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The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

For In Vitro Diagnostic Use Only.

Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analytes listed in the lot specific assigned values sheet.

The Fujirebio Diagnostics Tumor Marker Controls are used for validation of each HE4 EIA assay series. The HE4 EIA results should be considered valid if the mean HE4 values of control duplicates are within the specified HE4 EIA ranges indicated on the Assigned Value Sheet provided with the Fujirebio Diagnostics Tumor Marker Controls.

This submission is for a control device (Fujirebio Diagnostics Tumor Marker Control) intended to replace existing controls for the HE4 EIA kit. Therefore, the "device" in question is the control material itself, not a diagnostic test that detects a medical condition. As such, concepts like "test set," "ground truth," "expert consensus," "MRMC study," and "standalone performance" are not applicable in their usual diagnostic sense. The study focuses on verifying the control's performance to ensure it effectively monitors the precision of the HE4 EIA assay.

Here's an analysis based on the provided document, addressing the closest equivalent concepts for a control device:

Acceptance Criteria and Device Performance Study for Fujirebio Diagnostics Tumor Marker Control

The purpose of this 510(k) submission is to replace the current HE4 EIA kit controls with the Fujirebio Diagnostics Tumor Marker Control. The study focuses on demonstrating that the new control material performs equivalently and reliably to the predicate controls for monitoring the precision of the HE4 EIA assay.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported performance relate to the value assignment process for the control materials. The key performance indicators are related to the precision and stability of the control material when assayed with the HE4 EIA kit.

Note: The document describes the methodology for establishing the assigned values and ranges for the new controls, rather than presenting a direct "results" table showing statistical verification of each acceptance criterion post-study. The implication is that the study was conducted to meet these criteria. The "Target HE4 Concentrations" for the new device (75 and 500 pM) are different from the predicate (50 and 400 pM), which is explicitly stated as acceptable since the HE4 EIA range is 15-900 pM.

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

For value assignment of the Fujirebio Diagnostics Tumor Marker Control (K101809):

• Sample Size: 24 replicate analyses.
• Data Provenance: The replicates were collected in 4 independent runs, using "Different HE4 EIA kit reagent combinations in each run." The country of origin is not specified but implicitly Fujirebio Diagnostics, Inc. (Malvern, PA, USA is the submitter). The data is prospective as it was generated specifically for this submission.

For value assignment of the Predicate HE4 EIA kit controls (K072939):

• Sample Size: 26 replicate analyses.
• Data Provenance: Collected in 2 independent runs, using the "Same HE4 EIA kit reagent combination in each run." The country of origin is not specified.

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

This question is not applicable in the traditional sense for a control material. The "ground truth" for a control material is its assigned value, which is established through rigorous laboratory testing and statistical analysis, not expert interpretation of diagnostic images or clinical scenarios. The "experts" involved would be the laboratory scientists and statisticians who designed and executed the value assignment studies according to established protocols. Their specific number and qualifications are not detailed in this summary.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies in expert interpretations (e.g., in medical image analysis). For a control material's value assignment, the "adjudication" is inherent in the statistical methods used to calculate the mean and standard deviation from replicate analyses, and the predefined criteria for acceptance (e.g., CV% limits, mean falling within ±2SD).

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 question is not applicable. An MRMC comparative effectiveness study involving human readers and AI assistance is relevant for diagnostic devices that aid human interpretation. This submission is for a quality control material which does not involve human readers interpreting clinical cases or AI.

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

This question is not applicable. This is a control material, not a diagnostic algorithm. Its "performance" is in its ability to reliably produce expected results within defined ranges when tested with the HE4 EIA assay.

7. The type of ground truth used

For a control material, the "ground truth" is its assigned value and accepted range for HE4 concentration, established through a rigorous laboratory testing procedure outlined in item #2 and #9. This is not expert consensus, pathology, or outcomes data, but rather a derived value based on analytical measurements using a validated assay.

8. The sample size for the training set

This concept is not applicable for a control material. There is no "training set" in the context of machine learning or diagnostic algorithm development. The data described in section #2 for value assignment is analogous to characterization data for the control material itself.

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

This question is not applicable for a control material as there is no "training set." The "ground truth" (assigned values and ranges) for the control materials (both the new and predicate) was established through the following methods as described in the "Value Assignment comparisons" section:

• Fujirebio Diagnostics Tumor Marker Control (K101809):

  • 24 replicate analyses collected in 4 independent runs.
  • Different HE4 EIA kit reagent combinations were used in each run.
  • Criteria for value assignment: CV < 8% within run, and the mean value for each run had to be within ± 2SD for the other 3 runs.
  • Assigned range for Control Level 1: Total Mean ± 2SD, but not less than ± 30%.
  • Assigned range for Control Level 2: Total Mean ± 2SD, but not less than ± 25%.

• Predicate HE4 EIA kit controls (K072939):

  • 26 replicate analyses collected in 2 independent runs.
  • The same HE4 EIA kit reagent combination was used in each run.
  • Criteria for value assignment: Total CV% ≤ 5.
  • Assigned range for Control Level 1: Total Mean ± 30%.
  • Assigned range for Control Level 2: Total Mean ± 20%.

In summary, the study validates a laboratory control material, not a diagnostic algorithm. The "acceptance criteria" and "study" revolve around demonstrating the analytical performance and stability of the control material to ensure it accurately monitors the precision of the HE4 EIA assay.

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For In Vitro Diagnostic Use Only.

Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA.

This quality control product can be used as an objective judgment of the laboratory's procedures and personnel techniques. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing systems within the clinical range.

This document describes the Fujirebio Diagnostics Tumor Marker Control, a quality control product intended to monitor the precision of laboratory testing procedures for various tumor markers. It is a Class I, reserved medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative sense for the device's performance as a control material. Instead, its performance is measured by its equivalence to a predicate device in terms of intended use, analytes, matrix, form, and stability. The performance is reported by comparing its features and characteristics to those of the predicate devices.

The acceptance criterion for this 510(k) submission is "Substantial Equivalence" to the predicate devices. The study provided is a comparative analysis demonstrating that the proposed device is substantially equivalent to the predicate devices despite some differences in specific characteristics, which are deemed not to raise new questions of safety or effectiveness.

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

The document does not detail a specific "test set" in the context of patient samples or data. This is a quality control material, not a diagnostic test for patient samples. The "test set" implicitly refers to the control material itself, which was likely tested by the manufacturer to establish its stability, assigned values, and other characteristics compared to the predicate device.
Data provenance: Not explicitly stated, but assumed to be from internal laboratory testing of the control material (manufacturer's data). The country of origin of the data is not specified but would likely relate to the manufacturer's testing facilities (Fujirebio Diagnostics, Inc., Malvern, PA, USA and Fujirebio Diagnostics, AB, Gothenburg, Sweden). It would be prospective in nature, as the control material itself would be tested according to a protocol.

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):

Not applicable in this context. The "ground truth" for a quality control material is typically established through rigorous analytical testing to determine its assigned values and stability characteristics, often referencing established reference methods or certified reference materials, not through expert consensus in a clinical diagnostic sense. The document does not specify experts involved in establishing these analytical truths.

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

Not applicable. Adjudication methods are typically used in clinical studies where expert consensus is required for classification or diagnosis, which is not the case for a quality control material's analytical characterization.

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, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.

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

Not applicable. This is not an algorithm or an AI device.

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

The "ground truth" for a quality control material like this involves:

• Assigned Values: Established through multiple analyses using validated methods, potentially referencing international standards or reference materials for the specific analytes.
• Stability data: Determined by conducting real-time and accelerated stability studies of the product under various conditions.
• Matrix comparability: Demonstrated through analytical testing to ensure the control matrix behaves similarly to clinical samples in assays.

The document implies that these analytical ground truths were established through standard laboratory practices for quality control manufacturing but does not detail the specific methodologies or reference standards used.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. No training set is used for this device.

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