(101 days)
Sheridan cuffed, uncuffed and reinforced tracheal tubes are designed for oral or nasal intubation and are indicated for airway management.
The Sheridan Spiral-Flex Endotracheal Tubes are spiral tracheal tubes that are inserted into the trachea via the mouth or the nose in order to establish a patent airway to allow ventilation. The subject device are sterile, single use devices. The tracheal tubes contain a compatible cuff, inflation line, pilot balloon and one-way valve. Each tracheal tube is supplied with an appropriately sized 15mm connector.
This looks like a 510(k) summary for the Teleflex Sheridan Spiral-Flex Endotracheal Tubes. Based on the provided text, here's an analysis of the acceptance criteria and supporting study information:
This document does not describe a study related to AI/ML device performance, but rather summarizes the substantial equivalence of a medical device (endotracheal tubes) to previously cleared predicate devices. Therefore, many of the requested categories related to AI/ML performance studies, such as effect size of human readers with AI assistance, training set details, and specific expert qualifications for ground truth in an AI context, are not applicable in this submission.
The "study" in this context refers to bench testing to demonstrate the physical performance and safety of the endotracheal tubes.
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" with numerical targets in a table for a device performance study. Instead, it outlines the types of tests conducted and states that the device "meets its intended use" and "is substantially equivalent" to the predicate. The implication is that the device passed these tests and performed comparably to the predicate devices.
Here's a table based on the provided "Performance Data" section, interpreting the listed tests as fulfilling implicit acceptance criteria:
| Acceptance Criteria (Inferred from Tests) | Reported Device Performance (Summary) |
|---|---|
| Physical Integrity & Functionality | |
| Visual Inspection | No delamination on tip of reinforced tubes (Passed) |
| Cuff Inflation/Deflation | Device performed as expected (Passed; implies proper inflation, seal, and deflation) |
| Inflation System Leak | Device performed as expected (Passed; implies no leaks in the inflation system) |
| Cuff Herniation | Device performed as expected (Passed; implies cuff integrity under pressure) |
| Pilot Cuff Pull | Device performed as expected (Passed; implies robust attachment of pilot balloon to tube) |
| Simulated Use | Device performed as expected (Passed; implies proper function during simulated use scenarios) |
| Biocompatibility | |
| ISO 10993-1:2009 (Biological Evaluation) | Device performed as expected (Passed; implies biocompatibility for patient contact, likely through material assessment or specific biocompatibility tests) |
| Material/Design Conformance | |
| ASTM F623 Requirements | Device was tested to and met the requirements of ASTM F623 (Standard Specification for Tracheal Tubes) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify specific sample sizes for each of the bench tests listed (e.g., how many tubes were visually inspected, or how many cuffs were subjected to inflation/deflation cycles).
- Sample Size: Not explicitly stated for the individual tests. This is common for bench testing where the focus is often on representative samples across different sizes/types.
- Data Provenance: The tests were performed as part of Teleflex Medical, Inc.'s regulatory submission. This is prospective testing conducted specifically for this 510(k) submission, likely in a laboratory setting (manufacturer's or third-party). Country of origin is not specified but the company is based in Morrisville, NC, USA.
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)
This is not applicable as this is a physical medical device (endotracheal tube) submission, not an AI/ML diagnostic or prognostic device requiring expert interpretation for ground truth. The "ground truth" here is established by engineering and material science standards and test methods.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is used in clinical studies or expert consensus for AI/ML or diagnostic test evaluation, not for bench testing of physical device performance. The "adjudication" is inherent in the test method itself (e.g., does it leak or not, does it delaminate or not).
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 not an AI/ML device, and no MRMC study was conducted or is relevant for this type of medical device submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by:
- Engineering specifications and design requirements: Whether the tube meets its physical dimensions, material properties, and functional characteristics.
- Performance standards: Adherence to recognized standards like ASTM F623 for mechanical integrity and ISO 10993-1 for biocompatibility.
- Comparison to predicate devices: The "ground truth" for substantial equivalence is that the new device performs at least as well as and poses no new safety or effectiveness concerns compared to the legally marketed predicate devices.
8. The sample size for the training set
Not applicable. There is no AI/ML algorithm requiring a training set for this device.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML algorithm or training set for this device.
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).