(13 days)
- Pulmonary resuscitation during respiratory and/or cardiac arrest.
- Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.
The Genesis® BLS automatic/manually triggered resuscitators are designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation and Manual Ventilation into a single handpiece design that is a derivative of the Genesis® " Adult/Child device. The device is totally pneumatic in its function therefore requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi.
The provided text is a 510(k) submission for the Genesis® BLS Resuscitator, which is a device for respiratory support. This document is a regulatory submission for premarket notification and does not contain the detailed information necessary to fully answer the request as it pertains to a study proving the device meets acceptance criteria derived from a performance study involving a test set, experts, and specific statistical analyses.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Genesis® II A/C - 510K #: K932170) based on technological characteristics and non-clinical test data comparing it to existing standards.
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 |
|---|---|
| ISO 8382-1988 Compliance | "The submission incorporated a significant amount of non-clinical test data to support the claim of substantial equivalence. This test data reviewed the performance of the device against both the current domestic and international standards for these devices. In particular, references were made to ISO 8382-1988." |
| Performance against predicate device (Genesis® II A/C - K932170) | "The testing undertaken verified that the Genesis®II BLS device, when compared with the performance of the device to which substantial equivalence is claimed, performed within specification." |
Missing Information:
- Specific quantitative acceptance criteria (e.g., specific flow rates, tidal volumes, pressure safety limits, etc.) are not detailed.
- The exact numerical performance metrics of the device against these specific criteria are not provided. The document only states that it "performed within specification" and met referenced standards.
The following questions cannot be answered from the provided text, as the document describes a regulatory submission based on non-clinical testing and substantial equivalence, not a clinical or performance study with a test set, ground truth, or human-in-the-loop assessments.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Information Not Provided: The document refers to "non-clinical test data" and compliance with standards, not a test set of data (e.g., patient cases) typically used in AI/diagnostic device performance studies.
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)
- Not Applicable/Information Not Provided: No test set of cases requiring expert ground truth is mentioned. The device is a resuscitator, not an imaging or diagnostic device that typically relies on expert interpretation of test data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Information Not Provided: No test set requiring expert adjudication is mentioned.
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/Information Not Provided: This device is an automatic/manually triggered resuscitator, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers assessing AI improvement is not relevant to this device's type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Partially Applicable/Information Not Explicit: The "non-clinical test data" would inherently be a standalone evaluation of the device's physical performance (e.g., flow, pressure, timing) without human intervention in its operation for assessment. However, this is not in the context of an "algorithm only" as understood for AI devices. The document implies the device's mechanical and pneumatic functions were tested in a standalone manner against specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Information Not Provided: "Ground truth" in the context of clinical/diagnostic AI studies is not relevant here. The "ground truth" for this device's performance would be the physical and functional specifications derived from engineering design and safety standards (like ISO 8382-1988). The document states testing verified performance against these specifications.
8. The sample size for the training set
- Not Applicable/Information Not Provided: There is no mention of a "training set" as this device is not an AI or machine learning product.
9. How the ground truth for the training set was established
- Not Applicable/Information Not Provided: There is no training set.
§ 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).