(84 days)
The intended use of the NPB-295 Pulse Oximeter is the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. For use with nconatal, pediatric and adult patients, in hospital-type, intra-hospital transport and home cnvironments. For prescription use only.
The NPB-295 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 or a range of compansio from of SpO₂ and pulse rate, and pulse amplitude by means of a "blip bar" presentation. The NPB-295 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-295 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-295 also includes adjustable alarm silence duration and other provided. configurable power on settings. The NPB-295 provides an audible low battery warning to alert the user of impending loss of power and consequent loss of monitoring capability. The NPB-295 Pulse Oximeter has visual indicators for pulse search, motion, 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 and RS-422 interface) that provides ASCII output of real-time data every two seconds. This data can be printed on serial printers. TThere is also an interface for nurse call systems through the rear connector. The device is also Flash ROM upgradable.
Acceptance Criteria and Device Performance for NPB-295 Pulse Oximeter
The provided document describes the NPB-295 Pulse Oximeter and its substantial equivalence to predicate devices, but it does not explicitly state specific acceptance criteria or a dedicated study that proves the device meets predefined criteria with quantitative performance metrics.
Instead, the document mentions that "in-vitro and non-invasive controlled hypoxia studies were conducted to establish the NPB-295's accuracy and to ensure that the sensors meet their currently published accuracy specifications with the NPB-295." This implies that the acceptance criteria are tied to the "currently published accuracy specifications" of the compatible sensors and the general expectation of accuracy for pulse oximeters, as established by the predicate devices.
Given the information, a table of stated acceptance criteria and reported device performance cannot be conclusively filled with specific numerical targets from this document. However, we can infer the intent and the type of evaluation performed.
Here's a breakdown based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state numerical acceptance criteria for accuracy or precision. The performance is implied to be equivalent to the predicate devices and to meet sensor specifications.
| Performance Metric | Acceptance Criteria (Inferred) | Reported Device Performance (Inferred from study description) |
|---|---|---|
| SpO₂ Accuracy | Equivalent to predicate devices (N-3000 Pulse Oximeter) | Established through in-vitro and non-invasive controlled hypoxia studies. Sensors met their currently published accuracy specifications with the NPB-295. |
| Pulse Rate Accuracy | Equivalent to predicate devices (N-3000 Pulse Oximeter) | Established through in-vitro and non-invasive controlled hypoxia studies. Sensors met their currently published accuracy specifications with the NPB-295. |
| General Functionality | Consistent with "accepted industry standards" and the features of predicate devices. | Functionality confirmed through testing to accepted industry standards and comparison to predicate devices. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: The studies conducted were "in-vitro and non-invasive controlled hypoxia studies." This suggests the data was likely prospective and collected in a controlled environment as part of the device testing. The country of origin of the data is not specified, but given the company (Nellcor Puritan Bennett Inc.) and the FDA submission, it's likely from the US or a region adhering to similar medical device standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
The nature of pulse oximetry accuracy assessment typically involves comparison to a reference standard (e.g., co-oximetry of arterial blood samples). While experts (e.g., clinicians, laboratory technicians) would be involved in executing these studies and interpreting results, the document doesn't detail their specific role in "establishing ground truth" as might be the case for image-based diagnostic devices requiring expert consensus.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not specified.
For pulse oximeter accuracy studies using controlled hypoxia and co-oximetry, the ground truth (arterial oxygen saturation) is a direct physiological measurement, not typically subject to expert adjudication in the same way as, for example, classifying medical images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or indicated. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role and the AI's impact on reader performance is being evaluated. The NPB-295 is a monitoring device that provides direct physiological measurements.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Yes, implied. The "in-vitro and non-invasive controlled hypoxia studies" were conducted to "establish the NPB-295's accuracy." This type of study evaluates the device's output (SpO₂ and pulse rate) directly against a reference standard, which is a standalone performance evaluation of the algorithm and hardware without human intervention in the interpretive output.
7. Type of Ground Truth Used
- Type of Ground Truth: The context of "non-invasive controlled hypoxia studies" for pulse oximeters strongly suggests that the ground truth would be established using arterial blood gas analysis (e.g., co-oximetry), which is considered the gold standard for measuring arterial oxygen saturation (SaO₂).
8. Sample Size for the Training Set
- Sample Size for Training Set: Not specified.
The document states that "The NPB-295 uses the same SpO₂ and Pulse Rate software algorithm to process the information from the sensor as the predicate device, N-3000, cleared under K942347 and K952316." This implies that the algorithm itself might have been trained or developed based on data used for the predicate device, or it's a well-established, validated algorithm. The current submission focuses on demonstrating the new device's implementation of this existing algorithm.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not specified.
As mentioned above, the algorithm is stated to be the same as the predicate device. Therefore, any "training" (if applicable to the type of algorithm used) would have occurred prior to the predicate device's clearance. The document focuses on demonstrating the new device's performance with this established algorithm.
§ 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).