Search Results

The Maximus™ System provides features of both the Synclara™ System and the Volara™ System.

The Maximus™ System, when used as a Synclara™ Cough System is intended for use on patients who are unable to cough or clear secretions effectively due to reduced peak cough expiratory flow or respiratory muscle weakness.

The Maximus™ System, when used as a Volara™ System is intended for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with oxygen supply.

The Maximus™ System is a 2 in 1 device which combines 2 main types of therapies referred to as:

• MIE (Mechanical Insufflation-Exsufflation) Synclara®
• OLE (Oscillation and Lung Expansion) - Volara™

The modification is to add the ability to provide aerosol from the nebulizer via the Ventilator Tee adaptor during Continuous High Frequency Oscillations (CHFO) mode when connected to a ventilator. All components were cleared under K192143.

The provided text describes a 510(k) premarket notification for the Maximus™ System, a noncontinuous ventilator. The submission is for a modification to an already cleared device (K192143) to add the ability to provide aerosol from the nebulizer via a Ventilator Tee adapter during Continuous High Frequency Oscillations (CHFO) mode when connected to a ventilator.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparative testing conducted, aiming to demonstrate equivalence to the predicate device. The performance metrics reported are related to aerosol delivery, specifically Mass Median Aerodynamic Diameter (MMAD), Total Respirable Dose, and Fine Particle. The acceptance criteria for these metrics were that they should be "equivalent" across different patient interfaces.

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

• Sample Size for Test Set: Not explicitly stated as a number of devices or clinical cases. The testing was described as "comparative particle characterization testing comparing the following patient interfaces: Mouthpiece, Face Mask (already cleared under K192143) and delivery through the already cleared Ventilator Tee Adaptor." It was performed at "Adult flow rates (28 Lpm) and Pediatric flow rates (12 Lpm) with 1 drug at the lowest and highest set pressures (5 and 70 cmH2O)." This indicates bench testing rather than patient data.
• Data Provenance: The data is from bench testing performed by the manufacturer, Hill-Rom Services Pte Ltd. There is no mention of country of origin for the data or if it was retrospective or prospective, as it is not human subject data.

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

Not applicable. The ground truth for this submission is based on objective measurements from bench testing of aerosol delivery parameters, not expert human assessment.

4. Adjudication Method for the Test Set

Not applicable, as the evaluation is based on objective measurements from bench testing.

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

No. This submission describes a modification to a medical device (ventilator) and involves bench testing of its physical performance (aerosol delivery), not a diagnostic algorithm or human interpretation task. Therefore, an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study

No. This is a physical device, and the testing focuses on its mechanical and delivery performance. There is no AI or algorithm involved in the direct clinical function being evaluated.

7. Type of Ground Truth Used

The ground truth is established through objective physical measurements of aerosol particle characteristics (MMAD, Total Respirable Dose, Fine Particle) using standardized test methods.

8. Sample Size for the Training Set

Not applicable. This device does not involve a machine learning 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 a machine learning algorithm, there is no ground truth to establish for it.

Ask a specific question about this device

The Maximus™ System provides features of both the Synclara™ System and the Volara™ System.

The Maximus™ System, when used as a Synclara™ Cough System is intended for use on patients who are unable to cough or clear secretions effectively due to reduced peak cough expiratory flow or respiratory muscle weakness.

The Maximus™ System, when used as a Volara™ System is intended for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with oxygen supply.

The Maximus™ System is a 2 in 1 device which is a combination of two (2) already cleared devices. The Maximus™ System provides the individual therapies of the predicates: Vital Cough and MetaNeb®. The Maximus™ can be programmed to allow the user to provide both therapies or one only. The 2 main types of therapies are referred to as:

• . MIE (Mechanical Insufflation-Exsufflation)
• OLE (Oscillation and Lung Expansion) ●

The provided text is a 510(k) premarket notification for the Maximus™ System, a medical device for respiratory therapy. It outlines the device's indications for use and compares it to predicate devices to establish substantial equivalence with respect to safety and effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a formal "acceptance criteria" table with numerical targets, as is common for diagnostic accuracy studies. Instead, it argues for substantial equivalence to predicate devices. This means the primary acceptance criterion is that the Maximus™ System performs functionally and safely similar to its predicates (MetaNeb® and Vital Cough) and does not raise new or different questions of safety or effectiveness.

The comparison tables (Table 1, Table 2, Table 3 – although some are presented partially) serve as the 'reported device performance' against the implicit acceptance criterion of equivalence to the predicates.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes bench testing and comparative performance testing against predicate devices and reference devices. It does not refer to clinical studies with patient test sets in the context of diagnostic accuracy. Therefore, details regarding "sample size for the test set" or "data provenance (country of origin, retrospective/prospective)" for patient data are not applicable to this 510(k) submission, which focuses on substantial equivalence based on performance and safety characteristics compared to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. As this is a medical device submitting for substantial equivalence based on engineering and performance criteria rather than diagnostic accuracy with a ground truth established by experts, this type of detail is not expected or relevant in this context. The "ground truth" here is the established safe and effective operation of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no human adjudication of a "test set" in the context of diagnostic performance as described in the document.

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. The Maximus™ System is a therapeutic device (noncontinuous ventilator), not a diagnostic AI system that "assists human readers." Therefore, an MRMC comparative effectiveness study is not relevant to this submission.

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

Not applicable. The Maximus™ System is a physical electro-mechanical device that delivers therapy, not a standalone algorithm.

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

The "ground truth" in this 510(k) submission for substantial equivalence is the established safe and effective performance of the predicate devices (Hill-Rom MetaNeb® and Vital Cough), as well as reference devices (Bird IPV and Philips Respironics Cough Assist T70) for specific performance parameters. The device's performance is compared against these established benchmarks through various bench tests.

8. The sample size for the training set

Not applicable. The document describes a physical medical device, not a machine learning model that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no machine learning model or "training set," this question is not relevant.

Ask a specific question about this device