(203 days)
For emergency ventilation via a small lumen transtracheal catheter, in case conventional ventilation by mask and/or a large-bore endotracheal tube cannot be performed. Ventilation is accomplished by manual, intermittent ventilation with oxygen through the catheter for subsequent lung inflation and deflation.
Ventrain is a manually operated ventilation device that provides adequate ventilation through a narrow-bore transtracheal catheter, even in case of a completely obstructed upper airway. Ventrain is specifically designed for 'cannot intubate, cannot ventilate' emergencies where conventional ventilation by mask and/or large-bore endotracheal tube cannot be performed.
Ventrain consists of a handheld unit for manual control of gas flow to the patient. One side of the handheld is connected with an oxygen supply, such as an oxygen cylinder. The other side of the handheld is connected to a transtracheal catheter inserted in the patient.
The handheld contains a polymer manifold for channeling the gas flow through the device. The user controls ventilation by opening or closing holes in the manifold with the thumb and index finger.
Ventrain is capable of actively removing gas from the lungs in the expiration phase by suction (Expiratory Ventilation Assistance). Therefore, Ventrain can also be used for patients with a complete upper airway obstruction
The provided text is related to a 510(k) submission for the "Ventrain" device, a manually operated ventilation device. The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study for meeting specific acceptance criteria in the manner requested (e.g., performance metrics with numerical targets).
Therefore, I cannot extract the information required to populate all sections of your request, such as a table of acceptance criteria with reported performance, sample sizes for test/training sets, expert qualifications, or details on ground truth establishment, as these are typically found in performance testing reports or clinical study summaries, which are explicitly stated as "not required" for this submission (according to "Summary of Clinical testing" section).
Here's what can be extracted based on the provided text, and where gaps exist:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document in the format of specific numerical acceptance criteria. The document states:
"Ventrain passed a series of tests that demonstrate that the device is capable of performing to its stated Intended Use in its intended environments."
And, "The results of all verification and validation testing demonstrate that all system and design requirements for the Ventrain device have been met."
It also mentions performance specifications were compared to the predicate device, noting "maximum minute volumes are lower with Ventrain than with the predicate device. Literature showed that this smaller range of minute volumes possible with Ventrain is still sufficient for its intended use."
Without specific metrics and their target values, a table cannot be constructed.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified. The document mentions "a series of tests" and "verification and validation testing" but does not give sample sizes for these tests, nor does it refer to a distinct "test set" in the context of image-based or diagnostic AI.
- Data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/Not specified. The testing described is primarily engineering and performance testing on the device itself, not data analysis from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. As no clinical or data-based "test set" requiring expert ground truth is described, this information is not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. 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, an MRMC comparative effectiveness study was not done. The document explicitly states under "Summary of Clinical testing": "Clinical testing was not required to demonstrate substantial equivalence." This type of study would fall under clinical testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly applicable. The device is a manually operated mechanical ventilator. The concept of "standalone algorithm performance" as typically applied to AI or diagnostic software does not directly translate here. The device's performance is inherently tied to its mechanical function and user operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth in the context of diagnostic or interpretive outcomes is described, as no clinical study or data analysis is presented. The "ground truth" for the device's performance would be engineering specifications and standards (e.g., ISO10651-5), as stated in the document: "Qualification included performance testing as per 1S010651-5 standard, hazard analysis conform the ISO14971standard and system level verification and validation tests."
8. The sample size for the training set
- Not applicable/Not specified. The device is a mechanical ventilator; there is no "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI model, this information is irrelevant.
Summary of Study (Based on Provided Text):
The acceptance criteria for the Dolphys Medical - Ventrain device were primarily based on its ability to demonstrate substantial equivalence to a legally marketed predicate device (ManuJet III, K112783) and compliance with relevant engineering standards.
The study that proves the device meets "acceptance criteria" (understood as demonstrating safety and effectiveness for 510(k) clearance) was a series of engineering and performance tests, not clinical trials or AI performance evaluations. Key aspects of this "study" or submission included:
- Comparison to Predicate Device: The Ventrain was compared to the ManuJet III on aspects such as intended use, patient population, operating principle, energy source, gas supply, patient connections, performance specifications (frequency, minute volumes, I:E ratio), and ambient conditions.
- Performance Testing: "Ventrain passed a series of tests that demonstrate that the device is capable of performing to its stated Intended Use in its intended environments." This included qualification as per the ISO10651-5 standard (likely related to lung ventilators), ISO14971 standard for hazard analysis (risk management for medical devices), and "system level verification and validation tests."
- Biocompatibility: All gas-conducting parts were found to be biocompatible in accordance with ISO 10993-1:2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and testing.
The unique aspect of Ventrain providing (assisted) expiration was noted, and the manufacturer concluded it "did not introduce new risks." While maximum minute volumes were lower than the predicate, literature supported their sufficiency for the intended use.
Crucially, the submission explicitly states: "Clinical testing was not required to demonstrate substantial equivalence." This means no human-subjects clinical studies were conducted for this 510(k) clearance.
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).