(28 days)
The BEAR CUB 750 PSV Infant Ventilator is intended to provide clinically accepted features for the ventilation management of a patient population ranging from the small neonate (500 grams and larger) to a small pediatric patient (up to 30 kilograms).
The etiologies to which these devices may be applied consistent with current clinical practices include:
- Hyaline Membrane Disease Respiratory Distress Syndrome Low Surfactant Syndrome Chronic Lung Disease of the Neonate/Pediatric Patient Neurological Impairment Pulmonary Hypoplasia Persistent Pulmonary Hypertension Meconium Aspiration
The BEAR CUB 750 PSV Infant ventilators is a modification from the BEAR CUB 750 vs. The BEAR CUB 750 PSV Infant ventilators incorporate all previous (3) three modes with the addition of (4) four new modes. The additional modes are, Flow Cycle Assist Control, Flow Cycle SIMV, SIMVPSV, and PSV. The BEAR CUB 750 PSV Infant ventilators incorporate all previous function for the Bear Cub 750vs with the addition of, digital PEEP, monitored inspired tidal volume, a low minute volume alarm, an audible silence for the volume limit, CPAP/PSV back up function and the Low Inspiratory Pressure threshold was changed to a calculated threshold function.
The provided text is a 510(k) summary for the BEAR Cub 750 PSV Infant Ventilator. It describes the device, its intended use, and lists predicate devices. However, this document does not contain information regarding acceptance criteria, performance studies, sample sizes, expert involvement, or ground truth establishment for software or AI-driven device performance.
Therefore, I cannot fulfill your request for the specific information points you've asked for, as the document primarily focuses on the regulatory submission and device description, not on detailed performance validation studies that would include acceptance criteria and specific study methodologies.
Here's a breakdown of why each point cannot be addressed based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present in the document. The document describes the device's features and intended use but does not provide specific performance metrics or acceptance criteria for those features.
- Sample size used for the test set and the data provenance: Not mentioned. No test set or data provenance is detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. No ground truth establishment is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- 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 and not mentioned. This device is a ventilator, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware medical device (ventilator), not a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
§ 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).