(426 days)
The SMART BAG" Mo is intended for manual ventilation of patients using ambient air or supplemental oxygen supplied from an oxygen source. The SMART BAG®MD is available in a child and an adult size. The SMART BAG®MO is available with components that can be autoclaved, or can be chemically disinfected. A single use disposable version is also available. The SMART BAG®MO includes a flow limiting valve that limits the inspiratory flow to approximately 40 litres per minute, for the adult version and 30 litres per minute for the child version. The flow limiting valve is intended to minimize gastric inflation during manual ventilation. The flow limiting valve can be disabled to permit conventional operation of the resuscitator".
The SMART BAG® MO is a manual resuscitator comprising a self inflating bag, a one way valve and a facemask designed to supply ventilations to a non-breathing patient by the compression of the bag portion of the device by the operator. Similar in all respects to the predicate device, 510(k) #: K973419, this product has the addition of a flow-limiting valve that is responsive to the squeeze of the balloon applied by the rescuer. In cases where high flowrates are required to overcome mask leakage or adverse patient conditions, the Manual Override Control is provided to disable the flow controlling mechanism and allow the SMART BAG ®MO to act like a standard BVM.
The provided text describes the SMART BAG® MO, a manual resuscitator, and its clearance by the FDA based on substantial equivalence to a predicate device. However, the document does not contain the specific information requested in the prompt regarding acceptance criteria, performance data from a specific study, sample sizes, ground truth establishment, or expert details.
The "ASSESSMENT OF PERFORMANCE DATA" section states: "The submission incorporated a significant amount of non-clinical test data to support the claim of substantial equivalence. This test data reviewed the performance of the device against both the current domestic and international standards for these devices. In particular, references were made to ISO 8382-1988."
And the "CONCLUSIONS BASED ON PERFORMANCE DATA" section states: "The testing undertaken verified that the SMART BAG® MO device, when compared with the performance of the device to which substantial equivalence is claimed, performed within specification."
These statements indicate that performance data was submitted and reviewed, with reference to ISO 8382-1988, and that the device met specifications by performing similarly to its predicate. However, detailed acceptance criteria, the specific results against those criteria, information about sample sizes, ground truth, or expert involvement are not provided in this document.
Therefore, I cannot populate the requested table or answer the specific questions about the study that proves the device meets acceptance criteria.
Based on the provided text, the requested information is not available.
Here is a table summarizing what information is available (which is limited) and what is not available:
| Information Category | Details from Document |
|---|---|
| Acceptance Criteria & Device Performance | Not explicitly listed. Document states "performed within specification" against predicate and ISO 8382-1988, but no specific criteria or quantitative performance metrics are provided. |
| Sample size (test set) & data provenance | Not provided. The document refers to "non-clinical test data" but does not specify sample sizes or data origin (e.g., country, retrospective/prospective). |
| Number of experts & qualifications | Not provided. No mention of experts for establishing ground truth. |
| Adjudication method | Not provided. |
| MRMC comparative effectiveness study | Not conducted/mentioned as per the prompt's definition. The submission focused on equivalence to a predicate device based on non-clinical test data. |
| Standalone algorithm performance | Not applicable. This device is a physical resuscitator, not an AI algorithm. Its performance was tested as a standalone device against standards and a predicate, but not in the context of an AI algorithm. |
| Type of ground truth used | Not applicable/provided in the requested context. Performance was assessed against standards (ISO 8382-1988) and equivalence to a predicate device's performance. |
| Sample size for training set | Not applicable. This is a physical medical device, not an AI model requiring a training set. |
| How ground truth for training set was established | Not applicable. This is a physical medical device, not an AI model. |
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).