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For quantitative measurement of human chorionic gonadotropin (hCG) and its ß-subunit in human serum and plasma (EDTA or heparin) to aid in the early detection of pregnancy.

For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of human chorionic gonadotropin (hCG) and its ß-subunit in human serum and plasma (EDTA or heparin).

For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of human chorionic gonadotropin (hCG) and its ß-subunit.

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.

The assay is comprised of three main elements:

1. The VITROS Immunodiagnostic Products range of immunoassay products in this case the VITROS Immunodiagnostic Products Total B-hCG II Reagent Pack, the VITROS Immunodiagnostic Products Total B-hCG II Calibrators, and the VITROS Immunodiagnostic Products Total B-hCG II Range Verifiers (which are combined by the VITROS Immunodiagnostic system to perform the VITROS Total B-hCG II assay).

2. The VITROS Immunodiagnostic System - instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).

3. Common reagents - used by the VITROS Immunodiagnostic System in each assay include the VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

Note: High Sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total B-hCG Reagent Pack and VITROS Immunodiagnostic Products Total β-hCG Calibrators 510(k) premarket notification (K970894).

The VITROS Immunodiagnostic System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study details for the VITROS Immunodiagnostic Products Total β-hCG II assay.

Please note: This document is a 510(k) summary for an in-vitro diagnostic device, not an AI/ML-based medical device. Therefore, many of the requested categories (e.g., sample size for test set/training set, number of experts for ground truth, adjudication method, MRMC study, human reader improvement) are not applicable or available in this type of submission. This summary focuses on demonstrating substantial equivalence to a predicate device, primarily through performance characteristics of the assay itself.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new device are implicitly established by demonstrating substantial equivalence to the predicate device. This is primarily done by comparing performance characteristics such as analytical sensitivity, specificity, precision, and measuring range, and showing that the new device performs comparably or better.

Here's a table summarizing the reported device performance compared to the predicate, which serves as the de-facto acceptance criteria. The new device must meet or exceed the performance of the predicate to demonstrate substantial equivalence.

Note: The "Expected Values" table is also presented for comparison, but these are typically reference ranges derived from clinical populations rather than strict acceptance criteria for the device's technical performance.

Study Details

Given this is a 510(k) for an in-vitro diagnostic assay (laboratory test), the study design differs significantly from that of an AI/ML device.

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

   • The document does not explicitly state a "test set" sample size in the context of a diagnostic test for comparing against ground truth. Instead, performance characteristics (precision, sensitivity, specificity, measuring range) are evaluated using various types of samples.
   • Specificity and Analytical Sensitivity: The document states 0.70 mIU/mL analytical sensitivity and ≤ 10% cross-reactivity for FSH, LH, and TSH without providing specific sample counts for these tests.
   • Precision: Precision studies involved measuring samples multiple times to calculate Coefficients of Variation (CV). The specific number of samples for these studies is not detailed in the summary, but typical studies involve multiple replicates over several days with different operators and instrument runs.
   • Expected Values: The table for "Expected Values" in Table 1 shows sample sizes (n) for different gestational age groups: 1-10 weeks (n=112 for new device, n=50 for predicate), 11-15 weeks (n=43 for new device, n=50 for predicate), 16-20 weeks (n=50 for new device, n=50 for predicate), and 23-40 weeks (n=45 for new device, n=50 for predicate). This data provenance is generally from clinical populations.
   • Data Provenance: Not explicitly stated as retrospective or prospective, nor country of origin for all performance data, though the manufacturer site is in the United Kingdom. The "Expected Values" imply clinical samples.

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

   • Not applicable / Not explicitly stated. For an immunoassay, the "ground truth" for analytical performance tests (sensitivity, specificity, precision) is established through reference methods, certified reference materials, and standardized laboratory practices, not typically by expert consensus of human readers. For clinical reference ranges ("Expected Values"), the ground truth is derived from the measured hGC levels in a healthy population or population with known pregnancy status, often confirmed by clinical means (e.g., last menstrual period, ultrasound), but not requiring human expert adjudication of visual data.

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

   • Not applicable. Adjudication methods like 2+1 are used for human interpretation of images or complex data where consensus is needed to establish ground truth. For an automated immunoassay, the result is quantitative or qualitative based on the assay's chemical reaction and signal detection.

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

   • Not applicable. An immunoassay is an automated diagnostic test; it does not involve human "readers" interpreting results in the way an AI medical device for image analysis would. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

   • Yes, in essence. Immunoassays are inherently "standalone" in that once the sample is loaded and the test is run, the instrument produces the result without further human interpretation beyond reporting the quantitative value. The performance metrics discussed (sensitivity, specificity, precision, measuring range) are all measures of the device's standalone analytical performance.

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

   • The "ground truth" for demonstrating the performance of this in-vitro diagnostic device would typically involve:
     • Reference standards/materials: For analytical sensitivity and linearity, using known concentrations of hCG.
     • Clinical samples: For establishing expected values and potentially for cross-reactivity studies, samples from healthy individuals or individuals with confirmed conditions (e.g., pregnant patients, patients with elevated FSH/LH/TSH) might be used.
     • Comparative methods: Often, performance is validated by comparing results to a gold standard or well-established reference method.
   • The document does not explicitly detail the exact nature of the "ground truth" for all studies, but it is inferable from the types of performance claims made.

7. The sample size for the training set:

   • Not applicable. This device is an immunoassay, not an AI/ML algorithm that requires a "training set" in the computational sense. The assay's chemistry and detection principles are pre-determined during development, not "trained" on data.

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

   • Not applicable. As there is no training set for an immunoassay, there is no ground truth established for it in this context.

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