(280 days)
The NIOV Ventilator, with accessories; is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients that are capable of spontaneously breathing a minimum tidel volume of 3.5 ml/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical 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 their caregivers under the direction of a physician.
The Breathe Technologies NIOV Ventilator System is a battery powered, wearable, volume ventilator that augments the patient's spontaneous breathing. The NIOV Ventilator administers this physician-prescribed volume to the patient via the attached Breathe Technologies Patient Circuit (BT-PC) which inserts into the patient's tracheostomy tube, or via the Breath Technologies NIOV Pillows Interface, a type of nasal mask. The ventilator is small and light enough to be worn on a patient's belt, or slung over their shoulder. It is connected to a separate, third party, air or oxygen gas supply. The Ventilator is cleared for Institutional or Home Use.
The provided text describes the Breathe Technologies NIOV Ventilation System and its substantial equivalence to a predicate device, but it does not contain the specific information required to answer all parts of your request regarding acceptance criteria and a study proving those criteria.
Specifically, the text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed study results against specific, quantified acceptance criteria.
However, I can extract what is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantified, pass/fail manner. Instead, it refers to compliance with recognized standards and guidelines. The "reported device performance" is a general statement of compliance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with FDA Draft Reviewer Guide for Ventilators (July 1995) | Demonstrated continued compliance |
| Compliance with ASTM F1100-90 (1997) | Demonstrated continued compliance |
| Compliance with IEC 60601-1 (1988) | Demonstrated continued compliance |
| Compliance with IEC 60601-2-12 (2001-10) | Demonstrated continued compliance |
| Compliance with ASTM F1246-91 (1991, Reapproved 2005) | Demonstrated continued compliance |
| Operating as intended | Demonstrated by Software Design and Validation & bench testing |
The study that proves the device meets the (implied) acceptance criteria:
The study referenced is "bench testing of the device" and "Software Design and Validation process."
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" sample size in the context of clinical or performance data for the device itself. It mentions "bench testing," which implies laboratory-based tests on the device, but details on the number of units tested or specific scenarios are not provided. There is no mention of data provenance like country of origin or whether it was retrospective/prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The bench testing and software validation would likely rely on engineering and technical expertise to establish "ground truth" (i.e., correct device function or output), but no details on expert numbers or qualifications are given.
4. Adjudication method for the test set
This information is not provided.
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 such study is mentioned. The device is a ventilator, not an AI-powered diagnostic imaging tool that would typically involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not relevant to a mechanical ventilator like the Breathe Technologies NIOV. The device itself operates "standalone" in the sense that it performs its function (ventilation) without direct human intervention in each breath cycle, but it is operated by trained personnel, patients, or caregivers. The document indicates that "bench testing of the device" demonstrated its operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench testing and software validation, the ground truth would likely be based on:
- Engineering specifications and design requirements.
- Measurements against calibrated standards for parameters like volume, pressure, flow, and timing.
- Expected behavior defined by the referenced industry standards (e.g., ASTM, IEC).
8. The sample size for the training set
This information is not provided. The device relies on embedded software and control algorithms, but the document does not discuss machine learning or "training sets" in the context of AI.
9. How the ground truth for the training set was established
Not applicable, as no training set for AI is mentioned.
§ 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).