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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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The TRACOE® smart Cuff Manager is intended to maintain the HVLP (high volume low pressure) cuff pressure, of an endotracheal tube or tracheostomy tube, within the range of 20 to 30 cm H20 through passive control.

It is for single patient use, and indically ventilated or spontaneously breathing patients. It is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities or outpatient clinics and is suitable for interor intra-facility transport.

The TRACOE® smart Cuff Manager is an accessory device for high volume low pressure (HVLP) cuffed endotracheal/tracheostomy tubes to maintain the cuff pressure within a range of 20 cm H₂O to 30 cm H₂O. This device includes a spherical, hard shell (transparent) outer casing with an elastic inner balloon (blue), that is attached to a base housing with both a male and female luer connector. The male connector is inserted into the inflation line (pilot balloon valve of the endotracheal/tracheostomy tube HVLP cuff) and the female connector is attached to a cuff inflation device (syringe or cuff pressure monitor). When the TRACOE® smart Cuff Manager is connected to the cuff inflation line the inner balloon is inflated with a cuff inflation device until the balloon diameter is between 2/3 - 3/4 of the outer casing. The cuff inflation device is then removed from the TRACOE® smart Cuff Manager, and after a few minutes the cuff pressure is rechecked to confirm the cuff is properly inflated inner balloon of the TRACOE® smart Cuff Manager will act as a pressure reservoir, allowing the air to flow between the balloon and the endotracheal/tracheostomy cuff, through passive control, in order to maintain the pressure range.

When the endotracheal/tracheostomy tube cuff pressure increases, due to compression through patient motion, coughing etc., the surplus air flows slowly into the inner balloon of the TRACOE® smart Cuff Manager through the integrated damping function. The damping function prevents sudden changes in cuff pressure which could result in a gap between the trachea. When the cuff pressure is reduced (following the patient motion) the inner balloon will allow the stored air to freely flow (without damping) back into the endotracheal/tracheostomy tube cuff in order to reinstate the cuff pressure to the prescribed range of 20 cm H₂O to 30 cm H₂O.

The TRACOE® smart Cuff Manager is for single patient use, and provided sterile for ease of use when connecting in a sterile environment. The device is applicable for mechanically ventilated or spontaneously breathing patients under medical supervision in hospital (EMS), extended care facilities or outpatient clinics and is suitable for inter- or intra-facility transport.

The provided text describes the 510(k) premarket notification for the TRACOE® smart Cuff Manager. It details the device's intended use, its technical characteristics compared to predicate devices, and a summary of non-clinical testing performed to establish substantial equivalence.

Here's the information regarding acceptance criteria and the study that proves the device meets those criteria:

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

The document doesn't explicitly present a table of acceptance criteria and reported device performance in a numerical format. However, it states the key performance objective and describes how testing confirmed it.

The primary performance criterion for the TRACOE® smart Cuff Manager is to maintain the High Volume Low Pressure (HVLP) cuff pressure of an endotracheal tube or tracheostomy tube within the range of 20 to 30 cm H2O through passive control.

The reported device performance, demonstrated through non-clinical testing, is that the device successfully meets this criterion. The document states:

• "Mechanical testing confirmed luer connections, pressure reservoir filling, damping function and maintaining the cuff pressure range (20 cm H2O to 30 cm H2O) under multiple situations (e.g., extended time periods, cuff compression)."
• "Comparison testing with the predicate devices PressureEasy (K833327) and Lanz (K791045) included maintaining the cuff pressure during volume/pressure changes and over an extended period of time."
• "The results of this testing demonstrated that the TRACOE® smart Cuff Manager is substantially equivalent to the legally cleared predicate devices."
• "The TRACOE® smart Cuff Manager has passed all defined criteria."

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

The document describes non-clinical performance and mechanical testing, as well as comparison testing with predicate devices. However, it does not specify the sample size for these tests (e.g., how many devices were tested, how many testing cycles). The tests are performed on the device itself (TRACOE® smart Cuff Manager) and in comparison with predicate devices.

The data provenance is from non-clinical testing performed by the manufacturer, TRACOE medical GmbH, in Germany. The tests are inherently prospective as they are conducted specifically to validate the device's performance against predefined criteria.

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

This information is not applicable as the described study is a non-clinical performance and mechanical testing, not a study evaluating expert interpretation or clinical decision-making. The "ground truth" here is the physical measurement of cuff pressure and the device's ability to maintain it within a specified range, as measured by instruments.

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

This information is not applicable for non-clinical performance and mechanical testing. Adjudication methods are typically used in clinical studies involving expert reviews or subjective assessments, which is not the nature of the described tests.

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:

No, an MRMC comparative effectiveness study was not done. The device (TRACOE® smart Cuff Manager) is a passive mechanical device for maintaining cuff pressure, not an AI-assisted diagnostic or interpretive tool that would involve human readers. Clinical testing was explicitly stated as "not required to demonstrate substantial equivalence."

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

The described testing is essentially standalone performance testing of the mechanical device. The device operates through "passive control" without active human intervention once set up, making the non-clinical tests akin to standalone performance evaluations in a controlled environment.

7. The type of ground truth used:

The ground truth used for this device is physical measurement of cuff pressure. This is a quantitative, objective measurement taken by instruments to determine if the device successfully maintains the pressure within the specified range (20-30 cm H2O).

8. The sample size for the training set:

There is no training set mentioned or implied because this is a mechanical device, not a machine learning or AI algorithm that requires training data.

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

As there is no training set, this question is not applicable.

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