(392 days)
The Puritan Bennett 980 Series Ventilator System is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3kg (0.66lb). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air compressor or external air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively or non-invasively to patients who require the following types of ventilator support
- Positive Pressure Ventilation, delivered invasively (via endotracheal tube or tracheotomy tube) or noninvasively (via mask or nasal prongs)
- Assist/Control, SIMV, or Spontaneous modes of ventilation
The Puritan Bennett 980 Series Ventilator System is a dual-microprocessor-based, touch-screen controlled; critical care ventilator intended to provide continuous ventilation for neonate to adult patients who require either invasive ventilation or non-invasive ventilation. It can be used in hospitals and institutions and for intra –hospital transport applications with access to the appropriate services.
The ventilator system offers features for patient comfort while delivering sensitive, precise breaths to critically ill patients. The product ventilates Neonatal, Pediatric, and Adult patients with predicted body weights from 0.3 kg, and with tidal volumes for mandatory volume controlled breaths from 2 mL to 2500 mL.
The provided text is a 510(k) summary for the Puritan Bennett 980 Ventilator System. It details the device's characteristics, indications for use, and a comparison to predicate devices, primarily focusing on non-clinical evidence for substantial equivalence.
Based on the provided information, I can only provide limited answers to your request as the document does not contain details about acceptance criteria, device performance metrics, or a study that would involve a test set with ground truth, experts, or MRMC studies. This is because the submission is for a ventilator, not an AI/CADe device.
Here's an attempt to answer based on the available information, noting when the information is not available in the provided document:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided document. The document focuses on demonstrating substantial equivalence through non-clinical verification and validation, rather than specific performance metrics against acceptance criteria for an AI/CADe system.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not available in the provided document. The submission is for a ventilator, which does not typically involve a "test set" of data for performance evaluation in the way an AI/CADe device would. The "test sets" mentioned relate to engineering tests (e.g., electrical safety, EMC) rather than clinical data for AI model evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not available in the provided document. As it's a ventilator, there isn't a "ground truth" establishment by medical experts for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not available in the provided document.
5. 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
This information is not applicable and not available in the provided document. MRMC studies are typically used for assessing the impact of AI/CADe systems on human performance in diagnostic tasks, which is not relevant to a ventilator submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not available in the provided document. A ventilator's performance is not typically evaluated as a "standalone algorithm" in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable and not available in the provided document.
8. The sample size for the training set
This information is not applicable and not available in the provided document. The ventilator has software, but it is not described as an AI or machine learning system that requires a "training set" in the context of image analysis or diagnostic tasks.
9. How the ground truth for the training set was established
This information is not applicable and not available in the provided document.
§ 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).