(69 days)
The LifeBorne Infant Resuscitator is intended to provide the basic equipment required for pulmonary resuscitation of neonatal infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the neonatal infant.
The resuscitation system provides the basic equipment required for pulmonary resuscitation of neonatal infants. The LifeBorne Infant Resuscitator is a gas powered emergency resuscitation system. It is intended to be used inside the hospital by trained medical professionals to provide precise FIO2 delivery, manual ventilation, and emergency airway clearance as established by resuscitation guidelines to neonates and infants weighing less than 10 kg (22 lb).
Here's a breakdown of the acceptance criteria and study information for the LifeBorne Infant Resuscitator, based on the provided text:
Acceptance Criteria and Device Performance
| TEST | TEST REQUIREMENTS (Acceptance Criteria) | REPORTED DEVICE PERFORMANCE |
|---|---|---|
| Valve Function after Vomitus | The proper function of the circuit shall be verified within 20 seconds of becoming disabled by vomitus. Function is verified by verifying flow valve accuracy. | Passed. |
| Inspiratory Resistance | Pressure generated at the patient connection port during expiration should not exceed -5 cmH2O with inspiratory airflow set to 6 L/min. | Passed. |
| Expiratory Resistance | Pressure generated at the patient connection port during expiration should not exceed 5 cmH2O with expiratory airflow set to 6 L/min. | Passed. |
| Dead Space | The deadspace volume of the T-Piece circuit should be less than 7 mL. | Passed. |
| FIO2 accuracy | The proper function of the FIO2 adjustment knob shall be verified by comparing the FIO2 setting value with the output oxygen concentration. Values shall be within 5%. | Passed. |
| Primary and Secondary Flow Valve - Peak Flow | The proper function of the primary and secondary flow valves shall be verified by comparing the flow setting with the actual measured output flow. | Passed. |
| Airway Manometer Accuracy | The proper function of the airway manometer shall be verified by comparing the pressure readings with the actual measured output pressure. | Passed. |
| VOC Testing | The device should not add volatile organic compounds (VOCs) to the output gas delivered to the patient. | Passed. |
| Particulate Analysis | The output of particulate matter sizes 2.5 microns or less are no more than 12 micrograms/cubic meter of air at one atmospheric pressure. | Passed. |
Study Details
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a separate "test set" sample size. The document refers to "bench testing" as the method for performance evaluation. The tests themselves are functional evaluations of the device's components and overall system.
- Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory or simulated environment. The country of origin of the data is not specified, but the submission is from International Biomedical, located in Austin, TX, U.S.A. It is retrospective in the sense that the testing was completed before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device's performance was evaluated through bench testing against predefined technical specifications, not by expert interpretation of data. Therefore, no experts were used to establish ground truth in this context.
4. Adjudication method for the test set:
- Not applicable. As described above, the evaluation was based on meeting objective technical requirements through bench testing, not on human interpretation requiring adjudication.
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 medical device (resuscitator) that does not involve "human readers" interpreting medical cases or utilizing AI. Its effectiveness is determined by its mechanical and functional performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a way. The device itself operates "standalone" in performing its functions (e.g., delivering precise FIO2, controlling PIP/PEEP). The "bench testing" represents the performance of the algorithm/device without human intervention during the test itself (though humans operate the test setup). There is no "algorithm" in the sense of AI or image analysis involved.
7. The type of ground truth used:
- The ground truth for the device's performance was based on predefined technical specifications and engineering standards. Each test had a specific, measurable requirement (e.g., FIO2 within 5%, dead space less than 7 mL) which served as the objective ground truth against which the device's performance was measured.
8. The sample size for the training set:
- Not applicable. This device is a mechanical/electronic system, not one that uses machine learning or AI that would require a "training set" of data.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 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).