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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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The MetaNeb® 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® 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 MetaNeb® System (K124032) based on the provided 510(k) summary, structured to address your specific points:

Since this is a 510(k) submission for a non-continuous ventilator, the "acceptance criteria" are primarily established by demonstrating substantial equivalence to predicate devices, rather than meeting specific quantifiable performance targets like sensitivity or specificity for an AI device. The study performed is a "comparative effectiveness study" in the sense of comparing the new device's performance to the predicate devices through various bench tests.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MetaNeb® System are implicitly derived from demonstrating substantial equivalence to its predicate devices (PowerNeb® CoMedica K051964 and IPV - Percussionaire Corp K895485). This means the device must perform comparably in its intended use, safety, and effectiveness.

Table 1: Acceptance Criteria (as demonstrated by substantial equivalence to predicates) and Reported Device Performance

Study Details Proving Acceptance Criteria:

The submission relies on a series of non-clinical bench tests to demonstrate substantial equivalence, rather than human clinical trials.

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a "sample size" in the context of patients. The "test set" consists of mechanical/bench testing of the device and its components. The specific number of devices or components tested for each experiment (e.g., how many circuits were tested for particulate characterization, or how many full systems for life cycle testing) is not detailed.
   • Data Provenance: Retrospective, as it involves laboratory testing conducted by the manufacturer to support the 510(k) submission. Country of origin for the data is assumed to be Singapore where Hill-Rom Services Pte Ltd is located, or at a contracted testing facility.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. For a device performance bench test comparing against predicate devices, "ground truth" is established by validated testing methodologies and standards (e.g., aerosol particle sizing, pressure measurements) and comparison against the specifications/performance of legally marketed predicate devices. It doesn't involve expert consensus on medical images or clinical outcomes. The experts involved would be engineers and technical specialists conducting and analyzing the tests.

3. Adjudication method for the test set:

   • Not Applicable. As this is bench testing for substantial equivalence, clinical adjudication by medical experts isn't part of the process. Test results are compared directly against established engineering parameters, predicate device specifications, and relevant standards (e.g., ISO 10993-1).

4. 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 not an AI-powered diagnostic device, so a MRMC study is not relevant or applicable.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, in essence. The "standalone performance" is represented by the non-clinical bench testing where the device's technical specifications and performance characteristics (e.g., pressure output, aerosol particle size, frequency of oscillation) are measured directly and compared against the established performance ranges of the predicate devices under controlled laboratory conditions, without human interaction beyond initiating the test.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Technical Specifications and Predicate Device Performance. The "ground truth" for this submission is based on:
     • Validated engineering and physics principles (e.g., how pressure is measured, how aerosol particles are characterized).
     • Internationally recognized standards (e.g., ISO 10993-1 for biocompatibility).
     • The established and cleared performance characteristics of the legally marketed predicate devices.

7. The sample size for the training set:

   • Not Applicable. This is a hardware medical device, not an AI/machine learning algorithm requiring a "training set."

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no training set for an AI algorithm. The device's design and engineering are based on established pneumatic principles and medical needs for respiratory therapy.

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