FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The SensorMedics Infant Flow System, consisting of a Driver and NCPAP Prongs, is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.

Device Description

Infant Flow System, consisting of a Driver and NCPAP Prongs

AI/ML Overview

I am sorry, but the provided text does not contain the information requested in the prompt. The document is a 510(k) clearance letter from the FDA for the "Infant Flow System" and an "Indications for Use" statement. It does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

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K Number

K974303

Device Name

INFANT FLOW SYSTEM

Manufacturer

SENSORMEDICS CORP.

Date Cleared

1998-01-30

(74 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

The SensorMedics Infant Flow System, consisting of a Driver and NCPAP Prongs, is intended to provide CPAP for use in hospitals to treat newboms and infants with RDS or who are recovering from RDS.

Device Description

Infant Flow System, consisting of a Driver and NCPAP Prongs

AI/ML Overview

The provided documents are an FDA 510(k) clearance letter for the SensorMedics Infant Flow System. This type of document declares substantial equivalence to a predicate device and permits marketing. It does not contain the detailed study information required to answer your questions about acceptance criteria, performance metrics, sample sizes, ground truth establishment, or multi-reader studies.

Therefore, I cannot provide the specific information requested. The document primarily focuses on regulatory approval, not on the technical details of device validation studies.

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