(127 days)
The Pocket BVM Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support of adult patients.
The Pocket BVM is a manual emergency ventilator device whose purpose is to manually apply positive pressure to a patient's airways to support ventilation and oxygenation. The Pocket BVM incorporates bags and valve assemblies and is intended to provide emergency respiratory support to a patient through a face mask or a tube inserted into the patient's airway.
The Pocket BVM can apply ventilation to a patient either through a mask (supplied with the device) or an artificial airway (not supplied). The Pocket BVM device maintains the functionality of existing devices and also has the advantage of small external dimensions (when packed) and light weight. It can be unpacked and made operational in seconds. The Pocket BVM complies with ISO 10651-4:2002; Particular requirements for operator powered resuscitators.
The provided text describes a 510(k) submission for a medical device called the "Pocket BVM." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device that requires extensive clinical studies for performance evaluation.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the Pocket BVM are compliance with the international standard ISO 10651-4:2002, "Particular requirements for operator powered resuscitators." The reported device performance is that it "complies with all the requirements of ISO 10651-4:2002."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ISO 10651-4:2002 standard | The Pocket BVM complies with all requirements of ISO 10651-4:2002. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "Non-clinical testing: The Pocket BVM has been tested and complies with all the requirements of ISO 10651-4:2002." This typically implies laboratory-based, non-clinical testing performed according to the specified standard.
- Sample size: Not specified. Testing for standards compliance often involves a limited number of test units to demonstrate consistent performance within manufacturing specifications.
- Data provenance: Not explicitly stated, but non-clinical testing for international standards is generally conducted in a controlled laboratory environment. The submitter is MicroBVM Systems Ltd., Jerusalem, ISRAEL, so it's likely the testing was supervised or conducted in Israel or by contract labs following international guidelines. This would be considered prospective testing for the purpose of regulatory submission.
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)
This question is not applicable to the provided information. The "ground truth" for this device's acceptance is its technical compliance with an international standard (ISO 10651-4:2002), which defines objective performance characteristics (e.g., flow rates, pressure limits, material compatibility). This does not involve expert interpretation or clinical ground truth in the way an imaging AI device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As explained in point 3, the evaluation of this device is based on objective measurements against a standard, not on expert adjudication of subjective results.
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 device is a manual emergency ventilator, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI assistance evaluation is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a mechanical medical device, not an algorithm. Its performance is inherent in its design and manufacturing, tested against physical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or benchmark for this device's performance is compliance with the technical and performance specifications outlined in the ISO 10651-4:2002 standard. This standard dictates measurable parameters for manual resuscitators.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning system that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/machine learning system, there is no training set and therefore no ground truth establishment for a training set.
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, 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).