(112 days)
The DeVilbiss IntelliPAP/SleepCube Model DV57 Series Auto Bilevel is intended for use in treating OSA in spontaneously breathing patients 30 Kg and above by means of application of positive air pressure. The Device is to be used in home and clinical environments.
The role of the product from a patient's point of view is to provide a continuous source of bilevel positive airway pressure for the treatment of sleep apnea. Positive airway pressure is applied to the oropharynx to act as a pneumatic splint to prevent the collapse of the pharyngeal muscle, which occludes the patient airway during sleep. Auto Bilevel units are used over conventional CPAP units due to high pressures and/or patient intolerance to continuous pressure, making exhalation difficult.
The proposed DeVilbiss DV57 Auto Bilevel product is an addition to the sleep product line. The proposed Auto Bilevel device combines the functions of traditional (predicate) Bilevel and (predicate) Auto Adjust CPAP to provide bilevel pressure support therapy that responds to detected events and adjusts the IPAP pressure setting as the patient demand requires. The level of pressure support, difference between IPAP and EPAP is maintained at a level prescribed by a doctor.
Automatic and manual inhale/exhale trigger sensitivity is to be provided to allow the clinician to customize trigger parameters for specific operating conditions. The DeVilbiss Intellipap/SleepCube Auto Bilevel product is not intended to meet the needs for the "ventilator" market, which necessitates features such as alarms, higher operating pressures and other ventilator specific functions
Here's an analysis of the provided text regarding the acceptance criteria and study for the DeVilbiss Intellipap/SleepCube Auto Bilevel device:
Important Note: The provided document is a 510(k) Summary, which is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device. It typically focuses on design, function, and performance comparisons to predicates rather than presenting detailed, comprehensive clinical study results for novel acceptance criteria. Therefore, much of the requested information (like specific effect sizes from MRMC studies, detailed training set information with ground truth establishment, or specific sample sizes for tests) is not explicitly present in this type of document.
Acceptance Criteria and Reported Device Performance
The document doesn't provide a table of precise, quantifiable acceptance criteria with corresponding performance metrics like you might find for a novel device. Instead, it relies on demonstrating substantial equivalence to predicate devices. The acceptance is implicitly tied to meeting the performance characteristics and safety profiles of the already-cleared predicate devices.
Implicit Acceptance Criteria and Reported Performance (derived from the text):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use Equivalence | Device has the "same intended use" as predicate. Intended to treat OSA in spontaneously breathing patients 30 Kg and above in home and clinical environments. |
| Operating Principle Equivalence | Uses the "same operating principle" (bilevel positive airway pressure, responding to detected events, adjusting IPAP while maintaining pressure support). |
| Bilevel Modes and Settings Equivalence | Incorporates the "same basic Bilevel modes and settings" as predicate. |
| Material Equivalence | Incorporates "similar materials" as predicate. |
| Safety and Effectiveness Equivalence | "Analysis of comparison of design, function and features...together with the results of testing demonstrates the device to be substantially equivalent to the predicate devices in terms of meeting performance criteria and functioning as intended." |
| Standard Compliance (Non-Clinical) | "Tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols." Met "required performance criteria and functioned as intended." |
| Software Compliance (if applicable) | Tested according to FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). |
| Regulatory Framework (Non-Continuous Ventilator) | Classified as a Class II device under 21 CFR 868.5905 Noncontinuous Ventilator (IPPB). |
| Human Trigger Sensitivity | Automatic and manual inhale/exhale trigger sensitivity provided to allow clinician customization. |
Study Details
The document describes non-clinical testing rather than a clinical study with human patients comparing the device's diagnostic or therapeutic efficacy against a gold standard or human readers.
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The testing described is non-clinical (bench testing) against standards and performance characteristics of predicate devices.
- Data Provenance: Not applicable as it's non-clinical testing. It's likely internal laboratory testing data from DeVilbiss Healthcare LLC.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) summary for a CPAP-like device. Ground truth for performance would be based on engineering specifications and adherence to standards, which typically do not involve expert medical readers for establishing the truth, but rather engineers and quality control personnel for verification.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is non-clinical testing against engineering specifications and standards.
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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 MRMC study described. This device is a therapeutic device (CPAP-like) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, this type of study is not relevant to its clearance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone performance testing was done in the sense that the device's operational performance was tested independently against engineering specifications and standards. The device itself operates autonomously to deliver therapy based on pre-programmed algorithms for auto-adjustment and bilevel pressure delivery. However, this is not "standalone algorithm performance" in the context of an AI diagnostic that might be compared to human performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing, the "ground truth" would be the established engineering specifications, regulatory standards (ISO, ASTM, IEC), and the known performance characteristics of the predicate devices. Essentially, the device was required to perform according to its design and functional requirements, which were verified against these benchmarks.
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The sample size for the training set:
- Not applicable. This device is not an AI/ML device that requires a "training set" in the context of machine learning model development. Its algorithms are likely rule-based or control-loop-based, developed through engineering design and testing, not by training on large datasets in the way an image recognition algorithm would be.
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How the ground truth for the training set was established:
- Not applicable. (See point 7).
In Summary:
The K112220 510(k) submission for the DeVilbiss Intellipap/SleepCube Auto Bilevel focuses on demonstrating substantial equivalence to existing predicate devices (Resmed VPAP Auto - K082605, DeVilbiss Intellipap Bilevel S - K091919, DeVilbiss IntelliPAP Auto Adjust - K071689). The "acceptance criteria" are intrinsically linked to meeting the performance, safety, and functional characteristics of these predicates, as well as adherence to relevant industry standards. The testing described is primarily non-clinical bench testing to verify these characteristics, not clinical studies involving patient populations, expert readers, or AI algorithm training.
§ 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).