(90 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 510(k) summary for the BiPAP AutoSV device does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and the study that proves the device meets them. This document is a summary and primarily focuses on demonstrating substantial equivalence to predicate devices through
bench testing and general comparisons, rather than a detailed report of clinical study outcomes or specific acceptance criteria for performance metrics.
However, based on the provided text, here's what can be extracted and what information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary states: "Bench testing has confirmed that the BiPAP AutoSV performs equivalently to the device predicate VPAP Adapt (K051364). All tests were verified to meet the required acceptance criteria."
This statement confirms that acceptance criteria exist and were met, but the document does not specify what those criteria are, nor does it provide a table of performance metrics. It only broadly mentions "waveform performance data, triggering data, alarms data, and overall event diction and control data."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. | Equivalently performed to predicate VPAP Adapt (K051364) in waveform performance, triggering, alarms, and overall event detection and control data. |
| Specific thresholds for performance related to waveform, triggering, alarms, and event detection. | Met all required acceptance criteria for these tests. |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "comprehensive bench testing."
- Sample Size: The sample size for the test set is not specified. This typically refers to the number of devices or test conditions used in bench testing.
- Data Provenance: The data provenance is bench testing, meaning it's laboratory-generated data from Device A versus Device B comparison, rather than human subject data. The "country of origin" for the data is implicitly where the testing was conducted, likely the manufacturer's facilities (Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668, USA). This testing is retrospective in the sense that it compares a new device against an already cleared predicate device's performance characteristics.
3. Number of Experts and Their Qualifications for Ground Truth
- This device's submission relies on bench testing for proving equivalence, not clinical studies involving human patients where expert-established ground truth would be relevant for diagnostic or therapeutic accuracy. Therefore, information about the number or qualifications of experts used to establish ground truth is not applicable in this context as described in the summary.
4. Adjudication Method for the Test Set
- Since the testing described is primarily bench testing comparing device performance parameters, an "adjudication method" in the sense of resolving discrepancies between expert interpretations (e.g., 2+1, 3+1 for clinical evaluations) is not applicable. The "adjudication" would be based on objective measurements against pre-defined engineering or performance specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done according to this 510(k) summary. The document explicitly states the equivalence was demonstrated through "comprehensive bench testing." MRMC studies are typically used for diagnostic devices to assess the impact of AI on human reader performance, which doesn't fit the context of this ventilatory support system's submission as described.
6. Standalone (Algorithm Only) Performance
- The summary describes the device as a "microprocessor controlled blower based Bi-level positive pressure system that delivers two positive pressure levels." The "AutoSV algorithm" is mentioned as a component. While the algorithm is a key part of the device's functionality, the performance testing described is for the integrated device ("BiPAP AutoSV performs equivalently"). Therefore, a standalone algorithm-only performance study is not explicitly mentioned or implied. The performance is assessed at the device level.
7. Type of Ground Truth Used
- For the bench testing, the "ground truth" would be the established performance specifications and data from the predicate device (Resmed VPAP Adapt, K051364). The BiPAP AutoSV's performance data (waveform, triggering etc.) was compared against these established benchmarks to demonstrate "equivalence." It is not pathology, outcomes data, or expert consensus in a clinical diagnostic sense.
8. Sample Size for the Training Set
- This 510(k) submission is for a medical device (ventilator) that incorporates an algorithm. It is not an AI/ML diagnostic or prognostic software submission where a "training set" of patient cases for algorithm development would typically be disclosed as a distinct component. The document does not provide information on a "training set" for the AutoSV algorithm. Algorithm development often involves internal testing and refinement, but details about specific training data are not part of this 510(k) summary.
9. How Ground Truth for the Training Set Was Established
- As a "training set" for an explicit AI/ML algorithm is not described in this 510(k) summary, the method for establishing its ground truth is not applicable/not provided.
§ 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).