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Ambu® Mark IV Baby Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support. Ambu® Mark IV Baby Resuscitator is intended for infants and children with a body weight up to 44 lbs (20 kg), approx. 4-5 years of age. Ambu® Mark IV Baby Resuscitator is a reusable resuscitator.

Ambu® Mark IV Baby Resuscitator should only be used by persons trained in resuscitation. Ambu Mark IV Baby Resuscitator is used for manual pulmonary resuscitation and emergency respiratory support of neonates, infants and children up to 44 lbs (20 kg), approx. 4-5 years of age. Ambu® Mark IV Baby Resuscitator is a reusable device. The product can be cleaned after use according to the description in the direction for use. The product consists of a self inflating double walled resuscitator bag, with a self expanding inner bag and a non inflating walled outer cover. The outer cover has an airtight connection with the neck of the inner bag supported by the connector in one end. At the opposite end of the bag the outer cover has an airtight connection with the inlet valve housing. The Inlet Valve allows ambient air or supplementary oxygen to flow into the bag and prevents air flowing backwards from the bag through the inlet valve. An oxygen tube reservoir can be mounted to the Ambu® Mark IV Baby Resuscitator. The patient valve is attached to the bag by a turn able airtight patient connection. The patient valve directs the ventilation air through the patient airway and directs the patient expiration air through the expiration connector. A pressure-limiting valve (40 cm H₂O) with an override mechanism is placed in the patient valve housing. The manometer port in patient valve housing enables connection to a manometer. If a manometer is not attached the manometer port is closed with a cap. The patient- and expiration connectors are standard connectors to avoid unsuitable connections with other devices. The patient connector, patient valve housing and inlet valve housing is made of hard plastic. The self inflating bag is made of silicone rubber that can be squeezed by hand and returns to normal state when the hand is released. Ambu® Mark IV Baby Resuscitator has a 300 ml stroke volume.

The Ambu® Mark IV Baby Resuscitator is a manual emergency ventilator intended for manual pulmonary resuscitation and emergency respiratory support for neonates, infants, and children up to 20 kg (approximately 4-5 years of age). It is a reusable device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list specific numerical acceptance criteria (e.g., specific force, flow rates, or pressure ranges) for the device's performance. Instead, it states that the non-clinical tests were performed to ensure the product "meets the recognized consensus standards for manual product resuscitation" and has "equivalent functionality as the predicate devices."

Therefore, the acceptance criteria are implicitly tied to meeting the performance characteristics of the predicate devices and relevant consensus standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of clinical data for performance assessment. The studies conducted were non-clinical laboratory tests. Therefore, information regarding sample size for a test set of human subjects or patient data provenance is not applicable as no clinical tests were performed.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Since no clinical studies were performed and the evaluation was based on non-clinical laboratory tests and comparison to predicate devices, there were no experts used to establish ground truth in the typical sense of interpreting clinical data or images. The "ground truth" for compliance was defined by engineering specifications, recognized consensus standards for medical devices, and the established performance of legally marketed predicate devices.

4. Adjudication Method

There was no adjudication method described as there were no clinical studies or human-interpreted data that would require such a process. The evaluation was based on objective laboratory measurements and comparison to established device characteristics and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical medical device (manual ventilator), not an AI algorithm or diagnostic tool that would typically be evaluated with MRMC studies involving human readers. The regulatory submission explicitly states, "No clinical tests are performed."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This question is not applicable as the device is a mechanical medical device, not an algorithm or software. The "standalone" performance refers to the device's inherent mechanical and functional performance as assessed through laboratory testing, rather than an algorithm's performance.

7. The Type of Ground Truth Used

The ground truth used for evaluating the Ambu® Mark IV Baby Resuscitator was based on:

• Engineering Specifications and Design Requirements: The device was designed to meet specific technical parameters (e.g., 300 ml stroke volume, 40 cm H₂O pressure-limiting valve).
• Recognized Consensus Standards: Non-clinical laboratory tests ensured the product met these established safety and performance standards for manual resuscitation devices.
• Predicate Device Performance: The primary "ground truth" for equivalence was the established functional and technological characteristics of the legally marketed predicate devices. The new device's characteristics were shown to be "identical" to these predicates.

8. The Sample Size for the Training Set

There is no training set in the context of machine learning or AI as the device is a mechanical medical device. The term "training set" is not applicable here.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

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