(81 days)
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin and methemoglobin in samples of whole blood, serum, plasma and aqueous solutions as appropriate.
The Omni S analyzer represents a combined pH, blood gas, electrolyte, glucose, lactate, urea/BUN, total hemoglobin, hemoglobin derivatives, hematocrit and oxygen saturation test system classified as a Class II device based on the individual test parameters measured.
The provided text is a 510(k) summary for the Roche Diagnostics Omni S Analyzer. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance rather than detailing a specific study with acceptance criteria and performance metrics in the way a clinical trial report would.
Therefore, the information required to fully answer your request regarding acceptance criteria and the study that proves the device meets the acceptance criteria is not explicitly present in the provided document.
Here's what can be extracted and what is missing, based on the standard structure of your request:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The 510(k) summary states that the Omni S Analyzer has "incorporated the same blood gas modules as utilized in the Omni Modular and Omni C analyzers," and "the same ISE modules," "the same tHb (total hemoglobin ) and SO2 (oxygen saturation) sensor," and "similar types of MSS sensors." This implies that the performance of the Omni S is expected to be substantially equivalent to the predicate devices, but specific numerical acceptance criteria or performance results for the Omni S are not presented.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. While it mentions "samples of whole blood, serum, plasma and aqueous solutions," it does not specify the sample size used in any testing or the provenance (country, retrospective/prospective) of such data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. The device is a diagnostic analyzer for measuring various physiological parameters, and its ground truth would typically be established by reference methods or validated laboratory instruments, not necessarily through human expert consensus in the same way an imaging AI might.
4. Adjudication Method for the Test Set:
This information is not provided in the document. As mentioned above, the nature of the device's measurements would typically rely on instrument-based validation rather than human adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC study was not done. This type of study is relevant for devices like imaging AI that assist human readers in interpretation. The Omni S Analyzer is a laboratory instrument that provides direct measurements, not an assistive AI for human interpretation.
6. If a Standalone Study Was Done:
The document implies that the device (Omni S Analyzer) was tested for its performance, as it leverages components from previous cleared devices. However, a detailed "standalone study" report with specific performance metrics (e.g., accuracy, precision, linearity) for the Omni S itself is not included in this 510(k) summary. The summary focuses on demonstrating substantial equivalence by comparing its components and intended use to existing, legally marketed devices.
7. The Type of Ground Truth Used:
While not explicitly stated for the Omni S, for such laboratory analyzers, the ground truth would typically be established by reference methods or by measurements obtained from validated predicate devices or established laboratory techniques known to be accurate.
8. The Sample Size for the Training Set:
This information is not applicable as the Omni S Analyzer is not an AI/ML device that requires a "training set" in the conventional sense. It's an automated analyzer based on established sensor technologies.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
In summary:
This 510(k) summary is designed to demonstrate substantial equivalence to predicate devices, mainly by comparing the intended use, measured parameters, and the nature of the incorporated modules (e.g., "same blood gas modules," "similar types of MSS sensors"). It does not contain the detailed study results with acceptance criteria and performance metrics that would be part of a full validation report for the device.
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.