(255 days)
The Legendair XL2 is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 5 kg who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients who require the following general types of ventilatory support, as prescribed by an attending physician:
. Positive Pressure ventilation
Assist/Control, SIMV, or CPAP modes of ventilation .
Breath types including Volume, Pressure Control and Pressure Support. ◆
The ventilator is suitable for use in institutional, home, and transport settings. It is not intended for use as an emergency transport ventilator.
The LEGENDAIR® XL2 ventilator is composed of an airflow generator capable of supplying a range of flow rates and pressures and a valve enabling piloting of the expiration valve. The operation of the device is based on a self-adapting drive system governed by a closed loop flow generator. The speed of the flow generator (turbine) is servo-controlled to the patient pressure signal or the inspired flow signal.
The ventilation modes available are:
- -Pressure Support Ventilation
- . Pressure Support Ventilation with Back Up Rate
- CPAP mode -
- Pressure Controlled Ventilation ﮯ
- Pressure Assisted Controlled Ventilation -
- Volume Controlled Ventilation -
- Volume Assisted Controlled Ventilation -
- Synchronous Intermittent Mandatory Ventilation with either volume or pressure ﮮ targeted mandatory breaths
The provided text does not contain acceptance criteria or study details in the format typically used for AI/ML device submissions. This document is a 510(k) summary for a ventilator, a type of electro-mechanical medical device, not an AI/ML diagnostic or predictive tool.
Therefore, many of the requested fields are not applicable to the information provided in this document.
Here's an analysis based on the information available and how it relates to the questions, with an explanation of why other fields are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on "substantial equivalence" to predicate devices rather than specific quantitative performance metrics against predefined acceptance criteria for an AI/ML model.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Equivalence to predicate devices (TBird Legacy, Pulmonetic Systems LTV 1000) in performance modes, ranges of operation, and compliance with electrical and mechanical safety standards. | The Legendair XL2 demonstrated equivalence through detailed comparison, showing it is safe and effective and performs equivalently to the predicate devices. |
| No new questions of safety or effectiveness when compared to legally marketed predicate devices. | The technological characteristics and testing results did not raise new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This is not an AI/ML device where a "test set" of data samples (e.g., images, patient records) is used to evaluate an algorithm's performance. The "testing" referred to for this ventilator would involve engineering and functional tests on the physical device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. See point 2. Ground truth in the context of an AI/ML device is typically established by medical experts reviewing data, which is not relevant here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2.
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:
- Not Applicable. An MRMC study is relevant for AI-assisted diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. This is a ventilator, not a diagnostic AI tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a ventilator, not an algorithm, so the concept of standalone performance does not apply in the AI/ML sense. Its "performance" is inherent to its mechanical and software operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The "ground truth" for a ventilator would be its adherence to specified operational parameters (e.g., delivered pressure, flow rates, alarms functioning correctly) validated through engineering tests against known standards, not expert consensus on medical data or pathology. The document explicitly states "compliance with external electrical and mechanical safety standards" and "detailed comparison of performance modes, ranges of operation."
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a "training set" of data to learn patterns. The ventilator's operation is based on coded logic and physical engineering, not machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 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).