(88 days)
The Breathe Technologies™ Ventilator, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who 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, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients, or caregivers under the direction of a physician.
The Breathe Technologies Ventilator with Accessories (BT-V2S) is a small, wearable, ventilator that interfaces with proprietary nasal and tracheostomy breathing circuits.
The provided text describes the Breathe Technologies Ventilator (BT-V2S) and its accessories, and a 510(k) submission for expanded indication to include use in the Home Care Environment. The information focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed acceptance criteria or a study design in the way you've outlined for a typical AI/software device.
Specifically, the document discusses general standards and guidelines the device complies with, and "Human Factors Studies" to demonstrate proper operation by intended users. It does not provide quantitative performance metrics, sample sizes, ground truth establishment, or expert-based evaluations in the context of an AI/algorithm-driven device.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in the available information and indicate where data is not present.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or performance metrics directly from a study in the format typically seen for AI/diagnostic devices. Instead, it states that the device is compliant with various industry standards and guidelines, and that "Human Factors Studies" demonstrated proper operation.
| Acceptance Criteria (Implied from compliance/study goals) | Reported Device Performance (Summary from text) |
|---|---|
| Compliance with FDA Draft Reviewer Guide for Ventilators (July 1995) | Demonstrated compliance |
| Compliance with ASTM F1100-90 (1997) | Demonstrated compliance |
| Compliance with IEC 60601-1 (1988), Amd 1 (1991-11), Amd 2 (1995) | Demonstrated compliance |
| Compliance with IEC 60601-2-12 (2001-10) | Demonstrated compliance |
| Compliance with ASTM F1246-91 (1991, Reapproved 2005) | Demonstrated compliance |
| Proper operation by intended users (Human Factors) for Home Use | "Demonstrated that the intended users... can properly operate the device." |
| Conformance with FDA Guideline: Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management. July 18, 2000 | Documented conformance |
| Conformance with IEC 62366: 2007 | Documented conformance |
| Conformance with ANSI/AMEE HE75:2009 | Documented conformance |
2. Sample size used for the test set and the data provenance
The document mentions "three Human Factors Studies" but does not provide sample sizes for these studies or their data provenance (e.g., country of origin, retrospective/prospective nature), beyond stating "The first study was with clinicians, and the second was with respiratory therapy patients."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a mechanical ventilator, and the studies mentioned are Human Factors studies focused on usability and proper operation, not diagnostic accuracy requiring expert ground truth in the traditional sense of medical image analysis. The "experts" would likely be the clinicians and patients participating in the Human Factors studies.
4. Adjudication method for the test set
Not applicable. Adjudication methods are typically relevant for establishing ground truth in diagnostic studies, which is not the type of study described here.
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-driven 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 AI-driven device.
7. The type of ground truth used
For the Human Factors studies, the "ground truth" was likely defined by observational data and user feedback demonstrating the ability of users (clinicians, patients, caregivers) to safely and effectively operate the device according to its instructions and design, and to identify and address any usability issues. This is not a pathology or outcomes data ground truth in the diagnostic sense.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The "training" here refers to the actual training of users on how to operate the device.
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).