(37 days)
The Nonin® Avant® Model 4000 Digital Pulse Oximetry System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients. It is indicated for spot-checking and / or continuous monitoring.
The Avant Model 4000 Digital Pulse Oximetry System is a wireless pulse oximeter that includes a portable, tabletop display unit (Avant 4000) and a wrist-worn patient module Avant (4100). The System is designed for spot-checking and / or continuous noninvasive measuring and displaying of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate. The Avant 4000 System is intended for use with adult, pediatric, and infant patients. The Avant 4000 display uses light-emitting diodes (LED) components to present patient's SpO2 and pulse rate values, as well as alarm limit and volume settings. The Avant 4000 can be powered with a 12 VDC AC adapter or with an integral sealed 7.2-volt rechargeable NiMH battery pack. The Avant 4100 patient module is powered with two 1.5 volt AA batteries. The Avant 4000 System includes adjustable audible and visual pulse rate, oxygen saturation, and perfusion alarms. It also includes a variety of advanced features, including low battery alarms, event markers, real-time and print-on-demand data outputs. Incorporating Bluetooth® Technology in the Avant 4000 eliminates the connection from the wrist worn oximeter module to the display unit giving patients increased ability to move freely without being hindered by cables.
Here's an analysis of the provided text regarding the Avant® Model 4000 Digital Pulse Oximetry System, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state specific numerical acceptance criteria for the Avant® Model 4000 Digital Pulse Oximetry System in terms of accuracy (e.g., A
rms
value for SpO2 or pulse rate). It generally states that the device successfully underwent "both bench and clinical testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate devices."
Therefore, I cannot populate a table with specific acceptance criteria and reported performance values based on the given text.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample size used for the clinical testing. It only mentions "clinical testing."
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. Clinical testing generally implies prospective data collection, but this is not confirmed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not provide any information about the number of experts, their qualifications, or their role in establishing ground truth for the test set.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention or describe an MRMC comparative effectiveness study. Pulse oximeters are typically standalone measurement devices, and the concept of human readers improving with AI assistance does not directly apply in the same way it would for imaging diagnostics. The study aimed to demonstrate substantial equivalence, not to quantify human performance improvement with AI assistance.
6. Standalone Performance:
Yes, a standalone performance evaluation (algorithm only without human-in-the-loop performance) was implicitly done. For a pulse oximeter, "standalone performance" refers to the device's ability to accurately measure SpO2 and pulse rate independently. The document states "bench and clinical testing" was conducted to demonstrate functional features and substantial equivalence. This implies evaluating the device's measurements against a reference standard without human intervention adjusting the device's output.
7. Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used. For pulse oximetry, the typical gold standard or ground truth involves:
* Co-oximetry: Blood samples analyzed by a co-oximeter for precise arterial oxygen saturation (SaO2).
* Controlled Desaturation Studies: Human subjects undergoing controlled desaturation (to vary SpO2) while the device's readings are compared to co-oximetry.
Given the context of pulse oximetry, it is highly probable that co-oximetry and/or controlled desaturation studies were used as the reference standard to establish ground truth.
8. Sample Size for the Training Set:
The document does not specify any sample size for a training set. Pulse oximeters, especially those submitted in 2004, typically rely on physiological models and signal processing rather than large-scale machine learning training sets in the modern sense. The "training" of such a device usually refers to the development and calibration against known physiological responses under various conditions.
9. How the Ground Truth for the Training Set was Established:
As there's no explicit mention of a "training set" in the context of machine learning, the document does not describe how ground truth for a training set was established. If we interpret "training" more broadly as the developmental process, the ground truth would have been established through extensive laboratory testing, physiological modeling, and potentially smaller-scale clinical studies during the device's design and calibration phases, likely using co-oximetry as the reference standard.
§ 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).