(161 days)
Indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen to a conscious, spontaneously breathing patient
This is a device which can precisely dose a mixture of medical oxygen and medical nitrous oxide, depending on the adjusted mixture, for the sedation of patients in hospitals and at the dentist. The operator, a dentist is able to adjust the total flow and the concentration of nitrous oxide of this flow. Depending on these settings the level of sedation of the patient can be controlled by the operator. The FlowStar ® Analog Mixer device has been created with the following safety features. The total flow emitted can consist of a maximum of 70 % nitrous oxide, the mix up of gas types is prevented by mechanical encodings and the flow of pure nitrous oxide in the absence of a missing oxygen supply is prevented by a fail-safe device.
Two rotary knobs are used to select the desired total flow and N20/O2 gas mixture. The total flow can consist of between 0 (100% O₂) and 70 (30% O₂) percent N₂O. The minimum output of 30 % O2 prevents from a hypoxic mixture for the patient. The FlowStar® Analog Mixer device has an integrated O2 Flush knob which delivers at least over 40 l/min of pure oxygen if the user presses the knob to flush the N20 out of the patient circuit after the treatment or in the situation the patient is over sedated.
The FlowStar Analog Mixer device has an alarm system which generates an alarm in the case of an insufficient O2 supply. The device will shut off the sedation when the O2 supply reaches a critical level.
The FlowStar ® Analog Mixer has an integrated Bag T. The mixed gas to it. The Bag T is a device with one additional input and two outputs. The additional input is a valve which opens when the adjusted total flow is too low for the patient. The gas mixture is then enriched with additional ambient air. The first output of the Bag T is for the connected breathing bag which is filled by the mixing device when the patient exhales and is emptied when the patient inhales. The second output leads the gas mixture to the connected scavenger system and finally to the patient
The provided text is a 510(k) Premarket Notification for a medical device called "FlowStar Analog Mixer Flowmeter." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific performance acceptance criteria for an AI/ML-based algorithm.
Therefore, the requested information regarding acceptance criteria, device performance from a test set, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details cannot be extracted from this document as it does not describe a clinical performance study of an AI/ML algorithm.
The document discusses:
- Device Description: A breathing gas mixer for administering Nitrous Oxide and Oxygen.
- Indications for Use: Administering an adjustable mixture of Nitrous Oxide and Oxygen to a conscious, spontaneously breathing patient.
- Safety Features: O2 fail-safe system, alarm for insufficient O2 supply, O2 flush knob, mechanical encodings to prevent gas mix-up.
- Non-Clinical Testing: Compliance with standards like ISO 18562 (biocompatibility), ISO 14971 (risk management), ISO 15223-1 (labeling symbols), CGA V-5 (connectors), ISO 11195 (gas mixers), and IEC 62366-1 (usability testing). This mainly involves bench testing to ensure the physical and functional aspects of the device meet safety and performance standards.
- Clinical Testing: The document explicitly states, "Clinical testing was not required to establish substantial equivalence."
In summary, this document is a regulatory submission for a physical medical device (a gas mixer), not a clinical performance study for an AI/ML algorithm. As such, the specific metrics and study design elements requested in your prompt (e.g., acceptance criteria for an AI model's accuracy, expert reads, ground truth for data sets) are not relevant to this type of device and its regulatory clearance process as described here.
§ 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).