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The EZ-Blocker is indicated for use to intubate the patient's bronchi in order to differentially isolate the left or right lung for procedures which require one-lung ventilation, lung separation. Patient population: Patients requiring one lung isolation. Environment of use: Hospitals - OR and ICU.

The EZ-Blocker is a double lumen endobronchial tube made of polymer materials and inks. The distal part of the tube ends in a "y" shape with distal extensions for each branch of the lung. The extensions are symmetrical and colored differently (blue and yellow) for identification purposes. The device is supplied with an adapter for connection to a ventilator device. The symmetrical design facilitates introduction and positioning of the device in both main stem bronchi. When properly positioned, the cuff in the main stem branches of the non-ventilated lung can be inflated and lung isolation is achieved.

The provided text describes the EZ-Blocker, a tracheal/bronchial differential ventilation tube, and its submission for 510(k) clearance. The focus of the submission is to demonstrate substantial equivalence to a predicate device (Cook Inc. Endobronchial Blocker, K021920) rather than presenting a study where specific performance metrics are defined as acceptance criteria and then proven through a clinical or stand-alone algorithm study.

Therefore, the information requested regarding acceptance criteria for device performance, study details, sample sizes, expert involvement, and ground truth establishment primarily focuses on the physical and functional characteristics of the device as tested in a laboratory setting, and the biocompatibility tests, rather than a performance study involving a specific outcome measure like accuracy, sensitivity, or specificity.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated for each test (biocompatibility, function, leakage, bond strength, balloon verification, gas barrier). These are typically bench tests performed on a representative sample of manufactured devices.
• Data Provenance: The tests appear to be conducted by the manufacturer or a contracted lab ("CMI performed Balloon Verification Test"). The source of the data is the device manufacturer, EZ-Blocker B.V. The data is prospective for these engineering and lab tests, done specifically for the 510(k) submission. There is no mention of country of origin for test data, except for the manufacturing company (The Netherlands).

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

• This is not applicable to the type of studies presented. These are engineering and bench tests, not clinical studies involving expert interpretation of medical data (e.g., images). The "ground truth" for these tests are objective measurements and pass/fail criteria based on engineering standards and regulatory requirements.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like "2+1" are used in studies involving subjective assessment (e.g., by multiple readers of diagnostic images). These laboratory and engineering tests have objective outcomes (e.g., a burst pressure, a leakage rate, a pass/fail for cytotoxicity).

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 is not a study of an AI or diagnostic imaging device. It's an invasive medical device for lung isolation during surgery.

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

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• The "ground truth" for the device's characteristics are objective measurements against established engineering and biocompatibility standards.
  • Biocompatibility: ISO 10993-1 standards (e.g., cell viability in cytotoxicity tests).
  • Function, Leakage, Bond Strength: Manufacturer's internal specifications and performance requirements validated through testing.
  • Balloon Verification: Measurement of physical properties like diameter, and observable events like leakage, collapsing, and burst, against defined acceptance criteria.
  • Gas Barrier Property: Measurement of gas volume over time.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. No training set is involved.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" presented is a series of bench testing and laboratory evaluations conducted by the manufacturer (EZ-Blocker B.V.) and a testing facility (CMI) to demonstrate the physical and biological characteristics of the EZ-Blocker. These tests were performed to show that the device meets safety and performance requirements, primarily for demonstrating substantial equivalence to a predicate device.

The document states: "The EZ-Blocker has been tested and confirmed safe under ISO 10993-1 biocompatibility requirements. The assembly is validated for function, leakage, and bond strength. The device is confirmed safe and effective as a device used in standard medical practice."

This implies that for each specified characteristic (biocompatibility, function, leakage, bond strength, balloon integrity, gas retention, shelf life), individual tests were performed, and the results met predetermined internal or industry-standard acceptance criteria. The specific details of these test protocols (e.g., number of units tested per batch for quality control, specific numerical thresholds for "passing" a burst test) are not provided in this summary, but the overall conclusion is that the device "passed."

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