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Measurements of CKMB are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

The fluorometric analyzer is intended to duplicate manual analytical procedures by performing automatically various steps, such as pipetting, incubation and measuring fluorescence.

The Stratus® CS STAT fluorometric analyzer is a benchtop instrument capable of processing up to four in vitro diagnostic tests per sample. An operator of the analyzer introduces a specimen collection tube filled with whole blood into the instrument, along with the appropriate TestPaks for processing. The instrument transfers and spins an aliquot of the sample, delivers the spun plasma and other self-contained reagents to the reaction area of the TestPak, reads the reaction rate via front surface fluorescence and prints out quantitative test results.

The CKMB TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase in heparinized plasma.

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

1. Table of Acceptance Criteria and Reported Device Performance

Limitations on Acceptance Criteria: The document does not explicitly state defined acceptance criteria with pre-specified thresholds (e.g., "Slope must be between 0.95 and 1.05"). Instead, it presents the results of a comparison study and implies that these results demonstrate substantial equivalence to the predicate device. The FDA's letter confirms substantial equivalence based on these results.

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

• Sample Size: n = 215
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, but the description of a "split sample comparison study" suggests a prospective collection where samples were run on both devices concurrently.

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

• This information is not provided in the document. The study is a comparison between two in-vitro diagnostic devices, not a study evaluating human interpretation or a device's ability to diagnose conditions where ground truth would be established by experts. The "ground truth" in this context is the measurement provided by the legally marketed predicate device.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. The study compares the quantitative output of two diagnostic devices. There is no mention of adjudication of interpretations or diagnoses by experts.

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 information is not applicable/provided. This device is an in-vitro diagnostic analyzer for measuring a biomarker (CKMB) and is not an AI-assisted diagnostic imaging or interpretation device. Therefore, an MRMC study with human readers and AI assistance is not relevant to this submission.

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

• Yes, a standalone study was done. The "split sample comparison study" directly compares the performance of the new Stratus® CS STAT fluorometric analyzer and its CKMB TestPak against the predicate Dade Stratus® fluorometric analyzer. This comparison is of the device's performance itself, without human intervention in the result generation process beyond operating the instrument.

7. The Type of Ground Truth Used

• The "ground truth" in this context is the measurements obtained from the predicate device, the Dade Stratus® fluorometric analyzer. The study design aims to demonstrate that the new device's measurements are substantially equivalent to those of the legally marketed predicate.

8. The Sample Size for the Training Set

• This information is not provided and is likely not applicable. This device is a fluorometric analyzer and a test kit, not a machine learning or AI-based system that would typically require a distinct "training set" in the computational sense. The device's performance is based on its established analytical methodology and engineering, not on learning from data in a training phase.

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

• This information is not provided and not applicable for the reasons stated in point 8.

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