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The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER is a disposable sterile dual purpose catheter designed to provide both the functions of suctioning and supplying oxygen into the patient's trachea through an endotracheal tube. The first function provides maximum suction efficiency into the airway without compromising sterility and patient safety. The second function provides additional gas flow into the airway for the purpose of improving alveolar ventilation prior to and immediately following suctioning.

The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER is a disposable sterile dual purpose catheter designed to provide both the functions of suctioning and supplying oxygen into the patient's trachea through an endotracheal tube. The first function provides maximum suction efficiency into the airway without compromising sterility and patient safety. The second function provides additional gas flow into the airway for the purpose of improving alveolar ventilation prior to and immediately following suctioning.

The provided 510(k) summary for the "DUAL PURPOSE CLOSED CATHETER" does not include specific acceptance criteria or detailed results from the performance testing. Instead, it makes a general statement about substantial equivalence.

Here's a breakdown of the information that is available and what is missing for your specific questions:

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

• Acceptance Criteria: Not explicitly stated in the provided text.
• Reported Device Performance: Not explicitly enumerated in the provided text beyond the general statement of "substantially equivalent."

The document states: "Based on the results of performance testing conducted at HAUSER Laboratories the Spirit Medical Systems. Inc. DUAL PURPOSE CLOSED CATHETER is substantially equivalent to the Jinotti™ Closed Suction/Oxygen Catheter Systems manufactured and distributed by MedCare Medical Group, Inc." This indicates that performance testing was done, but the details of what was tested, the specific metrics, and the acceptance thresholds are not included in this summary.

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

• Sample Size: Not specified.
• Data Provenance: The testing was "conducted at HAUSER Laboratories," but details regarding the type of samples (e.g., in vitro, animal, human), their origin, or whether the study was retrospective or prospective are not provided. Given the nature of a catheter, it's highly likely this involved in-vitro and/or animal studies rather than human clinical trials for a 510(k) submission, especially from this era.

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

• This question is largely irrelevant for a device of this type (a physical catheter) undergoing performance testing for substantial equivalence. The "ground truth" would likely be objective measurements from laboratory tests, rather than expert interpretation of images or other diagnostic data. Therefore, no information is provided.

4. Adjudication method for the test set

• Not applicable/provided for the reasons stated in point 3.

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

• MRMC Study: No.
• Effect Size: Not applicable. This device is a physical catheter, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a physical catheter, not an algorithm.

7. The type of ground truth used

• While not explicitly stated, for a physical medical device like a catheter seeking substantial equivalence, the "ground truth" for performance testing (likely flow rates, suction efficiency, material compatibility, strength, etc.) would be established through objective laboratory measurements and engineering standards, not expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI devices. The comparison is made against the predicate device's established performance characteristics.

8. The sample size for the training set

• Not applicable/provided. This refers to a physical device, not an AI model requiring a training set.

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

• Not applicable/provided.

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