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The SensorMedics SiPAP Infant Nasal CPAP Circuit, consisting of a pressure generator, Nasal CPAP Prongs and Masks, is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.

Detailed description of the device circuit is contained in the SiPAP Infant Nasal CPAP Operator's Instructions.

This document describes a 510(k) submission for the SiPAP Infant Nasal CPAP Circuit. The submission claims substantial equivalence to previously cleared devices.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document explicitly states: "no additional clinical or non-clinical tests were performed or submitted in the premarket notification." This means there was no new test set for this specific 510(k) submission. The evaluation relies on data from the predicate devices.
• Data Provenance: The data provenance is from the studies conducted for the predicate devices (K960359, K945740, K974303, K984254, and K991972). The document instructs to "Refer to 510(k) numbers s K960359 and K945740 for this data," implying that the original testing for those devices established the safety and effectiveness. The nature of these original studies (retrospective or prospective, country of origin) is not detailed in this document.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. Since no new clinical or non-clinical tests were conducted for this submission, there was no new test set requiring new ground truth establishment or expert involvement for this specific 510(k) submission. The original predicate device studies would have had such experts, but their details are not provided here.

4. Adjudication Method for the Test Set

• Not Applicable. As no new test set was used, no new adjudication method was employed for this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. A MRMC comparative effectiveness study was not conducted for this 510(k) submission. The basis for clearance is substantial equivalence, not a new comparative effectiveness trial demonstrating improvement with or without AI assistance (which is not relevant for this device type).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No. This device is a mechanical CPAP circuit, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.

7. Type of Ground Truth Used

• The implicit "ground truth" for the substantial equivalence claim comes from the established safety and effectiveness of the predicate devices. This would have been based on performance data and potentially clinical outcomes from the studies supporting the original predicate device clearances. The specific type of ground truth (e.g., direct patient outcomes, expert clinical assessment of device function, etc.) from those prior studies is not detailed in this document.

8. Sample Size for the Training Set

• Not Applicable. This device is a mechanical medical device, not an AI/ML algorithm that requires a training set.

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

• Not Applicable. As there is no training set for this type of device, ground truth establishment for a training set is not relevant.

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