(17 days)
The Datex-Ohmeda 3900/3900P Pulse Oximeters measure arterial oxygem saturation and pulse rate noninvasively using Datex-Ohmeda disposable and reusable finger and ear sensors.
Additionally, the Datex-Ohmeda 3900/3900P Pulsc Oximeters measure Relative Perfusion Index™ pulsatile value, which is an indicator of relative perfusion at the sensor site.
The Datex-Ohmeda 3900/39001' Pulse Oxincters are noninvasive, arterial oxygen sammation and pulse rate monitors. Roth models feature two casy-to-read displays that present patient data and status information. The numeric LEDs (light-emitting diodos) show the SpOs and pulse rate values. The LDC (liquid crystal display) shows the plethysnographic waveform, the carrent Relative Porfusion Index™ pulsatile value (17,70), the current high and low SpO, and pulse rate linit settings and alarin messages as appropriate. You can choose, through a series of menu options, to send current or trend (SpO, or PL™ pulsatile value) data to the built-in printer (39001' only) or to a computer. The menn options also include setting the date and time, and labeling individual data records.
The provided text does not contain detailed information about a study that proves the device meets specific acceptance criteria. Instead, it is a 510(k) summary for the Datex-Ohmeda 3900/3900P Pulse Oximeters, primarily focused on establishing substantial equivalence to a predicate device (Datex-Ohmeda 3800 Pulse Oximeter) and outlining the device's features and compliance with general standards.
However, based on the information provided, I can infer what typical acceptance criteria for a pulse oximeter would involve and what the document generally states about performance and validation.
Implied Acceptance Criteria and Reported Device Performance (Inferred from device type and general compliance)
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance (from text) |
|---|---|---|
| Accuracy of SpO2 Measurement | To accurately measure arterial oxygen saturation (SpO2) across a defined range (e.g., 70-100%). | "The Datex-Ohmeda 3900/3900P Pulse Oximeters measure arterial oxygen saturation... noninvasively." (Implied accuracy, but no specific values like RMSd or bias are provided). The device is stated to be "substantially equivalent" to a legally marketed predicate device, implying similar performance. |
| Accuracy of Pulse Rate Measurement | To accurately measure pulse rate across a defined range. | "The Datex-Ohmeda 3900/3900P Pulse Oximeters measure... pulse rate noninvasively." (Implied accuracy, but no specific values are provided). |
| Functional Performance | Reliable display of plethysmographic waveform, Relative Perfusion Index, and alarm functions. | "Features two easy-to-read displays that present patient data and status information. The numeric LEDs... show the SpO2 and pulse rate values. The LCD... shows the plethysmographic waveform, the current Relative Perfusion Index™ pulsatile value..., the current high and low SpO2 and pulse rate limit settings and alarm messages..." |
| Safety and Electrical Compliance | Compliance with relevant electrical safety and electromagnetic compatibility (EMC) standards. | The device "comply[s] with the following standards: CSA C22.2 #GD1, IEC 601-1, Part 1 and Amendments 1 and 2, IEC 601-1-1, Part 1, IEC 601-1-2, Part 1, IEC 601-1-4, Part 1, ISO 9919 (1992), EN 2601-1." This directly indicates compliance with these safety and performance standards. |
| Software Validation | Software performs as intended and is free from critical defects. | "Additionally, the software for the Datex-Ohmeda 3900/3900P Pulse Oximeters was developed following a robust software development process and was fully specified and validated by Datex-Ohmeda." |
| Device Interoperability | Compatibility with specific sensors, printer output, and analog output. | "Compatibility with several types of Datex-Ohmeda sensors for flexibility," "send current or trend... data to the built-in printer (3900P only) or to a computer," "Two analog output channels, SpO2 and pulse rate, that can be connected to a chart recorder or polysomnography machine." |
Here's an analysis of the specific points requested, based only on the provided text. Many aspects are not explicitly stated, as 510(k) summaries often focus on conclusions of testing rather than detailed methodologies.
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A table of acceptance criteria and the reported device performance
See table above. The document doesn't provide specific quantitative acceptance criteria or detailed results like mean differences, standard deviations, or RMSd values for SpO2 or pulse rate accuracy, which are typical for pulse oximeter studies. It mostly focuses on functional features and compliance with general standards. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified. The document only mentions that the device was "validated through rigorous testing."
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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)
Not applicable as the text describes a medical device (pulse oximeter) that measures physiological parameters directly, not an AI or diagnostic imaging system that relies on expert interpretation for ground truth. For pulse oximeters, ground truth for SpO2 typically comes from co-oximetry of arterial blood samples. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for studies where multiple human readers interpret data, and their findings need to be reconciled to establish a ground truth for an AI or diagnostic application. This is not the type of study described or implied for a pulse oximeter. -
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
No MRMC study was done or is applicable. This is a medical device (pulse oximeter) that provides direct measurements, not an AI assistance tool for human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, essentially. The "rigorous testing" and "validation" mentioned for the 3900/3900P Pulse Oximeters would inherently constitute standalone testing of the device's performance in measuring SpO2 and pulse rate. The device operates independently to provide these measurements. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
While not explicitly stated, for pulse oximeters, the ground truth for arterial oxygen saturation (SpO2) is typically established by co-oximetry of arterial blood samples. This is the standard method for validating optical plethysmographic SpO2 measurements. Pulse rate ground truth would likely come from ECG or a reference heart rate monitor. -
The sample size for the training set
Not applicable. This is a traditional medical device, not an AI/machine learning model that requires a distinct "training set." The device's internal algorithms are based on established physiological principles and spectrophotometry, not learned from a dataset in the way a neural network would be. The "validation" refers to verifying its performance against established standards, not training an AI. -
How the ground truth for the training set was established
Not applicable for the same reasons as #8.
§ 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).