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The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva/5 MRI Anesthesia System performed to specifications when tested directly next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength that did not exceed 300 gauss.

The Aestiva SmartVent MRI Anesthesia System is substantially equivalent to the following currently marketed device: 1. Datex-Ohmeda Aestiva SmartVent MRI Anesthesia System - Class II -21CFR868.5160. The Aestiva/5 MRI provides the functional feature set offered by the conventional Aestiva 3000 (K973896) to the clinician with the added ability to be used in the MR environment (as cleared in K993410). Among those standard Aestiva 3000 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent (Including those cleared in K023366) along with the Aestiva breathing circuit. The Aestiva/5 MRI is constructed of primarily non-ferrous materials to help prevent attraction to the cryogenic magnets in the MRI systems. The Aestiva/5 MRI performed to specifications when tested directly next to an MRI device of the field strength listed in the product labeling. Safety features and devices within the Aestiva/5 MRI decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.

The GE Datex-Ohmeda Aestiva/5 MRI Anesthesia System is a gas machine for anesthesia or analgesia, designed to provide the functionalities of a conventional anesthesia system within an MRI environment.

Here's an analysis of its acceptance criteria and the study that supports it:

1. Acceptance Criteria and Reported Device Performance

The "study" evidencing these criteria is described as "rigorous testing" that validated the device, in part, supporting its compliance with the mentioned standards. This testing focused on both functional equivalence to its predicate device (Aestiva 3000) and its specific performance in an MRI environment (non-ferrous nature and specified operation near 1.5T and 3.0T MRI devices within 300 gauss field strength).

Details of the Study:

This submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a de novo clinical trial to prove efficacy or safety from scratch. Therefore, the "study" described is primarily a series of engineering tests and compliance evaluations against recognized standards and predicate device performance.

• 2. Sample size used for the test set and the data provenance:
  • Test Set: Not explicitly stated as a "sample size" in the context of patients or data records. Instead, the testing likely involved a limited number of physical prototype devices.
  • Data Provenance: The testing was conducted by the manufacturer (Datex-Ohmeda, Inc.) as part of the device development and validation process. This would be considered prospective engineering validation and verification testing. The geographical origin of the data is not specified beyond the manufacturer's location in Wisconsin, USA.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
  • Not applicable (N/A): This type of device (Anesthesia System) and submission (510(k) of an MRI-compatible version of an existing device) does not typically involve expert consensus to establish a "ground truth" on a test set of medical data (e.g., images for diagnosis). Instead, performance is assessed against engineering specifications and voluntary standards. Experts would be involved in the design, testing protocols, and interpretation of results (e.g., engineers, medical device specialists, potentially anesthesiologists for functional review), but not in creating a diagnostic ground truth.
• 4. Adjudication method for the test set:
  • N/A: As there's no "ground truth" to adjudicate in the typical sense of diagnostic accuracy, an adjudication method like 2+1 or 3+1 is not applicable. Performance would be determined by meeting predefined engineering criteria and passing standard-specific tests.
• 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-enabled diagnostic device and therefore an MRMC study comparing human readers with and without AI assistance is not relevant or performed for this type of submission.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
  • N/A: This is a physical medical device, not a software algorithm, so the concept of standalone performance (without human-in-the-loop) is not applicable in the typical sense of AI/software. Its functionality is inherently tied to human operation and interaction. The "standalone" performance here refers to the device itself operating according to specifications.
• 7. The type of ground truth used:
  • Engineering Specifications and Voluntary Standards: The "ground truth" for this device's performance is its adherence to its own design specifications, the functional features of its predicate device, and the requirements outlined in the cited voluntary standards (EN 740, EN 60601-1, EN 60601-1-2, ISO 5358, ASTM F1208-94) and relevant FDA guidance. For MRI compatibility, the ground truth was "performed to specifications when tested directly next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength that did not exceed 300 gauss."
• 8. The sample size for the training set:
  • N/A: This is not a machine learning model, so there is no concept of a "training set" of data for an algorithm. The development process would involve iterative design, prototyping, and testing.
• 9. How the ground truth for the training set was established:
  • N/A: See point 8.

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This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda Aestiva/5 Anesthesia Systems. 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 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. 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 tot he 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. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation (optional).

This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda Aestiva/5 Anesthesia Systems. 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 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. 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 tot he 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. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation (optional).

The Datex-Ohmeda 7900 Ventilator Enhancements to the Aestiva/5 Anesthesia System is a pneumatically driven, microprocessor-based, electronically controlled ventilator that provides patient ventilation during surgical procedures. The device includes a built-in monitoring system for inspired oxygen, airway pressure, and exhaled volume.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on regulatory substantial equivalence based on compliance with voluntary standards and comparisons to predicate devices, rather than explicit performance-based acceptance criteria with specific numerical targets. The "reported device performance" in this context refers to its successful validation against these standards and its similar functionality to predicate devices.

2. Sample size used for the test set and the data provenance

The document does not detail specific "test sets" or "data provenance" in the context of clinical studies for performance metrics. The validation is described as "rigorous testing" to ensure compliance with voluntary standards. This suggests engineering and bench testing, rather than a clinical trial with a patient test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document describes compliance with engineering and electrical safety standards, as well as functional equivalence to predicate devices, not interpretation of clinical data by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of a clinical test set requiring adjudication.

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

Not applicable. This is a ventilation device; its approval does not involve AI assistance or MRMC studies.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

Not applicable. This is a medical device, and its performance is assessed against established engineering and safety standards, and functional equivalence, not as an algorithm's standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is the successful demonstration of compliance with the detailed requirements outlined in the voluntary consensus standards (UL, EN/IEC, ASTM, ISO) and the functional specifications of the device itself, proving its substantial equivalence to the predicate devices. This involves engineering specifications, technical testing, and regulatory requirements rather than clinical ground truth from patient data.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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