(221 days)
Use of the Servo Ventilator 300A is indicated for adult, pediatric or neonatal patient populations in an environment where patient care is provided by Healthcare Professionals (Physician, Nurse, Technician), when the professional determines that a device is required to assist the breathing of the patient. The device can be used both for controlling the entire ventilation for patients without any ability to breathe, as well as for supporting patients with reduced ability.
The Servo Ventilator 300A is a modification of the Servo Ventilator 300 which was found Substantially Equivalent on October 25, 1996 (Premarket Notification K960010). The physical differences between the Servo Ventilator 300 and the Servo Ventilator 300A consist of a software change and adding of a new printed circuit board as well as a new switch and two LED's on the front panel.
In the Servo Ventilator 300A a new functionality called Automode has been added, which is a method that, by using functionality from existing breathing modes, allows the patient to better interact with the ventilator. Each controlled mode has a corresponding supported mode. This gives the possibility for the ventilator to react on patient effort - triggering, and lack of effort - apnea. Essentially the ventilator can be set in two states, support or control. Which of these states that are active is determined by a pre-defined algorithm.
This document describes the Siemens Servo Ventilator 300A, a modification of the Servo Ventilator 300. The primary change is the addition of "Automode" functionality, which allows the ventilator to automatically switch between controlled and supported breathing modes based on patient effort.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a specific table of acceptance criteria with quantitative targets (e.g., a specific percentage of accurate mode switches or a defined range for response times). Instead, the acceptance criteria are described qualitatively as ensuring the "Automode" functionality improves patient adaptation and ease of use without adversely affecting safety.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety: Device operates without adversely affecting patient safety. | "Analysis and tests has shown that the new functionality Automode ... without adversely affecting patient safety." (Page 3) |
| Effectiveness/Performance: Improves adaptation to patient needs. | "Analysis and tests has shown that the new functionality Automode improves the adaptation of the ventilator to the patient needs..." (Page 3) |
| "This software and hardware enhancement will adapt the ventilator status to the patient's breathing efforts, by automatic switching between controlled and supported breathing." (Page 4) | |
| "The switching between controlled and supported modes that is done automatically with Automode has always been possible to do manually on the Servo Ventilator 300. For some of the supported modes in Servo Ventilator 300, the Automode functionality improves the safety for the patient, by doing an automatic switch to a controlled mode in case of apnea, instead of just giving an alarm." (Page 2) | |
| Ease of Use: Improves ease of use. | "...as well as the ease of use of the device..." (Page 3) |
| Functionality: All new features (Automode) function correctly. | "All different settings of the new functionality was tested, as well as all the ventilation modes and the complete alarm system. All test were passed according to criteria that are equal or more stringent than the test criteria which were applied to the predicate device." (Page 2) |
| Equivalence to Predicate Device (Servo Ventilator 300): Maintain or exceed safety and effectiveness of the predicate device. | "Therefor, we conclude that the requirements specifications and validation testing show that the modified device is as safe and effective, and performs as well or better as the predicate device." (Page 3) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions a "clinical test has also been performed to evaluate the automatic switching between controlled and supported ventilation" (Page 2). However, it does not specify the sample size used for this clinical test (number of patients, number of events, etc.).
The data provenance (country of origin, retrospective/prospective) is not explicitly stated for this clinical test. Given the submitter's address (Sweden), it's possible the test was conducted there, but this is not confirmed. The document only mentions the intended use in the U.S. market.
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. There is no mention of experts establishing ground truth for the clinical test 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, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No MRMC comparative effectiveness study is mentioned. This device is not an AI-assisted diagnostic tool, but rather an automated feature within a medical device (ventilator). The "Automode" functionality is a direct automation of a clinical decision, not an aid for human interpretation. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not directly apply here.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
The "Automode" functionality is inherently a standalone algorithmic feature. It automatically switches between modes based on pre-defined algorithms and patient effort, without continuous human intervention for each switch. The clinical test evaluated this automated switching.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not explicitly state how "ground truth" was established for the clinical test of automatic switching. It's implied that the success of the automatic switching was evaluated based on its clinical appropriateness and effect on patient ventilation, likely against established physiological responses or clinical standards, but the specific method (e.g., expert review of ventilator logs, patient outcomes, direct observation) is not detailed. Crucially, it speaks to whether the system "improves the adaptation of the ventilator to the patient needs," suggesting clinical observation or physiological measurements as the basis for evaluation.
8. The Sample Size for the Training Set
The document refers to the "Automode" as a "software change and adding of a new printed circuit board" based on "functionality from existing breathing modes" (Page 1). This implies that the underlying algorithms and logic were primarily designed based on existing knowledge of ventilator operation and clinical practice, rather than trained on a large dataset in the sense of machine learning. Therefore, a "training set" in the context of deep learning or statistical model training is not applicable or mentioned. The "design" of the device was validated, not "trained."
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, a "training set" in the modern AI sense is not explicitly used or described. The "ground truth" for the device's design implicitly comes from established medical and engineering principles of ventilation, rather than a data-driven training process with established ground truth labels. The "design" itself reflects clinicians' understanding of optimal ventilation strategies.
§ 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).