(196 days)
The Aestiva SmarVent MRI provides the functional feature set offered by the conventional Aestiva 3000 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva 3000 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva SmartVent MRI performed to specifications when tested directly next to a 1.5 Tesla shielded MRI device 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: Datex-Ohmeda Aestiva 3000 Anesthesia System Class II 21CFR868.5160 1. Ohmeda Excel MRI Anesthesia System Class II CFR868.5160 2. The Aestiva SmarVent MRI provides the functional feature set offered by the conventional Aestiva 3000 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva 3000 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva SmartVent MRI is constructed of primarily non-ferrous materials to help prevent attraction to the cryogenic magnets in the MRI systems. The Aestiva SmartVent 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 SmartVent MRI decrease the risk of hypoxic mixtures and complete power or sudden gas supply failures.
This document is a 510(k) summary for the Datex-Ohmeda Aestiva SmartVent MRI Anesthesia System. It describes the device, its intended use, and its substantial equivalence to predicate devices, along with compliance with voluntary standards. However, it does not contain the detailed information necessary to complete the specific request regarding acceptance criteria and a study that proves the device meets those criteria.
Therefore, many sections of your request cannot be fulfilled using the provided text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be created. The document states "The Aestiva SmartVent MRI performed to specifications when tested directly next to an MRI device..." and "The Datex-Ohmeda Aestiva SmartVent MRI has been validated through rigorous testing that, in part, support the compliance of Aestiva SmartVent MRI to the above mentioned standards." However, it does not specify what those "specifications" or "performance" metrics were, nor does it provide a table of acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be determined. The document mentions "rigorous testing" but gives no details about sample size, data provenance, or whether the study was retrospective or 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)
- Not applicable / Cannot be determined. This device is an anesthesia system, not an AI/diagnostic device that relies on expert interpretation for ground truth. The document does not describe any such expert involvement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Cannot be determined. See point 3.
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 not an AI/diagnostic imaging device where human readers would typically be involved in interpreting output for a comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (anesthesia system), not an algorithm or AI. Performance is evaluated based on its functional specifications and safety in the intended environment.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not explicitly stated in the context of ground truth as typically understood for diagnostic AI. For this type of device, "ground truth" would likely refer to engineering specifications, safety standards, and physiological measurements to ensure the device performs as intended (e.g., delivers precise gas mixtures, ventilates according to parameters) and functions correctly in the MR environment. The document implicitly suggests compliance with voluntary standards (EN 740, EN 60601-1, etc.) as the "ground truth" for its design and performance.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of available information:
- Device Name: Datex-Ohmeda Aestiva SmartVent MRI Anesthesia System
- Intended Use/Key Performance Aspect: Provides functions of conventional Aestiva 3000 but with added ability to be used in the MR environment. Specifically states it "performed to specifications when tested directly next to a 1.5 Tesla shielded MRI device in a field strength that did not exceed 300 gauss."
- Compliance Relied Upon (Implicit Acceptance Criteria):
- EN 740 Anesthetic Work Stations
- EN 60601-1. IEC 601-1: 1988 Medical Electrical Equipment
- EN 60601-1-2, IEC 601-1-2: 1998 Medical Electrical Equipment Electromagnetic Comparability
- ISO 5358 Anesthetic Gas Machines
- ASTM F1208-94 Anesthesia Breathing Circuit Standard
- Guidance from "A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems"
This document serves as a regulatory submission demonstrating substantial equivalence and compliance with relevant standards for a medical device, rather than a detailed scientific study report with explicit acceptance criteria and performance metrics for an AI-enabled diagnostic tool.
§ 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).