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The STA Compact Max® is a fully automatic clinical analyzer designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

Diagnostica Stago's STA Compact Max® is a fully automatic clinical laboratory designed as a modification to the company's previously cleared STA Compact® analyzer (K093167). It performs tests which aid in the diagnosis of Haemostatic disorders and the monitoring of anticoagulant treatment. The device consists of a cuvette, a metal ball, three needles, oscillation amplitude detection, a light source and sensor, and software.

The STA Compact Max® is a modified version of the legally marketed device, STA Compact® (K093167). The modifications primarily involve updates to the onboard computer, operating system, and user interface, as well as minor external design changes. The company claims that these modifications do not alter the fundamental technological characteristics, principles of operation, or performance of the device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with numerical performance targets (e.g., sensitivity, specificity, accuracy) for the STA Compact Max®. Instead, the acceptance criteria are implicitly stated through the claim of "comparable performances" to the predicate device and the assertion that "no new questions were raised regarding the Safety, Effectiveness, Performance, Indication for Use, Technology and the Principles of Operation."

The device performance is described as:

The essential acceptance criterion is that the STA Compact Max® demonstrates "comparable performances" to the predicate device (STA Compact® K093167) despite the internal and external modifications. The study performed aims to demonstrate this equivalence. The specific performance metrics (e.g., precision, accuracy, linearity) that were likely evaluated to establish "comparable performances" are not detailed in the provided summary, but would have been part of the Verification and Validation utilized as part of the Design Controls.

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

The provided 510(k) summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It refers to "Validation Studies" and "Risk Assessment" but does not provide details of these studies. Given that this is a Special 510(k) for modifications to an existing device, the focus is on demonstrating that the changes do not adversely affect performance. The validation studies would have focused on verifying that the new hardware and software components perform as expected and do not introduce new risks or alter the previously established performance characteristics of the predicate device.

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 document. For a coagulation analyzer, "ground truth" would typically be established by comparing results to reference methods, other established analyzers, or clinical outcomes, perhaps interpreted by medical professionals. However, the details of expert involvement are not mentioned in this summary.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable to the STA Compact Max® device. This device is an automated clinical analyzer for in vitro coagulation studies and does not involve human readers interpreting images or data with AI assistance. It performs measurements directly on plasma samples.

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

The STA Compact Max® is an automated device, meaning it operates in a standalone manner without human-in-the-loop performance influencing its measurement results. The results are generated by the instrument's mechanical, optical, and software components. Human interaction is primarily for loading samples, reagents, and interpreting the output. So, in essence, its core function is "algorithm only" in terms of its diagnostic output. However, the document doesn't explicitly describe a separate "standalone study" in the context often associated with AI diagnostic algorithms. Rather, its inherent operation is standalone.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly state the type of ground truth used for the validation studies. However, for coagulation analyzers, ground truth often involves:

• Reference methods: Comparing results to established, highly accurate laboratory reference methods.
• Certified reference materials/standards: Using materials with known analyte concentrations.
• Comparison to predicate device: A primary method in a 510(k) where modifications are made to an existing device. The performance of the modified device would be compared against the predicate device using patient samples and quality control materials.

The study's goal was to demonstrate "comparable performances" to the predicate device, implying that the predicate's performance served as a de-facto 'ground truth' or benchmark for the new device.

8. The Sample Size for the Training Set

This information is not provided and is generally not applicable in the same way it would be for machine learning or AI-based devices. The "training" for this type of device involves engineering design, calibration, and verification/validation processes rather than a data-driven training set for an algorithm to learn from. The software migration and new graphical user interface were likely developed and tested against defined functional requirements rather than a "training set."

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

As explained above, the concept of a "training set" with established ground truth is not directly applicable to this type of automated medical device in the same way it is for AI algorithms. The "ground truth" for the development and testing of the device's components (hardware, firmware, and software) would be based on engineering specifications, physical laws, chemical reactions, and established principles of coagulation measurement, rather than a dataset with labeled medical conditions. The previous STA Compact® (predicate device) and its proven performance would serve as the benchmark for how the new device should function and deliver results.

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STA-R Evolution® Expert Series Hemostasis System is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

The STA-R Evolution® Expert Series Hemostasis System is designed as a fully automatic 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, support for instrument maintenance, and work load optimization. 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. chronometric) measurements and photometric assays (at specific wavelengths) on plasma samples.

The provided text describes modifications to an existing device, the STA-R Evolution® Expert Series Hemostasis System, and asserts its substantial equivalence to a predicate device. However, it does not provide a specific study with acceptance criteria, reported device performance, sample sizes, expert details, or ground truth methodologies that would typically be found in a detailed validation report.

Instead, the document focuses on regulatory approval (510(k) submission) by demonstrating that the modified device has:

• The same Indications for Use.
• The same Technology.
• The same Principles of Operation.
• "Comparable Performances" to the predicate device.

The modifications are stated to "Presult in better performance" due to new hardware/mechanical components, software updates for user enhancements, data post-processing for increased reliability, and bug corrections. It also mentions a "new option of Reverse Sequence Drilling Mode (referred to as PTB)" to increase results reliability when using capped tubes.

The document explicitly states: "Nevertheless, there are no new questions regarding the Safety, Effectiveness, Technology, Principles of Operation and Performance as evidenced by Risk Assessment and Validation Studies (including all the changes mentioned above." This implies that validation studies were performed, but the details of those studies (e.g., acceptance criteria, specific performance metrics, sample sizes, ground truth) are not included in this summary.

Therefore, I cannot provide the requested table and details because the information is not present in the provided text. The document acts as a summary for a 510(k) submission, confirming the existence of validation studies without detailing their results or methodology.

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