(90 days)
The intended use of the NPB-190 Pulse Oximeter is the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulserate. For violiti neonatal, pediatric and adult patients, in hospital-type, intra-hospital transport and home environments. For prescription use only.
The NPB-190 Pulse Oximeter is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate by use of one of a range of compatible Nellcor Puritan Bennett oxygen transducers (sensors). The NPB-190 displays digital values of SpO- and pulse rate and pulse amplitude by means of a "blip bar" presentation. The NPB-190 can be powered by an internal power supply operating on AC from a standard electrical utility receptacle (manually switchable from 115V to 230V) or alternatively an integral sealed 6V rechargeable lead-acid battery. The NPB-190 is intended for prescription use with adult, pediatric and neonatal patients in hospital, hospital-type, intra-hospital transport and home environments. Audible and visual alarms for high/low saturation, pulse rate and pulse search are The NPB-190 also includes adjustable alarm silence duration and other provided. configurable power on settings. The NPB-190 provides an audible low battery warning to alert the user of impending loss of power and consequent loss of monitoring capability. The NPB-190 Pulse Oximeter has visual indicators for pulse search, power mode (i.e. battery or AC) and alarm silence in addition to alarm features. In addition to the above mentioned device features, the instrument was designed to satisfy the needs of both the user and the patient. A convenient carrying handle is incorporated into the case. There is also a serial port (EIA-232 interface) that provides ASCII output of real-time data every two seconds. This data can be printed on serial printers and can interface with nurse call systems through the rear connector. The device is also Flash ROM upgradable.
Here's a breakdown of the acceptance criteria and study information for the Nellcor Puritan Bennett NPB-190 Pulse Oximeter, based on the provided K971946 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state specific numerical acceptance criteria for the NPB-190 Pulse Oximeter's accuracy (e.g., a specific SpO2 accuracy range). Instead, it relies on demonstrating substantial equivalence to predicate devices and performance against "currently published accuracy specifications" of its sensors.
However, the document mentions:
- Substantial equivalence to legally marketed predicate devices:
- Testing to accepted industry standards.
- Noninvasive controlled hypoxia studies were conducted to establish the NPB-190's accuracy and to ensure that the sensors meet their currently published accuracy specifications with the NPB-190.
Without the "currently published accuracy specifications" or the results of the hypoxia studies, a numerical table cannot be precisely filled. However, we can infer the acceptance criteria are implicitly met if the device performs comparably to the predicate devices and meets its sensor specifications in the hypoxia studies.
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not explicitly state the specific number of subjects or data points used in the noninvasive controlled hypoxia studies.
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: The "noninvasive controlled hypoxia studies" were conducted to "establish the NPB-190's accuracy," which implies a prospective study design specifically for this device's validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not specify the number or qualifications of experts used to establish ground truth in the hypoxia studies. In controlled hypoxia studies for pulse oximetry, the "ground truth" (arterial oxygen saturation, SaO2) is typically obtained via arterial blood gas (ABG) analysis, which is a direct measurement performed by laboratory technicians or medical professionals, not usually "experts" in the context of interpretation, but rather skilled operators.
4. Adjudication Method for the Test Set:
- The document does not mention any adjudication method for establishing ground truth. For controlled hypoxia studies relying on ABG measurements, adjudication as typically seen in image interpretation studies is not usually applicable. The ABG results are considered the direct and objective measurement of SaO2.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI systems that assist human operators in interpreting medical images or data. The NPB-190 Pulse Oximeter is a standalone monitoring device that provides direct readings of SpO2 and pulse rate. There is no human interpretation "with AI vs. without AI assistance" involved in the device's primary function.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, a standalone study was done. The "noninvasive controlled hypoxia studies" described are precisely a standalone performance evaluation. The device (NPB-190 Pulse Oximeter) directly measures and displays SpO2 and pulse rate, and its accuracy was evaluated by comparing its readings to a gold standard (presumably ABG measurements) during induced hypoxia. This assesses the algorithm's (referred to as the "SpO2 software algorithm" and "engine") performance without human intervention in the measurement or calculation process.
7. Type of Ground Truth Used:
- For the noninvasive controlled hypoxia studies, the ground truth would be arterial blood gas (ABG) measurements of functional oxygen saturation (SaO2), taken concurrently with the pulse oximeter readings. While not explicitly stated as "ABG," this is the standard gold standard for validating pulse oximeter accuracy.
8. Sample Size for the Training Set:
- The document does not provide information on the sample size for a training set. The NPB-190 uses an "SpO2 software algorithm" that is stated to be the same as the predicate device NPB-40. This suggests the algorithm was likely developed and "trained" (if machine learning was involved, which is unlikely for a 1997 device) or validated during the development of the NPB-40, rather than the NPB-190 itself. The K971946 submission focuses on demonstrating that the device incorporating this algorithm performs as expected.
9. How the Ground Truth for the Training Set Was Established:
- As the document does not provide information on a training set or its development, it also does not specify how its ground truth would have been established. Given the time period (1997) and the nature of the device (pulse oximeter), it's highly probable that the algorithm was derived from physiological models and empirical data collected from human studies (likely controlled hypoxia studies similar to the validation study) in previous development cycles for the NPB-40 or earlier predicate devices. The ground truth for such development would also have been established via ABG measurements.
§ 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).