(30 days)
The BiPAP AutoSV is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.
The Respironics BIPAP AutoSV is a microprocessor controlled blower based Bi-level positive pressure system that delivers two positive pressure levels (IPAP/EPAP). The dual pressure levels provide a more natural means of delivering pressure support therapy to the patient resulting in improved patient comfort. A flow sensor and redundant pressure sensors in the patient airway feed data on measured flow and pressure into a microprocessor controller, which in turn regulates the blower assembly. A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters.
The BiPAP AutoSV pressure control that contains various which are used to configure positive pressure therapies. With these controls, the device delivers minimum pressure support determined by the EPAP and IPAP Min controls. The device may automatically provide additional pressure support with inspiratory pressures between IPAP Min and IPAP Max to normalize patient ventilation during sleep disordered breathing events. Note: When EPAP
The provided text describes a 510(k) premarket notification for a modified device, the Respironics BiPAP AutoSV. The submission claims substantial equivalence to previously cleared predicate devices. The "study" mentioned refers to design verification tests performed on the device to ensure it meets required acceptance criteria. However, the document does not contain detailed information about a clinical study with a detailed methodology, acceptance criteria, and specific performance results in the format you requested for "proving" the device meets acceptance criteria.
Based on the provided text, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Design Verification Tests for risk analysis and product requirements | All tests were verified to meet the required acceptance criteria. |
| Compliance with applicable standards referenced in "Guidance for the Content of Pre-market Submissions for Software in Medical Devices," May 2006. | The modified device complies with these standards. |
| No impact on the safety and effectiveness of the device compared to the predicate. | Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. |
Missing Information:
- Specific quantitative acceptance criteria (e.g., "pressure accuracy must be within +/- X cmH2O").
- Specific quantitative performance results from the design verification tests (e.g., "pressure accuracy was Y cmH2O").
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "design verification tests" but does not detail the number of devices or scenarios tested.
- Data Provenance: Not specified. It's internal testing conducted by Respironics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for design verification tests is typically established through engineering specifications and regulatory standards, not expert consensus on patient data.
4. Adjudication method for the test set:
- Not applicable. This typically refers to clinical study data adjudication.
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:
- No. This type of study is not mentioned in the document. The device is a ventilator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that the device (which contains a microprocessor controller) underwent standalone testing as part of the design verification process. The "algorithm" here would be the control logic of the ventilator. However, specific details about protocol for standalone algorithm performance are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For design verification tests, the "ground truth" would be the engineering specifications and regulatory standards that the device is required to meet.
8. The sample size for the training set:
- Not applicable in the context of this document. This refers to AI/ML model training, which is not the focus of this submission. The device is microprocessor-controlled but not described as using machine learning that would require a "training set" in the common sense of the term for AI products.
9. How the ground truth for the training set was established:
- Not applicable (see point 8).
§ 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).