Search Results

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.
Patient Population: Patients requiring one lung isolation.
Environment of Use: Hospitals-OR and ICU.

The "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)" consists of a bronchial blocker tube; advanced through an endotracheal catheter, and a joint connector, 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 document is a 510(k) summary for a medical device called the "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria through a clinical study.

Therefore, many of the requested elements (like sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable or not present in the provided text.

The document primarily details bench testing and biocompatibility testing to show that changes in materials did not adversely affect the device's safety and performance compared to the predicate device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative manner with pass/fail thresholds for clinical performance. Instead, it describes tests performed to ensure the "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)" is substantially equivalent to its predicate device due to material changes. The "reported device performance" is essentially that the modified device yielded "almost the same results" as the predicate device in these tests.

2. Sample size used for the test set and the data provenance (country of origin of the data, retrospective or prospective):

• Sample Size: Not specified for any of the bench or biocompatibility tests.
• Data Provenance: Not specified. The company is based in Japan, so it's likely the tests were conducted there, but this is not explicitly stated.
• Retrospective/Prospective: Not applicable. These were bench and lab-based tests, not clinical studies on human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. No human experts were used to establish ground truth for these engineering and material science tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No human adjudication was involved in these non-clinical tests.

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 blocker tube, not an AI-assisted diagnostic or imaging device. No MRMC study was performed.

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.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the bench tests (cuff pressure, burst testing, inflation retention), the "ground truth" was derived from the performance characteristics of the legally marketed predicate device. The goal was to show that the modified device's performance was "almost the same."
• For biocompatibility testing, the ground truth was established by standard biocompatibility testing protocols, and the results were compared to the predicate device, which had no prior biocompatibility concerns.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning device; therefore, there is no "training set."

9. How the ground truth for the training set was established:

• Not Applicable. No training set exists.

Ask a specific question about this device

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."

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.

Ask a specific question about this device