(29 days)
The STA R Max® 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.
Diagnostica Stago's STA R Max® is a fully automatic clinical laboratory designed as a modification to the company's previously cleared STA-R Evolution® Expert Series analyzer (K093001). 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 provided text is a 510(k) summary for the STA R Max® device. This document focuses on demonstrating substantial equivalence to a predicate device (STA-R Evolution® Expert Series) for regulatory approval, rather than detailing a study that proves the device meets specific acceptance criteria based on performance metrics.
Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance studies, and ground truth establishment cannot be found in this document.
The document does describe the device's intended use, principle of operation, and how it is substantially equivalent to its predicate.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document primarily focuses on demonstrating substantial equivalence to a predicate device by comparing characteristics, not on presenting specific performance data against predefined acceptance criteria for the subject device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document does not describe a clinical or performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document does not describe the establishment of a ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. The document does not describe the use of a test set or an adjudication method.
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 provided in the document. The STA R Max® is an automated clinical instrument for coagulation studies, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study with human readers assisting AI is not relevant to this device's function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the STA R Max® as a "fully automatic clinical instrument" which performs tests and reports results. This implies a standalone (algorithm only) performance, however, specific performance metrics or a dedicated standalone study are not detailed. The document relies on similarity to the predicate device, not on new standalone performance studies of the subject device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. The document does not detail how specific ground truth was established for performance evaluation of the subject device. The clearance is based on substantial equivalence.
8. The sample size for the training set
This information is not provided in the document. The document does not describe a training set in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not provided in the document. The document does not describe a training set or its ground truth.
Summary of available information related to the device and its regulatory submission:
- Device Name: STA R Max®
- Regulation Number: 21 CFR 864.5425
- Regulation Name: Multipurpose system for in vitro coagulation studies
- Regulatory Class: Class II
- Product Code: JPA
- Indications for Use: The STA R Max® 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.
- Predicate Device: STA-R Evolution® Expert Series (K093001)
Key points from the "Substantial Equivalence Comparison" (Table 1):
The document argues for substantial equivalence based on the following:
- Identical Indications for Use/Intended Use.
- Identical Target Population (to aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy in patients).
- Identical Anatomical Sites (in vitro testing of human plasma).
- Identical Point of use (Hospital Laboratory or other Health Care Laboratory).
- Identical Chronometric Method of Coagulation Detection (Mechanical measurement of the oscillation of the metal ball in the cuvette).
- Identical Photometric Method of Coagulation Detection (Light absorption technique provided by a filtered light source (405μm, 540μm)).
- Identical Electrical Safety standards.
- Identical Disposables.
Differences highlighted in the table, but deemed not to affect substantial equivalence:
- Dimensions, Integrated PC specifications (processor, memory, hard disk), Weight, Connections, Disk drive, Computer table, Touch Screen: These are considered minor differences stemming from obsolescence of computer peripherals, ergonomic enhancements, and new graphical interface/communication protocol, with "no impact on performance, principle of operation, or fundamental technology."
Conclusion drawn from the document: The STA R Max® is substantially equivalent to the STA-R Evolution® Expert Series (K093001) predicate device because they share the same intended use, fundamental technology, principles of operation, and comparable performance characteristics. The modifications are primarily software (GUI, communication protocol), new peripherals, and external design changes for ergonomics. The document states that "no new questions of safety and effectiveness were raised" through risk assessment and verification/validation activities.
§ 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.