(43 days)
STA-R® Automated Multi-Parametric Analyzer is a fully automatic 311 TV Tratomated for the performance of tests on human ellinear in the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
The STA-R® instrument is a fully automatic laboratory analyzer designed to perform tests which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy. Once test samples and reagents are loaded onto the instrument, sample handling, reagent delivery, analysis and reporting of test results are performed automatically, making the STA-R® instrument a true "walk-away" system. A central processing unit controls instrument functions, including management of patient results, quality control, scheduling of instrument maintenance and workload organization. The instrument utilizes Diagnostica Stago (France) reagents, and is open to adaptation of other reagents currently commercially available from third-party manufacturers. Bar-coding of test reagents, calibrators and controls facilitates their use on the system and makes reagent management simple. Manual entry of reagent information enables the utilization of non barcoded reagents. The instrument performs multiple test methodologies in random access (as selected by the user); these include clot-based tests and photometric assays at predetermined wavelengths.
The provided text contains limited information regarding acceptance criteria and a study to prove the device meets these criteria. The document is primarily a 510(k) clearance letter and a summary of the device's characteristics, focusing on its substantial equivalence to a predicate device.
Here's an attempt to answer your questions based only on the provided text, highlighting what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of specific performance metrics (e.g., accuracy, precision, correlation with a gold standard). The primary "acceptance criteria" for 510(k) clearance here is substantial equivalence to the predicate device. | "Sample-to-sample carry-over has been demonstrated to be so low as to be undetectable." |
| Substantial equivalence to the commercially available STA® analyzer (K942117). | The STA-R® instrument is substantially equivalent to the commercially available STA® analyzer, also from the same manufacturer (Diagnostica Stago, France), that received 510(k) clearance under K942117. |
2. Sample size used for the test set and the data provenance
This information is not available in the provided text. The document refers to the demonstration of "sample-to-sample carry-over" but does not specify the sample size or details about the test set used for this demonstration or for establishing substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available in the provided text. The evaluation for substantial equivalence would have been performed by the FDA, but the internal studies by the manufacturer or the specific ground truth establishment methods are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available in the provided text.
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 MRMC study is not applicable here. The device is an automated laboratory analyzer, designed to perform tests, not to assist human readers in interpreting images or complex data in the same way an AI diagnostic tool would. The product itself automates the analysis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is described as "fully automatic" and a "true 'walk-away' system" that performs "sample handling, reagent delivery, analysis and reporting of test results... automatically." This suggests that its performance is standalone, without human intervention in the analysis process itself. However, a specific "standalone study" with detailed metrics is not described beyond the general statement of functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth used for establishing the performance or substantial equivalence is not explicitly stated. For a coagulation analyzer, ground truth would typically refer to reference methods or established assays for coagulation measurements.
8. The sample size for the training set
This information is not available in the provided text. The device is a physical instrument, not a machine learning algorithm in the typical sense that would require a "training set" of data for model development. Its development likely involved engineering, calibration, and testing against known standards and samples, but not "training data" in the AI context.
9. How the ground truth for the training set was established
As in point 8, the concept of a "training set" and its "ground truth" as relevant to AI algorithm development is not applicable here. The development would have involved engineering design, adherence to technical specifications, and validation against established scientific and laboratory standards.
§ 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.