(113 days)
Tracheostomy Tubes are intended for use in providing direct tracheal access for airway management.
The VITALTEC Rota-Trach Tracheostomy Tubes are made from the raw material of The VITALIEC Kota Track Track Tracksonsyland of connector and valve. The the seeff with Sincolle for medical ass, while the components of the propriate hardness, the cuff with tubes have such good perfectionsment tube and excellent biocompatibility.
Here's an analysis of the provided text regarding the acceptance criteria and study for the VITALTEC Rota-Trach Tracheostomy Tube:
This document is a 510(k) premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device. For such submissions, the primary "study" is often a comparison to the predicate device and adherence to recognized standards, rather than a separate clinical trial with specific performance metrics like sensitivity/specificity for diagnostic AI.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in terms of performance metrics commonly seen in diagnostic device studies (e.g., sensitivity, specificity, accuracy). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device and compliance with relevant international standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence | Same as predicate device: "Tracheostomy Tubes are intended for use in providing direct tracheal access for airway management." |
| Material Equivalence | Same as predicate device: "Silicone" |
| Connector Conformance | Same as predicate device; 15 O.D. per ISO 5356-1. |
| Sterilization Efficacy | Different method (Moist Heat vs. ETO) was "got the validation." (Implies successful testing against ISO 17665-1). |
| Dimensional & Design Conformance | Conformed to ISO 5356-1. |
| Sterility Conformance | Conformed to ISO 17665-1. |
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and sensitization). Stated as having "excellent biocompatibility." |
| General Safety & Effectiveness | Based on all the above, demonstrated substantial equivalence to predicate, indicating comparable safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of a typical algorithm or AI study. The evaluation is based on non-clinical data (bench testing, material testing, and standards conformance).
- Sample Size for Test Set: Not applicable in the context of an AI study. The evaluation relies on testing of the device itself for compliance with standards and comparison specifications.
- Data Provenance: Not applicable. The "data" are results from physical and biological tests conducted on the device, as well as its specifications. The manufacturer is VITALTEC CORPORATION in Taiwan, ROC.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This is not an AI or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a medical device (tracheostomy tube), not a diagnostic algorithm where human readers would be assessing performance with or without AI assistance.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical device, not an algorithm. The "standalone" evaluation refers to the device's conformance to standards and its specifications.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily established by:
- International Standards: ISO 5356-1 (connector dimensions), ISO 10993 series (biological evaluation), ISO 17665-1 (sterilization).
- Predicate Device Specifications: The established and accepted performance and design of the previously cleared "Medical Tracheostomy Tubes (K031553)."
- Physical and Biological Test Results: Data from tests demonstrating biocompatibility, sterility, and mechanical properties.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.