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For in vitro diagnostic use only.

For use in the calibration of the VITROS ECVECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of insulin in human serum and plasma (Li Heparin).

The VITROS® Immunodiagnostic Products Insulin Calibrators contain three levels of calibrator, Calibrator 1, 2, 3. Nominal values are 1 uIU/mL, 25 µIU/mL and 250 µIU/mL respectively. The calibrators are liquid and comprised of recombinant human insulin in buffer containing BSA with an antimicrobial agent. VITROS® Immunodiagnostic Products Insulin Calibrators kit contains 1 vial of each calibrator 1, 2, and 3. Each vial contains 1mL of calibrator.

This document is a 510(k) Premarket Notification from Ortho-Clinical Diagnostics, Inc. to the FDA regarding their VITROS® Immunodiagnostic Products Insulin Calibrators. It aims to demonstrate substantial equivalence to a legally marketed predicate device.

Based on the provided text, the device in question is a calibrator for in vitro diagnostic use, not an AI-powered medical device for image analysis or disease detection. Therefore, the questions related to AI performance metrics (like sensitivity, specificity, MRMC studies, human reader improvement with AI assistance, ground truth establishment for AI training sets, etc.) are not applicable to this submission.

The acceptance criteria and performance data for this type of device (a calibrator) typically revolve around analytical performance characteristics such as:

• Stability: How long the calibrator remains effective under different storage conditions (unopened shelf-life, opened on-board stability).
• Traceability: Ensuring the values assigned to the calibrators are linked to a recognized international standard.
• Value Assignment: The process by which the calibrator values are accurately determined.

Here's how the provided document addresses these aspects:

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

The document does not present a formal table of acceptance criteria with corresponding performance results in the way one would for an AI-powered diagnostic device (e.g., sensitivity/specificity targets). Instead, it discusses the studies and principles related to the calibrator's performance.

Acceptance Criteria (Implied for a Calibrator):

• Shelf-life: The calibrators must maintain their stated values and functionality for a specific duration when stored unopened.
• Opened Stability: The calibrators must maintain their stated values and functionality for a specific duration after being opened and placed on the instrument.
• Traceability: The assigned values must be traceable to an internationally recognized standard.
• Value Assignment Accuracy: The process for assigning values must be robust and accurate, ensuring reliable calibration curves.

Reported Device Performance (as described in the text):

• Unopened Stability: "Shelf-life of the VITROS Immunodiagnostic Products Insulin Calibrators will be determined by a real time stability study. The final shelf life claim will be based on the completed real time study results." (This indicates a study is ongoing/planned to establish the shelf-life, not that a final claim is being made in this report).
• Opened Stability: "Storage life for open vials of VITROS Immunodiagnostic Products Insulin Calibrators will be determined by a real time stability study and will support the open off board shelf life statement in the Instructions for Use." (Similar to unopened stability, the study is planned/ongoing).
• Traceability: "Values assigned to the VITROS Immunodiagnostic Products Insulin Calibrators are traceable to the WHO 1st International Reference Preparation 66/304."
• Value Assignment: "The Value assignment process transfers the calibration from the WHO Standard (66/304) to reference standards and then to calibrators used by the end user to establish a valid calibration curve on the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System."

Summary of Stability (from page 6):

• Unopened: "Store at 2-8°C until expiration date"
• Opened: "13 weeks"
  • Note: This appears in the "Comparison with Predicate - Differences" table (page 5), suggesting these are the claims for the new device, and the "Summary of Stability" on page 6 refers to the studies being conducted to support these claims, or previous studies that led to these claims. For the predicate device, opened stability is "Store at 2-8°C until expiration date."

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

The term "test set" in the context of AI models is not directly applicable here. For a calibrator, the "test set" would typically refer to the samples used in stability studies. The document states:

• "Shelf-life of the VITROS Immunodiagnostic Products Insulin Calibrators will be determined by a real time stability study."
• "Storage life for open vials of VITROS Immunodiagnostic Products Insulin Calibrators will be determined by a real time stability study."

Details on the sample sizes (e.g., number of calibrator lots, number of measurements per time point) or data provenance (country of origin) for these stability studies are not provided in this summary. The studies are described as "real time," indicating they are prospective studies.

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)

As this is a calibrator, "ground truth" is established via traceability to an internationally recognized reference preparation, not through human expert interpretation. The document states:

• "Values assigned to the VITROS Immunodiagnostic Products Insulin Calibrators are traceable to the WHO 1st International Reference Preparation 66/304."
  Therefore, human experts are not applicable for establishing "ground truth" in this context.

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

Not applicable. Adjudication methods are used in studies involving human interpretation or challenging diagnostic cases. For a calibrator, performance is assessed through analytical measurements and traceability, not through human adjudication of results.

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 calibrator, not an AI-powered diagnostic tool, and involves no human readers or image interpretation.

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

Not applicable. This device is a physical calibrator reagent, not an algorithm.

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

The ground truth for the calibrator's value assignment is based on traceability to a recognized international reference standard: "WHO 1st International Reference Preparation 66/304." This is a metrological ground truth for analytical measurement.

8. The sample size for the training set

Not applicable. As this is a calibrator for in vitro diagnostics, not a machine learning model, there is no "training set" in the AI sense. Calibration involves a direct measurement comparison against a reference, not a data-driven learning process.

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

Not applicable. See point 8.

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CalSet IGF-1 is used for calibrating the quantitative Elecsys IGF-1 assay on the Elecsys and cobas e immunoassay analyzers.

CalSet IGF-1 is used for calibrating the quantitative Elecsys IGF-1 assay on the Elecsys and cobas e immunoassay analyzers. CalSet IGF-1 is a two concentration level set of lyophilized human serum matrix that is traceable to the WHO IS 02/254 Reference Material. The CalSet includes:

• IGF-1 Call: 2 bottles, each for 1.0 mL of calibrator 1 .
• IGF-1 Cal2: 2 bottles, each for 1.0 mL of calibrator 2 .
  IGF-1 in two concentration ranges (approximately 20 ng/mL and approximately 500 ng/mL) in a human serum matrix.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CalSet IGF-1 device:

Acceptance Criteria and Device Performance Study for CalSet IGF-1

The CalSet IGF-1 is a calibrator used for the quantitative Elecsys IGF-1 assay. Its performance is primarily evaluated through studies demonstrating the stability and accurate value assignment of the calibrator itself.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes performance validation studies for the calibrator itself, rather than a diagnostic device tested on patient samples. Therefore, the concept of a "test set" in the context of patient data with country of origin and retrospective/prospective nature doesn't directly apply here.

• Value Assignment Test Set: For value assignment, calibrators are run in duplicate on four (4) cobas e 411 modules and four (4) modules of the MODULAR ANALYTICS E170/cobas e 602 with all Elecsys IGF-1 reagent lots available. The assigned value is the median over at least six (6) runs on at least three (3) modules.
• Stability Studies Test Set: For stability studies, "on-test and reference materials" (which are CalSet IGF-1 samples under different storage conditions) were tested in duplicate on the cobas e 411 immunoassay analyzer. A "freshly reconstituted set of CalSet IGF-1 (stored at 2 - 8°C)" served as the reference material for accelerated stability.
• Data Provenance: The studies were performed by Roche Diagnostics, a global company with facilities in Germany and the United States (as per the establishment registration numbers). The specific location where these studies were conducted is not explicitly stated, but it's internal company data for product validation. The data is prospective as it describes studies performed to validate the manufactured calibrator.

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 a calibrator, not a diagnostic tool requiring expert interpretation of patient data. The "ground truth" for the calibrator's value assignment is based on its traceability to a defined international standard (WHO IS 02/254 Reference Material) and the analytical performance of the Elecsys IGF-1 assay on specific immunoassay analyzers.

4. Adjudication Method for the Test Set

This is not applicable as the device is a calibrator. The value assignment process involves calculating a median value from multiple runs on multiple modules, which is an objective statistical calculation, not a subjective adjudication by experts.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that require human interpretation (e.g., radiologists reading images) where the AI assists the human reader. CalSet IGF-1 is a calibrator for an automated immunoassay, and human interpretation is not part of its intended use or evaluation.

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

The device itself is a calibrator, which functions without "human-in-the-loop" once it's used in the automated immunoassay system. The performance studies described (value assignment, stability) are essentially "standalone" evaluations of the calibrator's characteristics and its interaction with the specified immunoassay system. There isn't an "algorithm" in the typical sense; rather, it's a precisely defined chemical reference material.

7. The Type of Ground Truth Used

The ground truth for the CalSet IGF-1 is the WHO IS 02/254 Reference Material. This is an internationally recognized standard for IGF-1 quantification, providing the basis for traceability and accurate value assignment to the calibrator.

8. The Sample Size for the Training Set

This information is not applicable. The CalSet IGF-1 is a calibrator, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The calibrator's formulation and manufacturing processes are established based on scientific principles and analytical chemistry, not data training.

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

This information is not applicable. As stated above, there is no training set for this device. The ground truth for the calibrator's values is established through traceability to the WHO IS 02/254 Reference Material.

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The ARCHITECT Free T3 Calibrators are for the ARCHITECT i System when used for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.

The calibrators are devices intended for medical purposes for use in the ARCHITECT Free T 3 assay test system to establish points of reference that are used in the quantitative determination of values in the measurement of substances in human specimens. Free T3 measurements are used as an aid in the assessment of thyroid status. The calibrators are designed to be used on the ARCHITECT i System (i 2000gg, i 2000, and i 1000sR) with the ARCHITECT Free T3 Reagents. The ARCHITECT Free T3 Calibrator kit contains: ARCHITECT Free T3 Calibrator A contains human serum. Preservative: Sodium Azide. ARCHITECT Free T3 Calibrators B through F contain different concentrations of L-Thyroxine and L-Triiodothyronine prepared in human serum. Preservative: Sodium Azide.

This document does not describe a study involving an AI/Machine Learning device or diagnostic imaging. Instead, it is a 510(k) summary for a medical device called "ARCHITECT Free T3 Calibrators," which are used in laboratory settings to calibrate instruments for measuring Free T3 in human serum and plasma.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, study details, expert involvement, or ground truth for an AI/ML diagnostic imaging device, as this document pertains to a laboratory calibrator device.

The document focuses on demonstrating substantial equivalence to a predicate device, primarily by comparing:

• Intended Use: Remains the same.
• Instrumentation: Remains the same (ARCHITECT i System).
• Calibrator Levels: The candidate device uses 6 levels of calibrators (0.0, 1.4, 3.5, 7.0, 17.2, 30.0 pg/mL) compared to the predicate's 2 levels (1.4 and 30 pg/mL). This is a difference but is presented as an enhancement to provide broader calibration.
• Calibrator Composition: Similar, containing L-Thyroxine and L-Triiodothyronine in human serum with sodium azide as a preservative.
• Standardization Method: Remains the same (matched to an Abbott internal reference standard manufactured by gravimetric methods).
• Storage and Stability: Remains the same.
• Preparation for Use: Remains the same (ready to use).

The "study" described is a stability study for the calibrators, not a clinical trial evaluating diagnostic performance of an AI/ML algorithm.

Here's what the document mentions regarding acceptance criteria and the "study" for the calibrators:

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

The document doesn't provide a table of "acceptance criteria" in the sense of predefined performance metrics like sensitivity, specificity, or AUC for a diagnostic device. Instead, it discusses stability limits evaluation criteria for the calibrators themselves. The specific criteria are not detailed, but the results are reported:

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

• Sample Size for Stability Test: For the in-use condition, "a minimum of 10 replicates each of the on-test calibrators, reference controls, and reference panel" were used. For the real-time (closed vial) stability study, "three lots of test material" were stored and tested.
• Data Provenance: Not explicitly stated, but it's an internal study conducted by Abbott Laboratories. It's a prospective stability study.

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

Not applicable. This is a chemical/reagent calibrator, not a diagnostic device requiring expert interpretation of results for ground truth. The "ground truth" for the calibrators themselves is their assigned concentration values established by gravimetric methods and matching to internal reference standards.

4. Adjudication method for the test set:

Not applicable. This is not a clinical study involving human readers or interpretations.

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

Not applicable. This is not an AI/ML diagnostic device study.

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

Not applicable. This is for an in-vitro diagnostic calibrator.

7. The type of ground truth used:

• For the calibrators' intrinsic values: Gravimetric methods and matching to Abbott internal reference standards whose concentrations are established using L-Triiodothyronine (Liothyronine USP) and L-Thyroxine (Levothyroxine USP) as primary standards. This is a form of analytical ground truth based on chemical purity and precise measurement.
• For the stability studies: The "ground truth" is the initial assigned concentration of the calibrators and the expectation that their performance (as measured by the ARCHITECT i System) remains within acceptable limits over time.

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" for this calibrator device. Its "values" are assigned based on a defined manufacturing and standardization process, not learned from data.

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

Not applicable.

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Lumipulse G FSH-N Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G FSH-N on the LUMIPULSE G System.

Master calibration data are recorded in a two-dimensional bar code on the Lumipulse G FSH-N Immunoreaction Cartridge case. The calibration curve is created based on recorded master calibration data and the calibration data. The follicle-stimulating hormone (FSH) concentration of a specimen is automatically calculated from the calibration curve. The result of the calculation is reported in mIU/mL.

Lumipulse® G FSH-N Calibrators:

Lumipulse® G FSH-N Calibrators REF 230930 Each calibrator kit contains one bottle each of calibrators 1 - 2 and consists of the following:

CAL 1 0 mlU/mL FSH calibrator (1 x 1.5 mL) CAL 2 250 mlU/mL FSH calibrator (1 x 1.5 mL) *Contains follicle-stimulating hormone (FSH) in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.

Here's a breakdown of the acceptance criteria and study information for the Lumipulse® G FSH-N Calibrators, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Long-Term Stability (Tokyo, Japan):

  • 3 Lots of Lumipulse G FSH Calibrators.
  • 3 Lots of Lumipulse G FSH Immunoreaction Cartridges.
  • FSH solutions of 0 and 2 mIU/mL were measured in replicates of 3 at each test point.
  • 3 serum samples (ranged 10.5 - 185.0 mIU/mL) were tested in replicates of 3 for accuracy and replicates of 6 for reproducibility.
  • Provenance: Fujirebio, Inc. (Tokyo, Japan); data stored at 10°C, measured at 0, 3, 7, and 13 months.

• Real-Time (Intended Storage) Stability (Malvern, PA):

  • 3 Lots of Lumipulse G FSH-N calibrators.
  • Tested in duplicate at Month 0, 6, 12, and 13.
  • Provenance: Fujirebio Diagnostics, Inc. (Malvern, PA); study ongoing.

• Open-Vial (in-use) Stability (Malvern, PA):

  • 3 Lots of Lumipulse G FSH-N calibrators.
  • Tested in duplicate at Month 0, 6, 12, and 13.
  • Provenance: Fujirebio Diagnostics, Inc. (Malvern, PA); study ongoing.

• Transport Simulation (Tokyo, Japan):

  • Not explicitly stated, but the study implies testing of the Lumipulse G FSH-N Calibrators.
  • Replicates: Luminescence ratio (FSH-N calibrator 2 / FSH-N calibrator 1) for sensitivity, and single measurements (n=1) for accuracy.
  • Provenance: Fujirebio, Inc. (Tokyo, Japan).

• Transport Simulation (Malvern, PA):

  • Lumipulse G FSH-N Calibrators and Lumipulse G FSH-N ICs.
  • Calibrators were tested in duplicate, controls in replicates of 1, and panels in replicates of 3.
  • Provenance: Fujirebio Diagnostics, Inc. (Malvern, PA); study ongoing.

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

This device is a calibrator, not a diagnostic device requiring human interpretation of results. Therefore, the concept of "experts establishing ground truth" in the clinical sense (e.g., radiologists interpreting images) is not applicable here. The "ground truth" or reference values are established through metrological traceability and value assignment protocols.

4. Adjudication Method for the Test Set

Not applicable, as this is related to human interpretation and not directly relevant for a calibrator's performance evaluation.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This document describes performance of a calibrator.

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

Yes, the performance characteristics described (stability, traceability, value assignment, transport simulation) are all standalone performance evaluations of the calibrator product itself. The calibrator's ability to provide accurate and stable calibration values is assessed independently.

7. The Type of Ground Truth Used

The ground truth for the calibrators is established through a combination of:

• Metrological Traceability: Calibrators are traceable to the 1st International Standard, 1997 (code 92/510) provided by the National Institute for Biological Standards and Control (NIBSC).
• Gravimetric Preparation: Calibrators are prepared gravimetrically.
• Value Assignment Protocol: Involves provisional value assignment based on measurements using secondary calibrators, then rate-matching and adjusting tertiary calibrators to secondary calibrators.

8. The Sample Size for the Training Set

The concept of a "training set" in the context of an AI/machine learning algorithm is not applicable here. This device is a chemical calibrator for an immunoassay system, not an AI or algorithm that requires training data.

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

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

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Lumipulse G Progesterone-N Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G Progesterone-N on the LUMIPULSE G System.

Lumipulse G Progesterone-N Calibrator kit contains 3 bottles (1.5 mL each) of Lumipulse G Progesterone-N Calibrators 1, 2, and 3. Calibrators 1, 2, and 3 contain progesterone in 0.15 M sodium chloride in MES buffer with protein (bovine) and chemical stabilizers. Preservative: sodium azide.

Lumipulse G Progesterone-N Calibrators CAL 230893, Liquid 1x3 concentrations Each calibrator kit contains one bottle each of Calibrators 1 – 3. The calibrator kit is packaged separately.

CAL 1 0 ng/mL Progesterone calibrator (1 × 1.5 mL) CAL 2 0.5 ng/mL Progesterone calibrator (1 x 1.5 mL) 40 ng/mL Progesterone calibrator (1 x 1.5 mL) CAL 3 *Contains progesterone in 0.15 M sodium chloride in MES buffer with protein (bovine) and chemical stabilizers. Preservative: sodium azide.

This document is a 510(k) Premarket Notification for the Lumipulse® G Progesterone-N Calibrators. It focuses heavily on the stability and traceability of the calibrators rather than the performance of a diagnostic device in terms of clinical sensitivity or specificity. Therefore, many standard AI device performance metrics (like those relying on true positives, negatives, and human reader studies) are not applicable.

Here's an analysis of the provided text based on your request, highlighting what is and isn't available for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and performance data are primarily related to the stability and manufacturing consistency of the calibrators.

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

The "test set" in this context refers to the samples and calibrator lots used in the stability and value assignment studies.

• Long-Term Stability & Open-Vial/Real-Time Stability:
  • Calibrator Lots: 3 lots of reagents were used.
  • Calibrator Samples: Lumipulse G Progesterone-N Calibrator 1 and Calibrator 2 were tested in duplicate at each time point for sensitivity.
  • Serum Samples (for accuracy and reproducibility): 3 serum samples (concentrations: 3.15 - 24.42 ng/mL) were tested in replicates of 6 at each time point.
  • Data Provenance: Fujirebio, Inc. (Tokyo, Japan) and Fujirebio Diagnostics, Inc. (Malvern, PA). The studies are prospective in nature, as they involve monitoring stability over time.
• Value Assignment:
  • Replicates for provisional value: 6 replicates for initially assigned provisional value.
  • Replicates for assigned value: 10 replicates for primary calibrators and original calibrators over 3 runs on LUMIPULSE G.
  • Data Provenance: Implied to be internal studies at Fujirebio.
• Transport Simulation (Tokyo):
  • Specific sample count not provided beyond "the concentration of the panel replicates were determined."
  • Data Provenance: Fujirebio, Inc. (Tokyo, Japan).
• Transport Simulation (Malvern):
  • Calibrators were tested in duplicate, controls in singlicate, and panels in triplicate.
  • Data Provenance: Fujirebio Diagnostics, Inc. (Malvern, PA).

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

• Not Applicable. For a calibrator, the "ground truth" is established through highly controlled gravimetric preparations and traceability to international reference materials (ERM-DA347 and BCR-348R). This process does not involve human experts in the typical sense of interpreting diagnostic images or clinical outcomes. The "experts" would be analytical chemists or metrologists defining the concentration of the progesterone standard.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of results by multiple human readers (e.g., radiologists, pathologists). This document describes the analytical performance and stability of a calibrator, which involves quantitative measurements against predefined criteria, not human interpretation.

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

• No. MRMC studies are used to evaluate the impact of a diagnostic device (often AI-based) on human reader performance. This document concerns a calibrator, which is a component used in an in vitro diagnostic assay, not a diagnostic algorithm that assists human interpretation.

6. If a Standalone (Algorithm Only) Performance Study was Done

• No. This is not an AI algorithm. The device is a calibrator for an in vitro diagnostic test system (LUMIPULSE G System). The performance studies presented are for the calibrator's stability and accuracy in establishing known concentrations for the assay.

7. The Type of Ground Truth Used

The ground truth for the Progesterone-N Calibrators is established through:

• Metrological Traceability: Directly linked to internationally recognized reference materials (ERM-DA347 and BCR-348R by IRMM).
• Gravimetric Preparation: The calibrators are prepared by precise weighing of progesterone, ≥ 99%, from SIGMA-ALDRICH, dissolved in ethanol and spiked into a buffer.
• Assigned Values: The values are assigned based on measurements on the LUMIPULSE G system, cross-referenced with gravimetrically prepared stock solutions and ensuring the "mean ratio" (of primary to original calibrators) falls within an acceptable range (0.95 - 1.05).

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires a training set. The performance data relates to the physical and chemical properties of the calibrator itself.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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Lumipulse® GLH Calibrators are for in vitro diagnostic use in the calibration of Lumipulse GLH on the LUMIPULSE G System.

The Lumipulse® G LH Calibrator kit contains 2 bottles (1.5mL each) of Lumipulse® G LH Calibrators 1 and 2. Calibrators 1 and 2 contain luteinizing hormone (LH) in 0.15M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.

Lumipulse® G LH Calibrators CAL 230916, Liquid 1x2 concentrations

Each calibrator kit contains one bottle each of Calibrators 1 – 2. The calibrator kit is packaged separately.

CAL 1 0 mlU/mL LH calibrator (1 x 1.5 mL) CAL 2 250 mIU/mL LH calibrator (1 x 1.5 mL) *Contains luteinizing hormone (LH) in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide

The Lumipulse® G LH calibrator set is designed specifically for use on the LUMIPULSE® G System which has been previously cleared under K142895.

The provided text describes the Lumipulse® G LH Calibrators device, focusing on its regulatory approval, intended use, and performance characteristics, particularly its stability. This device is a calibrator, not a diagnostic or AI-powered imaging device, therefore many of the requested elements for AI/imaging studies are not applicable.

Here's the information extracted and organized based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a calibrator, and its performance is primarily assessed through stability studies and traceability.

2. Sample Size and Data Provenance

• Test Set (Stability Studies):
  • Shelf-Life Stability (Tokyo, Japan): Three lots of Lumipulse G LH Calibrators. Tested at Month 0, 3, 7, and 13.
    • Sensitivity: 0 and 20 mIU/mL LH solutions in replicates of 3.
    • Accuracy: 3 samples (5,850-162,217 mIU/mL) in replicates of 3.
    • Within-run Reproducibility: 4 samples (5.850-162.217 mIU/mL) in replicates of 6.
  • Transport Simulation Stability (Tokyo, Japan): Not explicitly stated as "samples" but implied for a single set of Lumipulse G LH Calibrators and other components.
    • Sensitivity: 0 and 2 mlU/mL LH solutions (replicates not specified but implied).
    • Accuracy: 3 control samples (4.1-55.6 mlU/mL) in replicates of 1, and 4 serum samples (11.1-294.0 mlU/mL) in replicates of 2.
  • Real-Time (Intended Storage and Open Use) Stability (Malvern, PA): Three lots of Lumipulse G LH Calibrators. Tested in duplicate at specified intervals up to 13 months. The number of "panels" is not specified but implied to contain various concentrations.
  • Transport Simulation Stability (Malvern, PA): Not explicitly stated, implied to be samples from the calibrator lots. Calibrators tested in duplicate, controls in replicates of 1, and panels in replicates of 3.
• Data Provenance:
  • Tokyo, Japan: Studies conducted at Fujirebio, Inc. with a predecessor instrument (LUMIPULSE Forte (f)) confirmed to have agreement with LUMIPULSE G1200. This is retrospective data for the "predecessor instrument," but it's used to support the current device.
  • Malvern, PA, USA: Studies conducted at Fujirebio Diagnostics, Inc. on the LUMIPULSE G1200 System. These are ongoing real-time studies, so they are prospective for the current device's claims.

The document does not specify a separate "test set" in the context of an algorithm's performance against ground truth, as it's a calibrator.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This is a medical device (calibrator) whose performance is evaluated through analytical studies, not expert review of images or clinical cases. The "ground truth" for calibrators is their assigned value and traceability to international standards.

4. Adjudication Method for the Test Set

Not applicable. This concept is typically used in clinical trials or diagnostic studies for resolving discrepancies in expert opinions. Performance here is based on quantitative analytical measurements.

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

Not applicable. This type of study is relevant for diagnostic imaging interpretation, assessing the impact of a device on human expert performance. This device is a calibrator for an in-vitro diagnostic assay.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical calibrator used within an assay system, not a standalone algorithm. Its performance is intrinsically linked to its use in the LUMIPULSE G System.

7. Type of Ground Truth Used

The ground truth for the Lumipulse® G LH Calibrators is established through:

• Traceability to International Standards: The calibrators are traceable to the 2nd International Standard, 1988 (code: 80/552) provided by the National Institute for Biological Standards and Control (NIBSC).
• Gravimetric Preparation and Value Assignment: Calibrators are prepared gravimetrically, and their values are assigned based on measurement against secondary calibrators, ensuring accuracy against the fundamental international standard.

8. Sample Size for the Training Set

Not applicable. This device is a calibrator, not an AI algorithm that undergoes "training." Its manufacturing and validation process (including stability and value assignment) are based on established analytical chemistry principles.

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

Not applicable (as above). The concept of a "training set" and "ground truth establishment" pertains to machine learning algorithms. For a calibrator, its "truth" is its certified concentration and its traceability to a universally accepted standard through rigorous analytical testing.

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Lumipulse G Prolactin Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G Prolactin on the LUMIPULSE G System.

Lumipulse G Prolactin Calibrator kit contains 2 bottles (1,5 mL each) of Lumipulse G Prolactin Calibrators 1 and 2. Calibrator 2 contains prolactin in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.

Lumipulse® G Prolactin Calibrators CAL 230954, Liquid 1x2 concentrations Each calibrator kit contains one bottle each of Calibrators 1 – 2. The calibrator kit is packaged separately.

CAL 1 0 ng/mL Prolactin calibrator (1 x 1.5 mL)
CAL 2 400 ng/mL Prolactin calibrator (1 x 1.5 mL)

Contains prolactin in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.

The provided text describes the performance characteristics and studies for the Lumipulse® G Prolactin Calibrators, a medical device used for in vitro diagnostic calibration.

Here's an analysis of the acceptance criteria and the studies performed, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This device is a calibrator, not a diagnostic test with typical sensitivity/specificity metrics. The performance criteria focus on its ability to provide stable and accurate reference points for the Lumipulse G Prolactin assay.

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

The document does not explicitly delineate a "test set" in the context of typical algorithm evaluation (e.g., retrospective vs. prospective patient data). Instead, the studies involve multiple lots of the calibrators themselves.

• Sample Size for Calibrators:
  • Long-term stability (Tokyo): 3 lots of reagents (calibrators and samples).
  • Value Assignment: 10 replicates of Lumipulse G Prolactin Calibrators and 10 replicates of secondary calibrators for calculation and adjustment.
  • Real-Time (Intended Storage) Stability (Malvern): 3 lots of calibrators.
  • Transport Simulation (Malvern): Not specified number of "calibrators" but describes the conditions and testing.
  • Open-vial (In-Use) Stability: Not specified number of calibrator vials directly, but "panels" are used for evaluation.
• Data Provenance:
  • Tokyo, Japan: Long-term stability and one transport simulation study were conducted here using the LUMIPULSE Forte (f) instrument (which uses the same cartridges and calibrators as the LUMIPULSE G1200 System).
  • Malvern, PA, USA: Real-time (intended storage) stability and a separate transport simulation study are ongoing at this location using the LUMIPULSE G1200 System.

Since this is a calibrator, the "data" primarily refers to the performance of the calibrator itself and its ability to maintain its specified values over time and under various conditions, rather than a patient dataset in the traditional sense. These are prospective studies of the calibrator product.

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

N/A. This is a calibrator, not a diagnostic device that interprets clinical output requiring expert review of medical images or patient data to establish ground truth. The "ground truth" for the calibrator levels and traceability is established through reference to an international standard (NIBSC 3rd International Standard, 1988 (code: 84/500)) and gravimetric preparation.

4. Adjudication Method for the Test Set

N/A. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers or experts provide independent assessments that then need to be reconciled for a definitive ground truth. This is not applicable for a device like a calibrator, where performance is measured against established analytical standards and physical properties.

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

N/A. This is a calibrator for an in vitro diagnostic assay, not an AI-powered diagnostic device or an imaging system. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

N/A. This is an in vitro diagnostic calibrator, meaning it's a physical and chemical component used to calibrate an automated assay system. It doesn't involve "algorithms" or "human-in-the-loop performance" in the way an AI diagnostic device would.

7. The Type of Ground Truth Used

The ground truth for the calibrators is established through:

• International Standard Traceability: The calibrators are traceable to the 3rd International Standard, 1988 (code: 84/500) provided by the National Institute for Biological Standards and Control (NIBSC).
• Gravimetric Preparation: The calibrators are prepared gravimetrically, meaning their concentrations are determined by precise weighing of components to achieve the desired analyte levels.
• Secondary Calibrator Rate-Matching: Calibrator 2 is rate-matched to a respective secondary calibrator.

This ground truth is based on established international standards and precise laboratory manufacturing and measurement techniques, rather than clinical outcomes or pathology.

8. The Sample Size for the Training Set

N/A. There is no "training set" in the context of artificial intelligence or machine learning for this device. The device is a calibrator, not an algorithm that learns from data.

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

N/A. As stated above, this device does not involve a training set for an algorithm.

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For IN VITRO diagnostic use as a calibrator in clinical chemistry assays for UIBC (Unsaturated Iron Binding Capacity). DC-UIBC-CAL may be used to check the linearity over the reportable patient range of UIBC assays.

DC-UIBC-CAL is a human based, lyophilized serum intended for use as a calibrator with Sekisui Diagnostics UIBC Assays. The concentrations and activities of the UIBC (Unsaturated Iron Binding Capacity) is optimized for the calibration of clinical chemistry systems - Beckman Coulter AU® Systems, Roche/Hitachi® Beckman Coulter SYNCHRON® Systems, and Cobas Mira®.

The DC-UIBC-CAL kit consists of the following:

Six vials with 10mL of lyophilized serum.

Human serum was used in the manufacture of this product. The human serum in this product has been prepared exclusively from the blood of donors tested individually and shown by FDAapproved methods to be free from HBsAg and antibodies to HCV and HIV. However, as no test method can rule out the potential risk of infection with absolute certainty, the material should be treated just as carefully as a patient sample. In the event of exposure, the directives of the responsible Health Authorities should be followed.

The provided text describes a 510(k) submission for a medical device called DC-UIBC-CAL, a calibrator for clinical chemistry assays. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than a full de novo performance study. As such, many of the typical elements requested for software-based AI/ML device studies are not present.

Here's an analysis based on the provided text, indicating where information is present and where it is not applicable or not provided:

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

The document does not explicitly state quantitative "acceptance criteria" in the format typically seen for diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device.

The reported performance is primarily around stability and traceability/value assignment.

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

The document relates to a calibrator, not a diagnostic test for patient samples. Therefore, the concept of a "test set" for patient data, sample size, and data provenance (country, retrospective/prospective) as typically applied to diagnostic algorithms is not applicable here.

The stability studies would have involved multiple units of the calibrator product. The traceability and value assignment involved using two reagent lots on instruments. No specific sample sizes for these internal validation tests are provided.

The device itself is manufactured using human serum, and mentions that "Human serum was used in the manufacture of this product."

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

This information is not applicable. The device is a calibrator, not an interpretative AI/ML diagnostic device. Ground truth for a calibrator relates to its chemical composition and assigned values, which are established through metrological traceability to reference materials (like NIST SRM 937) and internal protocols, not through expert human review of diagnostic outputs.

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

Not applicable for a calibrator device.

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

Not applicable. This is not an AI/ML diagnostic device for human interpretation.

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

Not applicable. This is a calibrator, a physical reagent device, not an algorithm.

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

The "ground truth" for the calibrator's UIBC concentration is established through metrological traceability to a reference material, specifically NIST SRM 937 (National Institute of Standards and Technology Standard Reference Material 937). Internal Sekisui protocols are also used for value assignment. This is a chemical/physical ground truth, not a clinical ground truth like pathology or patient outcomes.

8. The sample size for the training set

Not applicable. This is a calibrator, not an AI/ML algorithm requiring a training set.

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

Not applicable.

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Lumipulse & E2-III Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G E2-III on the LUMIPULSE® G System.

The Lumipulse G E2-III Calibrator kit contains 3 bottles (1.5mL each) of Lumipulse G E2-III Calibrators 1, 2 and 3. Calibrators 1 – 3 contain estradiol in 0.15M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.

Lumipulse G E2-III Calibrators CAL 233849. Liquid 1x3 concentrations Each calibrator kit contains one bottle each of Calibrators 1 – 3. The calibrator kit is packaged separately.

CAL 1 E2 calibrator 1 (1 × 1.5 mL)

E₂ calibrator 2 (1 x 1.5 mL) CAL 2

CAL 3 E2 calibrator 3 (1 × 1.5 mL)
*Contains 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.

The calibrator values vary for each lot. The actual values are printed on the calibration card included in the kit.

The provided document describes the Lumipulse® G E2-III Calibrators, which are intended for in vitro diagnostic use in the calibration of the Lumipulse G E2-III assay on the LUMIPULSE® G System. This device is a calibrator, not a diagnostic device that performs analysis or provides clinical outcomes, hence many typical performance metrics for diagnostic tools (like sensitivity, specificity, clinical cut-off, etc.) are marked as "Not applicable." The document focuses on the analytical performance related to being a calibrator.

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

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device as a calibrator, the performance metrics are related to its stability and value assignment, not diagnostic accuracy in the traditional sense.

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

• Sample Size for Test Set:
  • Shelf-life stability: 3 Lots of Calibrators, tested in replicates of 2 for sensitivity, and 3 serum samples (215.9 - 1530.2 pg/mL) in replicates of 6 for accuracy and reproducibility.
  • Transport Simulation (Japan Study): Not explicitly stated, but includes "calibrators" (plural) and "E2 calibrator 1 / E2 calibrator 6" for sensitivity, and "each calibrator" (n=1) for accuracy.
  • Real Time & Open-vial Stability (Malvern, PA Study): 3 Lots of Calibrators, tested in duplicate; controls in replicates of 1; panels in replicates of 3.
• Data Provenance: Studies were conducted at Fujirebio, Inc. (Tokyo, Japan) and Fujirebio Diagnostics, Inc. (Malvern, PA, USA). This indicates combination of international and USA-based data. The studies are prospective in nature, as they involve testing over specified intervals (e.g., 0, 1, 2, 4, 6, 9, 10, 13, 16 and 19 months for shelf-life stability).

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

Not applicable. This device is a calibrator, and its "ground truth" relates to its assayed values and stability, not interpretations by human experts in a clinical context.

4. Adjudication Method for the Test Set

Not applicable. The performance criteria involve analytical measurements (luminescence ratios, CVs, variation against assigned values), not subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic interpretation devices where multiple readers review cases. This device is a calibrator.

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

The device itself is a calibrator for an automated immunoassay system (LUMIPULSE® G System). Its performance is inherently "standalone" in the sense that it doesn't involve human interpretation to achieve its function. The studies evaluate the chemical and physical stability and accuracy of the calibrator itself for use in the automated system.

7. Type of Ground Truth Used

The ground truth for the calibrators is established through:

• Gravimetric preparation: Calibrators are prepared gravimetrically.
• Traceability to international standards: Traceable to BCR-577 by IRMM (Institute for Reference Materials and Measurements) and verified against ID-GC/MS.
• Rate-matching and measurement against secondary calibrators: Calibrator values are "rate-matched" and adjusted based on measurements in the Lumipulse G E2-III assay and comparison to secondary calibrators.
• Known concentrations: Target values are established for Calibrator 2 (50 pg/mL with a range of 40-60 pg/mL), Calibrator 1 (0 pg/mL), and Calibrator 3 (2000 pg/mL).

8. Sample Size for the Training Set

Not applicable. This device is a calibrator, not an AI/ML algorithm that requires a training set. Its function is to provide known reference points for an assay.

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

Not applicable, as there is no training set for a calibrator device.

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The ADVIA Centaur® Insulin (IRI) Master Curve Material (MCM) is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur® Insuin assay.

The ADVIA Centaur® Insulin (IRI) Calibrator is for in vitro diagnostic use in calibrating the ADVIA Centaur® systems Insulin assays.

ADVIA Centaur® Insulin (IRI) Master Curve Material is a set of ten vials of material containing various levels of insulin in buffered saline with casein, potassium thiocyanate (3.89%), sodium azide (

The provided text describes modifications to the "ADVIA Centaur® Insulin (IRI) Master Curve Material (MCM)" and "ADVIA Centaur® Insulin (IRI) Calibrator" and outlines the studies conducted to demonstrate their substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and the study information, extracting what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format with corresponding performance metrics for the modified devices. Instead, it states that "Verification testing was conducted and results show that the modified devices meet pre-determined acceptance criteria." and that a "method comparison study demonstrates that human clinical sample results are equivalent with both calibrators (modified and unmodified)."

However, based on the context, the implicit acceptance criteria and reported performance would be:

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