(76 days)
Teco ISE Reagent Set is intended for quantitative measurement of Sodium, Potassium; Chloride and Carbon Dioxide in human serum samples on the Beckman CX System. Teco ISE Reagent Set is used in the diagnosis and treatment electrolyte disorders. ISE Buffer reagent is intended for quantitative measurement of Sodium, Potassium, and Chloride. ISE Reference Reagent is to provide reference points for Sodium, Potassium, and Chloride. The CO2 Acid Reagent is to release Carbon Dioxide from serum samples. The CO2 Buffer Reagent is to provide a reference point for Carbon Dioxide. This reagent set is intended for in vitro diagnostic use only.
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This document is a 510(k) premarket notification letter from the FDA for a device called "Teco ISE Reagent Set for CX System." It primarily addresses the regulatory approval of the device and its intended use, rather than a detailed study report with acceptance criteria and performance data.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided text. This document is a regulatory approval, not a scientific study report.
However, based on the limited information, here's what can be gathered:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent... to legally marketed predicate devices." This implies that the device performance was compared to existing, approved devices, but the specific acceptance criteria and the detailed performance metrics of the Teco ISE Reagent Set are not disclosed in this letter.
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.
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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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 applicable and not provided in the document. The device is a "Teco ISE Reagent Set" for quantitative measurement of analytes, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable and not provided in the document. This device is a reagent set, not an algorithm. However, the performance assessment would effectively be "standalone" in the sense that the reagent set's analytical performance on the Beckman CX System would be evaluated independently. The document does not detail this evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For a diagnostic reagent set, the "ground truth" would typically be established through reference methods (e.g., highly accurate laboratory techniques, certified reference materials) or comparison to predicate devices with established accuracy. However, this specific information is not provided in the document.
8. The sample size for the training set:
This information is not applicable and not provided in the document. Reagent sets, unlike machine learning algorithms, do not typically have "training sets." Their performance is validated through analytical studies.
9. How the ground truth for the training set was established:
This information is not applicable and not provided in the document.
Summary of available information:
The provided document is a regulatory approval letter. It confirms the "Teco ISE Reagent Set for CX System" is deemed "substantially equivalent" to legally marketed predicate devices for the quantitative measurement of Sodium, Potassium, Chloride, and Carbon Dioxide in human serum samples on the Beckman CX System, for the diagnosis and treatment of electrolyte disorders. The letter does not contain the detailed technical study results, acceptance criteria, or methodological specifics of the performance evaluation that led to this determination.
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.