(74 days)
The VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 4i is indicated for humidification of the air delivered from a ResMed compatible CPAP therapy device. The VPAP ST and HumidAire 4i are intended for use in the hospital and home.
The VPAP ST is similar to the predicate devices, VPAP Malibu (K062291), S8 Pioneer (K041209), Sullivan VPAP II ST (K961783), and VPAP Auto (K071171). The VPAP ST provides CPAP, Bilevel and VAuto 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 splint" for effective treatment of OSA.
The system comprises the Flow Generator, HumidAire 4i, patient tubing, mask (patient interface), Smart Card and USB Adapter.
The performance and functional characteristics of the VPAP ST includes all the clinician and user friendly features of the predicate devices, VPAP Malibu (K062291), S8 Pioneer (K041209), Sullivan VPAP II ST (K961783), and VPAP Auto (K071171).
It appears there has been a misunderstanding. The provided document is a 510(k) Premarket Notification for the ResMed VPAP ST, a medical device used for treating Obstructive Sleep Apnea (OSA).
This type of document is a regulatory submission to the FDA to demonstrate substantial equivalence to a predicate device, not a study report detailing acceptance criteria for performance and experimental results.
Therefore, the requested information regarding a study proving acceptance criteria for device performance metrics (like sensitivity, specificity, accuracy, etc., which are common for AI/diagnostic devices) is not present in this document. The document confirms that design and verification activities were performed and that the VPAP ST met pre-determined acceptance criteria, but it does not provide the specifics of those criteria or the detailed results of a performance study in the format typically associated with AI or diagnostic device evaluation.
The key statement is: "Design and Verification activities were performed on the VPAP ST as a result of the risk analysis and product requirements. All tests confirmed the VPAP ST met the predetermined acceptance criteria." This refers to engineering and functional testing, not a clinical performance study with human readers, AI, FPs, FNs, etc.
Below is a breakdown of why I cannot fulfill your request based on the provided text, and what information is available:
- 1. A table of acceptance criteria and the reported device performance: Not provided. The document states that the device met "predetermined acceptance criteria" resulting from risk analysis and product requirements, but it doesn't list them or specific performance metrics from a clinical study.
- 2. Sample size used for the test set and the data provenance: Not provided, as this is not a study report.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- 4. Adjudication method for the test set: Not provided.
- 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 device is a ventilator, not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not present.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a piece of hardware, a ventilator. The concept of "standalone algorithm performance" does not apply.
- 7. The type of ground truth used: Not applicable in the context of this device's regulatory submission.
- 8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
- 9. How the ground truth for the training set was established: Not applicable.
Information that is available from the document:
- Device Name: VPAP ST
- Intended Use: For the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 4i is indicated for humidification of the air. Intended for use in the hospital and home.
- Regulatory Basis: Substantial equivalence to predicate devices (VPAP Malibu, S8 Pioneer, Sullivan VPAP II ST, VPAP Auto).
- Key Design Aspects: Provides CPAP, Bilevel, and VAuto therapy modes through a micro-processor controlled blower system.
- Regulatory Clearance: K080131, cleared on April 1, 2008.
To reiterate, this document is focused on regulatory clearance for a physical medical device (a ventilator) based on substantial equivalence, not on the performance evaluation of a diagnostic or AI-driven system against specific acceptance criteria like sensitivity or specificity.
§ 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).