(189 days)
The Excel 3000 Anesthesia Gas System is a gas machine that supplies set flows of medical gases to the breathing system. A large selection of frames, gases, vaporizers and ventilators, give full control of the system configuration. The Excel 3000 is available in wide or narrow trolley and pendant models. The narrow trolley and pendant come with two or three gases, two vaporizer positions and up to four cylinder connections. The wide trolley comes with two, three or four gases, three vaporizer positions and up to five cylinder connections. All models have O2 and N2O. The Excel 3000 comes with up to two optional gases (air, CO2, heliox). All Excel systems accept Tec 4, Tec 5 and Tec 6 vaporizers. Excel 3000 systems use either the 7900 Ventilator, 7800 Ventilator, or the 7000 Ventilator, along with being able to accept integral monitors for vital signs and respiratory gases. Safety features and devices within the Excel 3000 decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.
The Ohmeda Excel 3000 Anesthesia Gas System is a gas machine that supplies set flows of medical gases to the breathing system. A large selection of frames, gases, vaporizers and ventilators, give full control of the system configuration. The Excel 3000 is available in wide or narrow trolley and pendant models. The narrow trolley and pendant come with two or three gases, two vaporizer positions and up to four cylinder connections. The wide trolley comes with two, three or four gases, three vaporizer positions and up to five cylinder connections. All models have O2 and N2O. The Excel 3000 comes with up to two optional gases (air, CO2, heliox). All Excel systems accept Tec 4, Tec 5 and Tec 6 vaporizers. Excel 3000 systems use either the 7900 Ventilator, 7800 Ventilator, or the 7000 Ventilator, along with being able to accept integral monitors for vital signs and respiratory gases. Safety features and devices within the Excel 3000 decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.
The provided text describes a 510(k) summary for the Ohmeda Excel 3000 Anesthesia Gas System, focusing on its substantial equivalence to previously marketed devices and compliance with voluntary standards. However, it does not contain information about a study that assesses device performance against specific acceptance criteria in the context of AI/ML or diagnostic accuracy studies.
The document states that the device "has been validated through rigorous testing that, in part, support the compliance of the Ohmeda Excel 3000 Anesthesia Gas System to the above mentioned standards." This refers to engineering and safety performance testing against established industry standards (e.g., ASTM, IEC, EN, ISO) for medical devices, not a clinical performance study with acceptance criteria related to diagnostic accuracy, sensitivity, specificity, or human reader improvement, as would be relevant for an AI/ML device.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, ground truth, sample sizes for test/training sets, expert qualifications, or MRMC studies for this device based on the provided text. This device is an anesthesia gas system, a physical medical device, not an AI/ML diagnostic software.
§ 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).