(127 days)
The VPAP Auto system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 3i is indication of the air delivered from the VPAP Auto device. The VPAP Auto system and HumidAire 3i are intended for use in the hospital and home.
The VPAP Auto System is similar to the predicate device, (VPAP Auto with HumidAire 3 (K071171)) with a new and improved power supply and heater controller for the HumidAire 3i. Micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an "air splin" for effective treatment of OSA. The system comprises the flow generator, patient interface) and humidifier.
The performance and functional characteristics of the VPAP Auto system includes all the clinician and user friendly features of the predicate devices.
The provided text describes the VPAP Auto System, a device for treating Obstructive Sleep Apnea (OSA). However, the document does not contain a study that demonstrates the device meets specific acceptance criteria in the way described in your request (e.g., performance metrics, sample sizes, expert adjudication, MRMC studies, or standalone algorithm performance).
Instead, this is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical or technical performance study with specific acceptance criteria and results.
The document states:
"Design and Verification activities were performed on the VPAP Auto System as a result of the risk analysis and design requirements. All tests confirmed the product met the predetermined acceptance criteria."
This is a general statement that the device passed internal tests, but it does not provide the specifics of those tests, the acceptance criteria used, or the results.
Therefore, I cannot populate the table or answer most of your specific questions based only on the provided text.
Here's an attempt to answer what I can based on the limited information provided in the input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific acceptance criteria are not detailed in the provided text. | "All tests confirmed the product met the predetermined acceptance criteria." |
| "predetermined acceptance criteria" | Micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an "air splin" for effective treatment of OSA. |
| Performance and functional characteristics include all clinician and user-friendly features of predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified. The document relates to a device manufactured by ResMed Ltd in Australia but does not detail where test data would have originated.
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)
- Not specified. (This type of information is typically associated with clinical studies, which are not detailed here).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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
- Not applicable. The device is a CPAP system, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an algorithm assessing images/data for human interpretation. The device itself is a standalone system for delivering CPAP.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. Given the nature of the device (CPAP), "ground truth" would likely relate to objective measurements of pressure delivery, flow, and possibly indirect measures of OSA treatment effectiveness (e.g., AHI reduction), but these are not detailed in the provided text.
8. The sample size for the training set
- Not applicable. This device is not described as an AI/machine learning system that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable.
§ 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).