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The ADVIA 1650 Chemistry System is an automated, clinical chemistry analyzer that can run tests on human serum, plasma, or urine in random access, batch, and STAT modes at a throughput rate of 1200 photometric tests per hour and 450 electrolyte tests per hour. The photometric analyzer performs clinical chemistry and immuno-turbidimetric methods. The electrylyte portion of the analyzer measures the sodium, and chloride concentrations in serum, plasma or urine samples based on a potentiometric procedure that uses ion-selective electrodes. The ADVIA 1650 is intended for use in conjunction with certain reagents to measure a variety of analytes contained in human fluids.

The ADVIA 1650 Chemistry System is an automated, clinical chemistry analyzer that can run tests on human serum, plasma, or urine in random access, batch, and STAT modes at a throughput rate of 1200 photometric tests per hour and 450 electrolyte tests per hour. The photometric analyzer performs clinical chemistry and immuno-turbidimetric methods. The electrylyte portion of the analyzer measures the sodium, and chloride concentrations in human serum, plasma or urine samples based on a potentiometric procedure that uses ion-selective electrodes.

The provided text describes the performance of the Bayer ADVIA® 1650 Chemistry System for 21 different clinical methods, comparing it to predicate devices. Each method has its own set of performance data. Since the request asks for a table of acceptance criteria and reported device performance, and the provided text does not explicitly state acceptance criteria in a dedicated section (but rather reports performance metrics meant to demonstrate equivalence), I will interpret "acceptance criteria" as the performance levels observed in the predicate devices where available, or industry-standard expectations for such devices. The "reported device performance" will be the data presented for the ADVIA 1650.

Due to the length and detail of the provided text covering 21 methods, I will focus on a subset of the methods (Albumin, ALP-AMP, Amylase, AST, Calcium) to illustrate the acceptance criteria and device performance based on the information provided. The remaining methods follow a similar pattern of data presentation.

1. Table of Acceptance Criteria and Reported Device Performance

For each analyte, the acceptance criteria are implicitly set by the performance of the predicate devices or by general expectations for clinical chemistry analyzers (e.g., strong correlation, low imprecision, minimal interference). The reported device performance is explicitly stated for the ADVIA 1650.

Here's an example for a few selected methods:

Study Proving Device Meets Acceptance Criteria:

The study demonstrating that the ADVIA 1650 meets the acceptance criteria is a series of comparison studies against various predicate devices. For each clinical method, the ADVIA 1650's performance in terms of imprecision and correlation to a legally marketed predicate device is presented.

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

The sample sizes for the test sets (correlation studies) vary by method and by the specific comparison being made (e.g., ADVIA 1650 vs. a predicate device, or plasma vs. serum on ADVIA 1650).

• Albumin:
  • Serum vs DAX: N=156
  • Plasma vs Serum (ADVIA 1650): N=58
• ALP-AMP:
  • Serum vs DAX: N=43
  • Plasma vs Serum (ADVIA 1650): N=54
• Amylase:
  • Serum vs CX4: N=102
  • Plasma vs Serum (ADVIA 1650): N=53
  • Urine vs CX7: N=82
• AST:
  • Serum vs DAX: N=111
  • Plasma vs Serum (ADVIA 1650): N=54
• Calcium:
  • Serum vs DAX: N=100
  • Plasma vs Serum (ADVIA 1650): N=59
  • Urine vs Dimension: N=32
  • Urine vs CX3: N=63

Data Provenance: The data appears to be from retrospective clinical samples or controlled laboratory studies. The locations mentioned (MSK, TRYTN, BERLIN, ARI) suggest multiple clinical sites or internal laboratory studies, which likely involved samples from various geographical origins. The study type is retrospective as it involves comparing the new device's measurements with those obtained from existing, cleared predicate devices on already collected samples. It does not suggest prospective enrollment of patients for the purpose of the study.

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

The document does not mention the use of "experts" in the traditional sense (e.g., radiologists, pathologists) to establish ground truth for the test set. Instead, the ground truth is established by the measurements obtained from the existing, legally marketed predicate devices. These predicate devices are assumed to provide accurate measurements based on their prior clearance and established clinical use. Therefore, standard clinical laboratory procedures and quality control mechanisms would implicitly underpin the "ground truth" provided by the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. The study is a direct analytical comparison between devices, not a diagnostic decision-making study that would typically involve expert adjudication of results. The "truth" is based on the comparative measurements.

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

No MRMC comparative effectiveness study was done. This type of study is typically relevant for diagnostic imaging devices or other scenarios where human readers interpret outputs, often with and without AI assistance. The ADVIA 1650 is a fully automated clinical chemistry analyzer, and its performance is evaluated in terms of analytical accuracy, precision, and correlation with predicate devices, rather than human interpretive performance.

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

Yes, the studies presented are standalone performance studies. The ADVIA 1650 Chemistry System is an automated device. The performance data presented (imprecision, correlation, interference) reflects the performance of the device's analytical methods (the "algorithm only") without human interpretive intervention influencing the measurement results themselves. The "human-in-the-loop" is primarily for operating and maintaining the system, not for interpreting test results in a way that would alter the analytical output.

7. The Type of Ground Truth Used

The ground truth for the test set is established by the results obtained from legally marketed predicate devices. The performance of the ADVIA 1650 is compared to these predicate devices, assuming the predicate devices provide accurate and reliable measurements within their validated ranges. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic (IVD) devices.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the ADVIA 1650. Modern AI/ML devices often have distinct training sets. However, for a traditional clinical chemistry analyzer like this, the "development" or "calibration" of the assays would typically involve a large number of samples, controls, and calibrators during the manufacturing and R&D process, which effectively serve as a "training phase" to ensure the assay performs correctly. The specific size of these internal development datasets is not provided in this regulatory submission, which focuses on validation data for regulatory clearance.

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

Given that this is a 510(k) submission from 1999 for an automated chemistry analyzer, the concept of a "training set" with established ground truth in the context of machine learning (as often understood today) is not explicitly applicable or detailed. The "ground truth" for the development and calibration of such assays would traditionally be based on:

• Reference Methods: Highly accurate and precise laboratory methods, often more complex or time-consuming, used to establish true concentrations or activities in control materials and calibrators.
• Certified Reference Materials: Materials with precisely known analyte concentrations, often provided by national or international standards organizations.
• Internal Development and Validation: Rigorous studies performed by the manufacturer using a wide range of human samples, spiked samples, and linearity materials, with results typically confirmed against established internal laboratory standards or reference laboratories.

The document focuses on the validation of the final product against predicate devices, rather than the internal development process that precedes it.

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