(90 days)
Laser-Shield II 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 anesthesia gases or to overcome emergency obstruction of an airway.
Xomed Laser-Shield II is an endotracheal tube provided sterile with laser resistant overwraps of aluminum and fluoroplastic covering the silicone elastomer shaft. The tube is fitted with an inflatable cuff designed to provide tracheal seal. The inflation assembly/balloon contains dry methylene blue that mixes with a liquid inflation media (sterile normal saline) to provide visible detection of inadvertent cuff rupture by the laser. Sterile cottonoid patties are also provided for wetting and placement around the positioned and inflated cuff for additional heat sink.
The provided text is related to a 510(k) submission for a modification to an existing medical device, the Laser-Shield® II Tracheal Tube. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlines the intended use. However, it does not contain the detailed study information needed to fully address your request regarding acceptance criteria and device performance studies.
Here's a breakdown of what can be extracted based on the provided text, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document implies that the acceptance criterion for the modified device is "substantial equivalence" to the predicate device. This is a regulatory standard, not a performance metric with specific thresholds (e.g., >95% accuracy). The modification itself is described as "extension of the aluminum wrap under a portion of the cuff and covering of this extension with a flexible silicone sleeve." The key phrase is "The intended use and claims for the modified device remains unchanged and no new materials are being used." This suggests that the modified device should perform as safely and effectively as the original.
- Reported Device Performance: The text does not report specific quantitative performance metrics (e.g., laser resistance levels, cuff integrity under specific conditions) for either the original or the modified device. It merely states that the modification does not change the intended use or claims, implying that the performance is expected to be equivalent to the previously cleared device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantially Equivalent to predicate device (Laser-Shield® II) for all types of surgical procedures involving CO2 or KTP laser use. | The modified device's intended use and claims remain unchanged; no new materials are used. Performance is assumed to be equivalent to the predicate. Specific performance metrics are not provided in this document. |
| The modification (extended aluminum wrap, silicone sleeve) does not negatively impact safety or efficacy. | (Not explicitly stated in terms of performance data, but implied by the "substantial equivalence" determination.) |
Missing Information:
- Specific numerical or qualitative performance metrics (e.g., "withstanding X joules of laser energy for Y seconds").
- A direct comparison of the modified device's performance against the predicate device using quantitative data.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not describe a clinical or performance "test set" in the context of typical AI/diagnostic device studies. This submission is for a device modification of an existing physical medical device (an endotracheal tube), not a software algorithm. Therefore, concepts like "test set" in the machine learning sense, "country of origin," or "retrospective/prospective" studies do not apply in this document.
Missing Information: This entire section is not applicable or not present for this type of device submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Again, this submission is for a physical medical device. The concept of "ground truth" established by experts for a test set (e.g., for image interpretation or diagnosis) is not relevant here. The evaluation involves engineering principles, material science, and safety testing (e.g., biocompatibility guidance, laser resistance testing as per established standards for endotracheal tubes), not expert interpretation of outputs.
Missing Information: This section is not applicable or not present.
4. Adjudication Method for the Test Set
As there is no "test set" in the given context (no diagnostic performance study), an adjudication method is not described or relevant.
Missing Information: This section is not applicable or not present.
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
This document describes a physical medical device (an endotracheal tube), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this submission.
Missing Information: This section is not applicable or not present.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not an algorithm or software device. This question is not applicable.
Missing Information: This section is not applicable or not present.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For this type of physical device, "ground truth" would be established through a combination of:
- Engineering specifications and standards: The device is expected to meet certain physical and chemical properties.
- Performance testing: Laboratory tests demonstrating laser resistance, cuff integrity, etc. (though specific results are not in this summary).
- Biocompatibility data: Ensuring the materials are safe for human contact.
- Pre-clinical safety data: If animal or bench testing was done (not described in detail here).
The document states "The modified Xomed Laser-Shield II is identical to the current device with the exception of the extension of the aluminum wrap... The intended use and claims for the modified device remains unchanged and no new materials are being used." This implies that the ground truth for acceptability relies on the established safety and efficacy of the predicate device and the assessment that the modification does not alter this.
Missing Information: Specific details of technical performance studies that would constitute "ground truth" development for a physical device are not included in this high-level summary.
8. The Sample Size for the Training Set
This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the AI sense.
Missing Information: This section is not applicable or not present.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI model, this question is not applicable.
Missing Information: This section is not applicable or not present.
In summary, the provided 510(k) summary is for a physical medical device modification and focuses on demonstrating substantial equivalence to a predicate device. It does not contain the type of detailed performance study information, acceptance criteria, or ground truth establishment relevant to AI/diagnostic device submissions that your questions primarily target.
§ 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).