(84 days)
The VPAP III ST-A/Kidsta Mask system is intended to provide non-invasive ventilation for pediatric patients aged 7 years or older (>40lbs) with respiratory insufficiency or obstructive sleep apnea (OSA). The device is intended for use in the hospital or home.
The VPAP III ST-A is a flow-cycled, pressure-limited ventilator. A blower assembly generates airway pressure. A flow sensor and a pressure sensor in the patient airway feed data on measured flow and pressure into a microprocessor controller, which in turn regulates the blower assembly. A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters.
The VPAP III ST-A has a CPAP mode in which a fixed pressure is delivered, and three bi-level operating modes which determine how the changes between IPAP (Inspiratory Positive Airway Pressure) and EPAP (Expiratory Positive Airway Pressure) pressures are made: Spontaneous, Spontaneous/Timed and Timed.
The VPAP III ST-A is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable.
The Mirage Kidsta cushion size and headgear has been modified from the Mirage Vista to meet the requirements of the pediatric population. The Kidsta mask provides therapy through the nose only. The Mirage Kidsta comprises the following
- Mask frame, with two ports for connection to pressure sensor tubing. A 2-. ports cap can cover one or both ports.
- Mask elbow, connected to short air tubing, with a swivel, which allows a 360° . rotation of the air tube. The elbow has an integral exhaust vent for flushing CO2 in order to prevent re-breathing.
- Mask cushion, for patient comfort and adequate sealing between mask and . face.
- Headgear, a three-layered fabric attached to the mask frame by means of . clips to enable fast release of the mask. The mask can be tilted at five different angles by pressing on the tabs and changing the slot position on the headgear clips. The headgear side straps, connected to the headgear clips, are reinforced for increased stability.
The Mirage Kidsta mask comes in one frame size and cushion.
This 510(k) summary does not contain information on specific acceptance criteria and study results in the format requested. The document describes a submission for a pediatric indication for an existing device (VPAP III ST-A) and a modified mask (Mirage Kidsta). It focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance metrics from a specific clinical study with acceptance criteria.
However, based on the information provided, here's what can be extracted and inferred, along with what is explicitly stated as not available.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific performance metrics for pediatric use (e.g., ventilation efficacy, mask seal performance quantified) | NOT AVAILABLE: The document states that "Additional testing based on the VPAP III ST-A / Kidsta risk analysis was performed to ensure the safety and efficacy of the VPAP III ST-A / Kidsta system when used on the pediatric patient (>7 years and >40lbs)." However, it does not provide specific acceptance criteria or quantitative performance results from these tests. It only concludes that the system "can be safely and effectively used." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: NOT AVAILABLE. The document mentions "Additional testing" and "Human factors considerations and usability trials" but does not specify the number of subjects or cases included in these tests.
- Data Provenance: NOT AVAILABLE. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
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 APPLICABLE/NOT AVAILABLE. The document highlights "risk analysis" and "human factors considerations and usability trials," which likely involved expert input. However, it does not describe a process for establishing a "ground truth" for a test set in the way one would for diagnostic imaging or a comparable classification task, nor does it specify the number or qualifications of experts involved in these assessments. The focus is on safety and efficacy in the pediatric population rather than diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- NOT APPLICABLE/NOT AVAILABLE. As no specific "test set" for diagnostic performance or ground truth establishment is described, an adjudication method is not mentioned.
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. This device is a ventilator system, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The VPAP III ST-A is a medical device (ventilator), not an algorithm that performs a standalone diagnostic or predictive function. Its performance is inherent to its mechanical and software operation in delivering ventilation, which is always in conjunction with a patient and overseen by healthcare professionals or caregivers.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- NOT APPLICABLE/NOT AVAILABLE in the context of diagnostic "ground truth." The "ground truth" for this device's efficacy and safety would be established through engineering validation, simulated use, and clinical observations to confirm that it effectively delivers non-invasive ventilation and manages respiratory insufficiency or OSA in the target pediatric population without adverse effects. This is assessed against established physiological parameters and safety standards, rather than a diagnostic gold standard like pathology. The document states "Testing confirms that the unmodified VPAP III ST-A when used with the Mirage Kidsta mask can be safely and effectively used to treat the pediatric patient (>7 years and >40lbs)." This implies successful performance against pre-defined safety and efficacy benchmarks, though these benchmarks are not detailed.
8. The sample size for the training set
- NOT APPLICABLE. This device is a hardware and software system for ventilation, not a machine learning algorithm that requires a "training set" in the conventional sense. Its development follows traditional engineering design and testing processes.
9. How the ground truth for the training set was established
- NOT APPLICABLE. As there is no "training set" for a machine learning algorithm, there is no ground truth established in this manner.
§ 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).