(111 days)
The SOYALA SilkGel Full Face Mask is intended for adult patients (>66 pounds or 30kg) prescribed continuous positive airway pressure (CPAP) or bi-level therapy for multiple patient use in a hospital or clinic environment after high-level disinfection and for single-patient use in a home environment.
The SOYALA SilkGel Full Face Mask is a molded plastic mask, including an exhalation system, for the delivery of CPAP or Bi-level Positive Pressure therapy. It consists of a mask cushion, mask body, forehead cushion, rough adjustment component, fine adjustment component, headgear, headgear clips, pressure measurement connection, tube anchoring strap, rotating sleeve, elbow, and retaining ring. The mask provides a swivel and securely attached elbow connection for simple and secure handling of the tubing between the mask and the therapy device.
The document describes the SOYALA SilkGel Full Face Mask, a device intended for adult patients prescribed CPAP or bi-level therapy. The device is a full face mask designed to deliver positive airway pressure.
Here's an analysis of the provided information, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Bench testing was performed to verify equivalent performance. All tests were verified to meet acceptance criteria." However, it does not provide any specific acceptance criteria values or detailed performance results for the SOYALA SilkGel Full Face Mask. It only broadly states that the device met these unspecified criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). It only mentions "bench testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for any testing performed. The "bench testing" suggests engineering or laboratory testing rather than clinical evaluation involving expert interpretation.
4. Adjudication Method for the Test Set
No adjudication method is mentioned, as there is no indication of expert involvement or ground truth establishment in a way that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not report any MRMC comparative effectiveness study. There is no mention of human readers, AI assistance, or an effect size for human reader improvement.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Done
The device is a physical medical mask, not an algorithm. Therefore, the concept of a "standalone algorithm only" performance study is not applicable. The testing described is for the physical performance of the mask.
7. Type of Ground Truth Used
Given that only "bench testing" is mentioned, the "ground truth" would likely refer to engineering specifications, performance standards, or measurements of physical properties (e.g., seal integrity, pressure delivery, material durability) rather than clinical ground truth like pathology or outcomes data. The document does not explicitly state the type of ground truth, but it implies adherence to technical standards.
8. Sample Size for the Training Set
The document does not mention a training set as this device is a physical product and not an AI/ML algorithm that would typically require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned for this type of device.
Summary of Study Information Provided:
- Study Type: Bench Testing
- Purpose: To verify equivalent performance of the SOYALA SilkGel Full Face Mask to its predicate device (SOYALA FULL FACE MASK GEL vented, K073673).
- Results: All tests were verified to meet acceptance criteria (though specific criteria and results are not provided).
- Conclusion: The device is substantially equivalent to the legally marketed predicate device and is safe and effective.
In essence, the document provides a very high-level summary of "bench testing" that confirmed the device met internal or regulatory acceptance criteria, without detailing the specifics of those criteria or the testing methodology.
§ 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).