(252 days)
Fahl Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.
The Fahl Tracheostomy Tubes (Duravent, Duracuff, Laryngotec, Duratwix, Silvervent, Spiraflex, and Tracheotec) are available cuffed or uncuffed. They can be obtained sieved or unsieved, with or without speaking valve, cuffed or uncuffed, with or without inner cannulas. The accessories comprise different Humid Moist Exchangers (HME), decannulation plugs, neck holders, and stoma buttons. Fahl offers the tubes in varying sizes and length so that the physician can select a tracheostomy tube, which best fits the individual needs of the patient. All Fahl Tracheostomy Tubes are for adults only and available on prescription.
The provided text describes the performance data for Fahl Tracheostomy Tubes (Duravent, Laryngotec, Duracuff, Silvervent, Duratwix, Tracheotec, Spiraflex). The study described is a series of tests against established international standards rather than a clinical trial with human subjects/patients. Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set information) are not applicable or cannot be extracted from this type of regulatory document.
Here's a breakdown of the acceptance criteria and performance as reported:
1. Table of Acceptance Criteria and Reported Device Performance:
| Requirement/Tested Specification | Acceptance Criteria (Implied by "Passed") | Reported Device Performance (All Fahl Tracheostomy Tubes included in the test unless otherwise specified) |
|---|---|---|
| Measurements of T. Tubes according to ISO 5366-1 | Conformance to ISO 5366-1 | Passed |
| Leak-Tightness of Tracheostomy tube with cuff according to ISO 5366-1 | Conformance to ISO 5366-1 | Passed (for Duracuff, Duratwix, Tracheotec, Spiraflex; n.a. for others as they are uncuffed or not applicable) |
| Diameter of air filled Cuff according to ISO 5366-1 | Conformance to ISO 5366-1 | Passed (for Duracuff, Duratwix, Tracheotec, Spiraflex; n.a. for others) |
| Tensile Strength to the neck flange according 5366-1 | Conformance to ISO 5366-1 | Passed (for Duravent, Duracuff, Duratwix, Tracheotec, Spiraflex; n.a. for others) |
| Tensile Strength of attachments of the tube to the neck flange 5366-1 | Conformance to ISO 5366-1 | Passed (for Duravent, Duracuff, Tracheotec, Spiraflex; n.a. for Silvervent; Not tested for Duratwix) |
| Measurements of connectors According to ISO 5356-1 | Conformance to ISO 5356-1 | Passed |
| Surface Strength of connectors according to ISO 5356-1 | Conformance to ISO 5356-1 | Passed (n.a. for Silvervent) |
| Leak-Tighteness of Connectors according to 5356-1 | Conformance to ISO 5356-1 | Passed (n.a. for Laryngotec, Silvervent) |
| Biocompatibility according to ISO 10993-1 | Conformance to ISO 10993-1 | Passed (n.a. for Silvervent) |
| Biocompatibility - Ethylene Oxide sterilization residuals according to ISO 100993-7 | Conformance to ISO 100993-7 | Passed (n.a. for Duravent, Silvervent, Tracheotec, Spiraflex; "passed" for all others mentioned explicitly) |
| Validation of Sterilisation according to ISO 11135 | Conformance to ISO 11135 | Passed (Not tested for Laryngotec; "passed" for all others mentioned explicitly) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of units or samples tested for each specification. It generally states that "Test results provide reasonable assurance that the tubes are safe for their intended use."
- Data Provenance: The tests were conducted according to international standards (ISO 5356-1, ISO 5366-1, ISO 10993-1, and ISO 10993-7). The manufacturer is Andreas Fahl Medizintechnik-Vertrieb GmbH in Koeln, Germany, suggesting the testing was performed in a controlled laboratory environment, likely in Germany or a location complying with these international standards. This is prospective testing related to regulatory approval, not retrospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This study involves laboratory testing against established engineering and material standards, not expert clinical review or ground truth derived from expert consensus on medical images or clinical outcomes.
4. Adjudication method for the test set:
- Not Applicable. As this is laboratory testing against physical specifications and standards, there is no expert adjudication method as would be typical for clinical studies or AI-driven diagnostic tools.
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:
- Not Applicable. This is a regulatory filing for a medical device (tracheostomy tubes), not an AI/software as a medical device (SaMD) or diagnostic imaging study. Therefore, no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This premarket notification is for physical medical devices and does not involve an algorithm or AI.
7. The type of ground truth used:
- Standard Specifications: The "ground truth" for this study is defined by the technical requirements and acceptance criteria outlined in the referenced ISO standards (ISO 5356-1, ISO 5366-1, ISO 10993-1, ISO 10993-7, ISO 11135). The devices either "Passed" or met "n.a." (not applicable) for these standards.
8. The sample size for the training set:
- Not Applicable. This is not a machine learning or AI study, so there is no training set.
9. How the ground truth for the training set was established:
- Not Applicable. There is no training set for this type of device performance testing.
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.