(25 days)
The STA-R® Evolution (or STA-R®) 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-R® Automated Multi-Parametric Analyzer 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, system supervision, support for instrument maintenance, and work load optimization. The STA-R® Evolution is the modified or updated version of the company's STA-R®, legally marketed predicate device. The modification of the device involves the upgrade of the instrument's operating system from Windows NT to the Windows XP platform. Slight modifications to the application software were made to accommodate the new operating system along with operator/user enhancements but without logic configuration changes.
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 wave lengths) on plasma samples. The Technological Characteristics and Principles of Operation for the aforementioned analyses are the same between the subject submission device and the predicate device.
This document describes a Special 510(k) Notice for a modification to the STA-R® Automated Multi-Parametric Analyzer, updating its operating system from Windows NT to Windows XP. The information provided is for a regulatory submission and does not contain detailed acceptance criteria, study data tables, or specific performance metrics as requested.
Based on the provided text, the following information can be extracted/inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that a "validation study" was performed and that the device "demonstrate[s] that the STA-R® Evolution is as safe and effective as the predicate device." However, no specific acceptance criteria (e.g., sensitivity, specificity, accuracy, precision thresholds) or corresponding reported device performance metrics are provided in the text. This is a deficiency in the provided information for the requested table.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| NOT PROVIDED | NOT PROVIDED |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions a "validation study" but does not provide any details regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish ground truth or any details about their qualifications. This is expected for an IVD device where ground truth is typically based on laboratory-derived measurements rather than expert human interpretation of images or clinical data.
4. Adjudication Method for the Test Set:
The document does not mention any adjudication method for establishing ground truth, as it's not applicable to the type of device (automated instrument) and its validation as described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC study was not performed and is not relevant for this type of IVD device. The device is an automated instrument, not an AI intended to assist human readers with interpretation.
6. Standalone Performance Study:
Yes, a standalone study was inherently performed. The "validation study" mentioned would assess the performance of the STA-R® Evolution instrument itself. The purpose of the validation was to demonstrate that the upgraded operating system and minor software changes without logic configuration changes did not negatively impact the instrument's performance compared to its predicate.
7. Type of Ground Truth Used:
While not explicitly stated for the "validation study," for an IVD coagulometer, the ground truth would typically be established through laboratory reference methods or comparison to established, validated predicate devices using well-characterized calibrators and controls. The instrument performs "clotting time or clot-based tests (i.e. chronometric) measurements and photometric assays (at specific wave lengths) on plasma samples." Therefore, the ground truth would involve highly accurate and precise measurements obtained via these established laboratory techniques.
8. Sample Size for the Training Set:
The document does not mention a training set sample size. The device is described as an upgrade of an existing instrument's operating system and application software, not a de novo algorithm developed using a training set in the typical machine learning sense. The "logic configuration changes" were explicitly not made.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as the document does not describe a training set for a new algorithm. The modification was primarily an operating system upgrade and minor software enhancements without changes to the core analytical logic.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.