(90 days)
The MiniMe™ Pediatric Mask is intended to provide an interface for application of CPAP or bi-level therapy. It is intended for patients > 2 years old and
The SleepNet MiniMe™ Pediatric Mask with vent holes for a fixed leak during use and without vent holes when used with a patient circuit that incorporates its own anti-asphyxia valve, It is single patient, multi-use or multi-patient, reusable.
Here's an analysis of the provided text regarding the MiniMe™ Pediatric Mask, structured to address your specific points about acceptance criteria and the supporting study:
This 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices for a pediatric mask, which is a fairly low-risk device. Therefore, the "acceptance criteria" and "study" described are focused on comparative performance to established devices rather than demonstrating novel efficacy or specific clinical outcomes. The provided text doesn't contain a detailed clinical trial with a traditional "test set" or specific "ground truth" as one might expect for a diagnostic AI. Instead, it relies on engineering testing and comparison to predicates.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly from predicates) | Reported Device Performance (MiniMe™ Pediatric Mask) |
|---|---|---|
| Indications for Use | Provide an interface for CPAP or bi-level therapy; patients > 2 and |
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).