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.

Device Description

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

AI/ML Overview

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.

Summary

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K962021

JUN 24 1998

Summary of Safety and Effectiveness

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

1. Submitters Information

1 177

Contact person:	William J. Pignato
	Director of Regulatory Affairs

Address: Ciba Corning Diagnostics Corp. 63 North Street Medfield, MA 02052
Phone: 508 359-3825
Date Summary Prepared: May 22, 1996

2. Device Information

Proprietary Name:	Ciba Corning 348 System
Common Name:	Analyzer for Blood Gas, electrolytes and metabolites
Classification Name:	Electrode/Sensor measurement of blood gases, bloodpH and blood electrolytes
Classification Number:	Calcium - 21 CFR 862.1145, Class II
	Hematocrit - 21 CFR 864.6348, Class II
	Potassium - 21 CFR 862.1600, Class II
	Sodium - 21 CFR 862.1665, Class II
	pCO2 - 21 CFR 862.1120, Class II
	p02 - 21 CFR 862.1120, Class II
	pH - 21 CFR 862.1120, Class II

1. Predicate Device Information

Name:	Model 850 Analyzer
Manufacturer:	Ciba Corning Diagnostics Corp.
510(k) Number:	D.C. # K933373

2. Device Description

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:

م partial pressures of carbon dioxide; pCO2 .
partial pressure of oxygen pO2 .

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pH
sodium; Na* .
potassium; K* ●
ionized calcium; Ca** ●
. hematocrit: Hct

3. Statement of Intended Use

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.

4. Summary of Technological Characteristics

The 348 Series System uses measurement technology that is based on electrochemical phenomena. The device uses potentiometry, amperometry and conductimetric methods to convert the potential generated by the sensor to an electrical signal which the system then converts to a value that represents that concentration of a specific analyte in the whole blood sample.

The 348 Series sensors (i.e., electrodes) provide direct measurement of the specific analytes or substances in the sample. Each sensor in the 348 system is highly selective for one substance over others.

Sensor	Measurement Technology
pH, Na+, K+, Ca++,	potentiometric method using ion-selective electrode technology
reference	silver electrode in potassium chloride and silver chloride
pCO2	potentiometric method
pO2	amperometric method
hematocrit	conductimetic method

The sensors use the following measurement technology:

Regulation Number and Section

§ 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.