(155 days)
The VPAP Adapt is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. It is intended for home and hospital use.
VPAP Adapt System (VPAP Adapt with H5) is similar to the predicate device(s), using a blower based positive pressure system with an integrated heated humidfier and heater controller. The device platform is identical to the S9 VPAP Adapt (K102586) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure between 3-25 cmHzO as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, patient interface) and humidifier.
The VPAP Adapt is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV) to stabilize a patient's ventilation during sleep. The device continually measures the patient's instantaneous ventilation, and calculates a target ventilation based on to the patient's recent average. It then adjusts the degree of pressure support to servo-control the patient's ventilation to at least equal the target ventilation. Therapy modes contained in the VPAP Adapt are CPAP, ASV, and ASVAuto. CPAP and ASV therapy modes come from the S9 VPAP Adapt (K102586).
The functional characteristics of the VPAP Adapt system includes all the clinician and user friendly features of the predicate device.
The provided text is a 510(k) summary for the ResMed VPAP Adapt device, a non-continuous ventilator. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria in a clinical setting.
Based on the information provided, here's a breakdown of the requested points:
Device: VPAP Adapt (Non-continuous ventilator)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of clinical acceptance criteria (e.g., AHI reduction, oxygen saturation improvement) with corresponding device performance metrics. Instead, it refers to "predetermined acceptance criteria" for bench testing demonstrating the ASVAuto algorithm's specification and the device's adherence to safety and performance standards.
| Acceptance Criteria Category | Specific Criteria (as described) | Reported Device Performance | Study Type |
|---|---|---|---|
| ASVAuto Algorithm Performance | "Performs to specification" | "Demonstrated that the VPAP Adapt met the predetermined pass/fail criteria" | Bench Testing |
| EPAP Response | "EPAP response tests to Flow Limitation, Snore and Apnea events" | "Demonstrated that the VPAP Adapt met the predetermined pass/fail criteria" | Bench Testing |
| Safety and Essential Performance | Compliance with IEC 60601-1:2005 (General requirements for safety) | "passed all test protocols" | Standards Testing |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2007 (EMC requirements) | "passed all test protocols" | Standards Testing |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The "tests" mentioned are bench tests using "closed-loop and open-loop test scripts from patient models," not human subjects or a clinical test set. Therefore, there's no patient sample size.
- Data Provenance: Not applicable, as no clinical data from human subjects is mentioned for the verification activities. The "patient models" used in bench testing would be simulated data or hardware models.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" for the bench tests was based on the device's own specifications and the performance of the predicate device (S9 VPAP Adapt K102586). No human experts were used to establish ground truth for a test set in the clinical sense.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or conducted. The document focuses on demonstrating substantial equivalence through bench testing to a predicate device, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, in a way. The "Non-Clinical Testing" section describes "extensive bench testing using both closed-loop and open-loop test scripts from patient models designed to verify that the ASVAuto algorithm in the VPAP Adapt performs to specification." This is a form of standalone testing of the algorithm within the device against preset criteria. It's not a clinical standalone study, but an engineering verification.
7. Type of Ground Truth Used for the Testing
The ground truth for the bench testing was the design specification of the ASVAuto algorithm and the performance characteristics of the predicate device (S9 VPAP Adapt K102586). It's based on engineering requirements and existing device performance, not clinical pathology, expert consensus, or outcomes data from human subjects.
8. Sample Size for the Training Set
Not applicable. The document does not describe any machine learning training processes or a "training set" in the context of AI. The device's algorithm appears to be rule-based or pre-programmed, not learned from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned for an AI/machine learning model. The algorithm's behavior is described as "continually measures the patient's instantaneous ventilation, and calculates a target ventilation based on to the patient's recent average. It then adjusts the degree of pressure support to servo-control the patient's ventilation." This implies a deterministic, pre-defined control algorithm, not one developed through machine learning.
§ 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).