(205 days)
AS/3 Light Monitor is intended for stationary and mobile indoor monitoring of a patient's vital signs.
AS/3 Light Monitor is a portable patient monitor which measures ECG, 2 invasive blood pressures, oxygen saturation SpO2, 2 temperatures and non-invasive blood pressure NIBP. The measurement technics are similar to the AS/3 Compact Monitor with ESTP module and NIBP module. AS/3 Light Monitor will be available in two following configurations: LM which measures ECG, SpO2, 1 temperature and NIBP and LMP which measures ECG, SpO2, 2 invasive blood pressures, 2 temperatures and NIBP. The monitor can be driven with battery or with mains power.
The provided text is a 510(k) summary for the Datex AS/3 Light Monitor, a patient vital signs monitor. It describes the device, its intended use, and claims substantial equivalence to a predicate device (Datex AS/3 Compact Monitor with ESTP and NIBP modules).
However, the document does not contain information related to acceptance criteria, detailed study results proving device performance against acceptance criteria, or specifics about a study design involving experts, ground truth, or statistical analysis (like MRMC studies) typically associated with AI/ML device evaluations.
This 510(k) summary is for a traditional medical device (a vital signs monitor), not an AI/ML powered device. Therefore, the requested information elements, particularly those related to "AI improvement," "ground truth," "training set," and "expert consensus/adjudication," are not applicable and are not present in the provided text.
The document states that "The specifications of the monitors were compared and AS/3TM Light Monitor was tested against the specifications." This indicates that performance was evaluated against a set of predefined specifications, but the specifics of these specifications and the detailed test results are not included in this summary. The summary only concludes that the results "showed that AS/3TM Light Monitor is substantially equivalent with AS/3TM Compact Monitor."
If this were an AI/ML device submission, the requested information would be crucial. As it stands, the provided text does not allow for a complete answer to your detailed questions.
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Image /page/0/Picture/0 description: The image shows the word "Datex" in white letters on a black background. The word is centered and the font is bold. The background is a rounded rectangle.
510(k) SUMMARY
OCT 23 1996
27 March, 1996
Datex-Engström Division Instrumentarium Corp. P.O. Box 446 FIN-00101 Helsinki Finland Tel: +358 0 39411 Fax: +358 0 1463310
Contact person: Rauno Ruoho
PRODUCT NAMES
| Device name: | AS/3TM Light Monitor |
|---|---|
| -------------- | ---------------------- |
Common name: Hemodynamic measurement device
DESCRIPTION OF THE DEVICE
AS/3 Light Monitor is a portable patient monitor which measures ECG, 2 invasive blood pressures, oxygen saturation SpO2, 2 temperatures and non-invasive blood pressure NIBP. The measurement technics are similar to the AS/3 Compact Monitor with ESTP module and NIBP module. See section 3 for details.
AS/3 Light Monitor will be available in two following configurations:
LM which measures ECG, SpO2, 1 temperature and NIBP and
LMP which measures ECG, SpO2, 2 invasive blood pressures, 2 temperatures and NIBP. The monitor can be driven with battery or with mains power.
INTENDED USE
AS/3 Light Monitor is intended for stationary and mobile indoor monitoring of a patient's vital signs.
SUBSTANTIAL EQUIVALENCE
In terms of overall functions and parameters measured, the AS/3 TM Light Monitor is substantially equivalent in safety and effectiveness to Datex AS/3 ™ Compact Monitor ^ with ESTP and NIBP modules .
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Measurement parameters are the same as in Datex AS/3 ™ Compact Monitor with ESTP and NIBP modules. Measurement units are redesigned, but measurement technics and algorithms are the same.
The specifications of the monitors were compared and AS/3TM Light Monitor was tested against the specifications. The results showed that AS/3TM Light Monitor is substantially equivalent with AS/3TM Compact Monitor.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).