(90 days)
The DeVilbiss IntelliPAP/SleepCube Model DV55 S Series 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. Bilevel units are used over conventional CPAP units due to high pressures and/or patient intolerance to continuous pressure, making exhalation difficult. The DeVilbiss Bilevel S product will replace the 9055D in the sleep product line as well as provide a new product offering. The product will have a reduced manufactured cost, primarily derived from reduced material costs and improved engineering design associated with the existing Intellipan/SleepCube product platform. The market has dictated a need for lower cost and smaller sized bilevel units as well as improved functionality such as manually adjustable inhale/exhale triggering sensitivity. The triggering sensitivity overall must be increased as much as possible to be competitive with other bilevel devices currently available. 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 Bilevel S 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
The provided text describes the DeVilbiss Intellipap/SleepCube Model DV55 S Series CPAP and its regulatory submission. However, it does not contain information about acceptance criteria, device performance, a specific study proving the device meets acceptance criteria, or any of the detailed metrics requested in your prompt.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed performance study with acceptance criteria and results for the new device itself.
Here's what can be extracted and what is explicitly missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Missing. The document states that "This device has been tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols." and "The DeVilbiss Bilevel S/ST met the required performance criteria and functioned as intended." However, it does not provide a table outlining specific numerical acceptance criteria (e.g., pressure accuracy, trigger sensitivity thresholds) or the measured performance values of the device against those criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Missing. No information on sample size or data provenance for any specific test set is provided. It mentions testing "according to guidance" and "applicable voluntary standards" but not details of the tests themselves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Missing. This type of information is generally relevant for studies involving human interpretation (e.g., image analysis, clinical diagnosis), which is not detailed here. The testing described is primarily non-clinical/engineering.
4. Adjudication Method for the Test Set:
- Missing. Not applicable given the lack of detail on the test set and ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- Missing. An MRMC study involves human readers, and no such study is described. The document focuses on the device's technical characteristics and comparison to predicate devices, not human-in-the-loop performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially Addressed (implied, but without specifics): The document implies standalone (non-clinical/engineering) testing was done. It states: "This device has been tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols." and "The DeVilbiss Bilevel S/ST met the required performance criteria and functioned as intended." This refers to the device's inherent performance. However, there are no specific performance metrics or studies detailed.
7. The type of ground truth used:
- Implied (Engineering Standards): For the non-clinical testing mentioned, the "ground truth" would be the specifications and requirements defined by the referenced ISO, ASTM, IEC standards, and other applicable regulatory guidance. No specific "ground truth" like pathology or outcomes data is relevant or mentioned.
8. The Sample Size for the Training Set:
- Not Applicable / Missing: This device is a CPAP machine, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "development" would involve engineering design and validation, not model training.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable / Missing: As above, this concept doesn't apply to this type of medical device submission.
In summary, the provided document is a regulatory filing focused on establishing substantial equivalence for a medical device (a CPAP machine). It confirms that testing was performed according to standards and that the device met required performance criteria, but it does not provide the granular detail about specific acceptance criteria, test results, study methodology, or sample sizes for performance evaluation that your questions request. To obtain that information, one would typically need access to the full test reports or design validation documentation, which are not part of this publicly available 510(k) summary.
§ 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).