(205 days)
The Spacelabs Medical 90519 Anesthesia Delivery System provides intermittent or continuous gas inhalation for adults and children (neonatal and pediatric). It allows the administration of operator selected gas mixtures of oxygen, nitrous oxide and air with any of the anesthetic agents: Halothane, Isoflurane, Enflurane, or Sevoflurane, It provides safe and accurate gas flows to maintain patient respiration during anesthesia, and incorporates a ventilator, an oxygen monitor, and a respiratory monitor. The ventilator provides the necessary power, as air or oxygen, to generate volumes and pressures in the ventilating system to ventilate a patient connected to the anesthesia machine. It is recommended for use only by trained physicians, in the operating room or similar surgical environments.
The Spacelabs Medical 90519 Anesthesia Delivery System is designed to deliver anesthetic gases in a controlled hospital environment. The System incorporates a valveless patient circuitry design which offers very low resistance during spontaneous breathing since it allows for the ebb and flow of natural breathing gases. Oxygen, nitrous oxygen, and air are supplied to the gas distribution system for mixing with the selected anesthetic agent and delivery to the patient through the ventilation system. Another circuit separately provides for the cycling of patient expiration gases. The operator may select from two operating modes options: in manual mode the patient can be ventilated manually via a hand bag or the patient can breathe spontaneously; alternately, the controls can be set so that the patient is continually ventilated by the device. The control settings provide ease of use for both pediatric and adult patient populations in that the System may be set by the anesthesiologist for the appropriate tidal volume range based on patient needs. The System uses standard, commercially-available anesthesia system accessories appropriate to meet the needs of the clinician and patient. The delivery of gases is time cycled, volume controlled, pressure limited, and monitored for alarm states and error messages. Additional user-selectable convenience features include a hold switch to permit the temporary cessation of mechanical (continual) ventilation to facilitate the taking of imagery (e.g. x-rays) and a "sigh" switch to provide extra volume above the set tidal volume at a defined interval to allow for the more complete expiration of carbon dioxide.
The provided text describes the Spacelabs Medical 90519 Anesthesia Delivery System and its 510(k) submission. However, it does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics in the format requested. The document focuses on establishing substantial equivalence to a predicate device (the Falcon Anaesthesia System) and mentions general safety and performance testing.
Therefore, many of the requested details cannot be extracted directly from the given text.
Here's a breakdown of what can and cannot be answered based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document states: "The Spacelabs Medical 90519 Anesthesia Delivery System has been subject to extensive safety and performance testing, to ensure that the device meets all its functional requirements and performance of specifications."
However, it does not provide a table specifying exact acceptance criteria (e.g., specific thresholds for flow rates, pressure limits, or accuracy of gas mixing) nor does it report the quantitative results or performance metrics from these tests. It only mentions that the device is designed to meet general safety requirements and industry standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for any test set or provide details on data provenance (country, retrospective/prospective).
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 provided in the document. The testing described is for an anesthesia delivery system, which typically involves engineering and safety evaluations against specifications and standards, rather than expert-derived ground truth as might be seen for diagnostic imaging devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This document describes a medical device for anesthesia delivery, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related comparative effectiveness is not relevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is an anesthesia delivery system, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document describes "safety and performance testing" against "functional requirements and performance of specifications" and "applicable industry and safety standards." The ground truth for such device testing would typically be the pre-defined engineering specifications and regulatory standards themselves, verified through direct measurement and testing, rather than expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or predictive AI.
8. The sample size for the training set
This document describes a physical medical device, not a machine learning model. Therefore, the concept of a "training set" with a specified sample size is not applicable.
9. How the ground truth for the training set was established
As in point 8, this is not applicable to the described physical medical device.
§ 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).