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This in vitro immunoassay is intended to quantitavely measure CA 15-3 values in human serum. When used in conjunction with other clinical and diagnostics procedures, serial testing using ADVIA IMS CA 15-3 Assay on a Bayer ADVIA® IMS ™, is indicated for monitoring the course of disease and therapy in metastatic breast cancer patients, and for the detection of recurrence in previously treated Stage II, with greater than two positive lymph nodes, or Stage III breast cancer patients.

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The information provided describes the performance of the CA 15-3 Assay for the Bayer ADVIA® Integrated Modular System (IMS)™ as part of a 510(k) premarket notification. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating the device's impact on human readers or clinical outcomes.

Here's an analysis of the provided information, structured according to your request:

Acceptance Criteria and Device Performance

The provided document doesn't explicitly state "acceptance criteria" for each performance metric as a numerical threshold, but rather presents the device's performance characteristics with the implicit understanding that these values are considered acceptable for substantial equivalence to the predicate device. The conclusion explicitly states: "Performance of the ADVIA IMS CA 15-3 Assay on a a Bayer ADVIA® IMS ™ is equivalent to the performance of the CA 15-3 Assay on the predicate device (Immuno 1) and is within proposed specifications."

Study Details:

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

   • Imprecision: Not explicitly stated as a "test set" sample size but typically involves multiple replicates over several days with control materials. Not specified for the ADVIA IMS data.
   • Correlation: 73 serum specimens.
   • Data Provenance: Not explicitly stated. Given it's a 510(k) submission for a US market device, the data is typically generated in a controlled laboratory setting by the manufacturer, which could be in the US or internationally, but specific country of origin is not mentioned. The data is retrospective in the sense that samples were run and compared to the predicate, but specific retrospective/prospective collection of patient samples is not detailed.
   • Interfering Substances: Specific sample sizes for each substance challenge are not provided, but typically involves a batch of samples spiked with interferents.

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

   • This is an in vitro diagnostic (IVD) device, not an AI or imaging device that requires human expert review for "ground truth". The "ground truth" for this assay is the actual concentration of CA 15-3 in the specimen, as measured by a reference method or the predicate device that the new device is being compared against.
   • Therefore, no human experts (e.g., radiologists) were used to establish ground truth in the context you're asking. The analytical performance is established by comparing the device's results to those from the predicate device or known concentrations of analytes in quality control materials.

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

   • Not applicable. This type of adjudication is used in studies where human interpretation of medical images or clinical data forms the ground truth, often with disagreement among reviewers. For an IVD assay, the comparison is quantitative and objective, typically against a reference measurement or predicate device, not subjective human interpretations.

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:

   • No. This is an IVD device for measuring a biomarker in blood, not an imaging or AI-assisted diagnostic tool. Therefore, an MRMC study and the concept of "human readers improving with AI assistance" are not relevant to this device or its submission.

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

   • Not applicable in the context of an AI algorithm. The device, by its nature as an automated immunoassay, operates in a "standalone" fashion where the instrument and reagents produce a quantitative result without direct human intervention in the result generation process itself (though human operators initiate and monitor the process). Its performance is evaluated independently of human interpretation of the raw signal; the numerical result is the output.

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

   • For Imprecision, the ground truth is the "true" concentration of the control material, established by the manufacturer and often traceable to higher-order reference materials, or an average of multiple measurements.
   • For Correlation, the "ground truth" for comparison is the measurement obtained from the predicate Immuno 1 system. This is a common approach for demonstrating substantial equivalence for IVDs.
   • For Interfering Substances, the ground truth is the known concentration of CA 15-3 in the sample before the addition of the interfering substance.

7. The sample size for the training set:

   • This device, being an IVD immunoassay, does not have a "training set" in the context of machine learning or AI models. The development and calibration of such assays involve extensive R&D, reagent formulation, and analytical testing, but not a "training set" of data in the AI sense.

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

   • As there is no "training set" in the AI sense, this question is not applicable. The assay's performance characteristics are established through rigorous analytical verification and validation against known standards and comparison to a predicate device.

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