(134 days)
PowerNeb® 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 PowerNeb is a pneumatic, single-patient use device used to enhance secretion clearance, deliver aerosol, and recruit lung volumes. PowerNeb uses a fixed venture against a user-set orifice to create a continuous high frequency oscillation (CHFO) waveform at 180-220 breaths per minute (BPM). The PowerNeb can also deliver a continuous expiratory pressure (CPEP) when switched to CPEP mode. This device is pneumatic in operation and does not incorporate any electronic parts or software. This device is non-sterile, and is not intended to be sterilized by the user. The PowerNeb is packaged with a a small-volume nebulizer/mouthpiece, and a disposable manometer, each of which has been previously 510k cleared.
Here's an analysis of the provided text regarding the PowerNebTM device, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary for a medical device seeking clearance based on substantial equivalence. This type of submission typically does not include detailed clinical study results or acceptance criteria in the same way a PMA (Pre-Market Approval) or a full clinical trial publication would. The focus here is on demonstrating that the new device is as safe and effective as existing legally marketed predicate devices. Therefore, direct "acceptance criteria" and "study proving device meets acceptance criteria" as might be found in a clinical trial report are not explicitly stated in this document.
The "Performance Testing" mentioned is comparative testing against predicate devices and particle size testing for the nebulizer component, not a full-scale clinical trial with predefined end-point acceptance criteria in the traditional sense.
Acceptance Criteria and Device Performance
Since explicit acceptance criteria for a "study proving the device meets the acceptance criteria" are not detailed in this 510(k) summary, the table below will instead reflect the comparative features to predicate devices, which serve as the implicit "acceptance" for substantial equivalence. The "Acceptance Criteria" column will list critical features where the proposed device is expected to be comparable or equivalent to its predicates. The "Reported Device Performance" will detail how the PowerNeb® aligns with these features.
| Acceptance Criteria (Derived from Predicate Device Comparison) | Reported Device Performance (PowerNeb® Features) |
|---|---|
| Indications for Use: | |
| • Mobilization of endobronchial secretions | |
| • Lung expansion therapy | |
| • Treatment and prevention of atelectasis | • Mobilization of endobronchial secretions |
| • Lung expansion therapy | |
| • Treatment and prevention of atelectasis | |
| • Also has the ability to provide supplemental oxygen when used with compressed oxygen. | |
| Creates Positive Expiratory Pressure | Creates a positive expiratory pressure |
| Increases Patient Functional Residual Capacity (FRC) | Increases patient Functional Residual Capacity (FRC) |
| Creates Positive Inspiratory Pressure | Creates a positive inspiratory pressure |
| Percussive Mode Peak Pressures | Selector ring adjustable in percussive mode (CHFO™) to provide peak pressures ≤ 30 cmH2O. |
| Static Flow Mode Airway Pressures | Provides a clinician controlled flow in static flow mode (CPEP™) for positive airway pressures of 0-20 cmH2O. |
| Nebulization Feature | Nebulization is standard feature. |
| Ability to provide Percussive or Static Lung Inflation | Can provide a percussive or static lung inflation component. |
| Percussive Frequency Rate | Percussive frequency rate pre-set at 100 - 300 bpm. |
| Interface Circuit Type | Disposable, single-patient use interface circuit. |
Study Details (Based on the 510(k) Summary)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Size: Not specified. The document mentions "comparative testing against the predicate devices" and "testing of particle sizes from the small-volume nebulizer," but does not provide details on the number of devices tested or the specific test protocols.
- Data Provenance: Not specified. It's likely these were internal laboratory or bench tests conducted by the manufacturer, Comedica, Inc. (Dallas, TX, USA). The document does not indicate the country of origin of data or whether it was retrospective or prospective.
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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):
- Not applicable. This was a 510(k) submission for a noncontinuous ventilator, not an imaging or diagnostic device requiring expert interpretation for ground truth. Performance would be assessed through objective measurements against engineering specifications and predicate device performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. This document describes performance testing of a mechanical device.
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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 device is a noncontinuous ventilator and does not involve "human readers" or "AI assistance" in the context of diagnostic interpretation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in the sense that the device's performance was assessed independently. The document states, "Performance testing includes comparative testing against the predicate devices, as well as testing of particle sizes from the small-volume nebulizer both with and without the PowerNeb, to determine any effects of the PowerNeb on the nebulizer's performance." This implies bench testing of the device's functional attributes. The device itself is described as "pneumatic in operation and does not incorporate any electronic parts or software," so there is no "algorithm" in the modern AI sense.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For this type of device, "ground truth" would be established by:
- Objective engineering measurements: Such as pressure measurements (cmH2O), flow rates, frequency (bpm), and particle size distribution for nebulization.
- Comparison to predicate device specifications/performance: Demonstrating that the PowerNeb® operates within expected parameters analogous to the legally marketed predicate devices.
- For this type of device, "ground truth" would be established by:
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The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).