(50 days)
Intended Use: The device is intended to be used to provide and artificial airway in order to provide access to the patient's airway for airway management. When inserted in a tracheotomy stoma, the device is secured in place with a neck strap around the patient's neck which is attached to an integral neck plate, thereby providing for a secure artificial airway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment.
Indications for Use: This device is intended for use in providing tracheal access for airway management.
The Shiley Neonatal, Pediatric, Pediatric Long Tracheostomy Tube Cuffless tube is a single cannula tracheostomy tube which also contains a neck strap and obturator. The device is intended to be used to provide and artificial airway in order to provide access to the patient's airway for airway management. When inserted in a tracheotomy stoma, the device may be secured in place with a neck strap around the patient's neck which is attached to an integral neck plate, thereby providing for a secure artificial airway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment.
The provided text is a 510(k) Summary for a medical device (tracheostomy tubes) and does not contain information about software or AI-driven devices. Therefore, the questions related to acceptance criteria, study details, sample sizes, ground truth, expert involvement, adjudication methods, or MRMC studies for an AI device are not applicable to this document.
This submission is for a medical device that received a 510(k) clearance based on substantial equivalence to existing predicate devices, with changes primarily in size extension, materials, and manufacturing process. The "Non-Clinical Data" section mentions bench testing for compliance with ISO standards and biocompatibility testing, but these are for the physical device, not an AI algorithm.
Here's a summary of the available information:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The device was tested to meet the requirements of specific ISO standards for tracheostomy tubes:
- ISO 5366-3:2001/Cor:2003 (Pediatric Tracheostomy Tubes)
- ISO 5356-1:2004 (Conical connectors)
- ISO 5366-1:2000 (Tracheostomy tubes - adults, used for the 6.5mm PDL model which falls outside the scope of ISO 5366-3 for pediatrics)
- Biocompatibility testing followed ISO 10993-1:2009.
- Reported Device Performance: The non-clinical data section states that the device "meets the requirements" of these ISO standards and "satisfied all of the requirements" of ISO 10993-1:2009. No specific performance metrics (e.g., success rates, error rates) are provided beyond this general statement of compliance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable as this is a physical medical device. The "test set" would refer to the physical samples used for bench testing. The document does not specify the number of samples used for these bench tests or their provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth for a physical device is established through engineering and laboratory testing against established standards, not expert consensus on medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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. No AI component is described or evaluated.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. No algorithm is described or evaluated.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the non-clinical testing, the "ground truth" or reference for performance would be the specifications and requirements defined in the cited ISO standards.
8. The sample size for the training set:
- Not applicable. No AI model or training set is described.
9. How the ground truth for the training set was established:
- Not applicable. No AI model or training set is described.
§ 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.