(16 days)
The AM-6000 Anesthesia machine is intended for general anesthesia use. The AM-6000 Anesthesia machine will delivery operator set concentrations of oxygen and anesthesia gases as well as deliver controlled breaths to the patient with either a constant or a deceleration flow pattern. AM-6000 Anesthesia machine is also intended to allow for the provision of manual ventilation.
The AM-6000 Anesthesia Machine is a continuous flow Anesthesia Machine which offers manual or automatic vehtilation, easily adjustable fresh gas delivery, anesthetic agent delivery, ventilation monitoring, convenient ergonomics, and state-of-the-art safety systems. The AM-6000 is designed to decrease the risk of hypoxic mixtures and the inadvertent movement of the air flow control knobs. Additionally, the AM-6000 provides battery power in the event of an AC power outage. Multiple ventilation modes, i.e., CMV, PCV, SIMV and PSV, are offered by the AM-6000 with electronic PEEP available in each of the modes. The fresh gas dosing subsystem offers features of a traditional Anesthesia Machine along with dual flow tubes which display the gas flows at all times. The AM-6000 contains two vaporizers and a heated breathing system to minimize condensation and return moisture to the patient.
I am sorry, but the provided text does not contain the necessary information to construct a table of acceptance criteria and reported device performance, nor does it detail a study proving the device meets acceptance criteria. The document is a 510(k) summary for an anesthesia machine and primarily focuses on its description, indications for use, comparison to a predicate device, and the FDA's substantial equivalence determination.
Specifically, there is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used for testing or training sets.
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).