(458 days)
The intended use of the PLV Continuum ventilator is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes pediatric and adult patients who weigh at least 5 kg (11 lbs). The PLV Continuum ventilator is intended for use in home, institutional and portable settings and may be used for invasive as well as non-invasive ventilation.
The PLV Continuum ventilator is a microprocessor controlled, compressor-based, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PLV Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The user interface on PLV Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings and for the display of alarm conditions. PLV Continuum is capable of providing the following types of ventilatory support:
- Positive Pressure Ventilation, delivered either invasively (via endotracheal or . tracheostomy tube) or non-invasively (via mask or mouthpiece).
- Assist/Control. Spontaneous Intermittent Mandatory Ventilation (SIMV) or . Continuous Positive Airway Pressure (CPAP) modes of ventilation.
- Volume-Controlled (VC). Available in A/C and SIMV. .
- Pressure-Controlled (PC). Available in A/C and SIMV. .
- Pressure Support (PS). Available in SIMV and SPONT. ●
Here's an analysis of the provided text regarding the acceptance criteria and study for the PLV Continuum Ventilator:
Acceptance Criteria and Device Performance for PLV Continuum Ventilator
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance Testing | The results of all testing demonstrate that all design and system requirements for the PLV Continuum have been met per ASTM F 1100-90 and F 1246-91.* |
| EMC Testing | Performed per IEC 60601-1-2. |
| Electrical, Mechanical, and Environmental Testing | Performed in accordance with the FDA Draft Reviewer Guidance for Premarket Notification Submissions (1993). |
| Software Validation Testing | Performed per FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998). |
| Substantial Equivalence | PLVC has similar performance characteristics to the predicate devices, the same intended use, same environment of use and patient populations. PLVC does not raise new questions of safety or effectiveness. |
| Technological Characteristics | Utilizes an internal compressor and software algorithms equivalent to currently marketed Respiratory Esprit ventilator (K981072). Does not incorporate new technological characteristics. |
| Intended Use Alignment | Provides continuous or intermittent ventilatory support for pediatric and adult patients (at least 5kg) in home, institutional, and portable settings, for invasive and non-invasive ventilation. |
Note: The document states that the results "demonstrate that all design and system requirements...have been met," implying successful adherence to the standards. Specific numerical performance data against acceptance thresholds from ASTM F 1100-90 and F 1246-91 are not explicitly detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The document refers to "Performance testing," "EMC testing," "Electrical, mechanical and environmental testing," and "Software validation testing" as being conducted, but typical details like the number of devices tested, number of patients, or specific test scenarios are not included in this high-level summary.
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 summary. Performance testing for a ventilator typically involves engineering and functional tests against specifications, rather than expert-established ground truth in the same way a diagnostic imaging AI might.
4. Adjudication Method for the Test Set
This information is not applicable or provided. The document describes performance testing against established standards and guidance, not an adjudication process of expert opinions.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic AI devices where human readers interpret medical images or data. The PLV Continuum Ventilator is a mechanical ventilator, and its evaluation focuses on its functional performance, safety, and equivalence to predicate devices, not on human-in-the-loop diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Given that the device is a mechanical ventilator, the "standalone" performance would encompass the various performance tests mentioned (e.g., breath delivery accuracy, alarm functionality, power consumption) without direct human intervention in its core mechanical operation. The summary states: "Breath delivery is controlled by software algorithms." This implies algorithmic function is evaluated as part of the overall device performance. However, there isn't a separate "algorithm only" study specifically described as it would be for an AI diagnostic device. The performance testing evaluates the device's functions, which are driven by its algorithms.
7. The Type of Ground Truth Used
The "ground truth" for the PLV Continuum Ventilator's performance testing is based on established engineering standards and regulatory guidance. This includes:
- ASTM F 1100-90 and F 1246-91: These are standards for ventilators, providing the criteria against which the device's mechanical and functional performance (e.g., volume delivery, pressure control, alarm thresholds) would be measured.
- FDA Draft Reviewer Guidance for Premarket Notification Submissions (1993): This guidance dictates the requirements for electrical, mechanical, and environmental testing.
- FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998): This guidance sets the "ground truth" for software validation.
Essentially, the "ground truth" is defined by compliance with these recognized safety and performance standards for medical devices.
8. The Sample Size for the Training Set
The concept of a "training set" is usually applicable to machine learning or AI models that learn from data. The PLV Continuum Ventilator is described as a "microprocessor controlled" device with "software algorithms" that are "equivalent to those used on the currently marketed Respironics Esprit ventilator." This suggests that the software algorithms were developed based on established engineering principles for ventilator function, possibly iteratively tested and refined, rather than being "trained" on a large dataset in the sense of a deep learning model. Therefore, a "training set" in the context of an AI model driven by data is not explicitly mentioned or directly applicable here.
9. How the Ground Truth for the Training Set Was Established
As the device relies on established software algorithms and engineering principles rather than a data-driven AI model, the concept of a "training set" with established ground truth as it applies to AI/ML is not relevant here. The ground truth for the development of such a device's software would stem from physiological requirements for ventilation, mechanical engineering principles, and the performance characteristics of predicate devices, which were then codified into algorithms. The testing described then verifies that these algorithms, as implemented in the device, meet the specified performance and safety requirements.
§ 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).