(58 days)
The Breathe Technologies™ Ventilator BT-V2S, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory in u vouln'is assist patients with a tracheostomy that are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occurational therapy, respiratory therapy, and other rehabilitation efforts in an institutional environment. The device is intended for operation by trained personnel under the direction of a plysician
The Breathe Technologies™ Ventilator (BT-V2S) is a battery powered (which may be charged during use) wearable, volume ventilator that augments the patient's spontaneous breathing. The BT-V2S administers this physician-prescribed volume to the patient via the attached Breathe Technologies Patient Circuit (BT-PC). The end of the BT-PC is inserted into the patient's tracheostomy tube. The ventilator is small and light enough to be worn on a patient's belt, or slung over their shoulder.
The provided text describes a 510(k) premarket notification for the Breathe Technologies BT-V2S Ventilator. This submission focuses on demonstrating substantial equivalence to a predicate device (BT-VS) rather than presenting a de novo study with acceptance criteria and performance metrics for a new, unclassified device.
Therefore, the input document does not contain the acceptance criteria and study data typically associated with proving a device meets specific performance criteria through a clinical or rigorous standalone study. It primarily states that "Bench testing has demonstrated that the device is in compliance with the medical community's expectations, the product labeling and pertinent sections of the guidance's and standards."
Without a separate study report or detailed performance data, it's not possible to populate the requested table or answer most of the questions.
However, I can extract the information provided:
1. A table of acceptance criteria and the reported device performance:
The document explicitly states: "Bench testing has demonstrated that the device is in compliance with the medical community's expectations, the product labeling and pertinent sections of the guidance's and standards." This implies that the 'acceptance criteria' were likely defined by those standards and expectations, and the 'reported device performance' was that it met them. However, the specific quantitative criteria and results are not provided in this document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The document refers to "bench testing," not a test set with patient data or a clinical study.
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 applicable. No test set with ground truth established by experts is mentioned. The "medical community's expectations" are a general reference, not a specific expert panel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set with adjudication is mentioned.
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. This is not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-only device. The ventilatory function is directly interacting with the patient. The statement "Bench testing has demonstrated that the device is in compliance..." refers to the device's physical and functional performance, which is inherently "standalone" in the sense that it's the device's performance being assessed against engineering and medical standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the bench testing, the "ground truth" would be the engineering specifications, relevant industry standards (e.g., ISO 10993 for biocompatibility), and "medical community's expectations" related to ventilator performance. The document doesn't provide specifics on how these were quantified for each test.
8. The sample size for the training set:
Not applicable. This is a ventilator device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable, for the same reason as 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).