(237 days)
The Nitronox Plus is intended to provide a mixture of N20/02, on demand, to a conscious, spontaneously breathing patient. The Nitronox Plus is designed for use with adult and pediatric patients and is not intended to be used with infants or neonates.
The Nitronox Plus is a portable "on demand" analgesia system used to deliver a mixture of nitrous oxide and oxygen gases to a conscious, spontaneously breathing patient. The device is designed for use with adult and pediatric patients and is not intended to be used with infants or neonates. It is only for use in a healthcare setting by healthcare professionals. The Nitronox Plus is available in three models which differ only in adjustability and maximum ratio of nitrous oxide that can be delivered. The Nitronox Plus features a 0-70% N2O adjustable model, 0-50% N2O adjustable model, and 50% N2O/50% O2 fixed model.
The Nitronox Plus is a pneumatic system. Oxygen and nitrous oxide are supplied to the device through flexible hoses. Inlet gas is regulated and equalized through the use of an oxygen piloted dual diaphragm regulator. The inlet pressure of both gases and the mixed gas pressure are displayed on the front panel of the device through the use of pressure gauges. The device is designed to function with a medical breathing circuit and face mask or mouthpiece accessory.
Delivery of mixed gas starts with a patient's demand; upon inhalation through a face mask or mouthpiece, a demand valve opens and supplies mixed gas to the patient through the connected Medical Breathing Circuit. In adjustable models, the healthcare professional is able to set the desired concentration through the use of a control knob on the front panel. Mixed gas is supplied through the breathing circuit until inhalation ceases.
The Nitronox Plus contains several safety features. Pneumatically powered alarms for both gas inlets alert the user when either gas supply begins to deplete. The device will also maintain delivery of the set concentration with depleting oxygen pressure. Once the oxygen pressure drops below a certain threshold, the device will allow ambient air to be delivered through an Emergency Air Intake valve. The device also features a key lock to control the nitrous oxide gas supply, allowing healthcare professionals to prevent unauthorized use of the device.
The provided text describes the safety, operational, and performance requirements for the Nitronox Plus breathing gas mixer, but it does not provide a specific table of acceptance criteria or detailed results of a study proving the device meets those criteria, especially at the level of detail requested for AI/diagnostic studies. Instead, it broadly states that performance testing was conducted and demonstrates the device meets "all design input requirements."
Therefore, many of the requested details cannot be extracted from this document, as it focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed performance study with specific metrics, sample sizes, and ground truth methodologies relevant to AI or diagnostic devices.
However, I can provide what can be inferred from the text based on its content about non-clinical performance testing.
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of quantitative acceptance criteria or detailed reported device performance values. It generally states that "performance testing was conducted to verify performance characteristics, safety features, capabilities compared to the predicate device, and biocompatibility." The "reported device performance" is essentially that the device "meets all design input requirements, including functional, operational, and performance requirements."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not explicitly provided in the document. The testing described is "non-clinical performance testing," which typically involves bench testing, engineering verification, and validation, rather than clinical studies with human subjects or data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and is not provided. The "ground truth" in this context would likely refer to engineering specifications and measurements, not expert consensus on diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and is not provided. Adjudication methods are typically used in clinical trials or studies involving expert review, which is not the type of testing described here.
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
No such study was conducted or is mentioned in the document. This is a breathing gas mixer, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical breathing gas mixer, not a software algorithm. Its "performance" is inherently standalone in that it functions according to its design specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device would be established through engineering specifications, validated test methods, and measurement standards for gas mixtures, pressure regulation, alarm functionality, and other specified device characteristics. The document implies that these standards were used in the "performance testing."
8. The sample size for the training set
This information is not applicable as the device is not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI model.
Summary of available information regarding the acceptance criteria and study:
The document states that "performance testing was conducted to verify performance characteristics, safety features, capabilities compared to the predicate device, and biocompatibility; validate reprocessing activities; and ensure usability of the device to meet patient needs when used as intended."
The study proving the device meets its acceptance criteria is referred to as "non-clinical performance testing."
- Acceptance Criteria (Implied): The device "meets all design input requirements, including functional, operational, and performance requirements." These requirements would likely include specifications for N2O/O2 mixture accuracy, pressure regulation (45-60 psi input, low pressure mixed gas output), alarm activation thresholds (e.g., N2O/O2 input below 35 psi), demand valve responsiveness, and the proper functioning of safety features like the O2 piloted system, DISS fittings, and the Emergency Air Intake Valve.
- Reported Device Performance: "The results of performance testing demonstrate that the Nitronox Plus meets all design input requirements..." and "Performance testing supports the conclusion that the subject device is as safe and effective as the predicate device, and therefore the two devices are substantially equivalent."
This is a substantial equivalence (510(k)) submission, which focuses on demonstrating that a new device is "as safe and effective" as a legally marketed predicate device, rather than providing detailed clinical efficacy trial data, which would be typical for a PMA submission or for AI/diagnostic devices. The "study" here is a set of "non-clinical performance tests" that show the device functions according to its engineering and safety specifications, aligning with the predicate device's performance profile (where applicable, and noting differences and new features).
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).