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The Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human venous whole blood and hemolysate specimens using ion-exchange high performance liquid chromatography (HPLC).

This test is to be used as an aid in diagnosis of diabetes and identifying patients who may be at risk for developing diabetes, and for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

The Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human venous whole blood and hemolysate specimens using ion-exchange high performance liquid chromatography (HPLC). The Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 analyzer is to be used in the clinical laboratory setting. The analyzer hemolyzes and dilutes whole blood specimens and subsequently injects the diluted and hemolyzed sample into the injection valve and onto the TSKgel GR01 HbA1c Column. Manually hemolyzed and prediluted samples can be loaded in sample cups directly for analysis on the analyzer. Separation of hemoglobin fractions is achieved by using differences in ionic interactions between the cation exchange group on the column resin surface and the hemoglobin components by a step gradient elution with three elution buffers of different ionic strengths. Changes in light absorbance at 415nm caused by hemoglobin fractions eluting from the column are monitored. The GR01 software has chromatographic peak retention time windows for the six expected hemoglobin fractions, A1a, A1b, HbF, LA1c+, SA1c, and A0. In addition, the software has retention time windows for the presumptive identification of the common hemoglobin variants, D, S, C, and E. An analysis requires 50 seconds per sample to complete. A printout of the results includes the sample ID, date, percentage, and retention time of each hemoglobin fraction, the SA1c percentage along with a chromatogram of the elution pattern of the hemoglobin fractions. The analyzer is equipped with external USB ports. These can be used to store assay results, to update and backup program versions, to attach an external device, for example an external printer or an optional handheld barcode scanner, and for software installation or backup of data. The last 150,000 assay results are automatically saved to the analyzer's internal memory and can be retrieved as list data in .CSV format and chromatograms in .PDF format.

The Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 system consists of the following components.

• GR01 HbA1c Elution Buffer No. 1, No. 2, No. 3
• TSKgel® GR01 HbA1c Column
• Hemoglobin A1c Controls Levels 1 and 2
  • 21 CFR 862.1660, Product Code JJX
• Hemoglobin A1c Calibrator Set
  • 21 CFR 862.1150, Product Code JIT
• Hemolysis and Wash Solution (L) and (LL)
  • 21 CFR 864.8540, Product Code GGK

N/A

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The Tosoh ST AIA-PACK BNP assay is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of BNP in human (K2EDTA) plasma on Tosoh AIA System Analyzers. BNP is used as an aid in the diagnosis of heart failure (HF) in patients presenting to the emergency department (ED) with clinical suspicion of new onset HF, acutely decompensated or exacerbated HF.

The ST AIA-PACK BNP is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK BNP test cups. BNP present in the test sample is bound with monoclonal antibody immobilized on magnetic beads and enzyme-labeled monoclonal antibody. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the BNP concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using the curve.

The Tosoh ST AIA-PACK BNP Assay aims to extend its measuring interval beyond 2,000 pg/mL through manual and automated 1:5 and 1:10 dilutions. This is a special 510(k) submission, meaning it refers to a device that has already been cleared (K192380) and modifications were made to it that do not significantly alter its performance or safety (e.g., modified firmware, revised labeling, minor material changes, etc.). Since this is a Special 510(k) and not a de novo submission, this document is a justification for substantial equivalence to its predicate device (K192380), and does not contain detailed information for how the predicate device was evaluated.

Therefore, the study summary below only refers to the performance of the modified device compared to its predicate device, and not a full evaluation of the predicate device's performance.

1. Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample sizes used for the manual and automated dilution studies, nor does it specify the 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

Not applicable. The ground truth method does not involve human experts; it relies on direct measurement.

4. Adjudication method for the test set

Not applicable. The ground truth method does not involve human experts.

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 versus without AI assistance

Not applicable. This is not an AI-assisted diagnostic device, but an in vitro diagnostic assay.

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

Not applicable. This device is an in vitro diagnostic assay, not an algorithm.

7. The type of ground truth used

The ground truth used for both manual and automated dilution studies is the recovery value of the BNP concentration after dilution, indicating the accuracy of the dilution process. This is a direct measurement based on the expected concentration after dilution.

8. The sample size for the training set

Not applicable. This device is an in vitro diagnostic assay and does not involve machine learning or a training set.

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

Not applicable. This device is an in vitro diagnostic assay and does not involve machine learning or a training set.

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The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in venous whole blood specimens using ion-exchange high-performance liquid chromatography (HPLC). This test is an aid in diagnosis of diabetes and identifying patients who may be at risk for developing diabetes, and for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is an automated High-Performance Liguid Chromatography (HPLC) system that separates and reports stable hemoglobin A1c (sA1c) percentage in venous whole blood. The operational portion of the G8 is composed of a sampling unit, liquid pump, degasser, column, detector, microprocessors, sample loader, smart media card, operation panel, and a printer. The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 uses ion-exchange HPLC for rapid, accurate, and precise separation of the stable form of HbA1c (sA1c) from other hemoglobin fractions. The G8 uses a non-porous cation exchange column and separates the hemoglobin components in the blood. Separation is achieved by utilizing differences in ionic interactions between the cation and exchange group on the column resin surface and the hemoglobin components in a step gradient elution. The hemoglobin fractions (designated as A1a. A1b. F. LA1c+, SA1c, A0, and, if present, H-V0, H-V2, H-V2 and H-V3) are subsequently removed from the column by performing a step-wise elution gradient using the varied salt concentrations in the Variant Elution Buffers HSi 1, 2 and 3. The peaks, H-V0, H-V1, H-V2 and H-V3 are typically presumptive HbAD, HbAS, HbAC and HbAE respectively. The software compares the retention times of hemoglobin fractions in a sample to the expected "windows of retention" and labels each fraction that correctly elutes within a defined expected window of retention. The software designates a hemoglobin fraction as POX (where X is the order of the peak as it elutes from the column) if it does not match a defined window of retention. All automated processes in the G8 are controlled by internal microprocessors, using software downloaded via a smart media card. The result report is printed and can be stored on the instrument. The data can be transmitted to a host computer through a bi-directional interface. The result report includes the sample ID, date, percentage and retention time of each fraction of hemoglobin, sA1c percentage and total A1 percentage, along with a chromatogram of the elution pattern of the hemoglobin fractions. If a sample contains a hemoglobin variant, the column elutes the fraction depending upon its charge.

The provided text describes the non-clinical performance testing of the Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (subject device) to support its substantial equivalence to a predicate device. This document focuses on the analytical performance of a diagnostic device rather than an AI/ML powered device, so some of the specific questions regarding AI/ML study design (e.g., number of experts, adjudication methods, MRMC studies) are not applicable.

Here's the information extracted from the document:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the statement "All performance testing results met their pre-determined acceptance criteria." While explicit numerical acceptance criteria for each test are not listed in a consolidated table, the discussion throughout the "Summary of Non-Clinical Performance Testing" implicitly defines them through the methodology and results. For example, for precision/repeatability, the claim of "imprecision at ≤ 2%" was a pre-established criterion. Similarly, for hemoglobin variant interference, "Non-clinically significant interference was defined as <= 6% relative difference in the results from a comparative method."

It's important to note that the provided text is a 510(k) summary, which often summarizes detailed study reports. The full reports would contain explicit acceptance criteria thresholds.

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

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

• Precision/Repeatability Study:
  • Sample Size: Four concentrations of HbA1c% in K2EDTA venous whole blood. A total of 720 measurements per concentration were performed (three analyzers, over 20 non-consecutive days, with three reagent lots, samples run in duplicate, two times per day).
  • Data Provenance: The study was implicitly conducted retrospectively on collected samples. The country of origin is not explicitly stated, but the testing was performed at "Tosoh Bioscience, Inc." laboratories, likely in the US (given the South San Francisco address).
• Method Comparison Study:
  • Sample Size: 220 K₂EDTA venous whole blood specimens with HbA1c concentrations spanning the measuring range (4.0-16.9%). Each specimen was tested in duplicate.
  • Data Provenance: The study was conducted at "two separate sites," one a "moderate complexity clinical laboratory" (for the candidate device) and the other an "NGSP SRL" (for the comparator device). The precise country of origin is not explicitly stated. The specimens were collected and likely used retrospectively for the comparison.
• Endogenous Interfering Substances / Hemoglobin Variant Interference Studies:
  • Sample Size:
    • Endogenous interference: Not explicitly stated per substance, but specimens were "spiked with increasing amounts of the interfering substance."
    • Hemoglobin Variant Interference:
      • HbC: 26 samples
      • HbD: 24 samples
      • HbE: 26 samples
      • HbS: 29 samples
      • HbA2: 20 samples
      • HbF: 21 samples
  • Data Provenance: Not explicitly stated, but implies lab-tested, potentially spiked, and clinical samples from unknown origin (likely retrospective).

3. Number of Experts and Qualifications for Ground Truth:

This device is an automated in vitro diagnostic analyzer for quantitative measurement of HbA1c. The "ground truth" for such devices is typically established by:

• Reference methods (e.g., NGSP SRL certified methods).
• Traceability to international standards (DCCT, IFCC).
• Direct analytical measurements and statistical comparisons, rather than expert consensus on image interpretation.

Therefore, the concept of "number of experts used to establish the ground truth" similar to that in an AI imaging study is not applicable here. The ground truth is the chemical measurement itself, validated against recognized reference standards.

4. Adjudication Method for the Test Set:

Not applicable, as this is an analytical device for quantitative measurement, not an interpretative AI/ML system requiring human adjudication of results. The "adjudication" is through statistical agreement with reference methods and assessment against predetermined analytical performance criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. An MRMC study is relevant for AI/ML systems that assist human readers in tasks like image interpretation. This device performs automated quantitative measurements, and its performance is evaluated against reference methods and analytical standards, not human readers.

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 (Tosoh Automated Glycohemoglobin Analyzer HLC-723G8) without human intervention in the measurement process itself. The device is an automated HPLC system.

7. The Type of Ground Truth Used:

The ground truth for evaluating the subject device's performance is based on:

• Reference Methods: Specifically, the NGSP SRL (National Glycohemoglobin Standardization Program Secondary Reference Laboratory) using the Trinity Biotech Premier Hb9210™ HbA1c Analyzer (for method comparison) and Primus Model CLC 330 (for some hemoglobin variant interference testing), and the Bio-Rad VARIANT II TURBO HbA1c Kit - 2.0 (for some hemoglobinopathy interference testing).
• Traceability and Standardization: The device's results are traceable to the Diabetes Control and Complications Trial (DCCT) reference method and IFCC, and it is certified by the NGSP.
• Analytical Standards: For precision, linearity, and interference, the "ground truth" reflects the known concentrations of spiked samples or validated concentrations in patient samples, against which the device's measurements are compared.

8. The Sample Size for the Training Set:

The provided document describes non-clinical performance testing to support substantial equivalence after a software modification (v5.24). It does not provide information on the training set used for the development of the device's algorithms or software. This 510(k) summary is focused on verification and validation of the modified device.

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

This information is not provided in the 510(k) summary. Given that the device is an automated HPLC system, its "training" per se would involve optimization of its operational parameters, calibration curves, and potentially peak detection/integration algorithms, likely using well-characterized samples with known HbA1c concentrations established by reference methods. However, the details of such a "training set" and its ground truth establishment are not discussed here.

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The ST AIA-PACK hsE2 Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK hsE2 assay.

• 2 x 1 mL ST AIA-PACK hsE2 Calibrator (1) 0 pg/mL Human serum containing no detectable concentration of estradiol with sodium azide as a preservative.
• 2 x 1 mL ST AIA-PACK hsE2 Calibrator (2) 25 pg/mL (approx.)
• ST AIA-PACK hsE2 Calibrator (3) 50 pg/mL (approx.)
• ST AIA-PACK hsE2 Calibrator (4) 100 pg/mL (approx.)
• ST AIA-PACK hsE2 Calibrator (5) 500 pg/mL (approx.)
• ST AIA-PACK hsE2 Calibrator (6) 1,100 pg/mL (approx.)
  Human serum containing the assigned concentration of estradiol (described on each vial) with sodium azide as a preservative.
  ST AIA-PACK hsE2 Calibrator Set P/N # 025325
  The ST AIA-PACK hsE2 Calibrator Set is designed specifically for use on the Tosoh AIA System Analyzers which have been previously cleared as a family of instruments under K971103. Only materials obtained from Tosoh should be used. Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on Tosoh materials.
  The ST AIA-PACK hsE2 Calibrator Set is designed for use with ST AIA-PACK hsE2 and ST AIA-PACK hsE2 Sample Diluting Solution.

The provided document describes the ST AIA-PACK hsE2 Calibrator Set and its performance.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document details two types of stability studies, each with its own acceptance criteria and results for recovery and reproducibility (CV%).

Regarding Value Assignment, separate acceptance criteria are also provided:

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

• Real Time Testing: The calibrator sets were tested at 6, 12, and 13 months. The exact number of calibrator sets (samples) used for each time point is not specified, but it refers to "ST AIA-PACK hsE2 Calibrator Set" in plural.
• Open Vial Stability: Samples were reconstituted and stored for 0, 7, and 8 days. The exact number of samples tested for each time point is not specified.
• Value Assignment (200 Standard): 5 replicates on each of 2 analyzers and 3 lots of reagent were used. This means 5 * 2 * 3 = 30 measurements for the 200 Standard assignment.
• Value Assignment (ST-AIA PACK hsE2 Calibrator): 5 replicates of each calibrator level on 2 analyzers and 3 lots of reagent were used. For each calibrator level shown in the table (Cal 2-6), this means 5 * 2 * 3 = 30 measurements.
• Data Provenance: The document does not specify the country of origin but implies data was generated internally by Tosoh Bioscience, Inc. The studies appear to be prospective as they involve specific testing protocols to assess stability and value assignment.

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

This device is a calibrator set for an in vitro diagnostic assay. The "ground truth" here is the assigned concentration of estradiol, which is established through a metrological traceability chain rather than expert consensus on medical images or diagnoses.

• The calibrators are referenced to the IRMM (Institute for Reference Materials and Measurements) CRM577 (Traceability section).
• The 17β-estradiol chemical compound used is from SIGMA, derived from a plant source.
• The "experts" in this context are the analytical chemists and laboratory personnel conducting the value assignment studies, and ultimately, the established reference materials and their certification bodies (like IRMM). The document does not specify the number or qualifications of the personnel performing these lab tests.

4. Adjudication method for the test set:

Not applicable in the traditional sense of clinical interpretations. The "adjudication" for value assignment is based on meeting the predefined statistical acceptance criteria (<10% CV for grand mean).

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 is not applicable. The device is an in vitro diagnostic calibrator set, not an AI-assisted diagnostic tool that involves human readers.

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

This is not applicable. The device is a calibrator set, not an algorithm. Its performance is evaluated through analytical stability and accuracy against reference materials.

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

The ground truth for the assigned values of estradiol in the calibrator set is established through:

• Reference Materials: Specifically, the IRMM CRM577.
• Chemical Purity and Dilution: 17β-estradiol purchased from SIGMA and diluted in a base matrix.
• Analytical Measurement: Rigorous analytical testing using multiple replicates, analyzers, and reagent lots, with statistical criteria to assign values.

8. The sample size for the training set:

This is not applicable. As a calibrator set, it does not involve machine learning or a "training set" in the conventional sense of AI development. Its purpose is to calibrate a measurement system.

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

This is not applicable as there is no training set.

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The ST AIA-PACK PROG III Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK PROG III assay.

• 2 x 1 mL ST AIA-PACK PROG III Calibrator (1) 0 nq/mL Bovine protein matrix containing no detectable concentration of progesterone with sodium azide as a preservative (Liquid).
• 2 x 1 mL ST AIA-PACK PROG III Calibrator (2) 0.5 ng/mL (approx.)
• ST AIA-PACK PROG III Calibrator (3) 1.5 ng/mL (approx.)
• ST AIA-PACK PROG III Calibrator (4) 5.0 ng/mL (approx.)
• ST AIA-PACK PROG III Calibrator (5) 15 ng/mL (approx.)
• ST AIA-PACK PROG III Calibrator (6) 45 ng/mL (approx.)
  Bovine protein matrix containing the assigned concentration of progesterone (described on each vial) with sodium azide as a preservative.
  The ST AIA-PACK PROG III Calibrator Set is designed specifically for use on the Tosoh AIA System Analyzers which have been previously cleared as a family of instruments under K971103. Only materials obtained from Tosoh should be used. Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on Tosoh materials.
  The ST AIA-PACK PROG III Calibrator Set is designed for use with ST AIA-PACK PROG III and ST AIA-PACK PROG III Sample Diluting Solution.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them, formatted as requested:

Acceptance Criteria and Device Performance Study for ST AIA-PACK PROG III Calibrator Set

This document describes the ST AIA-PACK PROG III Calibrator Set, a device intended for in vitro diagnostic use for the calibration of the ST AIA-PACK PROG III assay. The information provided heavily focuses on stability and value assignment studies to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:
  • Real Time Stability: Not explicitly stated, but calibrator sets were assayed at 3, 6, and 9 months (implied multiple samples/replicates at each time point).
  • Open Vial Stability: Not explicitly stated, but samples were "reconstituted and stored... for 2 days and tested."
  • Value Assignment: 5 replicates of the test calibrator were analyzed for each calibrator level (Cal 2-6).
• Data Provenance: Not specified, but generally, such studies for regulatory submission are prospective and conducted in-house or by contract research organizations under the manufacturer's control. No country of origin is explicitly mentioned for the data itself, beyond the US location of the submitter.

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

• This device is a calibrator set for an in vitro diagnostic assay, not an AI or imaging device requiring human expert ground truth. The "ground truth" for calibrators is related to the reference materials and their assigned concentrations.
• For Value Assignment: The primary reference material was USP (United States Pharmacopeia) Standard (Lot #I1J239). The progesterone value of this reference material was assigned gravimetrically, which is a chemical/analytical method, not typically involving human expert consensus in the diagnostic sense.

4. Adjudication Method for the Test Set

• Not applicable. This is a calibrator set for an in vitro diagnostic device, and adjudication methods (like 2+1, 3+1 for medical image interpretation) are not relevant here. The evaluation relies on analytical performance criteria (recovery, CV%) against established reference values.

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

• No. This is not an AI or imaging device; therefore, an MRMC study is not relevant.

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

• The device itself is a calibrator, which is a reagent used by an instrument. Its performance is evaluated analytically, which is inherently "standalone" in the sense that its function (calibration) is determined by its chemical and physical properties and how it interacts with the instrument. There isn't an "algorithm only" performance metric in the typical sense of AI. The "algorithm" here is the assay procedure itself on the Tosoh AIA System Analyzers, and the calibrator's performance helps ensure the accuracy of that system.

7. The Type of Ground Truth Used

• Analytical/Reference Standard: The ground truth for the calibrator concentrations is established by referring to the USP (United States Pharmacopeia) Standard (Lot #I1J239). The values were assigned gravimetrically (for the primary reference material). This is a highly controlled chemical/analytical method, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. This is an in vitro diagnostic calibrator, not an AI model that requires a training set of data. The "training" in this context refers to the development and manufacturing of the calibrator itself, where the concentrations are established and verified against reference standards.

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

• Not applicable, as there is no "training set" in the AI sense for this type of device. The "ground truth" for the calibrator's assigned values is based on traceability to the USP (United States Pharmacopeia) Standard (Lot #I1J239), with primary reference material values assigned gravimetrically. These are highly standardized analytical procedures to ensure accuracy and consistency. The product calibrator values were then assigned using AIA-2000 instruments with the secondary reference material as calibrator.

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ST AIA-PACK 25-OH Vitamin D is designed for in vitro diagnostic use only for the quantitative measurement of total 25-hydroxyvitamin D (25-OH vitamin D) in human serum, Na-heparinized plasma or EDTA plasma on TOSOH AIA System Analyzers. The Tosoh ST AIA-PACK 25-OH Vitamin D is intended as an aid in the determination of Vitamin D sufficiency.

The ST AIA-PACK 25-OH Vitamin D Calibrator Set is intended for in vitro diagnostic use only for the calibration of the ST AIA-PACK 25-OH Vitamin D assay.

The ST AIA-PACK 25-OH Vitamin D is a one-step delayed competitive enzyme immunoassay which, after sample pretreatment, is performed entirely in the ST AIA-PACK 25-OH Vitamin D test cup. Sample pretreatment reagents (containing sodium hydroxide) disassociate 25-OH vitamin D from its binding proteins in the test sample. 25-OH vitamin D present in the pretreated sample is bound to 25-OH vitamin D-specific monoclonal antibody immobilized on magnetic beads. After that, the enzymelabeled 25-OH vitamin D is added to the reaction mixture. The enzyme-labeled 25-OH vitamin D competes with 25-OH vitamin D for binding to the antibody on magnetic beads in the reaction mixture.

After the second incubation, the magnetic beads are washed to remove the unbound enzymelabeled 25-OH vitamin D and are then incubated with a fluorogenic substrate, 4- methylumbellifery phosphate (4MUP). The amount of enzyme-labeled 25-OH vitamin D that binds to the beads is inversely proportional to the 25-0H vitamin D concentration in the test sample. A standard curve is constructed, and unknown 25-OH vitamin D concentrations are calculated using this curve.

The ST AIA-PACK 25-OH Vitamin D Calibrator Set contains human sera with assigned levels of 25-OH Vitamin D. The calibrator set consists of six calibrators with assigned concentrations of approximately 0, 8, 17, 33, 66 and 135 ng/mL. Each level contains the assigned concentration of the 25-OH vitamin D (described on each vial) with sodium azide as a preservative.

This looks like a 510(k) Summary for a medical device called "ST AIA-PACK 25-OH Vitamin D" and its associated calibrator set. The document describes the device, its intended use, and provides evidence of its performance and substantial equivalence to a predicate device.

Let's break down the requested information based on the provided text.

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

The document doesn't explicitly state "acceptance criteria" in a separate section with pass/fail thresholds against which the performance is measured. Instead, it presents performance characteristics and largely uses the performance of the predicate device or established clinical standards (like CLSI guidelines) as a benchmark for comparison or to demonstrate expected performance.

However, we can infer some criteria from the presented performance characteristics.

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

• Precision:
  • Sample Size: Three levels of unaltered serum specimens (Serum-B and Serum-C) and three spiked serum specimens (Serum-E and Serum-F) were assayed. Each level involved 2 replicates in a single run, 2 times a day for 20 non-consecutive days, across 2 analyzers and 2 lots of reagents. This totaled 40 runs and 80 determinants per lot.
  • Data Provenance: Not explicitly stated, but typically clinical laboratory studies are prospective and involve samples collected for internal validation or purchased from biorepositories. No country of origin is mentioned.
• Linearity:
  • Sample Size: Not explicitly stated, but typically involves a series of diluted samples to cover the assay range.
  • Data Provenance: Not explicitly stated.
• Standardization and Traceability (Method Comparison vs. RMP):
  • Sample Size: 111 serum specimens.
  • Data Provenance: The RMP (Reference Measurement Procedure) was performed at the University of Ghent, in Ghent, Belgium. The samples were value-assigned by the Ghent University ID-LC-MS/MS RMP. This suggests these were likely retrospective samples used for standardization purposes in a prospective study design to validate the device's traceability.
• Method Comparison (vs. Predicate):
  • Sample Size: 181 unaltered serum specimens.
  • Data Provenance: Not explicitly stated, but likely from various sources for routine clinical testing. Implied to be a prospective comparison study.
• Reference Ranges:
  • Sample Size: 252 serum samples (111 females, 141 males).
  • Data Provenance: Specimens were obtained from "apparently healthy individuals" in Maryland, Pennsylvania, Wisconsin, and Southern California (USA). Samples were collected in March, May, June, and July, indicating a prospective collection over several months.
• Limit of Detection and Limit of Quantitation:
  • LoB: 60 measurements of 3 different blank specimens.
  • LoD: 12 measurements of 5 low-level sample ranges, using 3 lots of reagents.
  • LoQ: Series of low Vitamin D samples assayed in replicates of 8 for 5 days (total 40 replicates per sample).
  • Data Provenance: Not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• For this in vitro diagnostic device, "ground truth" is primarily established by highly accurate reference methods or clinical standards, rather than expert consensus on interpretation.
• Standardization and Traceability: The ground truth for this segment was the ID-LC/MS/MS 25-OH Vitamin D Reference Measurement Procedure (RMP) at the University of Ghent. This is a highly specialized analytical chemistry method considered the "gold standard" for measuring 25-OH Vitamin D, not typically performed by individual "experts" in the clinical sense, but rather by trained laboratory personnel following precise protocols. The qualifications of the individuals performing the RMP are implied to be high-level analytical chemists/technicians experienced in ID-LC/MS/MS.

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

• Adjudication methods like 2+1 or 3+1 are typically used in clinical imaging studies where subjective interpretation is involved.
• For an in vitro diagnostic device measuring a quantitative analyte like 25-OH Vitamin D, the "adjudication" is inherent in the analytical method's precision, accuracy, and traceability to a recognized reference method (like the ID-LC/MS/MS RMP). Discordant results would be investigated through re-testing or troubleshooting, not through a consensus of human reviewers. Therefore, the concept of a multi-observer adjudication method is not applicable here.

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 is an in vitro diagnostic device for measuring a biochemical marker (Vitamin D). The concept of "multi-reader multi-case (MRMC) comparative effectiveness study" for human readers improving with or without AI assistance is not applicable to this type of device. There is no "reading" of images or complex data by human experts being assisted by AI in the context of this submission. The device performs an automated quantitative measurement.

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

• This device is an automated, standalone assay system. Its performance characteristics (precision, linearity, LoD, LoQ, method comparison) are its standalone performance without continuous human intervention in the interpretive phase. While humans operate the instrument and perform quality control, the measurement itself is algorithmic. Therefore, the presented studies (precision, linearity, method comparison, etc.) represent the standalone performance of the device algorithm.

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

• The primary ground truth used for validating the accuracy and standardization of the device is the Isotope Dilution-Liquid Chromatography/Tandem Mass Spectrometry (ID-LC/MS/MS) 25-OH Vitamin D Reference Measurement Procedure (RMP). This is a highly accurate and precise analytical method recognized as the gold standard for 25-OH Vitamin D measurement, traceable to NIST Standard Reference Material (SRM) 2972.

8. The sample size for the training set

• This document describes a 510(k) submission for a diagnostic assay, not a machine learning or AI algorithm in the context of typical training/test sets. The "training" for such an assay involves the development and optimization of the reagents, assay protocol, and calibration procedures using various samples. There isn't a single, defined "training set" sample size in the sense of AI model development.
• The "training" data, in an analogous sense, would be all the samples and experiments conducted during the development phase to establish the assay's performance characteristics, optimize reagent concentrations, and set initial calibrator values. This information is typically not detailed in a 510(k) summary as a single "training set."

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

• As mentioned above, the concept of a distinct "training set" with ground truth in the AI sense is not directly applicable here. However, the development and initial calibration of the assay would have relied on highly characterized samples, likely correlated with established reference methods or primary standards (such as those traceable to NIST SRMs) to ensure accuracy and consistency from the earliest stages of development. The subsequent "standardization" step (as described in the document, traceable to the University of Ghent's ID-LC/MS/MS RMP) represents a formal validation and adjustment process to ensure consistency with recognized reference methods.

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ST AIA-PACK SHBG is designed for In Vitro Diagnostic Use Only for the quantitative measurement of sex hormone binding globulin (SHBG) in human serum or Na heparinized plasma on Tosoh AIA System Analyzers. The ST AIA-PACK SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.

The ST AIA-PACK SHBG Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK SHBG assay.

The ST AIA-PACK SHBG is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK SHBG test cups. SHBG present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the test cups. The magnetic beads are washed to remove unbound enzyme-labeled antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the SHBG concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.

The provided text describes the performance characteristics of the ST AIA-PACK SHBG device, which is an in vitro diagnostic assay for measuring Sex Hormone Binding Globulin (SHBG). The studies conducted for this device do not involve AI or human readers for image interpretation, but rather focus on analytical performance criteria typical for a laboratory diagnostic assay. Therefore, questions related to AI assistance, human reader improvement, and adjudication methods are not applicable.

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

1. Table of Acceptance Criteria and Reported Device Performance

For analytical devices like the ST AIA-PACK SHBG, acceptance criteria are typically specified in terms of performance metrics like precision (CV%), linearity (measuring range), limit of detection (LoD), and correlation with a predicate device. The document generally presents the performance metrics achieved by the device without explicitly stating pre-defined "acceptance criteria" numerical targets. However, comparisons to the predicate device and CLSI guidelines serve as implicit benchmarks for acceptability.

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

• Precision Study:
  • Three levels of serum and heparinized plasma specimens were assayed.
  • Measurements were taken in 2 replicates in a single run, 2 times a day for 20 non-consecutive days.
  • This implies a total of 3 (levels) * 2 (matrices) * 2 (reps/run) * 2 (runs/day) * 20 (days) = 480 measurements per reagent lot, but the actual number of distinct biological samples is not directly specified beyond "three levels of serum and heparinized plasma specimens".
• Linearity Study: Sample size not explicitly stated for this particular study, but it was performed with guidance from CLSI Protocol EP6-A.
• Method Comparison: 126 serum specimens.
• Matrix Comparison: 116 patient specimens (diluted to obtain the low end of the measuring range).
• Reference Ranges Study: 488 apparently healthy American and European individuals (244 male and 244 female).
• Interference Study: Not specified, but involved adding various interfering substances to "human specimens".
• Limit of Detection (LoD) and Limit of Quantitation (LoQ):
  • LoD: 60 measurements of 4 different blank specimens; 12 measurements of 10 low-level samples.
  • LoQ: 12 measurements of 5 samples.

Data Provenance:

• Reference Ranges: "488 apparently healthy American and European individuals." This indicates a prospective collection from multiple geographical locations.
• For other studies (Precision, Method Comparison, Matrix Comparison, Interference, LoD/LoQ), the provenance (country of origin, retrospective/prospective) is not explicitly stated, but the use of "human serum or Na heparinized plasma," "patient specimens," and "human specimens" suggests clinical samples.

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

This information is not applicable as the device is an in vitro diagnostic assay that generates quantitative measurements of a biochemical marker (SHBG). The "ground truth" for such devices is established through analytical validation against reference methods or accepted standards, not through expert consensus on qualitative assessments like image interpretation. There are no "experts" in the traditional sense mentioned, but rather scientific and clinical validation methodologies.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as in point 3. Adjudication is typically relevant for studies where subjective interpretation (e.g., by radiologists) is part of establishing ground truth or evaluating performance, which is not the case for this quantitative 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

This information is not applicable. This device is a standalone laboratory assay and does not involve AI assistance or human readers for diagnostic interpretation in the manner described for MRMC studies (e.g., in radiology).

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

Yes, the studies performed (e.g., precision, linearity, LoD, method comparison) represent the standalone performance of the analytical instrument and assay kit. These tests evaluate the accuracy and reliability of the device's measurements directly, without human interpretation in the diagnostic pathway, other than performing the test and reviewing the quantitative results.

7. The Type of Ground Truth Used

The ground truth used for this device's validation is primarily reference methods and established analytical standards:

• Predicate Device Comparison: The ST AIA-PACK SHBG assay's performance was compared against the Abbott Architect SHBG Immunoassay (K060818), which serves as a legally marketed predicate and a standard for comparison.
• International Standards: The calibrators are traceable to the 2nd International Standard for SHBG from the National Institute for Biological Standards and Control (NIBSC) code 08/266. This is a critical aspect of establishing the "ground truth" for the quantitative values.
• CLSI Protocols: The studies were conducted with reference to widely accepted Clinical and Laboratory Standards Institute (CLSI) protocols (e.g., EP5-A2 for precision, EP6-A for linearity, EP9-A2 for method comparison), which define rigorous scientific methods for demonstrating analytical performance.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI, as this is an analytical diagnostic assay. The term "training set" would not typically apply here. Instead, numerous samples are used during the development and validation phases to establish the assay's performance characteristics. For example, during the creation of calibrators or development of the assay, various characterized samples would have been used.

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

As there is no "training set" in the context of AI/machine learning for this device, this question is not applicable. The ground truth for the assay's performance validation is established through comparison to predicate devices, traceability to international standards, and adherence to CLSI guidelines, as described in point 7.

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The AIA-PACK C-Peptide Control Set is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the ST AIA-PACK C-Peptide II assay.

2 x 2 mL AIA-PACK C-Peptide Control Level 1 Buffered bovine serum albumin containing approximately 2 nq/mL of C-peptide (Lyophilized). See the vial label for the assigned concentration range. AIA-PACK C-Peptide Control Level 2 2 x 2 mL Buffered bovine serum albumin containing approximately 20 ng/mL of C-peptide (Lyophilized). See the vial label for the assigned concentration range. The AIA-PACK C-Peptide Control Set contains buffered bovine serum albumin with assigned levels of C-peptide. The C-peptide controls shall be run at the beginning of each day on which C-peptide assays are scheduled.

This document describes the TOSOH BIOSCIENCE, INC. AIA-PACK C-Peptide Control Set, a quality control material. The provided text primarily focuses on demonstrating substantial equivalence to a predicate device and summarizing stability and value assignment studies. It does not contain information about a study proving the device meets clinical acceptance criteria for diagnostic performance, as it is a control set, not a diagnostic device itself.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance) are not applicable or discussed for this type of device (a quality control material).

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:
  • Stability Studies: Three different lots of the AIA-PACK C-Peptide Control Set were used as samples for the study.
  • In-Use Stability: A single lot of control set was used. Each specimen was assayed in 5 replicates.
  • Value Assignment: Two lots for control levels 1 and 2 were used. Measurements were made in 5 replicates.
• Data Provenance: Not explicitly stated, but clinical laboratory studies involving control materials are typically conducted internally by the manufacturer or by contract labs in the country where the manufacturer is based (USA in this case, based on the address provided). The studies described appear to be prospective studies specifically designed to assess the performance of the control set under various conditions.

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

• Not applicable. This device is a quality control material. Its performance is assessed against defined analytical criteria (recovery, reproducibility) rather than by expert clinical interpretation. The "ground truth" for the assigned values is established through a traceable process using reference materials, not expert consensus on diagnostic images or patient outcomes.

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

• Not applicable. This is a quality control material. Its performance is based on analytical measurements against pre-defined quantitative criteria.

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 device is a quality control material and not an AI-powered diagnostic device or a system intended for human reader assistance.

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

• Not applicable. This device is a quality control material; it does not involve an algorithm for diagnostic performance.

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

• For the stability and in-use studies, the "ground truth" is the expected original concentration of C-peptide in the control material, against which recovery and reproducibility are measured.
• For value assignment, the ground truth for the primary reference material was assigned based on C-Peptide of Human Insulin, International Reference Reagent (WHO International Reference Reagent). The secondary reference material and the control set values were then assigned using this primary reference material as a calibrator, following a hierarchical traceability scheme.

8. The sample size for the training set

• Not applicable. This is a quality control material; it does not involve a "training set" in the context of machine learning.

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

• Not applicable. There is no training set for this type of device.

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The ST AIA-PACK PROG II Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK PROG II assay.

2 x 1 mL ST AIA-PACK PROG II Calibrator (1) 0 ng/mL Protein matrix containing no detectable concentration of PROG with sodium azide as a preservative (Liquid).
2 x 1 mL ST AIA-PACK PROG II Calibrator (2) 0.5 ng/mL (approx.)
ST AIA-PACK PROG II Calibrator (3) 1.5 ng/mL (approx.)
ST AIA-PACK PROG II Calibrator (4) 5.0 ng/mL (approx.)
ST AIA-PACK PROG II Calibrator (5) 15 ng/mL (approx.)
ST AIA-PACK PROG II Calibrator (6) 45 ng/mL (approx.)
Human serum containing the assigned concentration of progesterone (described on each vial) with sodium azide as a preservative.

The ST AIA-PACK PROG II Calibrator Set is designed specifically for use on the Tosoh AIA System Analyzers which have been previously cleared as a family of instruments under K971103. Only materials obtained from Tosoh should be used. Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on Tosoh materials.

The ST AIA-PACK PROG II Calibrator Set is designed for use with ST AIA-PACK PROG II and ST AIA-PACK PROG II Sample Diluting Solution.

Here's a breakdown of the acceptance criteria and study information for the ST AIA-PACK PROG II Calibrator Set, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • For stability studies (Real-Time and Open Vial): The exact number of individual samples tested isn't explicitly stated, but it mentions "AIA-PACK Progesterone Calibrator Set were stored..." and "Samples were reconstituted..." implying multiple sets or vials.
  • For value assignment: 5 replicates for each of the 5 calibrator levels (Cal 2-6) were analyzed.
• Data Provenance: The document does not specify the country of origin for the data. The data appears to be prospective as it involves the testing of the newly formulated ST AIA-PACK PROG II Calibrator Set under defined conditions (stability studies, value assignment protocol).

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

• The document does not mention the use of experts to establish the ground truth for the test set.
• The ground truth for the calibrators is established through a chain of traceability:
  • Primary reference material uses USP (United States Pharmacopeia) Standard as calibrator.
  • Secondary reference material is assigned against the primary reference material.
  • Product calibrators are assigned against the secondary reference material.
• The "experts" are the "Tosoh AIA-2000" instruments and the established calibration process rooted in the USP Standard.

4. Adjudication Method for the Test Set

• No human adjudication method (e.g., 2+1, 3+1) is mentioned or implied for the test set.
• The determination of acceptance is based on quantitative measurements against predefined criteria (recovery % and CV%).

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, an MRMC comparative effectiveness study was not done.
• This device is a calibrator set for an in vitro diagnostic assay, not an AI-powered diagnostic tool that assists human readers. Therefore, this type of study is not applicable.

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

• This device is a calibrator set, not an algorithm. Therefore, "standalone algorithm performance" is not applicable in the context of AI.
• However, the performance of the calibrator itself is tested in a "standalone" fashion in that its stability and assigned values are determined within the analytical system (Tosoh AIA-2000 with the specified assay) without human interpretation being part of the performance measurement itself. The results are quantitative and objective based on instrument readings.

7. The Type of Ground Truth Used

• The ground truth for the calibrator values is established based on a reference standard and hierarchical assignment process:
  • The highest level of truth is the USP (United States Pharmacopeia) Standard for progesterone.
  • Subsequent calibrator lots and levels are then assigned values through a traceable process against this primary reference and internal secondary standards.

8. The Sample Size for the Training Set

• This document describes a calibrator set and its performance validation, not a machine learning or AI model. Therefore, there is no training set in the context of AI. The "training" for this device would be analogous to the manufacturing and value assignment process itself, ensuring each lot meets specifications.

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

• N/A, as there is no training set in the AI context. The ground truth for the calibrator's assigned values is established through traceability to the USP Standard as described in point 7.

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The ST AIA-PACK C-Peptide II Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK C-Peptide II assay.

2 x 1 mL ST AIA-PACK C-Peptide II Calibrator (1) 0 ng/mL Protein matrix containing no detectable concentration of C-peptide with sodium azide as a preservative (Liquid).
2 x 1 mL ST AIA-PACK C-Peptide II Calibrator (2) 0.5 ng/mL (approx.)
ST AIA-PACK C-Peptide II Calibrator (3) 2 ng/mL (approx.)
ST AIA-PACK C-Peptide II Calibrator (4) 6 ng/mL (approx.)
ST AIA-PACK C-Peptide II Calibrator (5) 15 ng/mL (approx.)
ST AIA-PACK C-Peptide II Calibrator (6) 33 ng/mL (approx.)
Protein matrix containing the assigned concentration of C-peptide (described on each vial) (Lyophilized).
The ST AIA-PACK C-Peptide II Calibrator Set is designed specifically for use on the Tosoh AIA Svstem Analyzers which have been previously cleared as a family of instruments under K971103. Only materials obtained from Tosoh should be used. Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on Tosoh materials.
The ST AIA-PACK C-Peptide II Calibrator Set is designed for use with ST AIA-PACK C-Peptide II, ST AIA-PACK C-Peptide Sample Diluting Solution, AIA-PACK C-Peptide Control Set.

Here's an analysis of the provided text regarding the ST AIA-PACK C-Peptide II Calibrator Set, focusing on acceptance criteria and supporting studies.

Based on the provided 510(k) Summary, this document primarily discusses the substantial equivalence of a calibrator set, not a diagnostic device with performance metrics like accuracy, sensitivity, or specificity in relation to a disease state. Therefore, many standard questions about AI device performance (like MRMC studies, standalone performance, training set details, expert qualifications for ground truth, etc.) are not applicable to this type of submission.

The "acceptance criteria" and "device performance" in this context refer to the stability and reproducibility of the calibrator set itself, not its diagnostic accuracy in patients.

1. Table of Acceptance Criteria and Reported Device Performance

This calibrator set's "performance" is assessed based on its stability and reproducibility rather than diagnostic accuracy.

The conclusions from these studies allowed the manufacturer to set:

• Shelf-life: 12 months at 2-8°C (based on 13-month data meeting criteria)
• In-use stability: 1 day (24 hours) after reconstitution at 2-8°C (based on 2-day data meeting criteria)

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

• Test Set (Stability Studies) Sample Size:
  • Shelf-Life Stability: Three different lots of calibrator set. Each specimen (presumably from each lot at each time point) was assayed in 5 replicates. This refers to the number of lots tested, not patient samples.
  • In-Use Stability: One lot of calibrator material. Three sets of calibrator material were opened and reconstituted. Urine, serum, and EDTA plasma specimens were chosen for this study. Each specimen was assayed in 5 replicates. The number of patient specimens (urine, serum, EDTA plasma) is not explicitly stated, only that such specimens were chosen.
• Data Provenance: Not specified, but generally for such in-vitro diagnostic (IVD) calibrators, the studies are conducted internally by the manufacturer. The text does not mention country of origin or whether the studies were external. The nature of the study (stability of a reagent) suggests it's prospective testing in a lab setting.

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

• Not applicable. This device is a calibrator set, not a diagnostic device requiring expert interpretation of results to establish a "ground truth" for clinical performance. Its "ground truth" (assigned C-peptide concentrations) is established through an analytical traceability chain to international standards (WHO 1ª IRP 84/510).

4. Adjudication Method for the Test Set

• Not applicable. There is no "adjudication" in the context of stability and reproducibility testing for a calibrator. The performance is assessed against predefined recovery and CV% criteria.

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

• No. This is not an AI-powered diagnostic device, and thus MRMC studies are not relevant.

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

• No. This is a calibrator product for an in-vitro diagnostic assay, not an algorithm.

7. The Type of Ground Truth Used

• Analytical Traceability to International Standard complemented by Internal Referencing: The assigned value of C-peptide in the primary reference material (which is then used to assign values to the calibrators) was based on WHO 1ª IRP 84/510. This is an internationally recognized reference preparation for C-peptide. Subsequent secondary reference materials and product calibrators are assigned values using Tosoh AIA instruments, comparing measured results with those obtained with previous lots or a primary reference.

8. The Sample Size for the Training Set

• Not applicable. This is a calibrator set, not an AI or machine learning model that requires a training set. The values are assigned based on analytical methods and traceability, not learned from data.

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

• Not applicable, as there is no "training set." The "ground truth" for the calibrator values is established through the analytical traceability described in point 7.

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