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Rusch Endobronchial Tubes are 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 Rusch Endobronchial Tube is a sterile, single patient use PVC Double-Lumen Endobronchial Tube (also referred to as a DLT) that is inserted into the trachea via the mouth in order to selectively ventilate one lung. The Endobronchial tube is sold with or without accessories, contains a stylet and is available in Robertshaw, Carlens and White styles.

The provided text describes a 510(k) premarket notification for the "Rusch Endobronchial Tubes." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical acceptance criteria through a comparative effectiveness study or AI-related metrics.

Therefore, many of the requested categories in your prompt are not applicable to this document. This submission does not involve AI, machine learning, or complex diagnostic performance evaluation against an established ground truth in the way your prompt implies.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted to demonstrate substantial equivalence to predicate devices, focusing on physical and mechanical properties. It doesn't present "acceptance criteria" in the sense of accuracy, sensitivity, or specificity for a diagnostic algorithm, nor does it provide specific numerical "reported device performance" against those criteria. Instead, it describes the principle of the test to ensure the device functions as intended and is safe.

| Test | Principle of Test | Acceptance Criteria (Implied) | Reported Device Performance |
|-------------------------------|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Connector bonding strength | The security of the attachment of the connector to the Endobronchial tube is tested by applying an axial separation force to the connector | Must meet specified force without separation (per ISO 5356) | Meets requirements for safe and effective use. |
| Cuff resting diameter | The resting diameter of the cuff is measured when the cuff is inflated to a reference pressure which is intended to remove creases but minimize stretching of its walls | Must fall within acceptable diameter range (per ISO 5361) | Meets requirements for safe and effective use. |
| Tube collapse | The patency of the Endobronchial tube airway lumen is tested by passing a steel ball through the Endobronchial tube lumen with the cuff inflated within a transparent tube | Steel ball must pass without obstruction (per ISO 5361) | Meets requirements for safe and effective use. |
| Cuff herniation | The tendency of the cuff to herniate beyond the plane perpendicular to the long axis of the tube at the nearest edge of the bevel is tested by applying an axial force with the cuff inflated within a transparent tube. A cuff which protrudes excessively at its patient end may partially or completely occlude the orifice at the patient end | Cuff protrusion must be within acceptable limits to prevent occlusion (per ISO 5361) | Meets requirements for safe and effective use. |
| Cuff Burst Evaluation | The cuff restrained burst test is designed to ensure the cuff will not burst or rupture when inflated inside the trachea | Cuff must not burst or rupture under specified inflation pressure inside the trachea. | Meets requirements for safe and effective use. |
| Cuff Bond Strength | To evaluate the strength needed to separate the cuff from the tube | Cuff must remain bonded to the tube under specified force. | Meets requirements for safe and effective use. |
| Side arm bonding strength | To evaluate the retention force of the inflation line connection to the Endobronchial tube | Inflation line connection must be retained under specified force. | Meets requirements for safe and effective use. |

Note: The phrase "Meets requirements for safe and effective use" is an interpretation based on the "Substantial Equivalence Conclusion" stating that "Performance test results demonstrate that the proposed device meets its intended use." Specific numerical results for each test are not provided in this summary.

The following sections are NOT applicable to the provided document, as it pertains to a traditional medical device (endobronchial tube) and not an AI/ML powered device or diagnostic tool.

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
  • Not applicable. Physical device testing typically involves a set number of manufactured units, not a "test set" of 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)
  • Not applicable. "Ground truth" in the context of diagnostic interpretation by experts is not relevant here.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
  • Not applicable. No expert adjudication process is described for this type of device.
• 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 explicitly for AI-assisted diagnostic studies, which this is not.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
  • Not applicable. There is no algorithm here.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
  • Not applicable. For mechanical testing, the "ground truth" is typically the physical measurement against a standard or specification.
• 8. The sample size for the training set
  • Not applicable. There is no "training set" for this type of device.
• 9. How the ground truth for the training set was established
  • Not applicable. There is no "training set" or corresponding ground truth.

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