(18 days)
The GE Datex-Ohmeda Aisys is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.
The GE Datex-Ohmeda Aisys Carestation supplies set flows of medical gases to the breathing system using electronic gas mixing. Gas flows are selected by the user using the keypad and rotary controller on the main display unit and then displayed as electronic flow indicators on the system display unit. The Aisys is equipped with a pneumatic back-up O2 delivery system and traditional flow tube, as well. A large selection of frames, gases, and vaporizers are available to give the user control of the system configuration. The Aisys is also available in a pendant model. It is available with two or three gases, and up to three cylinder connections. All models have O2. The Aisys comes with up to two optional gases (air, N2O). Safety features and devices within the Aisys are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Aisys system is available with optional integrated respiratory gas monitoring. When supplied as an option, the integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-CAiO and M-CAiOV software revision 3.2 and above K# 001814) which is physically integrated into the Aisys, receives electronic power from the Aisys and communicates measured values to the Aisys for display on the system display unit. The anesthetic agent delivery for the Aisys is controlled via an anesthesia computer through user input from the central display. The vaporization technology is based upon the electronic vaporizer cleared as part of the Datex-Ohmeda Anesthesia Delivery Unit (ADU) cleared via K973985. An Aladin cassette (also cleared as part of K973895) or Aladin 2 is inserted into the active cassette bay. The cassette holds the agent to be delivered - Halothane, Enflurane, Isoflurane, Desflurane or Sevoflurane. Agent is delivered as a percent volume/volume. The Aisys is designed to allow only one active cassette at a time. Per the user input into the main display, valves within the active cassette bay will open and allow agent to be delivered. The agent is mixed with gas from the FGC unit. After mixing, the combination of gases and agent is delivered to the breathing system and then onto the patient. The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Aisys Anesthesia System. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. The user interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilator modes for the device include Volume Mode, Pressure Control Mode, Pressure Support with Apnea Backup Mode (Optional) and Synchronized Intermittent Mandatory Ventilation (SIMV) Mode (Optional). Ventilator parameters and measurements are displayed on the system display unit. The system display unit is mounted to an arm on the top shelf of the Aisys. The arm is counter balanced and capable of moving vertically and/or horizontally, and also tilting the display, enabling the user to position the display to the most advantageous viewing position. The arm length is limited such that the display position is always within the footprint of the Aisys frame. The arm also supports the mounting of additional display units for a variety of patient monitors. Several frame configurations are available, including one that allows for the physical integration of the Datex-Ohmeda S/5 Anesthesia Monitor (most recently cleared via K030812). This configuration also provides cable management solutions such that the necessary connections from the monitor display unit to the monitor are hidden within the Aisys frame. An additional option allows the S/5 AM to be linked to the power supply of the Aisys such that when the Aisys is turned on, the S/5 AM is also turned on. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Aisys.
The provided text is a 510(k) summary for the GE Datex-Ohmeda Aisys Carestation, an anesthesia gas machine. It primarily focuses on demonstrating substantial equivalence to a predicate device and lists voluntary standards the device complies with.
Crucially, this document does not contain explicit acceptance criteria or detailed study results proving the device meets those criteria in the format requested.
Instead, the document states: "The GE Datex-Ohmeda Aisys Carestation has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Aisys Carestation to the standards listed above." This indicates that verification and validation testing was performed to ensure compliance with the referenced voluntary standards, but the specifics of that testing (acceptance criteria, reported performance, sample sizes, ground truth, etc.) are not included in this summary.
Therefore, many of the requested fields cannot be filled directly from the provided text.
Here's an attempt to answer based on the information available and what can be inferred, with clear indications of what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from standards compliance) | Reported Device Performance (Not explicitly stated in this summary) |
|---|---|
| UL 2601 General requirements for Medical Electrical Equipment | Not explicitly stated. Compliance with standard is asserted. |
| EN 740 Anesthetic Work Stations | Not explicitly stated. Compliance with standard is asserted. |
| EN/IEC 60601-1: General requirements for Medical Electrical Equipment | Not explicitly stated. Compliance with standard is asserted. |
| EN/IEC 60601-1-2: Medical Electrical Equipment Electromagnetic Compatibility | Not explicitly stated. Compliance with standard is asserted. |
| EN 475 Electrically Generated Alarm Signals | Not explicitly stated. Compliance with standard is asserted. |
| ASTM F1463-93 Standard Specification for Alarm Signals | Not explicitly stated. Compliance with standard is asserted. |
| ASTM F1208-94 Anesthesia Breathing Circuit Standard | Not explicitly stated. Compliance with standard is asserted. |
| ASTM F1101-90 Standard Specification for Ventilators Intended for Use During Anesthesia | Not explicitly stated. Compliance with standard is asserted. |
| ISO 5358 Anesthetic Gas Machines | Not explicitly stated. Compliance with standard is asserted. |
| Functional Specifications (e.g., accuracy of gas delivery, ventilator performance) | Details of such performance are not provided in this summary. The device is intended to provide specific features like electronic gas mixing, an electronic vaporizer, and a microprocessor-based ventilator with various modes. |
| Safety Specifications (e.g., decrease risk of hypoxic mixtures, agent mixtures, power/gas supply failures) | Safety features are mentioned as being designed to decrease these risks, but specific performance metrics are not given. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified in the provided document. Testing would have been conducted on prototypes or production units of the Aisys Carestation, but the number of units or test cases is not detailed.
- Data Provenance: Not applicable in the context of data provenance for AI/ML models. This is a hardware/software medical device. Testing would be performed in a controlled laboratory environment by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable to the type of device and testing described. The "ground truth" for this medical device's performance would be objective measurements against engineering specifications and voluntary standards, not expert consensus on medical images or patient outcomes. Engineering and quality assurance professionals would perform the testing.
4. Adjudication method for the test set
- Not applicable as explained above. Device performance is typically evaluated against pre-defined specifications and regulatory requirements, not through a consensus-based adjudication process.
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
- No. This is not an AI/ML diagnostic or assistive device that would involve human "readers" or an MRMC study. The device is an anesthesia gas machine and ventilator.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device itself is a standalone medical device in its function as an anesthesia gas machine and ventilator. Its performance as an independent system would be evaluated against the technical specifications and standards it claims to meet. There is no "algorithm only" component in the context of AI/ML performance being studied here; rather, it's the integrated system's functionality.
7. The type of ground truth used
- For this type of device, the "ground truth" would be established by:
- Engineering specifications and design requirements: The device's performance is measured against its intended technical capabilities (e.g., gas flow rates, pressure accuracy, alarm thresholds).
- Voluntary standards: Compliance is demonstrated against the requirements of standards like UL, EN, IEC, ASTM, and ISO, which often involve specific test methods and performance criteria.
- Predicate device performance: Substantial equivalence relies on demonstrating that the new device performs as safely and effectively as a legally marketed predicate device.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML model that would use "training data" in the conventional machine learning sense. Its functionality is based on established engineering principles, hardware, and embedded software.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the context of AI/ML data for this device. The design and development of the device would follow medical device design control processes, where requirements are defined and verified.
§ 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).