(245 days)
The Sunset Heated CPAP Tube is a heated wire breathing tube intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. It is indicated for single-patient reuse in the home and in clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities. It may be used with non-invasive ventilation for adult patients. It is compatible with the Philips Respironics System One Heated Humidifier and Philips Respironics Dreamstation Heated Humidifier.
The Sunset Heated CPAP Tube warms air, or breathable gas, as it travels to and from the respiratory patient along the breathing circuit of a respiratory system. It reduces condensation that can form in breathing circuit. The Sunset Heated CPAP Tube has a proprietary connector with two locking tabs that makes it compatible with the Respironics System One and with the Respironics Dreamstation series.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "Sunset Heated CPAP Tube":
The provided document is a 510(k) Premarket Notification from the FDA, which focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance acceptance criteria and study outcomes in the way a clinical trial or a more comprehensive performance study would. Therefore, much of the requested information (like specific numerical performance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truths) is not explicitly available in this type of regulatory submission.
However, I can extract the general categories of testing performed and the standards met, which imply the acceptance criteria.
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific numerical acceptance criteria alongside reported device performance values. Instead, it indicates that the device was tested against and meets the requirements of various international and national performance and safety standards. This implies that the acceptance criteria are embedded within these standards.
General Categories of Bench Testing Performed:
| Acceptance Criteria (Implied by Standards Met) | Reported Device Performance Statement |
|---|---|
| Performance of sleep apnea breathing therapy equipment (per ISO 80601-2-70) | Device was tested and meets the requirements of ISO 80601-2-70. |
| Performance with interaction of respiratory humidifying equipment (per ISO 80601-2-74) | Device was tested and meets the requirements of ISO 80601-2-74. |
| Requirements for breathing sets and connectors (per ISO 5367) | Device was tested and meets the requirements of ISO 5367. (ISO 5367 compliant) |
| Electromagnetic compatibility (EMC) (per IEC 60601-1-2) | Device complies with IEC 60601-1-2. |
| Electrical safety testing (per ANSI/AAMI/ES 60601-1) | Device complies with ANSI/AAMI/ES 60601-1. |
| Mechanical safety testing | Bench testing was carried out, implying satisfactory results. (No specific standard cited for "mechanical safety testing" in the performance list, but covered by general safety standards) |
| Human Factors and Usability Engineering (per FDA Guidance) | Usability evaluation was conducted as per the guidance. (Implies satisfactory outcome) |
| Biocompatibility (per ISO 10993-1, ISO 18562 series) | Device meets the requirements of these biocompatibility standards. |
| Electrical & Mechanical safety in home healthcare (per IEC 60601-1-11) | Device complies with IEC 60601-1-11. |
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 does not specify numerical sample sizes for any test sets. The testing described (bench testing, usability testing, biocompatibility) is indicative of engineering and lab-based evaluations rather than patient studies. Therefore, data provenance in terms of country of origin or retrospective/prospective nature isn't applicable in the context typically understood for clinical data. The testing is non-clinical, likely conducted in a lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The type of testing described (bench, safety, biocompatibility, usability) typically relies on expert engineers, testers, and potentially human factors specialists, but the document does not detail their numbers or qualifications, nor does it explicitly mention "ground truth" establishment in the context of expert consensus as one would for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document and is generally not applicable to the types of bench and safety testing described. Adjudication methods like 2+1 or 3+1 are typically used for clinical endpoints or image interpretation where expert disagreement might arise.
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
An MRMC study was not done. This type of study is irrelevant for a heated CPAP tube, as it is a physical medical device, not an AI-based diagnostic or assistive technology for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to the "Sunset Heated CPAP Tube" as it is a hardware device (a heated breathing tube), not an algorithm or software. It does not have an "algorithm only" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench, safety, and biocompatibility testing, the "ground truth" implicitly refers to compliance with the specified international and national standards. For usability testing, the "ground truth" would be adherence to human factors principles and satisfactory user performance/feedback, but the specific validation method is not detailed beyond stating it was "conducted as per the Guidance."
8. The sample size for the training set
The concept of a "training set" is not applicable here, as the device is a hardware product, not a machine learning model.
9. How the ground truth for the training set was established
As there is no training set mentioned or implied, this question is not applicable.
§ 868.5270 Breathing system heater.
(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).