(171 days)
The Well Lead Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
The Well Lead Endobronchial Tube is made of Polyvinylchloride and is available in sizes 28fr to 41fr. They are designated as double lumen tube with 2 cuffs and separate 15mm connectors for isolating and ventilating one lung during surgical procedures. The tubes contain an x-ray opaque line that runs through the tube making them detectable by x-ray.
The document provided is a 510(k) summary for the Well LEAD Endobronchial Tubes. It highlights the substantial equivalence of the device to previously cleared devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria through clinical performance.
Based on the provided text, here's what can be extracted and what is not available:
1. A table of acceptance criteria and the reported device performance:
The document states: "All testing that is required by the required standards has been performed. None clinical testing was performed and included standards such as ISO 5361, ISO 16628 and ISO 10993-1. The Well Lead Medical Instruments Endobronchial Tubes have been found to fall within the required limits of the testing."
This indicates that the acceptance criteria are defined by the required limits set forth in the referenced ISO standards. However, the specific quantitative acceptance criteria (e.g., maximum leak rate, specific material strength values) and the exact performance metrics achieved are not provided in the summary. The summary only gives a general statement that the device met these "required limits."
Therefore, a table with specific acceptance criteria and reported device performance cannot be fully constructed from the provided text.
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 explicitly states: "None clinical testing was performed."
- Sample size for test set: Not applicable, as no clinical testing was performed.
- Data provenance: Not applicable, as no clinical testing was performed.
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, as no clinical testing with ground truth establishment was performed. The evaluation relied on non-clinical performance and biocompatibility testing against established standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no clinical testing requiring adjudication was performed.
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 an endobronchial tube, not an AI-assisted diagnostic device, and no MRMC study was mentioned or required.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device, not an algorithm, and the evaluation was based on non-clinical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical studies requiring ground truth were performed. The "ground truth" for non-clinical testing would be the defined acceptable ranges and properties within the referenced ISO standards.
8. The sample size for the training set:
Not applicable, as no machine learning or AI component is described.
9. How the ground truth for the training set was established:
Not applicable, as no machine learning or AI component is described.
Summary of what can be inferred about acceptance criteria and "study" from the provided text:
The "study" that proves the device meets acceptance criteria consists of non-clinical performance testing and biocompatibility testing against recognized international standards.
- Acceptance Criteria Source: ISO 5361 (Anesthetic and respiratory equipment - Tracheal tubes and connectors), ISO 16628 (Tracheal tubes and other connection devices - Cuffs - Test methods for resistance to pressure and deflation), and ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process).
- Device Performance: The Well Lead Medical Instruments Endobronchial Tubes were found to "fall within the required limits of the testing." This is a qualitative statement indicating compliance.
- Type of Study: Non-clinical (bench testing) and biocompatibility testing.
- Clinical Data: Explicitly stated as "None clinical testing was performed."
- Basis for Equivalence: Substantial equivalence was claimed based on equivalent intended use, manufacturing materials, operating principles, and physical operational specifications compared to predicate devices (K771219 - Mallinckrodt Bronch-Cath and K051522 - Fuji Double Lumen Bron Tube).
In essence, for this specific device, the FDA cleared it based on demonstrating adherence to established non-clinical performance standards and substantial equivalence to existing devices, without requiring human clinical trials or AI-related performance studies.
§ 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).