(232 days)
The Juno VPAP ST-A is indicated to provide noninvasive ventilation for patients weighing more than 30lbs (13 kg) with respiratory insufficiency or obstructive sleep apnoea (OSA).
The iVAPS mode is indicated for patients weighing more than 66lbs (30 kg).
The Juno VPAP ST-A is intended for home and hospital use.
The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.
The subject device Juno VPAP ST-A retains all the same hardware, technologies and manufacturing characteristics as previously cleared in K153061. The device is used in a wider breathing circuit which typically comprises patient tubing and a mask (patient interface) to deliver a prescribed positive airway pressure treatment to patients.
Some of the kev features of the device include an in-line power supply: fully integrated humidifier: alarms module; heater controller; colour LCD and simple controls for ease of use. The device also allows data transfer/connectivity via an integrated wireless module (When used in a hospital setting, remote changes may not be appropriate for certain patients, as these setting changes may not be communicated to all hospital personnel treating the patient. Hospital staff should liaise with the patient's regular care provider such that the desired therapy outcome is achieved).
Juno VPAP ST-A utilizes a Micro-processor controlled blower system that generates positive airway pressure (CPAP) between 4-20 cmHJO as required to maintain an "air splint" for effective treatment of OSA and (Bilevel) pressures between 3-30 cmH2O for the treatment respiratory insufficiency.
The therapy modes available in the Juno VPAP ST-A include CPAP, Spontaneous, Spontaneous/Timed, Timed, PAC and iVAPS. In this subject device now features an optional "AutoEPAP" function on iVAPS mode. AutoEPAP automatically adjusts EPAP pressure (within set values) in response to flow limitations of the upper airway.
Juno VPAP ST-A is intended to be used under the conditions and purposes indicated in the labelling provided with the product.
It is a prescription device, supplied non-sterile.
The document describes the Resmed Juno VPAP ST-A device (K161492), which is an update to a previously cleared device (K153061). The key change in the subject device is the addition of an optional "AutoEPAP" function to the iVAPS therapy mode.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, suitability for market is based on demonstrating substantial equivalence to the predicate device (Juno VPAP ST-A, K153061) and demonstrating that the new AutoEPAP algorithm provides equivalent therapy to the fixed EPAP setting of the predicate.
The reported device performance is that the AutoEPAP iVAPS therapy mode was as efficacious as iVAPS with fixed EPAP in terms of several clinical metrics.
| Acceptance Criterion (Inferred from Substantial Equivalence Claim) | Reported Device Performance (from Clinical Data) |
|---|---|
| Equivalence in maintaining upper airway patency | AutoEPAP iVAPS was as efficacious as iVAPS with fixed EPAP. |
| Equivalence in Apnea-Hypopnea Index (AHI) | Equivalent |
| Equivalence in Oxygen Desaturation Index (ODI) | Equivalent |
| Equivalence in Blood Oxygen Saturation (SPO2) | Equivalent |
| Equivalence in Transcutaneous Carbon Dioxide (PtcCO2) | Equivalent |
| Equivalence in Sleep Quality | Equivalent |
| No serious adverse events or complications | No serious adverse events or complications related to the study device were recorded. |
| Compliance with relevant standards and specifications | The subject device meets all requirements of the Juno VPAP ST-A System Specification and complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11, FDA Draft Reviewer Guidance for Ventilators, and FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for the test set: Not explicitly stated. The document mentions "patients with respiratory insufficiency" but does not provide the number of participants.
- Data provenance: Not explicitly stated, but the study was a "clinical trial" which implies prospective data collection. The country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As this is a study evaluating the clinical efficacy of a ventilator mode, the "ground truth" would be established by direct physiological measurements and clinical assessments rather than expert review of images or data.
4. Adjudication Method 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
No, an MRMC study was not done. This device is a ventilator, not an AI-assisted diagnostic tool that would typically involve human readers interpreting data or images. The study focuses on the direct efficacy of the ventilator's automated function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the clinical trial described appears to be a standalone performance evaluation of the AutoEPAP iVAPS algorithm. It directly compares the efficacy of the new automated algorithm with the fixed EPAP mode, which also functions automatically (without real-time human intervention during therapy delivery).
7. The Type of Ground Truth Used
The ground truth was established using physiological measurements and clinical outcomes data such as:
- Apnea-Hypopnea Index (AHI)
- Oxygen Desaturation Index (ODI)
- Blood Oxygen Saturation (SPO2)
- Transcutaneous Carbon Dioxide (PtcCO2)
- Sleep Quality (presumably based on polysomnography or other clinical assessments)
8. The Sample Size for the Training Set
The document describes a clinical trial (double-blinded, randomized, crossover study) which evaluates the performance of the implemented algorithm. It does not mention a separate "training set" in the context of an AI/machine learning model development lifecycle. The AutoEPAP algorithm would have been developed and internally validated by the manufacturer, but the specific details of its training data (if any for a machine learning component) are not provided. The clinical trial serves as the validation or test set for the device's efficacy.
9. How the Ground Truth for the Training Set Was Established
As explained above, a "training set" in the machine learning sense is not explicitly discussed. For the clinical trial (validation data), the ground truth was established through direct physiological measurements and clinical assessments as listed in point 7.
§ 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).