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The ETView Viva EB is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.

The ETView Viva EB is designed to administer one-lung ventilation, by using a conventional endotracheal tube and a fiber optic bronchoscope. The device consists of a bronchial blocker tube, advanced through an endotracheal tube, 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 the ETView Viva EB, an endobronchial blocker. This type of regulatory submission primarily focuses on establishing "substantial equivalence" to predicate devices, rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way a clinical trial for a novel drug or a high-risk device might.

Therefore, the information available in the document does not include the detailed breakdown of acceptance criteria and a study proving those criteria were met in the typical sense for an AI/algorithm-based device. Instead, it focuses on demonstrating that the device is as safe and effective as previously cleared devices through performance testing against established standards and a comparison of features.

Here's an analysis based on the provided text, addressing your points where possible, and noting limitations:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" and "reported device performance" in a quantitative table format for a clinical outcome. Instead, it states that the device was tested and complies with several ISO/ANSI standards. These standards inherently contain performance criteria that must be met. The "Performance Testing" section lists the types of tests conducted, implying that the device met the requirements outlined in those tests and standards.

Since specific quantitative acceptance criteria and their corresponding reported performance values are not provided in the text for clinical outcomes, I will list the types of performance tests conducted, implying they met the underlying standard requirements.

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 describes performance testing which refers to engineering and bench testing relevant to the physical properties and functionality of the device (e.g., cuff strength, dimensions, inflation). It does not describe a clinical study in humans or animals with a "test set" sample size for evaluating clinical efficacy or safety in a patient population. Therefore, this information is not available in the provided text. The "data provenance" similarly refers to the bench testing environment, not patient data.

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)

This N/A. The testing described is physical performance testing, not involving expert interpretation or "ground truth" establishment in a clinical context.

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

This N/A for the same reasons as above.

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 N/A. The device is an endobronchial blocker, a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This N/A. The device is a physical medical device, not an algorithm.

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

For the physical performance tests, the "ground truth" would be established by the engineering specifications and established standards (e.g., ISO 5361). The device's performance is compared against these predetermined specifications to ensure compliance.

8. The sample size for the training set

This N/A. The device is a physical medical device, and the testing described is not related to machine learning or AI.

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

This N/A. (See point 8)

Summary of what the document does provide regarding meeting criteria:

The primary method for "proving" the device meets acceptance criteria, in the context of this 510(k) submission, is through:

• Compliance with recognized international standards: ISO 5361:1999, ANSI/AAMI/ISO 11135-1:2007, ISO 14971-1:2007, and ISO 10993-1:2003(E). These standards define performance and safety requirements.
• Performance Testing: A series of specific engineering tests (listed under "Performance Testing" in section {2}) were conducted to demonstrate that the device functions as intended and meets the requirements stipulated by the standards, and is comparable to predicate devices.
• Substantial Equivalence: The overarching study and argument is that the Viva EB is "as safe and effective as the cleared predicate devices" and that its "minor differences...do not raise any new questions of safety or efficacy." This is the core of a 510(k) submission.

In essence, for this type of device and regulatory pathway, the "acceptance criteria" are the requirements outlined in the referenced standards and the implicit performance demonstrated by predicate devices, and the "study" is the battery of engineering/bench tests confirming the device's physical properties and functionality meet these criteria.

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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.

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