use. Elution buffers A to C, sample cups, inside and outside cuvettes are sold separately from kit.

The Wako AFP-L3 Calibrator set and Control set are sold separately. The calibrator set consisted of Calibrator 1 and 2. Calibrator 1 contains human AFP -L1 fraction and Calibrator 2 has human AFP-L3 fraction. The control set consisted of Control 1 and 2, each containing different concentrations of human AFP-L1 and L-3.

Here's an analysis of the provided 510(k) summary, extracting the requested information about acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance for Wako LBA AFP-L3

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary provided does not explicitly define acceptance criteria in a structured table for each performance characteristic. However, it presents measured performance values and, for linearity, implicitly sets criteria within the reported ranges for slope and R². For clinical performance, the intended use statement sets a clear threshold for risk assessment.

Here's an inferred table based on the provided data:

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

The primary clinical study involved 494 evaluable patients from:

• 6 US clinical sites (Lahey (MA), MCV (VA), Miami (FL), Mt. Sinai (NY), UCSF (SF), UPenn (PA))
• 1 Canadian clinical site (Toronto (Canada))

The study was a double-blind, multi-site prospective study. Serum samples were collected and stored frozen, and AFP-L3% tests were performed retrospectively by Wako Chemicals USA, Inc.

For the relative risk calculation, 57 patients from Group 4 (No HCC) were excluded due to less than 21 months of follow-up, resulting in a dataset of 312 patients (39 HCC, 273 No HCC) being used for the primary relative risk calculation.

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

The summary does not explicitly state the number or specific qualifications of experts used to establish the ground truth for the clinical study. However, the diagnosis of HCC for all enrolled patients was made by "at least one or a combination of the following observations," indicating clinical judgment by physician investigators:

• HCC result on a liver biopsy
• Enlarging mass by imaging (ultrasound, CT, MRI) with elevated serum total AFP
• Enlarging mass by CT or MRI in the setting of cirrhosis
• Very high serum total AFP (>400-500 ng/mL) alone
• At least 3 serial blood draws showing rising serum AFP in the setting of a liver mass
• Mass on CT scan enhancing in arterial phase and hypoattenuating in venous phase.

For evaluable subjects without HCC at enrollment, they were categorized by "the physician investigators" based on biopsy, explanted liver histology, and imaging results. This implies that the ground truth was established by the clinical team at each site.

4. Adjudication Method for the Test Set

The adjudication method for the test set is not explicitly described as a formal numerical system (e.g., 2+1, 3+1). Instead, the diagnosis of HCC was based on a combination of clinical observations and confirmatory tests, as determined by the "physician investigators." This suggests a consensus-based or standard clinical practice approach at each site, rather than a centralized, predefined adjudication panel for the study.

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

No MRMC comparative effectiveness study was done. This device is a quantitative immunoassay for a biomarker (AFP-L3%) and is not an imaging device or AI-assisted diagnostic tool that would typically involve human readers. The study focuses on the standalone performance of the test in assessing HCC risk.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)

Yes, a standalone performance study was done. The entire clinical study described is a standalone evaluation of the Wako AFP-L3% assay. The device measures AFP-L3% in serum, and its performance is evaluated based on its correlation with subsequent HCC development (risk assessment). Human intervention in the diagnostic process occurred after the test result was obtained, not as part of the test interpretation itself. The AFP-L3% values and the 10% cutoff are directly used to stratify patient risk.

7. Type of Ground Truth Used

The ground truth for the clinical study was primarily established through clinical diagnosis based on a combination of pathology (liver biopsy, explanted liver histology), imaging results (CT, MRI, ultrasound), and serial biomarker measurements (total AFP), as determined by physician investigators and standard oncology practice guidelines. This represents a robust clinical ground truth.

8. Sample Size for the Training Set

The 510(k) summary does not specify a separate training set for the clinical performance evaluation. The clinical study described appears to be the primary validation study (test set) for the device's intended use claim. For the analytical performance (precision, linearity, etc.), specific samples (control sera, spiked samples, diluted samples) were used, but these are not referred to as a "training set" in the context of machine learning model development. Given this is an immunoassay, the "training" aspect is more about assay optimization and standard curve generation during assay development than a machine learning training phase.

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

As no dedicated "training set" is identified in the context of a machine learning algorithm, this question is not directly applicable. For the analytical studies, the ground truth was inherently established by:

• Known concentrations in spiked samples.
• Reference materials (e.g., 1st International standard for AFP from WHO) for calibrator and control value assignments.
• Manufacturer-defined preparations for control sera (e.g., purified AFP-L1 and L-3 spiked into pooled serum).

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The Multi-Chem Calibrator A is designed to be used with Wako's assays to betermine The Multi-Offern Oulibratel free used in the determination of Calcium, FE, UIBC, Inorganic Phosphorus and Magnesium in human serum.

Not Found

This appears to be a 510(k) clearance letter from the FDA for a medical device. However, the provided document does not contain any information about acceptance criteria, study design, or device performance data.

The letter is a regulatory document affirming that the device, "Multi-Chem Calibrator A," is substantially equivalent to a predicate device and can be marketed. It lists the device name, regulation number, regulatory class, and product code, along with the device's intended use.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided input. The information you are looking for (acceptance criteria, study details, sample sizes, ground truth, etc.) would typically be found in the 510(k) summary, test reports, or clinical study reports, which are not part of this document.

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The Multi-Lipid Calibrator is designed to be used with Wako's assays to determine the points of reference that are used in the determination of HDL-C, LDL-C, Cholesterol, and Triglycerides in human serum.

Not Found

This looks like a 510(k) clearance letter for a medical device called "Multi-Lipid Calibrator." Based on the provided text, there is no information about acceptance criteria, device performance, a study, or any of the specific details requested in your prompt.

The document is an FDA clearance letter stating that the device is substantially equivalent to a legally marketed predicate device. It defines the device, its intended use, and acknowledges that the manufacturer can market it subject to general controls.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance study results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information is typically found in the 510(k) submission itself (which is not provided here) or in accompanying performance studies, not in the clearance letter.

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