(119 days)
The V60 ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with spontaneous respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.
The Ventilator is intended to support pediatric patients weighing 20kg (44 lbs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. The Ventilator is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
The ventilator is intended to be used only with various combinations of Respironics recommended patient circuits, interfaces (masks), humidifiers and other accessories.
The V60™ ventilator is a microprocessor controlled positive pressure ventilatory assist system incorporating a user interface with multifunction keys, real-time graphic displays, and integral patient and system alarms. The ventilator provides noninvasive and invasive ventilatory support for spontaneously breathing adult and pediatric patients.
The provided text describes a 510(k) submission for the Respironics V60 Ventilator. The summary states that "Bench performance testing was performed comparing the new V60 and the predicate devices, and was found to be substantially equivalent." and "Performance testing and human factors testing demonstrate that the device is as safe, as effective and performs as well as or better than the predicate device."
However, the document does not provide specific acceptance criteria, reported device performance metrics, detailed study designs, sample sizes, information on ground truth establishment, or any details about multi-reader multi-case (MRMC) comparative effectiveness studies.
Therefore, I cannot populate the table or answer most of the questions based on the provided text. The document focuses on demonstrating substantial equivalence to predicate devices through general performance and human factors testing, rather than presenting a detailed clinical study with quantitative acceptance criteria.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text | Not specified in the provided text |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Bench performance testing" and "human factors testing" but does not specify sample sizes for any test sets, nor does it provide details about data provenance (e.g., country of origin, retrospective or prospective nature).
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 specified in the provided text. The document does not describe the establishment of a "ground truth" using experts for the performance testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not specified in the provided text.
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 study is mentioned. The device is a ventilator, and the testing described is performance and human factors testing of the device itself, not a study evaluating human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable in the context of a ventilator. The described "Performance testing" is inherently standalone in the sense that it tests the device's functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically defined for diagnostic AI studies using expert consensus or pathology is not applicable to the performance testing of a ventilator as described in this document. The "ground truth" for a ventilator's performance would be engineering specifications and established physiological parameters it is designed to achieve.
8. The sample size for the training set
Not applicable. The document describes a medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. The document describes a medical device, not an AI/ML algorithm that requires a training set.
§ 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).