(75 days)
The Magellan-2200 Model-2 Anesthesia Machine is intended for spontaneous, manually assisted or automatic ventilation of patients during anesthesia. It may be used for the delivery of gases and anesthetic vapor. It is capable of monitor/alarm functions for oxygen concentration, breathing pressure and respiratory volumes.
The Magellan-2200 Model-2 Anesthesia Machine in indicated for use with spontaneous, manually assisted or automatic ventilation of patients during anesthesia. It may be used for the delivery of gases and anesthetic vapor. It is capable of monitor/alarm functions for oxygen concentration, breathing pressure and respiratory volumes.
The Magellan-2200 Model-2 consists of the following components:
Gas Manifold with Safety Connections
Low Pressure Oxygen Alarm
Oxygen and Air Pressure Gauges
Oxygen Auxiliary Flow Selector
Oxygen and Air Flowmeters
The provided text is for a 510(k) summary for the Oceanic Medical Products, Inc. Magellan-2200 Model-2 Anesthesia Machine. The performance data section describes the testing conducted for this device.
Here's an analysis of the acceptance criteria and study information:
Description of Acceptance Criteria and Study
The Magellan-2200 Model-2 Anesthesia Machine was tested to ensure it functioned as designed, particularly with its replacement ventilator and electrically-powered air compressor source. The primary approach to demonstrating its performance was by comparing it to its predicate device, the Magellan-2200 Model-1 Anesthesia Machine.
The core of the study relies on the premise of substantial equivalence. Rather than establishing new acceptance criteria and conducting a de novo study, the device was deemed acceptable if it performed the same protocols and achieved results as expected when compared to the established performance of the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: The Magellan-2200 Model-2 must function as intended, particularly with the new ventilator and air compressor source. | "In all instances, the Magellan-2200 Model-2 functioned as intended..." |
| Bench Testing Results: Bench test results for the Magellan-2200 Model-2 should be consistent with those of the predicate device. | "...the bench testing and electrical testing results observed were as expected." |
| Electrical Testing Results: Electrical test results for the Magellan-2200 Model-2 should be consistent with those of the predicate device. | "...the bench testing and electrical testing results observed were as expected." |
| Mechanical Testing: All recommended mechanical testing should be completed. | "All recommended mechanical and electrical testing was completed simultaneously by the manufacturers of the anesthesia machine and/or the ventilator." |
| Electrical Testing: All recommended electrical testing should be completed. | "All recommended mechanical and electrical testing was completed simultaneously by the manufacturers of the anesthesia machine and/or the ventilator." |
| Safety and Effectiveness: No new issues of safety or effectiveness should be raised by the minor technological differences. | "The Magellan-2200 Model-2 Anesthesia Machine is as safe and effective as the Magellan-2200 Model-1 Anesthesia Machine... The minor technological difference... raise no new issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for the test set in terms of number of devices or number of test scenarios. It mentions "All recommended mechanical and electrical testing was completed," suggesting comprehensive testing.
The data provenance is not explicitly stated. The tests were performed by "the manufacturers of the anesthesia machine and/or the ventilator," implying internal testing by Oceanic Medical Products, Inc. and/or their ventilator supplier. It can be inferred as retrospective in the sense of testing a finished product against established protocols.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. This type of study does not involve expert readers establishing ground truth in the typical sense of a diagnostic imaging or AI-driven decision support system. The "ground truth" here is the expected operational performance of an anesthesia machine, as defined by safety standards and the performance of the predicate device.
4. Adjudication Method for the Test Set
Not Applicable. As there are no human readers or interpretations being adjudicated, no adjudication method was used. The assessment appears to be based on objective measurements and comparison to predefined performance norms for the predicate device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is not relevant for an anesthesia machine where the primary concern is the functional, electrical, and mechanical performance of the equipment itself, rather than human interpretation of data assisted by AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. The device is an anesthesia machine, not an algorithm or AI system. The testing focused on the standalone performance of the physical device components.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Predicate Device Performance: The known and accepted performance characteristics of the Magellan-2200 Model-1 Anesthesia Machine.
- Design Specifications: The intended functioning and operational parameters of the Magellan-2200 Model-2, especially concerning the new ventilator and compressor.
- Industry Standards: Implied adherence to relevant mechanical and electrical testing protocols for such medical devices.
8. The Sample Size for the Training Set
Not Applicable. This is a hardware medical device; there is no "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set, there is no ground truth to establish for it in this context.
§ 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).