(74 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 indicated for humidification 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 devices, VPAP Malibu (K062291), S8 Pioneer (K041209), and S7 Elite CPAP System (K013909). The VPAP Auto provides CPAP, Bilevel and Vset therapy modes to adult patients with OSA. This is achieved through the use of a micro-processor controlled blower system that generates airway pressures as required to maintain an "air sployout" for effective treatment of OSA.
The system comprises the Flow Generator, HumidAire 3i, patient tubing, mask (patient interface), Smart Card and USB Adapter.
The performance and functional characteristics of the VPAP Auto system includes all the clinician and user friendly features of the predicate devices, VPAP Malibu (K062291), S8 Pioneer (K041209), and S7 Elite CPAP System (K013909).
The provided text describes a 510(k) premarket notification for the ResMed VPAP Auto System. However, it does not contain the specific details about acceptance criteria, device performance results, sample sizes for test or training sets, expert qualifications, or adjudication methods that would be needed to fully answer the request.
The document focuses on demonstrating substantial equivalence to predicate devices, outlining the device's intended use and general description, and confirming that design and verification activities were performed.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted or inferred, and what cannot:
1. Table of acceptance criteria and the reported device performance
The document broadly states: "All tests confirmed the VPAP Auto System met the predetermined acceptance criteria." However, it does not list what those specific acceptance criteria were nor does it provide a table of reported device performance metrics against those criteria. It only mentions compliance with general FDA guidance documents for ventilators and software.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "All tests confirmed the VPAP Auto System met the predetermined acceptance criteria." (Specific metrics not provided) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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 provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 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 provided in the document. The device is a "Noncontinuous ventilator (IPPB)" and its functionality is described as a "micro-processor controlled blower system that generates airway pressures," suggesting it does not involve AI or human "readers" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a noncontinuous ventilator, not a diagnostic algorithm. Performance would be assessed through engineering and clinical validation related to pressure delivery, safety, and effectiveness in treating OSA, rather than standalone algorithm performance in a diagnostic sense. The document implies functional testing was performed ("Design and Verification activities were performed"), but details are not given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. Given the nature of the device (ventilator for OSA), ground truth for performance would likely relate to objective measures of pressure delivery and potentially physiological outcomes (e.g., AHI reduction), but no specifics are given.
8. The sample size for the training set
This information is not provided in the document. The device is a hardware system; while it contains a microprocessor, the document doesn't suggest it uses machine learning in a way that typically involves "training sets" for an AI model.
9. How the ground truth for the training set was established
This information is not provided in the document. (Refer to point 8).
§ 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).