(100 days)
The Babi*Plus Bubble PAP Valve is a single patient use positive end expiratory pressure valve for use with infant patients weighing
Single patient use water seal positive end expiratory pressure device.
The provided text describes a 510(k) premarket notification for the Babi*Plus Bubble PAP Valve, and it primarily focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the context of AI/ML performance.
Therefore, many of the requested categories for AI/ML device performance studies are not applicable based on the provided document. The document describes a traditional medical device (a mechanical valve) and its regulatory review, not an AI/ML system.
However, I can extract the information relevant to device performance and substantiation that is present in the text:
Acceptance Criteria and Device Performance (as per the 510(k) submission):
| Acceptance Criteria (Bench Testing Reference) | Reported Device Performance (Babi*Plus Bubble PAP Valve) |
|---|---|
| Meets the requirements set forth in ISO 5356-1:2004 ("Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets"). | Confirmed to meet the requirements of ISO 5356-1:2004. |
| Accuracy at gas flows from 1 to 12 liters per minute. | Bench testing confirmed the accuracy of the device at gas flows from 1 to 12 liters per minute. |
| Substantially equivalent in indications for use, environment of use, patient population, material, and function to identified predicate devices. | Stated as substantially equivalent to pre-1976 and post-1976 predicate devices across these aspects. |
| Performance substantially equivalent to identified predicate devices. | Stated as having substantially equivalent performance to identified predicate devices. |
Study Details (based on information available in the text):
-
Sample size used for the test set and the data provenance:
- The document mentions "Bench testing" but does not specify a sample size for the tests conducted.
- Data provenance is implicitly from internal A Plus Medical testing (bench testing). No country of origin for the data is specified beyond the manufacturer's location. The tests are explicitly "bench testing," meaning they were laboratory-based, not clinical data (retrospective or prospective).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a physical device undergoing bench testing against engineering standards and functional parameters, not a diagnostic or prognostic AI/ML system requiring expert-established ground truth from clinical cases.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept is for clinical data adjudication, not bench testing of a mechanical device.
-
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/ML device, and no MRMC study was conducted or is relevant for this device type.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm. The device performance described is standalone in the sense that it operates mechanically.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on engineering standards (ISO 5356-1:2004) and functional measurements (accuracy at specified gas flows).
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device that uses training data.
-
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that uses training data.
§ 868.5965 Positive end expiratory pressure breathing attachment.
(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).