(32 days)
The Ciba Corning 348 System is intended for the point-of-care and laboratory testing of blood gases, electrolytes and metabolites in arterial, venous and capillary whole blood samples.
The 348 Series system analyzer is a point of care and laboratory testing analyzer used for the direct measure of whole blood samples for the determination of the following parameters:
- partial pressures of carbon dioxide; pCO2 .
- partial pressure of oxygen pO2 .
- pH
- sodium; Na* .
- potassium; K* ●
- ionized calcium; Ca** ●
- . hematocrit: Hct
Here's an analysis of the provided text, extracting the requested information about acceptance criteria and the study, while noting where information is not present:
The provided text describes a medical device, the Ciba Corning 348 System, and its technological characteristics. However, it does not contain information about acceptance criteria for device performance, nor does it detail a specific study proving the device meets such criteria.
The document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined acceptance criteria. While it mentions the device measures various analytes, it doesn't quantify expected accuracy or precision.
Therefore, most of the requested fields cannot be filled from the given input.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be answered from the provided text. The document lists the analytes the device measures (pCO2, pO2, pH, Na+, K+, Ca++, Hct) and their measurement technologies, but it does not specify any acceptance criteria (e.g., accuracy, precision limits) or report specific performance metrics against such criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be answered from the provided text. No information about a test set sample size, data provenance, or study design (retrospective/prospective) is available.
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)
- Cannot be answered from the provided text. There is no mention of experts or a ground truth establishment process for any test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be answered from the provided text. No information about an adjudication method is provided.
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
- Cannot be answered from the provided text. This device is an analyzer for blood gases, electrolytes, and metabolites, not an imaging or AI-assisted diagnostic tool. Therefore, an MRMC study or AI assistance is not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be answered from the provided text. While the device operates automatically, the document doesn't detail performance studies, standalone or otherwise. This question is more typically relevant to AI/algorithm-based devices, which this is not.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be answered from the provided text. No information about ground truth is mentioned. For this type of device, ground truth would typically come from a reference method or validated laboratory standard.
8. The sample size for the training set
- Cannot be answered from the provided text. This device isn't described as having a training set in the context of machine learning. The technology relies on established electrochemical principles, not a data-driven training paradigm in the modern AI sense.
9. How the ground truth for the training set was established
- Cannot be answered from the provided text. See explanation for point 8.
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.