(274 days)
The COOPDECH Endobronchial Blocker Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
The "Coopdech Endobronchial Blocker Tube" consists of a bronchial blocker tube; advanced through an endotracheal catheter, and a joint connecting the bronchial blocker tube to the endotracheal catheter. A cuff, incorporated at the distal tip of the tube, is inflated to block the targeted bronchus.
The provided text describes a 510(k) premarket notification for the "Coopdech Endobronchial Blocker Tube". This is a medical device submission, which typically focuses on demonstrating substantial equivalence to a previously marketed device rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical analysis as might be seen for novel technologies or PMA submissions.
Therefore, the information requested (acceptance criteria, specific study details like sample size, ground truth, MRMC studies, etc.) is not explicitly present in the provided document in the format typically associated with such requests for AI/software-based medical devices or novel clinical devices.
The document discusses various engineering and bench tests performed to assure reliable design and performance, and then asserts substantial equivalence based on these tests and similar specifications to predicate devices. It does not describe a clinical study in the sense of comparing performance against specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) using a defined test set, ground truth established by experts, or AI performance metrics.
Here's an attempt to answer your questions based only on the provided text, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with numerical performance targets and reported results. Instead, it lists the types of tests performed and generally states that "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for use as a Bronchial Differential Ventilation Tube."
| Acceptance Criteria Category | Reported Device Performance Summary (from text) |
|---|---|
| Mechanical/Physical Properties | |
| Bond Strength | Analysis performed. |
| Deflection Angles | Analysis performed. |
| Cuff Pressure and Dimension at Various Inflation Volumes | Analysis performed. |
| Balloon Burst Strength | Testing performed. |
| Balloon Cuff Inflation Retention | Analysis performed (against internal specification). |
| Balloon to Shaft Bond | Evaluation performed. |
| Joint Connector Dimensions & Ports | Evaluation performed. |
| Gas Barrier Property | "at least equal to the Cook '7.0 Fr. Endobronchial Blocker' (K021920)." |
| Biocompatibility | Biocompatibility tests performed. |
| Sterility/Contamination | Endotoxin tests performed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the tests.
- Data Provenance: Not specified, but given the nature of the tests (bench/engineering tests), it's implied to be laboratory-generated data rather than clinical patient data. There's no mention of country of origin of data or whether it was retrospective/prospective.
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. The tests performed are engineering/bench tests (e.g., bond strength, burst testing); they don't involve expert-established ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication process is described as these are not clinical performance studies.
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 physical medical tube, not an AI or imaging diagnostic device. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the described tests, the "ground truth" would be established by engineering standards, physical measurements, and material specifications. For example, a "balloon burst test" 's ground truth would be the pressure at which the balloon bursts, measured against a specified threshold. This is not clinical ground truth from patient data.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
§ 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).