(70 days)
The Silbroncho® is used to isolate the left or the right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
The Silbroncho® double lumen tube is made of silicone and is available in sizes 33 to 39 French. They are designed as a double lumen tube with 2 cuffs and separate 15 mm connectors for isolating and ventilating one lung during surgical procedures.
The provided text describes a 510(k) premarket notification for the "Silbroncho® tubes," a double lumen tube. The submission focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting performance studies against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from the provided text.
Here is the information that can be extracted, and where the requested details are not available, it is noted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance results from a study. The submission is based on demonstrating substantial equivalence to pre-existing predicate devices.
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|
| (Not provided in the text) | The device (Silbroncho®) is substantially equivalent to predicate devices (Mallinckrodt Broncho-Cath K771219 and Vitaid wire reinforced ET tube K932647) in terms of indications for use, environments of use, patient population, technology, design features, and materials (with some noted differences in material and sizes). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a performance study with a test set. This is a 510(k) submission focused on substantial equivalence.
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)
Not applicable. No performance study using a ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No performance study with adjudication is described.
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 device is a medical tube, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical tube, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No performance study requiring a ground truth is described.
8. The sample size for the training set
Not applicable. The document does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established
Not applicable. The document does not describe a machine learning algorithm or a training set.
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).