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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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Luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva and serum. Measurements obtained by this device may be used in the diagnosis and treatment of various hormonal sexual disorders and can be used to evaluate ovarian function. This test is not intended for assessing placental function in complicated pregnancy.

Luminescence immunoassay (LIA) based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labeled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After addition of the luminescence substrate solution the intensity of the luminescence measured is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.

The IBL Estradiol LIA is a luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free Estradiol in saliva and serum.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are not explicitly stated as distinct pass/fail thresholds in the provided document. Instead, the document presents performance characteristics and comparisons to established methods. The "acceptance" is implied by the FDA's substantial equivalence determination. We can infer the functional performance criteria from the reported values and comparisons.

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

• Normal Ranges in Saliva:

  • Premenopausal Women: 28 women (month profiles, so multiple samples per woman), age 19-43.
  • Postmenopausal Women: 5 women, age 42-62.
  • Males: 40 males, age 20-63.
  • Data Provenance: Not explicitly stated, but likely prospective for the normal range establishment as saliva samples were collected daily "until first day of bleeding" or as single samples for postmenopausal women and males. No country of origin is specified, but the manufacturer is based in Germany, suggesting European or international data.

• Comparison of Serum and Saliva (to published/commercial RIA):

  • Saliva Comparison: 50 saliva samples.
  • Serum Comparison: 60 serum samples.
  • Data Provenance: Not explicitly stated, but likely retrospective or a combination of prospective/retrospective for convenience from adult healthy individuals. No country of origin is specified.

• Serum to Saliva Comparison (using IBL Estradiol LIA):

  • Paired Samples: Not explicitly stated, but derived from "saliva and serum pairs collected at the same time." The number of pairs is not provided.
  • Data Provenance: Not explicitly stated, but likely prospective for this specific comparison.

• Cross-Reactivity, Analytical Sensitivity, Functional Sensitivity, Precision, Linearity, Recovery:

  • The sample sizes for these analytical performance studies are embedded within the tables (e.g., n=10 for precision at each level). These are typically laboratory studies using spiked samples, controls, and calibration materials rather than patient samples for the direct "test set" definition often associated with diagnostic device clinical trials.
  • Data Provenance: Laboratory validation studies.

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

• Normal Ranges: The "ground truth" here is the observed ranges in the healthy populations studied. There is no mention of external experts establishing a ground truth for these ranges; they are empirical observations from the study participants themselves.
• Comparison Studies: The "ground truth" for the comparison studies are the results obtained from the "published procedure that used a modification in the handling of saliva for a typical RIA test" and a "commercially available RIA test kit." These are established reference methods. There is no mention of individual expert adjudicators for these data points.

4. Adjudication Method for the Test Set

Not applicable in the context of this device. The comparisons are against established laboratory methods, not subjective diagnoses requiring adjudication by human experts.

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

Not applicable. This is an in vitro diagnostic immunoassay, not an imaging or diagnostic device requiring interpretation by human readers. Therefore, an MRMC study and effects of AI assistance are not relevant to this submission.

6. Standalone Performance Study

Yes, the entire submission describes the standalone performance of the IBL Estradiol LIA. The comparisons to RIA methods ("Comparison of Serum and Saliva," "Serum to Saliva Comparison") are designed to demonstrate its performance relative to existing technologies, but the listed metrics (Normal Ranges, Cross-reactivity, Sensitivity, Precision, Linearity, Recovery) represent the intrinsic performance of the IBL Estradiol LIA device itself.

7. Type of Ground Truth Used

• Normal Ranges: Empirical observation from defined healthy populations.
• Comparison Studies: Results from established, commercially available, or published reference immunoassay methods (RIA).
• Analytical Performance (Cross-Reactivity, Sensitivity, Precision, Linearity, Recovery): These are based on established laboratory analytical methods using controlled samples, calibrators, and known concentrations (e.g., spiked samples).

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI development. For an immunoassay, the equivalent would be the samples used to develop and optimize the assay's reagents, protocols, and calibration curves. This information is not provided in detail. The normal range studies and comparison studies would be considered part of the validation and testing, rather than a "training set" in the modern AI sense.

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

As there is no distinct "training set" discussed in the context of AI/ML, this question is not directly applicable. However, for the development of the immunoassay itself, the "ground truth" for calibrators and controls would be established through rigorous analytical chemistry techniques, often traceable to international standards, and verified by expert analytical chemists during the assay development phase. The document implicitly relies on standard immunoassay development and validation practices.

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The DPC IMMULITE 1000 is an automated immunoassay system intended to assay the same broad range of analytes in patient samples as does IMMULITE. The intent of the system is to impart the same automation to the array of immunoassays in the same hospital and commercial laboratory settings as IMMULITE. The system is intended to produce safe and effective performance when used by medical laboratory personnel as is the IMMULITE predicate system.

The DPC IMMULITE 1000 product is essentially an upgrade of the current IMMULITE system. All of the current functionality will be retained; however, the system will be enhanced with regard to the user interface, casework, and system footprint. The operating system will be changed to a Windows 2000 environment. In addition, the system will be remodeled to give the IMMULITE a more "modern" look and feel to be part of the "IMMULITE Family". Finally, the total system footprint will be decreased by such mechanisms as integrating the PC into the architecture of the system and provide a defined area for storing bulk materials (i.e., waste, water, and, probe wash).

The provided text is a 510(k) summary for the IMMULITE® 1000 Automated Immunoassay Analyzer, which is essentially an upgrade of an existing system (IMMULITE). The document states that the modifications do not change the indications for use or the intended use, and the device is intended to assay the same broad range of analytes in patient samples as the predicate IMMULITE.

However, the 510(k) summary does not contain the detailed information required to answer many of the questions asked. This type of regulatory submission often focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive de novo study details with specific acceptance criteria, sample sizes for test and training sets, expert qualifications, or comparative effectiveness studies.

Here's an analysis based on the provided text, highlighting what's available and what's missing:

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

The document does not explicitly present a table of acceptance criteria for specific performance metrics (e.g., accuracy, precision, limits of detection for various analytes) or report detailed device performance results against these criteria. It focuses on the equivalence to the predicate device.

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

The document does not specify the sample size used for any test set or provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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 provided. Since this is an automated immunoassay analyzer, the "ground truth" would typically come from reference methods or established clinical diagnostics, not from expert consensus interpreting images or other qualitative data.

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

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for qualitative assessments, often in imaging studies where multiple readers interpret cases. For an immunoassay analyzer measuring analytes, performance is usually assessed quantitatively against reference standards.

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

An MRMC comparative effectiveness study is not mentioned. This type of study is relevant for AI-assisted diagnostic devices where human readers interpret data. The IMMULITE 1000 is an automated immunoassay analyzer, not a diagnostic imaging AI system that "assists" human readers.

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

The IMMULITE 1000 is inherently a "standalone" automated system in the sense that it performs the immunoassay measurements without continuous human intervention during the assay process. The results are generated by the instrument. However, the document does not detail specific "standalone performance studies" in a structured way that would be typical for a novel AI algorithm's standalone evaluation. Instead, it implies that the performance is demonstrated to be equivalent to the predicate IMMULITE system.

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

The ground truth for an immunoassay analyzer would typically be established by:

• Reference Methods: Using established, highly accurate laboratory methods for analyte measurement.
• Certified Reference Materials/Standards: Calibrating and verifying performance against materials with known analyte concentrations.
• Comparison to Predicate Device: Given that this is a 510(k) for an upgrade, the primary "ground truth" implicitly relies on the proven performance of the predicate IMMULITE system for the broad range of analytes. The document states, "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for the IMMULITE 1000 Analyzer," implying that the data primarily demonstrated equivalence.

8. The sample size for the training set

This information is not provided. Immunoassay analyzers are not "trained" in the same way machine learning models are. Their "training" or calibration involves using specific calibrators and controls to establish a standard curve or reference points for measurement, which is a different concept than a "training set" for AI.

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

As mentioned above, the concept of a "training set" and its "ground truth" in the context of machine learning, is not directly applicable to this device in the way implied by the question. The "ground truth" for the calibration and verification of an immunoassay system would be established using certified calibrators and controls with known values, or by comparison to established reference methods and the predicate device. The document does not elaborate on these details.

Summary of what the document does communicate:

• Acceptance Criteria (Implied): The primary acceptance criterion for this 510(k) appears to be substantial equivalence to the predicate IMMULITE system. The device needs to produce "safe and effective performance" for the "same broad range of analytes in patient samples" as the IMMULITE.
• Study Proving Acceptance Criteria: The document states that "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for the IMMULITE 1000 Analyzer." This implies that studies were conducted to demonstrate that the IMMULITE 1000 performs comparably to the original IMMULITE system across its intended applications. These studies would typically involve method comparison, precision, linearity, and interference studies, but the specific results and methodologies are not detailed in this public 510(k) summary.
• Changes to the Device: The modifications are primarily focused on the user interface, casework, system footprint, and operating system (Windows 2000 environment), not fundamental changes to the underlying immunoassay technology (14-inch polystyrene antibody coated beads, alkaline phosphatase labeled antibody/antigen, chemiluminescent detection). This reinforces the focus on demonstrating equivalence rather than proving novel performance.

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