(76 days)
The STA Compact® Automated Multi-Parametric Analyzer 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 Compact 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, 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 STA Compact® is the modified version of the Company's STA Compact® (K961579), legally marketed Predicate Device. The modification of the device involves replacement of components for reliability of operation or obsolescence reasons, change in the device application software to provide operator/user use enhancements and modification of the data post-processing to increase results reliability.
The provided text describes a special 510(k) submission for a modified medical device, the STA Compact® Automated Multi-Parametric Analyzer. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets a specific set of new acceptance criteria through a standalone study with detailed performance metrics.
The core of the submission revolves around the modification of an already legally marketed device. Therefore, the "acceptance criteria" discussed are largely centered on demonstrating that the modifications do not introduce new risks or alter the fundamental performance, operation, or safety profile of the device, rather than establishing entirely new performance benchmarks.
Here's an attempt to extract and infer the requested information, acknowledging that a direct "acceptance criteria table" with specific numerical targets and direct "device performance" results for new criteria is not explicitly present in the provided text. The "study" referenced is a "Validation Study" conducted as part of the Risk Assessment to demonstrate substantial equivalence.
Acceptance Criteria and Device Performance for Modified STA Compact® Automated Multi-Parametric Analyzer (K093167)
The provided document describes a special 510(k) submission for modifications to the STA Compact® Automated Multi-Parametric Analyzer. The primary goal of this submission is to demonstrate substantial equivalence to its predicate device (STA Compact® K961579), rather than establishing new, independent acceptance criteria against specific numerical performance targets for an entirely new device. The "acceptance criteria" here are therefore interpreted as demonstrating that the modified device's performance is comparable to the predicate and that the modifications do not negatively impact safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from 510(k) rationale) | Reported Device Performance (Summary) |
|---|---|
| Functional Equivalence: The modified device performs the intended functions (coagulation tests, photometric assays) comparable to the predicate device. | "Principles of Operation for the aforementioned analyses are the same between the subject submission device and the Predicate Device." The device continues to perform clotting time (chronometric) measurements and photometric assays. The modifications "have been slightly modified to improve performance, without changing the principle of operation or the technological characteristics." |
| Increased Reliability: Replacement of components improves operational reliability. | "The modification of the device involves replacement of components for reliability of operation or obsolescence reasons." "new hardware and mechanical components to increase the operation reliability or to replace obsolete components." |
| Operator/User Enhancements: Software changes provide improved user experience. | "change in the device application software to provide operator/user use enhancements." |
| Increased Results Reliability (Data Post-Processing): Modifications to data post-processing enhance result reliability, particularly for vWF testing. | "modification of the data post-processing to increase results reliability." Specifically, the software adds a "Hook Effect Detection when the vWF (Von Willebrand factor) test is performed on the sample plasma." This function "identifies the hook effect (showing abnormally low results for high concentrations of the vWF factor) which subsequently allows the instrument to perform appropriate re-dilutions to obtain reliable results." |
| Safety and Effectiveness Equivalence: No new questions regarding safety, effectiveness, performance, indications for use, technology, and principles of operation are raised. | "As evidenced by Risk Assessment and Validation Studies (including all the changes mentioned above), no new questions were raised regarding the Safety, Effectiveness, Performance, Indications for Use, Technology and the Principles of Operation." The device is stated to be "Substantially Equivalent to the STA Compact® Predicate Device." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in the provided text. The document refers to "Validation Studies" and "Risk Assessment" but does not give specific numbers of samples or cases used in these studies.
- Data Provenance: Not explicitly stated. Given it's a modification to an existing device, it's likely internal validation data, potentially using both retrospective and prospectively generated samples. The country of origin is not mentioned.
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. For an IVD device like this, ground truth would typically come from existing diagnostic methods or certified reference materials, not necessarily expert consensus on complex image or clinical data.
4. Adjudication Method for the Test Set
This information is not provided in the document. It is unlikely to be relevant in the traditional sense of human adjudication for an automated IVD instrument performing coagulation tests, where ground truth is typically established by laboratory reference methods.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned and is not applicable to this type of device. The STA Compact is an automated in vitro diagnostic (IVD) instrument; it does not involve human "readers" interpreting output in the way an AI-assisted diagnostic imaging device would. The "AI" component described is specifically for hook effect detection and re-dilution, which is an enhancement to the instrument's automated analytical capabilities, not an assistance tool for human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the device operates in a standalone (algorithm only) manner for its primary function. The modifications, particularly the hook effect detection, are enhancements to its automated analytical capabilities without human intervention during the testing process itself. The document implicitly supports standalone performance by describing it as a "fully automatic clinical instrument."
7. The Type of Ground Truth Used
The ground truth for performance validation of an automated coagulation analyzer would typically be established using:
- Reference laboratory methods: Established and validated laboratory techniques for measuring coagulation parameters.
- Reference materials/calibrators: Certified reference materials or calibrator values.
- Clinical correlation: Comparison to established clinical diagnoses or patient outcomes, especially for demonstrating the utility of results in aiding diagnosis of coagulation abnormalities or monitoring anticoagulant therapy.
The document does not explicitly state the specific type of ground truth used for the validation studies, but these are standard for IVD devices.
8. The Sample Size for the Training Set
This information is not provided in the document. For an IVD instrument with embedded software algorithms and data post-processing, "training set" might refer to data used during software development and algorithm refinement. The document focuses on the validation studies for the final modified device.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. Similar to point 7, ground truth for training (if applicable) would likely follow standard IVD validation practices, but the specifics are not detailed.
§ 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.