(137 days)
The Navigator Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
The Navigator System is intended for use by licensed clinicians, for patient requiring anesthesia within a health care facility, and can be used in both adult and pediatric populations.
The Navigator Anesthesia Delivery System is a continuous flow anesthesia system which offers manual or automatic ventilation, easily adjustable fresh gas delivery, anesthetic agent delivery, ventilation monitoring, convenient ergonomics, and state-of-the-art safety systems. The Navigator System is designed to decrease the risk of hypoxic mixtures and the inadvertent movement of the air flow control knobs. Additionally, the Navigator provides battery power in the event of an AC power outage. Multiple ventilation modes, i.e., CMV, PCV, SIMV and PSV, are offered by the Navigator System with electronic PEEP available in each of the modes. The fresh gas dosing subsystem offers features of a traditional anesthesia system along with dual flow tubes which display the gas flows at all times. The Navigator contains two vaporizers and a heated breathing system to minimize condensation and return moisture to the patient.
The provided text describes the 510(k) summary for the Navigator Anesthesia Delivery System. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.
Therefore, the information required to fully answer your request (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not provided in the given text.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as specific performance thresholds. The document generally states compliance with "recognized safety, performance and electromagnetic compatibility standards."
- Reported Device Performance: Not quantified. The document states it has been "tested and found to be in compliance" with these standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned.
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)
- Number of Experts: Not applicable. The "testing" mentioned refers to compliance with engineering/safety standards, not clinical ground truth established by experts.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable.
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
- MRMC Study: No, this is an anesthesia delivery system, not an AI-assisted diagnostic tool for human readers.
- Effect Size of AI: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable as it's not an algorithm, but a medical device. The "software has been validated" refers to internal software validation, not a standalone performance evaluation in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable in the traditional sense of diagnostic AI. The "ground truth" for this device would be established by validated engineering tests and compliance with recognized standards.
8. The sample size for the training set
- Sample Size for 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
- How Ground Truth was established: Not applicable.
Summary of available information regarding the "study" (Performance Testing):
The document mentions a "Summary of Performance Testing" which states:
- "The Navigator System has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards."
- "A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards."
- "The device's software has been validated in accordance with the requirements set forth in the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)."
- The conclusion states that based on this performance testing, the device is "safe, effective and substantially equivalent to the predicate device."
In essence, the "study" proving the device meets acceptance criteria is a series of engineering and software validation tests demonstrated to comply with established medical device standards and FDA guidance for substantial equivalence, rather than a clinical study with detailed performance metrics, patient cohorts, or expert ground truth.
§ 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).