(287 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 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, occupational 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 physician.
The Breathe Technologies™ Ventilator (BT-V) is a battery powered, wearable, volume ventilator that augments the patient's spontaneous breathing. The BT-V administers this physician-prescribed volume to the patient via the attached Breathe Technologies Transtracheal Tube (BT-TT). The end of the BT-TT 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, because it has only a subset of the features of a full-featured ventilator.
The document provided is a 510(k) summary for the Breathe Technologies Ventilator & Accessories, indicating FDA clearance, but it does not contain detailed information about specific acceptance criteria, device performance metrics, or the study that proves the device meets those criteria in the format requested.
The document primarily focuses on:
- Device Description and Intended Use: Explaining what the device is, who it's for, and how it's used.
- Comparison to Predicate Devices: Asserting substantial equivalence to existing ventilators.
- Summary of Supporting Data (High-Level): Mentioning biocompatibility and bench testing compliance with "medical community's expectations," "product labeling," and "pertinent sections of the guidance's and standards."
Therefore, I cannot populate the requested table or provide detailed answers to most of the study-related questions based on the provided text.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific performance metrics (e.g., flow rate accuracy, pressure accuracy, battery life, alarm thresholds) | NOT SPECIFIED IN DOCUMENT. The document only states: "Bench testing has demonstrated that the device is in compliance with the medical community's expectations, the product labeling and the pertinent sections of the guidance's and standards." No quantifiable performance metrics or criteria are provided. |
| Biocompatibility in compliance with ISO 10993 | Device is in compliance with ISO 10993. |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not specified in the provided document. The document mentions "bench testing" but does not give details about the size or nature of any test set used in a clinical or performance study.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not available in the provided document. The document refers to "bench testing" and compliance with "medical community's expectations," but no details on expert involvement for ground truth establishment are given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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/Not mentioned. This device is a ventilator, not an imaging or diagnostic device typically evaluated with MRMC studies or AI assistance in the context of "human readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not mentioned. This is a physical medical device (ventilator), not an algorithm or AI system. Its performance would be evaluated as a standalone device, as hinted by "bench testing."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly defined. For a ventilator, ground truth would typically relate to meeting physiological performance parameters, safety standards, and functional specifications. The document only references "compliance with the medical community's expectations, the product labeling and the pertinent sections of the guidance's and standards" and "bench testing."
8. The sample size for the training set
- Not applicable/Not mentioned. This device is not described as involving machine learning or AI models with training sets.
9. How the ground truth for the training set was established
- Not applicable/Not mentioned. (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).