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• Pulmonary resuscitation during respiratory and/or cardiac arrest.
• Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.

The EMT 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® II 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 describes a 510(k) submission for the EMT Resuscitator, claiming substantial equivalence to the Genesis® II A/C device (K932170). The documentation focuses on non-clinical performance data and does not contain details about a clinical study with human patients, nor does it include information about AI integration or expert review for ground truth.

Here's an analysis of the provided information relative to your request:

1. A table of acceptance criteria and the reported device performance

Explanation: The documentation indicates that the device's performance was compared against thepredicate device and relevant standards (ISO 8382-1988). The conclusion states that the EMT Resuscitator performs "within specification" when compared to the predicate device. However, specific numerical performance metrics, thresholds, or "acceptance criteria" are not detailed in this section of the 510(k) summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable. The submission incorporated "significant amount of non-clinical test data." This suggests bench testing or simulated environments, not a test set derived from a patient population.
• Data Provenance: Not applicable. As it's non-clinical test data, there's no country of origin or retrospective/prospective classification in the sense of patient data. The manufacturer is O-Two Systems International Inc. from Canada.

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. The study is non-clinical performance testing against specifications and standards, not a study requiring expert-established ground truth on medical conditions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There is no mention of a human-adjudicated test set.

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. This is a 510(k) submission for a medical device (resuscitator), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is a mechanical resuscitator, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. The "ground truth" for this device's performance is its adherence to engineering specifications and international standards (like ISO 8382-1988) as demonstrated through non-clinical testing.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

• Not applicable. No training set is mentioned.

Summary of Device Performance Study:

The provided information describes a substantial equivalence claim for the EMT Resuscitator. The study to support this claim consisted of non-clinical test data that reviewed the device's performance against both domestic and international standards (specifically referencing ISO 8382-1988) and compared it to the legally marketed predicate device, Genesis® II A/C. The conclusion states that the EMT Resuscitator performed "within specification" when compared to the predicate device. This type of submission relies on demonstrating that the new device has "similar technological characteristics" and performs comparably to a device already on the market, primarily through bench testing and adherence to recognized standards, rather than clinical trials with human subjects or AI-specific validation.

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