(246 days)
The Tenax® Laser Resistant Endotracheal Tube is intended for endotracheal intubation. It is indicated for use for all types of surgical procedures involving carbon dioxide (10.60 microns) or KTP (532 nm) laser use (normal pulsed or continuous beam delivery in the non-contact mode), when endotracheal intubation is required to administer anesthetic gases or to overcome emergency obstruction of an airway.
The Tenax® Laser Resistant Endotracheal Tube is an endotracheal tube with two inflatable cuffs. It is indicated for use in surgical procedures where intubation is required in the presence of KTP or CO2 lasers.
The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations. There are no associated device accessories.
The provided text is a 510(k) premarket notification for a medical device and describes various tests performed to demonstrate substantial equivalence to a predicate device, rather than a study designed to prove the device meets specific acceptance criteria in a clinical or AI performance context.
Therefore, much of the requested information (like sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness, standalone performance, and training set details) is not applicable or cannot be extracted from this document, as it pertains to specific types of clinical or AI performance studies which are not described here.
However, I can extract information related to the performance data provided to support the substantial equivalence claim.
Acceptance Criteria and Reported Device Performance
The document describes various performance tests conducted for the Tenax® Laser Resistant Endotracheal Tube to support its substantial equivalence. While specific numerical acceptance criteria are not explicitly detailed in this summary, the tests implicitly demonstrate that the device performs as intended and is safe and effective when compared to the predicate device.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the provided test types):
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Dimensional Conformance | |
| (Dimensions meet specified requirements for safe and effective use) | Dimensional testing performed. |
| Dimensions: Length: 34cm. ID: 5.0mm, 5.5mm, 6.0mm, 6.5mm, 7.0mm, 7.5mm. OD: 7.9mm, 8.6mm, 9.3mm, 10.0mm, 10.6mm, 11.0mm. | |
| Mechanical Integrity - Bend Radius | |
| (Device maintains integrity and functionality when bent) | Bend radius testing performed. |
| Cuff Functionality | |
| (Cuffs inflate/deflate correctly within specified time/pressure, and do not burst prematurely) | Cuff inflation/deflation/burst testing (time and pressure) performed. |
| Leak/Damage Indication | |
| (Internal dye clearly visible upon puncture/damage) | Dye visibility testing performed. |
| Laser Resistance | |
| (Device effectively resists specified CO2 and KTP laser energies) | Laser resistance testing performed. |
| Maximum power density for CO2 laser: 10,394 W/cm². | |
| Maximum power density for KTP laser: 5,305 W/cm². | |
| Maximum continuous irradiation: 30 seconds. | |
| Tracheal Tube Dimensions Conformance | |
| (Specific dimensions conform to standards for tracheal tubes) | Tracheal tube dimensions testing performed. |
| Connector Integrity | |
| (Connector to ventilation source does not leak) | Connector leakage testing performed. |
| Biocompatibility | |
| (Device materials are safe for human contact) | Biocompatibility evaluation conducted in accordance with ISO 10993-1. |
| Tests included: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity. | |
| Device is considered tissue-contacting for less than 24 hours. |
Study Information (Based on available text):
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Sample size used for the test set and the data provenance: Not explicitly stated for each test. The document mentions "The non-clinical test data support the safety of the device and the verification and validation testing data demonstrate that the Tenax® Laser Resistant Endotracheal Tube shall perform as intended in the specified use conditions." The nature of these tests (e.g., dimensional, mechanical, laser resistance) suggests laboratory-based testing on samples of the device. Data provenance (country of origin, retrospective/prospective) is not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are non-clinical engineering and laboratory performance tests, not studies requiring expert interpretation of clinical data for ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. These are objective engineering and material performance tests.
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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 document describes a medical device (endotracheal tube), not an AI-powered diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for an endotracheal tube, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the performance tests listed (e.g., dimensional, bend radius, cuff function, laser resistance), the "ground truth" would be established by validated engineering specifications, material standards, and physical measurements/observations during the tests. For biocompatibility, it's compliance with ISO 10993-1 standards and the results of the specific biological tests.
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The sample size for the training set: Not applicable. There is no AI model or training set described in this document.
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How the ground truth for the training set was established: Not applicable. No training set is described.
§ 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).