(116 days)
The Datex-Ohmeda 3800 Series and 3900 Series Oximeters with TruTrak Plus are indicated for spotchecking and continuous monitoring of functional oxygen saturation and pulse rate, including monitoring during conditions of clinical patient motion. These devices are intended for use with adult, pediatric and neonatal patients in both hospital and non-hospital environments.
The Datex-Ohmeda 3800/3900/3900P Pulse Oximeters and Accessories are designed to measure noninvasive arterial blood oxygen saturation and pulse rate.
The provided text does not contain detailed information about specific acceptance criteria for performance, nor does it describe a study that explicitly proves the device meets such criteria. The document is a 510(k) summary for the Datex-Ohmeda 3800/3900/3900P Pulse Oximeters and Accessories, focusing on regulatory clearance based on substantial equivalence to predicate devices, and compliance with general safety and performance standards.
Therefore, many of the requested details cannot be extracted from this document.
Here's an attempt to answer based only on the provided text, indicating where information is missing:
Acceptance Criteria and Device Performance Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured and the target) | Reported Device Performance (Result and evaluation against criterion) |
|---|---|
| Not explicitly stated in the provided document. | Not explicitly stated in the provided document. |
2. Sample size used for the test set and data provenance
- Test set sample size: Not specified in the provided document.
- Data provenance: Not specified in the provided document.
3. Number of experts used to establish the ground truth for the test set and their qualifications
- Not applicable as the document does not describe a clinical study with expert ground truth establishment.
4. Adjudication method for the test set
- Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, the document does not mention an MRMC comparative effectiveness study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This device is a pulse oximeter, a medical device that directly measures SpO2 and pulse rate. The concept of "standalone algorithm performance" (without human-in-the-loop) in the context of AI is not directly applicable here. The device's performance would be evaluated as a standalone product. The document states it was "validated through testing" to support compliance with standards, implying standalone performance testing. However, no specific details on these tests are provided.
7. The type of ground truth used
- Not explicitly stated for performance testing. In a pulse oximeter validation, ground truth for oxygen saturation would typically be established by co-oximetry (blood gas analysis) from arterial blood samples. The document mentions compliance with standards like "EN 865 Pulse Oximeters - Particular Requirements" and "ISO 9919 Pulse Oximeters - Particular Requirements," which generally outline the methodology for establishing accuracy against a reference method.
8. The sample size for the training set
- Not applicable, as this document describes a physical medical device, not an AI algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable.
Summary of what the document does provide regarding validation:
The document states: "The Datex-Ohmeda 3800/3900/3900P Pulse Oximeters and Accessories has been validated through testing that, in part, support the compliance of the device to the above mentioned standards."
The referenced standards include:
- EN 865 Pulse Oximeters - Particular Requirements
- ISO 9919 Pulse Oximeters - Particular Requirements
These international standards typically define the methods and requirements for testing pulse oximeter accuracy, particularly against arterial blood gas co-oximetry, and specify acceptable bias and accuracy root mean square (ARMS) limits. However, the results of such testing and the specific acceptance criteria met are not detailed in this 510(k) summary. The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, as well as adherence to recognized voluntary standards.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).