Search Results

The intended use of the NPB-195 Pulse Oximeter is the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. For use with neonatal, pediatric and adult patients, in hospital, hospital-type, intra-hospital transport and home environments. For prescription use only.

The NPB-195 Pulse Oximeter is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate by use of one of a range of compatible Nellcor Puritan Bennett oxygen transducers (sensors) The NPB-195 displays digital values of SpO2 and pulse rate, and pulse amplitude by means of a "blip bar" presentation. The NPB-195 is also capable of displaying a Pleth Waveform and trends on its LCD display. The NPB-195 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 by an integral sealed 6V rechargeable lead-acid battery. The NPB-195 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 provided. The NPB-195 also includes adjustable alarm silence duration and other configurable power on settings. The NPB-195 provides an audible low battery warning to alert the user of impending loss of power and consequent loss of monitoring capability. The NPB-195 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 has been 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.

The provided text mentions that "noninvasive controlled hypoxia studies were conducted to establish the NPB-195's accuracy and to ensure that the sensors meet their currently published accuracy specifications with the NPB-195." However, it does not explicitly state the acceptance criteria or provide the specific results of these studies in a format that allows for a table of acceptance criteria versus reported performance.

Therefore, I cannot directly fulfill item 1, 2, 3, 4, 5, 6, 7, 8, and 9 with the information given. The document is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices and describes the device's main features and intended use. It does not contain the detailed study results or methodology typically found in a clinical study report.

Based on the provided text, here's what can be extracted and what cannot be:

1. A table of acceptance criteria and the reported device performance:

• Cannot be provided directly. The document states that studies were done "to establish the NPB-195's accuracy and to ensure that the sensors meet their currently published accuracy specifications," but it does not list what those specifications are, nor does it provide the accuracy results from these studies.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Cannot be provided directly. The text mentions "noninvasive controlled hypoxia studies" but does not specify the number of subjects, their demographics, or where the studies were conducted. It implies prospective studies ("were conducted").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Cannot be provided. For pulse oximeters, the "ground truth" for oxygen saturation is typically established by arterial blood gas analysis (co-oximetry), not by expert consensus on visual assessment. The document does not mention the methodology for establishing ground truth during the hypoxia studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Cannot be provided. As the ground truth would likely be established by objective measurements (e.g., co-oximetry), an adjudication method by experts is not relevant in this context.

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:

• Not applicable. This device is a pulse oximeter, which is an automated measurement device, not an AI-powered diagnostic imaging tool that requires human reader interpretation. Therefore, an MRMC study with human readers improving with AI assistance is not relevant to this technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, implicitly. The "noninvasive controlled hypoxia studies" described would assess the accuracy of the device (algorithm and sensor combined) in measuring SpO2 and pulse rate, which is a standalone performance evaluation for a pulse oximeter. However, the specific results of this standalone performance are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Implied arterial blood gas analysis (co-oximetry). While not explicitly stated, the standard for establishing ground truth for oxygen saturation in controlled hypoxia studies for pulse oximeters is simultaneously drawn arterial blood samples analyzed by a co-oximeter. This is the gold standard for SpO2 accuracy.

8. The sample size for the training set:

• Not applicable/Cannot be provided. The text states that the NPB-195 uses the "same SpO2 software algorithm" as the predicate device, NPB-40 (cleared under K963707). This suggests that the algorithm was developed and "trained" (in a historical sense) prior to the NPB-195, likely during the development of the NPB-40. The document does not provide details of the training set used for that algorithm.

9. How the ground truth for the training set was established:

• Not applicable/Cannot be provided. Similar to point 8, this information pertains to the original algorithm development, which is not detailed for either the NPB-195 or its predicate in this summary. It would likely have been established using arterial blood gas analysis during earlier development studies.

Ask a specific question about this device