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The STA Satellite™ Automated Multi-Parametric AnalyzerSatellite® Automated Multi-Parametric Analyzer is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

The STA Satellite® Automated Multi-Parametric Analyzer is designed as a fully automatic bench-top system. Samples and test reagents are loaded into the instrument where sample handling, reagent delivery, analysis, and reporting of results are performed automatically. A central processing unit controls instrument functions such as, management of patient results, quality control, system supervision, support for instrument maintenance, and work load optimization. The STA Satellite® is the bench-top version of the company's STA-R®, legally marketed predicate device.

The instrument utilizes Diagnostica Stago reagents in addition to open adaptation of other currently available reagents. Barcoding of test reagents, calibrators, and controls facilitate their use on the system and permits reagent management simple. Manual entry of reagent information enables the use of non-barcoded reagents.

The instrument performs multiple test methodologies in random access as selected by the user. These include clotting time or clot-based tests (i.e. Chronometricchronometric) measurements and photometric assays (at specific wave lengths) on plasma samples. The principle of the chronometric method consists in measuring the variation of the oscillation amplitude of the ball (in the cuvette). A decrease in oscillation amplitude corresponds to an increase in the viscosity of the media (i.e. ., coagulation). The principle of the photometric measurements on the instrument is based on measured absorbance (also referred to as Optical Density, or OD) of monochromatic light of predetermined wavelength passing through the cuvette as a (clotting) reaction takes place.

The provided text describes a 510(k) summary for the STA Satellite® Automated Multi-Parametric Analyzer, a modified version of the STA-R® device, intended for in vitro coagulation studies.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: The document states that "Test samples were analyzed in duplicate on the STA -Satellite and the STA-R." However, the number of test samples or the total number of subjects from which these samples were derived is not specified in the provided text.
• Data Provenance:
  • Country of Origin: The validation study was performed at "an internal site and two external sites." The direct country of origin for these sites is not explicitly stated. However, the submitter, Diagnostica Stago, Inc., is based in Parsippany, New Jersey, USA. The predicate device manufacturer, Diagnostica Stago SAS, is likely based in France given the "CE Marked" status of the device and its commercialization in France since September 2004. It's plausible that one or more sites were in the USA, and potentially one in France, but this is an inference, not a direct statement.
  • Retrospective or Prospective: The text does not explicitly state whether the study was retrospective or prospective. The phrasing "Test samples were analyzed" suggests a prospective collection and analysis for the validation study.

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

This information is not provided in the text. The study focuses on method comparison between two instruments rather than an expert-adjudicated ground truth for patient diagnoses.

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

This information is not applicable and therefore not provided, as the study is a method comparison and does not involve adjudication of expert interpretations for a ground truth.

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:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an automated instrument for performing coagulation tests, not an AI or imaging diagnostic tool that would involve human readers interpreting results with or without AI assistance.
• Effect Size: Therefore, there is no information on the effect size of human reader improvement with AI assistance.

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

Yes, the study described is a standalone performance study of the instrument itself. The device is an "Automated Multi-Parametric Analyzer," meaning it performs the analysis automatically. The "Performance Data" section describes a comparison of the STA Satellite® instrument's results to those of the STA-R® predicate device, indicating the algorithm/instrument's performance in isolation.

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

The "ground truth" in this study is the results obtained from the predicate device, STA-R®. The study's objective was to demonstrate substantial equivalence by showing that the STA Satellite® produces statistically similar results to the legally marketed STA-R®. This is a method comparison study, where the established method (predicate device) serves as the reference.

8. The sample size for the training set:

This information is not provided in the text. The document describes a validation study comparing the new device to a predicate, not the internal development or "training" of a machine learning algorithm. If there was any internal development or calibration, the details are not included here.

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

This information is not provided as there is no mention of a training set or ground truth in the context of training for this medical device's performance validation. The study focuses on direct comparison to a predicate device's measured results.

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