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The Cuffix is intended to measure and regulate, through passive control, the intracuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supraglottic airways). The device is intended for single patient use, under medical supervision in hospital (EMS), extended care facilities or outpatient clinics, where a patient may be intubated.

The Cuffix is a battery-operated cuff pressure controlling device which is intended to be used with ventilation tubes (ETT, Tracheostomy, LMA) It is a single patient-use, non-sterile device designed to be used continuously for up to 14 days. The device is connected to the pilot balloon of airways with inflatable air-filled cuffs via the device's extension line. The operating range of the Cuffix is 0-99 cmH2O. The device body houses the passive pressure mechanism component as well as the active pressure monitoring mechanism which displays the cuff pressure on the digital screen. An indicator light provides an additional visual aid to indicate whether the cuff pressure is at the correct pressure (green) or is the pressure is out of the set range (red). The elastic band hanger allows to attach the Cuffix as needed (e.g., to the ventilation circuit, the patient bed rail, etc.).

This document is a 510(k) Pre-market Notification for the Cuffix device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with human-in-the-loop or standalone AI performance. Therefore, many of the requested details, particularly those related to AI algorithm validation (like MRMC studies, training/test set sample sizes for AI, expert adjudication, etc.), are not present in this document.

However, based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail table format. Instead, it describes performance characteristics and compares them to predicate devices. The closest to acceptance criteria are the "Accuracy" and "Cuff pressure intended use range" specifications.

Note: The table above is constructed from the comparative table provided in the document. The "Acceptance Criteria (Implied)" column reflects what the Cuffix device aims to achieve, as demonstrated by its own specifications.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Animal and clinical performance data was not included." This implies there was no "test set" in the context of clinical data for performance evaluation in human subjects. The comparative testing mentioned appears to be non-clinical (e.g., bench testing, laboratory evaluations).

Therefore, information on sample size for a clinical test set and data provenance (country, retrospective/prospective) is not available in this document.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since no clinical test set or human-in-the-loop study involving interpretations (e.g., radiology images) was performed, there were no experts used to establish ground truth in the context of diagnostic or clinical assessment.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This is a device for measuring and regulating tracheal tube cuff pressure, not an image-based diagnostic AI device. The comparison is primarily against predicate devices based on technical specifications and non-clinical performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

The Cuffix is a hardware device with an active pressure monitoring and passive pressure regulation mechanism. It is not an AI algorithm in the sense of a standalone diagnostic or predictive AI. Its "performance" is based on its physical properties and mechanical/electronic accuracy.

7. Type of Ground Truth Used

The "ground truth" for the Cuffix device's performance would have been established through:

• Bench testing: Using calibrated pressure sensors/manometers as a reference standard to verify the Cuffix's pressure measurement accuracy.
• Engineering specifications and tests: For characteristics like battery life, response time, kinking resistance, etc.

It is not expert consensus, pathology, or outcomes data in the clinical sense, as the evaluation is primarily focused on the device's physical and functional performance, not its diagnostic or clinical interpretation capabilities.

8. Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device that involves a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is not an AI/machine learning device.

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