(66 days)
The Nonin® Model 7500 Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients. It is indicated for spot-checking and / or continuous monitoring of patients during both motion and non-motion conditions, and for patients who are well or poorly perfused.
The Nonin® Model 7500 Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients. It is indicated for spot-checking and / or continuous monitoring of patients during both motion and non-motion conditions, and for patients who are well or poorly perfused.
The Model 7500 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 Model 7500 can be powered internally with a 12 VDC 1.5A AC adapter or with an integral sealed 7.2-volt rechargeable NiMH battery pack.
The Model 7500 includes adjustable audible and visual pulse rate, oxygen saturation, and perfusion alarms. It also includes a variety of advanced features, including low battery alarms, sensor fault detection (SPIM), user defined defaults, real-time data outputs, and patient security mode.
This 510(k) summary for the Nonin Model 7500 Digital Pulse Oximeter indicates that human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications. However, the document does not provide explicit acceptance criteria, detailed performance metrics, or specific information about the study design that would allow for a complete answer to all parts of your request.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
The document does not explicitly state numerical acceptance criteria for accuracy or precision. It generally refers to "conformance to accuracy and precision specifications." In the context of pulse oximeters, these typically relate to the accuracy of SpO2 readings compared to a reference standard (e.g., arterial blood gas analysis), often expressed as an Arms (Accuracy Root Mean Square) value.
Reported Device Performance:
The document does not provide specific numerical performance metrics such as Accuracy Root Mean Square (Arms) for SpO2 or accuracy for pulse rate. It only states that "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications." and concludes that the device is "substantially equivalent to the predicate device in terms of accuracy, functional design and principles of operation."
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Human oxygenation evaluations were conducted," implying a human test set. However, it does not specify:
- The sample size (number of subjects) used in the human oxygenation evaluations.
- The country of origin for the data.
- Whether the study was retrospective or prospective. (Typically, such evaluations for new devices are prospective.)
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information about:
- The number of experts involved in establishing ground truth.
- The qualifications of any such experts.
- For pulse oximetry, the ground truth for SpO2 is usually established via arterial blood gas (ABG) measurements, not through expert consensus on visual interpretation. ABG analysis is usually performed by trained laboratory technicians or medical staff, not "experts" in the sense of radiologists.
4. Adjudication Method for the Test Set
Given that the ground truth for SpO2 is typically established through a direct physiological measurement (ABG), adjudication methods like 2+1 or 3+1 are not applicable in the same way they would be for image-based diagnostic devices where expert consensus is needed. The document does not mention any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not mention or imply that an MRMC comparative effectiveness study was conducted. Pulse oximeters are typically standalone measurement devices, and the evaluation focuses on their accuracy against a reference standard, not augmentation of human reading performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the entire evaluation described implies a standalone performance assessment. The "human oxygenation evaluations" were conducted to test the device's accuracy in measuring SpO2 and pulse rate, which is the device's direct output, independent of human interpretation or intervention in the measurement process itself.
7. The Type of Ground Truth Used
Based on common practice for pulse oximeters, the most probable type of ground truth used for SpO2 accuracy is arterial blood gas (ABG) analysis. The document refers to "human oxygenation evaluations," which strongly suggests the use of ABG as the reference standard.
8. The Sample Size for the Training Set
The document does not mention a "training set" or provide any information about its sample size. For traditional medical devices like pulse oximeters, especially in the context of a 2007 submission, there generally isn't a "training set" in the machine learning sense. The device's algorithms for calculating SpO2 and pulse rate are based on established physiological principles and spectrophotometry, often calibrated during development but not typically "trained" on a separate dataset in the way an AI algorithm would be.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" in the context of machine learning is not indicated or implied for this device, a description of how its ground truth was established is not provided and not applicable in the conventional sense. The core algorithms would have been developed and validated against physiological models and potentially pre-clinical data during the research and development phase.
§ 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).