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The SCIS will be used to inflate to 25±2 cmH2O the cuff of a high-volume, low-pressure endotracheal tube that has been intubated by a trained medical professional.

The Spiritus Cuff Inflation Syringe (SCIS) is a disposable syringe that will initially inflate the cuff on an endotracheal tube (ETT) to a pressure of 79 cmH2O ± an average standard deviation of 9 cmH2O to create a proper seal with the patients trachea and then automatically decrease the pressure in the cuff to a final pressure of 25cm H2O ± an average standard deviation of 2 cmH2O. The SCIS is designed in the form of a syringe to reflect current practice of using a syringe to inflate the cuff. The device is made of medical grade ISO approved plastic material. The SCIS is intended as a single patient use disposable device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Spiritus Cuff Inflation Syringe (SCIS)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided text is a 510(k) summary and discusses substantial equivalence to predicate devices rather than detailing a dedicated study with acceptance criteria and results. The "reported device performance" above is derived from the device description and the claim of achieving these specific pressure outcomes automatically. The 510(k) process focuses on demonstrating substantial equivalence, not necessarily on a formal study proving acceptance criteria in the same way a PMA would.

The provided document is a 510(k) Summary, which is a premarket notification to the FDA. For such submissions, a comprehensive "study" proving device performance against detailed acceptance criteria, especially for a new technology, is often not presented in a single, dedicated clinical trial report within the summary. Instead, the focus is on demonstrating substantial equivalence to already legally marketed predicate devices.

Based on the document, the "study" demonstrating the device meets the acceptance criteria is implicit within the technical description and comparison to predicate devices:

Study Type (Implicit): Technical performance evaluation/bench testing demonstrating the automatic inflation and pressure reduction capabilities of the device. This is inferred from the declarative statements about the device's function and the comparison against predicate devices which also achieve specific pressure ranges.

Specific Information Points:

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 explicitly stated. The document describes the device's intended performance and capabilities, and compares it to predicate devices. It does not provide details of a specific test set size (e.g., number of devices tested, number of inflation cycles).
   • Data Provenance: Not specified. This would typically be from bench testing conducted by the manufacturer, but no details are given. It is not mentioned as clinical data (retrospective or prospective) from patient use.

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):

   • Number of Experts: Not applicable/not specified. The device's performance (pressure inflation/reduction) is a physical measurement, not a subjective interpretation requiring expert consensus on a "ground truth" in the diagnostic imaging sense.

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

   • Adjudication Method: Not applicable/none. As this is a mechanical device performing a specific physical function, expert adjudication of results in the traditional sense is not relevant. The device's internal mechanics are designed to achieve the specified pressure through engineering rather than human judgment.

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. This is a medical device (syringe for cuff inflation), not a diagnostic algorithm or AI-powered tool. An MRMC study is not applicable.

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

   • Standalone Performance: Yes, implicitly. The device is designed to automatically perform the inflation and pressure reduction. The human simply operates the syringe; the mechanical design handles the pressure regulation automatically. The text states: "the SCIS device establishes high and low cuff pressures automatically" and "Automatically set by device mechanical design."

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

   • Type of Ground Truth: Mechanical measurement of physical pressure. The "ground truth" for the device's function is the absolute pressure within the cuff, measured by appropriate pressure sensors during design and testing.

8. The sample size for the training set:

   • Sample Size for Training Set: Not applicable. This is a mechanical device, not an AI or machine learning algorithm that requires a "training set."

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

   • Ground Truth for Training Set: Not applicable. As above, no training set or AI is involved.

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