(150 days)
The V200 Ventilator is a microprocessor-controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric, and neonatal patients as prescribed by a physician. The V200 Ventilator is intended for use in either invasive or non-invasive applications.
The IntelliTrak option provides new triggering and cycling functionality that is intended for use only with adult and pediatric patients in invasive applications.
The V200 Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. The IntelliTrak Software Option will add a new triggering and cycling mechanism based on the equation of motion for the purpose of improving patient-ventilator synchrony. The IntelliTrak software option is activated and is integrated into the V200 in the same way as other currently marketed V200 software options. It can either be installed in the factory or in the field as an upgrade to existing V200 ventilators. The IntelliTrak option is added to the currently commercially released software version and instrument. Downloading this option will add a "button" to the Graphical User Interface (GUI), which is used to turn IntelliTrak on and off.
The provided text describes a 510(k) premarket notification for a modification to a ventilator device, the V200 Ventilator with IntelliTrak Option. The submission focuses on demonstrating substantial equivalence to a predicate device (the unmodified V200 Ventilator) based on bench performance testing and software verification/validation.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly list a table of acceptance criteria with specific numerical targets. Instead, it states that "bench performance testing was performed for the new option and performance was compared between the Respironics V200 with flow triggering set at 3 LPM and cycling set at 25% of peak flow and the Respironics V200 IntelliTrak option." This implies the acceptance criterion was that the IntelliTrak option performs comparably or acceptably in a bench setting to the predicate device's specified settings.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance of IntelliTrak option is acceptable and comparable | "Bench performance testing was performed for the new option and performance was compared between the Respironics V200 with flow triggering set at 3 LPM and cycling set at 25% of peak flow and the Respironics V200 IntelliTrak option." |
| Does not raise new questions regarding safety and effectiveness | "performance testing data demonstrates that the IntelliTrak option does not raise any new questions regarding safety and effectiveness." |
| Software activities completed in accordance with guidelines | "All software activities, including verification and validation have been successfully completed in accordance with Respironics California, Inc, policies and procedures and the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices dated May 11, 2005." |
2. Sample size used for the test set and the data provenance:
The document mentions "bench performance testing" but does not specify the sample size of these tests (e.g., number of test scenarios, duration of tests, number of physical devices tested). The provenance is implied to be internal testing ("Respironics California, Inc, policies and procedures") and is retrospective as it's part of a 510(k) submission showing the device meets certain standards before market approval. There is no information on the country of origin of the data beyond the company's location (Carlsbad, CA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the use of experts to establish ground truth for the bench performance testing. The "ground truth" for this type of device modification would likely be the expected mechanical and physiological responses simulated during the bench tests, as defined by engineering specifications and potentially clinical guidelines.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
There is no mention of an adjudication method, as the testing described is bench performance testing, not human-in-the-loop evaluation requiring expert consensus.
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 MRMC comparative effectiveness study was done or mentioned. This is a ventilator modification, not an imaging or diagnostic AI tool that would typically involve human "readers." The focus is on the device's operational performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The performance testing described is inherently "standalone" in the sense that it's testing the device's (or its software's) mechanical triggering and cycling functionality on a bench. There is no human intervention mentioned as part of the primary performance evaluation. The IntelliTrak option is an algorithm that modifies how the ventilator triggers and cycles breaths.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" implicitly used for the bench performance testing would be the expected and established mechanical and physiological responses of a ventilator under controlled conditions, based on engineering specifications and potentially industry standards for ventilator performance. It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
The document does not mention a "training set." The IntelliTrak option is described as a software feature that provides new triggering and cycling functionality based on the "equation of motion." This suggests it's likely a model-based control algorithm rather than a machine learning algorithm that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established:
As no training set is mentioned or implied, this question is not applicable based on the provided text. The "ground truth" for the development of such an algorithm would be the principles of respiratory mechanics and the "equation of motion," which are established scientific and engineering principles.
§ 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).