(211 days)
The SolidAIRity III Endotracheal Standard Tube is indicated for airway management of patients requiring oral intubation.
The SolidAIRity III Endotracheal Suction Tube is indicated for airway management of patients requiring oral intubation and for evacuation and drainage of subglottic secretions that accumulate above the cuff.
The SolidAIRity III Endotracheal Tube Stabilizer is indicated for airway management of patients by securing a SolidAIRity III Endotracheal Tube during oral intubation.
The SolidAIRity III Airway Stabilization System consists of:
- Two (2) types of Oral Endotracheal Tubes (the SolidAIRity III Standard Oral Endotracheal Tube or the SolidAIRity III Suction Oral Endotracheal Tube), and
- The SolidAIRity III Endotracheal Tube Stabilizer
Each type (standard and suction) of the SolidARity III Oral Endotracheal Tubes will be available in the following five (5) adult sizes:
- 6.0mm ID
- 6.5mm ID
- 7.0mm ID
- 7.5mm ID
- 8.0mm ID
A clinician inserts the endotracheal tube into a patient's trachea, via the mouth, in accordance with standard clinical technique to maintain an open airway. The stabilizer remains outside the patient's mouth and, by means of a locking device and straps, secures the endotracheal tube in place.
The provided text is a 510(k) summary for the SolidAIRity III Airway Stabilization System. It describes the device, its indications for use, and a comparison to predicate devices. The summary of testing outlines various tests conducted to demonstrate the device's safety and effectiveness.
Here’s an breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria alongside performance data in a detailed quantitative manner for most tests. Instead, it generally states that "The results of all testing met acceptance criteria." and "The results of the testing satisfy the requirements of the study protocols and comply with ISO 10993-1." However, for Biocompatibility, it lists the tests and states "Pass" for each. For the "Resistance to Movement Against Force testing," an acceptance criterion is implied by the statement "to resist tube movement against multidirectional external forces of up to 20 pounds."
Here's a condensed table based on the information available:
| Test Category | Specific Test | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Comply with ISO 10993-5 | Pass |
| Sensitization | Comply with ISO 10993-10 | Pass | |
| Irritation | Comply with ISO 10993-10 | Pass | |
| Acute Systemic Toxicity | Comply with ISO 10993-11 | Pass | |
| Material-Mediated Pyrogenicity | Comply with ISO 10993-11 | Pass | |
| Subacute / Subchronic Toxicity | Comply with ISO 10993-11 | Pass | |
| Genotoxicity | Comply with ISO 10993-3 | Pass | |
| Implantation | Comply with ISO 10993-6 | Pass | |
| Sterilization | Sterilization Process Validation | Comply with ISO 11135-1 and ISO 10993-7 | Met acceptance criteria |
| Packaging | Package Integrity Validation | Comply with ISO 11607-1 (non-aged and 2-year accelerated aging) | Met acceptance criteria |
| Performance Bench | Endotracheal Tube Conformance Test | (Predefined acceptance criteria based on ISO 5361) | Met predefined acceptance criteria |
| Cuff Inflation Tube Leak Test | (Predefined acceptance criteria based on ISO 5361) | Met predefined acceptance criteria | |
| Cuff Resting Diameter Test | (Predefined acceptance criteria based on ISO 5361) | Met predefined acceptance criteria | |
| Cuffed Tube Collapse Test | (Predefined acceptance criteria based on ISO 5361) | Met predefined acceptance criteria | |
| Cuff Herniation Test | (Predefined acceptance criteria based on ISO 5361) | Met predefined acceptance criteria | |
| Tracheal Seal Test | (Predefined acceptance criteria based on ISO 5361) | Met predefined acceptance criteria | |
| Kink Resistance Test | (Predefined acceptance criteria based on ISO 5361) | Met predefined acceptance criteria | |
| Radiopaque Marker Compliance Test | (Predefined acceptance criteria based on ISO 5361) | Met predefined acceptance criteria | |
| KAD Collar/Inflation Tube Pull Test | Ensure proper performance strength against external forces | Met predefined acceptance criteria | |
| Suction Tube Performance Test | Performance substantially equivalent to predicate (based on ISO 8836) | Met predefined acceptance criteria | |
| Resistance to Movement Against Force | Resist tube movement against multidirectional external forces up to 20 pounds | Validated (met acceptance criteria) | |
| Human Factors | Usability Validation | Users can perform all phases of advanced airway management as safely and effectively as predicate | Demonstrated (met acceptance criteria) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the test sets in any of the described tests (biocompatibility, sterilization, packaging, performance bench, or human factors).
Regarding data provenance:
- For Biocompatibility, the testing was performed, but the location or specific origin of the samples/data is not mentioned beyond compliance with FDA Guidance and ISO standards.
- For Human Factors, the study was "conducted in simulated use scenarios employing accepted models of evaluation" and "in simulated environments consistent with those environments in which representative users typically perform airway management." It doesn't state the country of origin of the data explicitly but implies a controlled, simulated environment rather than real-world patient data.
- The document implies that all tests were conducted by the manufacturer, Securisyn Medical, LLC, or their appointed testing facilities to support the 510(k) submission.
- The studies were prospective in nature, as they were conducted specifically to support the 510(k) submission and evaluate the performance of the device against predefined criteria. No retrospective data analysis is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide this information.
- For the Human Factors Validation Study, it mentions "representative users," but does not specify the number or qualifications of experts involved in establishing ground truth or evaluating performance.
- For bench testing, ground truth is typically established by engineering specifications and industry standards (e.g., ISO 5361, ISO 8836), not by human experts interpreting data for a "ground truth" purpose in the way described for AI/diagnostic studies.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method. This level of detail is typically associated with clinical studies or studies involving subjective assessments that require consensus, which are not explicitly detailed here. The tests described are primarily objective and involve predefined criteria for pass/fail.
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, an MRMC comparative effectiveness study was not done.
The device described is a physical medical device (airway stabilization system), not an AI/software device that assists human readers in interpreting diagnostic images or data. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm-only) performance test was not done in the context of AI.
Again, the device is a physical medical device. Performance testing was conducted on the physical device itself (bench testing) and in simulated human use scenarios (human factors study), which inherently involves a "human-in-the-loop" interaction with the device.
7. The Type of Ground Truth Used
For the various tests, the "ground truth" was established by engineering specifications, industry standards (e.g., ISO 5361, ISO 8836, ISO 10993, ISO 11135-1, ISO 11607-1, ASTM 1980), and predefined acceptance criteria. For the human factors study, the "ground truth" was established based on the ability of users to perform tasks "safely and as effectively as the predicate" in simulated use scenarios. There is no mention of pathology, expert consensus in a diagnostic sense, or outcomes data being used as ground truth for these tests.
8. The Sample Size for the Training Set
Not applicable.
This term typically refers to the data used to train an AI algorithm. As this is a physical medical device and not an AI/machine learning device, there is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
As there is no training set for an AI algorithm, the establishment of ground truth for such a set is not relevant to this submission.
§ 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).