(106 days)
The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula is intended to provide tracheal access for airway management.
The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula is intended to provide tracheal access for airway management.
The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula is also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.
The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula is also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.
The subject devices are single patient-use dual cannula tracheostomy tubes that are intended to provide an artificial airway for airway management. The subject device represents a line extension introducing the option of a reusable inner cannula.
This document is a 510(k) Summary for the Shiley™ Adult Flexible Tracheostomy Tube, Reusable Inner Cannula. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics. Therefore, many of the requested elements for describing an acceptance criteria study are not directly applicable to this document.
However, I can extract information related to non-clinical testing used to support substantial equivalence.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present explicit acceptance criteria with numerical targets for clinical performance (e.g., sensitivity, specificity, accuracy) typical of diagnostic or AI-driven devices. Instead, it describes non-clinical performance tests designed to confirm the new device's performance aligns with predicate devices and relevant standards.
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Insertion/Removal force | Expected to perform as well as the predicate device. |
| Lock & pinch force | Expected to perform as well as the predicate device. | |
| ISO 5366-1:2009 (Tracheal tubes) | Compliance demonstrated. | |
| ISO 5361:2012 (Tracheal tubes - connectors and adapters) | Compliance demonstrated. | |
| Biocompatibility | ISO 10993-1:2009 | Met all biocompatibility requirements for intended use. |
| Cytotoxicity | Performed. Outcomes supported compliance. | |
| Sensitization | Performed. Outcomes supported compliance. | |
| Acute systemic toxicity | Performed. Outcomes supported compliance. | |
| Genotoxicity | Performed. Outcomes supported compliance. | |
| Subchronic toxicity implantation | Performed. Outcomes supported compliance. | |
| Chemical characterization | Performed. Outcomes supported compliance. | |
| Risk assessment | Performed. Outcomes supported compliance. | |
| Sterilization & Cleanliness | Cleaning methods for reusable inner cannula | Validated in accordance with AAMI TIR 30. |
| Ethylene oxide residual tests (EtO-sterilized device) | Compliance to ISO 10993-7:2008 for intended use. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as this was not a clinical study on human subjects in the traditional sense. The "test set" would refer to the physical devices subjected to the non-clinical performance and material tests. The number of devices tested for each non-clinical assessment (e.g., insertion force, biocompatibility) is not provided.
- Data Provenance: The device is manufactured by Covidien, a US-based company (Boulder, CO). The non-clinical tests would have been performed in a laboratory setting, likely within the US or by a contracted lab. The document does not specify the country of origin for the test data, but it refers to international standards (ISO, AAMI). These were laboratory/bench tests, not retrospective or prospective studies involving 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 document describes non-clinical testing against engineering standards and material properties, not an evaluation of a diagnostic device requiring expert consensus for ground truth on patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As per point 3, there was no ground truth establishment by experts for a test set of patient cases. The evaluation was based on compliance with predefined standards and test protocols.
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:
- No. This device is a tracheostomy tube, a physical medical device for airway management, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study or AI-related effectiveness assessment is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical medical device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the traditional sense. The "ground truth" for the non-clinical tests was compliance with established engineering and biocompatibility standards (e.g., ISO 5366-1:2009, ISO 5361:2012, AAMI TIR 30, ISO 10993-1:2009, ISO 10993-7:2008). The ground truth is adherence to these predefined, objective criteria.
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device, so there is no training set.
9. How the ground truth for the training set was established:
- Not Applicable. No training set exists for this device.
§ 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.