(200 days)
The Ohmeda 7900 Anesthesia Ventilator provides mechanical ventilation for patients during surgery, as well as adiustment and monitoring various patient parameters-
The 7900 Anesthesia Ventilator is a microprocessor based, electronically driven ventilator with a built in monitoring system for inspired oxygen, ainway 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 compensation of compression losses, fresh gas contribution, and small leakage in the breathing absorber, bellows and system. User settings and microprocessor calculations catterns. 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.
The provided document is a 510(k) summary for the Ohmeda 7900 Anesthesia Ventilator, dated February 29, 1996. It primarily focuses on demonstrating substantial equivalence to a predicate device (Ohmeda 7800 Anesthesia Ventilator) and adherence to various medical device standards.
This document does not contain information responsive to your request about acceptance criteria and a study proving a device meets those criteria, particularly within the context of AI/ML device performance or clinical studies involving human readers and AI assistance.
Specifically, the document lacks the following information that you requested:
- A table of acceptance criteria and the reported device performance: While it lists various standards the device complies with, it doesn't provide specific quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) or device performance parameters from a study.
- Sample size used for the test set and the data provenance: There is no mention of a test set, study participants, or data origin.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As there's no clinical performance study described, there's no mention of experts or ground truth establishment.
- Adjudication method for the test set: Not applicable as no specific test set or study is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This document predates widespread AI in medical devices and does not describe any MRMC studies or AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's not an AI/ML device.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable as it's not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
The document mainly focuses on:
- Substantial equivalence to a predicate device.
- Description of the device's function and monitored parameters.
- Compliance with various medical device standards (e.g., ASTM, ISO, IEC, UL) which typically refer to electrical safety, electromagnetic compatibility, and basic functional requirements, not clinical performance metrics in a study.
- Mention of a "rigorous software development process" and software validation, but this is a general statement about software quality assurance, not a specific clinical performance study.
In summary, the provided text does not contain the type of acceptance criteria and study details relevant to AI/ML device performance that your request is looking for.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).