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The MetaNeb® 4 System is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.

The MetaNeb® 4 System is a therapeutic device that uses a systematic approach to enhance normal mucus clearance and resolve or prevent patchy atelectasis. The system has three modes: Aerosol, CHFO (Continuous High Frequency Oscillation), and CPEP (Continuous Positive Expiratory Pressure). There are three major components: Circuit, Controller, and Stand.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria, structured according to your request:

Device Name: MetaNeb® 4 System

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices, particularly the MetaNeb® (K124032), rather than establishing new, specific performance acceptance criteria for the MetaNeb® 4 System itself. The acceptance criteria are implicitly met by showing the MetaNeb® 4 System performs equivalently or better than the identified predicates in key performance parameters.

The key performance comparisons are related to peak pressure in different therapy modes.

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

• Performance Comparison (Peak Pressure): The sample size for the bench tests is not explicitly stated as a numerical value (i.e., 'n'). The testing involved comparing the MetaNeb® 4 System to the MetaNeb® (K124032), PowerNeb (K051964), and IPV (K895485). The data provenance is generally "bench testing" performed by the manufacturer (Hill-Rom Services Pte Ltd). It's a prospective study of the device's physical performance characteristics.
• Usability Study: The sample size is referred to as "2 user groups: caregivers and lay users." The specific number of participants within each group is not provided in this summary. The data provenance is a usability study conducted to evaluate the device's use in the home environment, likely a prospective study. The country of origin of the data is not specified.

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

This type of information is not applicable to this submission. The "ground truth" for the performance tests (peak pressure) is the physical measurement of the device's output, compared against its own specifications and the previously cleared predicate devices' performance. For the usability study, the "ground truth" is the observation of user performance, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable as it typically refers to methods for resolving discrepancies in expert interpretations (e.g., in medical image analysis). For bench testing, direct measurement and data collection are used. For the usability study, observations of user performance were recorded, often with predefined criteria for success/failure, but an adjudication method for conflicting expert opinions is not mentioned because experts (in the sense of adjudicators) are not setting the "ground truth."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The MetaNeb® 4 System is a therapeutic medical device (non-continuous ventilator), not an AI/CAD (Computer-Aided Detection/Diagnosis) system. Therefore, MRMC studies and AI-assisted improvements for human readers are not relevant.

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

This information is not applicable. The MetaNeb® 4 System is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• Performance Comparison (Peak Pressure): The ground truth is established through physical measurements and engineering specifications of the device's output in various modes, compared to the previously established performance of predicate devices. This falls under bench testing data.
• Usability Study: The ground truth is established through direct observation of user performance in conducting critical tasks with the device in a simulated environment. This is a form of empirical user performance data.

8. The Sample Size for the Training Set

This information is not applicable. Since this is a physical medical device (MetaNeb® 4 System) and its development involved engineering design and validation against performance specifications and predicate devices, there isn't a "training set" in the context of machine learning or AI.

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

This information is not applicable for the reasons stated above (not an AI/ML device). Engineering validation and design controls are used during device development, which are different from establishing ground truth for a "training set" in AI.

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