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The Hamilton Medical ARABELLA® NCPAP Masks (single patient use only) are intended for use with the Hamilton ARABELLA® infant nasal CPAP system which consists of (a.) the tubing and support set and (b.) the monitoring oxygen/air mixer. This system is intended to provide CPAP therapy with a nasal mask or nasal prongs in hospitals or other clinical settings to treat newborns and infants.

The ARABELLA® NCPAP Masks are single-patient use only infant nasal CPAP masks which can be used with the Hamilton ARABELLA tubing and support set (K945740) as an alternative to the NCPAP prongs. The tubing and support set has been designed to work with the ARABELLA Monitoring Oxygen/Air Mixer (K990293 and K960359). The items covered by K945740 and K990293/K960359 together form the Hamilton Medical ARABELLA infant NCPAP system.

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

The provided document is a 510(k) summary for the Hamilton Medical ARABELLA® NCPAP Masks. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing direct clinical effectiveness through a complex study with standalone performance metrics or controlled human reader studies.

Therefore, many of the requested criteria related to AI/algorithm performance, ground truth establishment with experts, MRMC studies, and detailed statistical power are not applicable or not explicitly provided in this type of regulatory document. The "acceptance criteria" here are primarily about demonstrating that the new device performs comparably to the predicate and meets its own stated specifications.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document states: "Among the information and data presented in the 510(k) submission to support the equivalency of the ARABELLA® NCPAP Masks to the predicate device are: (a.) device description, (b.) comparison to the legally marketed predicate device, (c.) human factors information, (d.) laboratory verification and validation testing of the device specifications, and (e.) comparison testing of NCPAP mask performance to NCPAP prong performance within the ARABELLA infant NCPAP system. The testing demonstrated compliance with the mask specifications and showed no difference in the performance, safety or effectiveness between the nasal masks and the nasal prongs."

This paragraph describes the "study" (or rather, a collection of tests and comparisons) that supports the claim of substantial equivalence. The primary mechanism for meeting "acceptance criteria" here is demonstrating substantial equivalence to a predicate device through these various tests and comparisons.

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

• Sample Size: Not explicitly stated for specific tests. The comparison table lists mask sizes (Small, Medium, Large) for the ARABELLA masks and corresponding sizes for the predicate, implying that tests were conducted across these sizes.
• Data Provenance: Not specified, but given the nature of laboratory verification and validation, it would be laboratory-generated data rather than patient data from a specific country. It is retrospective in the sense that the data was collected for the purpose of the 510(k) submission after device development.

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

• Not applicable/Not provided. This type of information is typically found in studies involving diagnostic accuracy or clinical interpretation. The evaluation here is for a medical device accessory's performance characteristics (e.g., dead space, pressure range, material biocompatibility) and functional equivalence, not for diagnostic accuracy where expert ground truth is critical. Biocompatibility testing was done at a "nationally recognized biological testing laboratory," implying expert oversight in that specific area.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. Adjudication methods (like 2+1, 3+1) are for determining ground truth in cases of disagreement among interpreters, which is not relevant for the type of device performance testing described.

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. This device is an infant nasal CPAP mask, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was performed.

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

• Not applicable. This device is a physical medical device accessory, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on the specifications of the device, established engineering principles, and comparison to the predicate device's known performance.
  • For performance metrics (e.g., dead space, treatment range), the "ground truth" would be measurements obtained through laboratory testing according to validated methods.
  • For biocompatibility, the ground truth would be established through adherence to biocompatibility testing standards at a specialized laboratory.
  • For functional equivalence, the ground truth is the performance and characteristics of the legally marketed predicate device.

8. The Sample Size for the Training Set

• Not applicable/Not provided. This refers to machine learning models. This document describes a physical medical device accessory. Design and testing would involve prototypes and production samples, not a "training set" in the AI sense.

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

• Not applicable. As above, there is no "training set" in the machine learning context for this device.

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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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The SensorMedics Infant Flow Nasal CPAP Mask is intended for use with the SensorMedics Infant Flow System, consisting of a Driver and NCPAP Generator. It is intended to provide CPAP with a nasal mask for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.

The SensorMedics Infant Flow Nasal CPAP Mask is a silicone mask that fits into the generator of the Infant Flow System in place of the standard nasal prongs.

The provided text refers to a 510(k) premarket notification for the "Infant Flow Nasal CPAP Masks." This is a medical device submission seeking clearance based on substantial equivalence to predicate devices, rather than a de novo submission requiring extensive clinical trials to prove efficacy. Therefore, much of the requested information (like acceptance criteria, specific device performance metrics, large-scale clinical study details, MRMC studies, ground truth establishment for training, etc.) is not present in the provided document.

Here's an analysis based on the available information:

Key Takeaway: The submission leverages the existing clearances of similar CPAP systems and states that no additional clinical tests were performed because the mask's function is the same as the already cleared prongs in the Infant Flow System, with only differences in facial mounting and labeling. The core argument for equivalency relies on non-clinical testing demonstrating no differences in safety or effectiveness when using the mask compared to the prongs.

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria or detailed performance metrics are provided in the document. The basis for clearance is substantial equivalence, primarily supported by the argument that the mask functions identically to already cleared components within the same system.

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

• Sample Size: Not applicable in the context of a clinical test set as described in the prompt. The document explicitly states: "Because there are no differences other than facial mounting and labeling between the SensorMedics Infant Flow System prongs and the SensorMedics Infant Flow Mask, no additional clinical tests were performed or submitted in the premarket notification."
• Data Provenance: The "non-clinical testing" mentioned is not detailed, so its provenance (country of origin, retrospective/prospective) is unknown. It's likely internal lab testing.

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

• Not applicable. No clinical test set with ground truth established by experts is described for this specific device (the mask). The determination of safety and effectiveness relied on "non-clinical testing" and a claim of functional equivalence to previously cleared devices/components.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring expert adjudication is described for this device.

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. This device is a nasal CPAP mask, not an AI diagnostic or assistive technology for human readers. No MRMC study was conducted or is relevant.

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

• Not applicable. This device is a physical medical device (mask), not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Not applicable for this specific device's clearance. The "ground truth" for the clearance of the mask was the established safety and effectiveness of the predicate devices and the existing prongs within the Infant Flow System, as determined by previous FDA clearances (K962848, K974303, K960359, K945740). The current submission relies on non-clinical testing to demonstrate the mask's equivalence to those established components.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical device, not an AI system that requires a training set.

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

• Not applicable. As above, no training set for an AI system is involved.

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