(90 days)
The Model 2001 Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate units in neonatal, pediatric and adult patients in hospital-type facilities and intra-hospital transport environments such as the operating room, emergency department and intensive care units. The Model 2001 and its sensors are intended to be used by trained operators when pulse oximetry monitoring is required in the judgement of a physician.
The Model 2001 Pulse Oximeter is designed for continuous, non-invasive monitoring of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoqlobin and pulse rate is measured using the time between successive pulses. The O2 saturation sensors are already legally marketed as accessories to the Model 520A monitor. The Model 2001 displays digital values of SpO2 and pulse rate as well as a graphic display of the plethysmogram. The Model 2001 monitor consists of a dual microprocessor based data acquisition system that measures oxygen saturation data. The firmware for the primary microprocessor performs the functions of the existing Model 520A including data acquisition, display, trending and communications with external devices. The firmware for the second microprocessor, a digital signal processor, performs the filtering, pulse rate and saturation calculations of the existing algorithms and additional calculations which analyze the incoming signals and perform noise reduction on that signal when the presence of noise is detected.
The provided text is a 510(k) premarket notification for the Novametrix Medical Systems, Inc. Model 2001 Pulse Oximeter. It describes the device, its intended use, and its technological characteristics, and asserts substantial equivalence to predicate devices. However, the document does not contain explicit acceptance criteria or a detailed study report proving the device meets specific performance criteria beyond general assertions of accuracy and compliance with industry standards.
The document states: "In addition, inter-device comparison studies and non-invasive controlled hypoxia studies were conducted to establish the Model 2001 accuracy and to ensure that the sensors meet their currently published accuracy specifications with the Model 2001." This is the only mention of studies conducted to evaluate the device's accuracy.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and MRMC studies cannot be extracted from this document.
Here's an attempt to answer the questions based on the limited information available:
1. Table of acceptance criteria and the reported device performance
Based on the provided document, specific numerical acceptance criteria and a detailed report of the device's performance against these criteria are not available. The document only generally states that "inter-device comparison studies and non-invasive controlled hypoxia studies were conducted to establish the Model 2001 accuracy and to ensure that the sensors meet their currently published accuracy specifications with the Model 2001." This implies the acceptance criteria were related to achieving accuracy comparable to previous models and meeting sensor specifications, but the specific metrics are not quantified.
A hypothetical table structure would look like this if the information were present:
| Performance Metric (Acceptance Criteria) | Reported Device Performance |
|---|---|
| Accuracy (SpO2) | (e.g., ±X% compared to reference) |
| Accuracy (Pulse Rate) | (e.g., ±Y bpm compared to reference) |
| Performance in motion artifact | (e.g., maintains accuracy under defined motion conditions) |
| ... | ... |
2. Sample size used for the test set and the data provenance
The document only mentions "inter-device comparison studies and non-invasive controlled hypoxia studies." It does not specify the sample size (number of subjects or cases) used in these studies, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide details on how ground truth was established for the "inter-device comparison studies" or "non-invasive controlled hypoxia studies." It does not mention the use of experts, their number, or their qualifications for establishing ground truth.
4. Adjudication method for the test set
The document does not describe any adjudication method for establishing ground truth in the studies mentioned.
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
No MRMC comparative effectiveness study is mentioned. This device is a pulse oximeter, which provides a direct measurement (SpO2 and pulse rate) rather than diagnostic images requiring human interpretation, so an MRMC study would not be applicable in this context. The document focuses on the device's accuracy in measuring physiological parameters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone algorithm (Model 2001 Pulse Oximeter) that "measures functional oxygen saturation data" and performs "filtering, pulse rate and saturation calculations of the existing algorithms and additional calculations which analyze the incoming signals and perform noise reduction." The mentioned "inter-device comparison studies and non-invasive controlled hypoxia studies" would inherently evaluate this standalone performance.
7. The type of ground truth used
While not explicitly stated with detail, "non-invasive controlled hypoxia studies" typically involve inducing controlled levels of hypoxia in subjects and comparing the device's SpO2 readings against a gold standard method, such as arterial blood gas analysis (co-oximetry) or another highly accurate reference oximeter. Therefore, the ground truth would likely be a reference measurement from an established medical device or direct physiological measurement. The "inter-device comparison studies" would likely use readings from the predicate devices as a comparative "ground truth" or reference.
8. The sample size for the training set
The document does not mention a "training set" in the context of machine learning, as this device was developed in 1999 and pre-dates widespread use of complex AI algorithms requiring large training datasets as we understand them today. The device uses "proprietary algorithms" and "artifact filtering software" developed based on "existing algorithms." Therefore, there's no explicitly defined "training set" in the modern sense.
9. How the ground truth for the training set was established
As there is no mention of a "training set" for AI/machine learning algorithms, the method for establishing its ground truth is not applicable or described in the document. The algorithms were likely developed and refined based on engineering principles, signal processing, and performance against known physiological responses and noise conditions rather than a labeled training dataset.
§ 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).