(185 days)
The CuffTrek is intended to measure and regulate the intracuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supractottic airways). The device is intended for single patient use from pediatric to adult, under medical supervision in hospitals, prehospital (EMS), extended care facilities and outpatient clinics, where a patient may be intubated. It is for disposable single patient use.
The device is a battery-operated cuff pressure-controlling device 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 7 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 device is 0-99 cmH2O. The device body houses 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 or if the pressure is out of the set range of 20-30 cmH2O (red).
The provided text is a 510(k) summary for the device "CuffTrek," an inflatable tracheal tube cuff pressure regulator. It outlines the device's characteristics, indications for use, comparison to predicate devices, and performance testing.
However, the document primarily focuses on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, rather than detailing a clinical study with a rigorously defined acceptance criteria table and performance study results as requested in the prompt. The document explicitly states "Clinical Study: Not applicable."
Therefore, I cannot extract the information required for a comprehensive answer regarding acceptance criteria and a study proving the device meets them via a clinical study. The document describes non-clinical performance testing.
If the request refers to non-clinical acceptance criteria and performance data, I can extract information related to accuracy, response time, and the types of tests conducted. Based on the provided text, here's what can be extracted for non-clinical performance:
Non-Clinical Performance Criteria and Reported Device Performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Accuracy: ±2 cmH2O | Accuracy: ±2 cmH2O (Identical to Predicate) |
| Operating Range: 0-99 cmH2O | Operating Range: 0-99 cmH2O (Identical) |
| Cuff Pressure Range: 20-30 cmH2O | Cuff Pressure Range: 20-30 cmH2O (Identical) |
| Alarm when pressure is out of range | Yes - blinking red light (Same as reference device) |
| Continuous monitoring of cuff pressure | Yes (Same as reference device) |
| Inflation by syringe function | Yes (Identical) |
| Connection to pilot balloon using luer connector | Yes (Identical) |
| Operation time | up to 7 days (Verified by performance test) |
| Fluid leakage resistance | Test conducted, expected to comply with requirements |
| Sub-atmospheric pressure air leakage resistance | Test conducted, expected to comply with requirements |
| Stress cracking resistance | Test conducted, expected to comply with requirements |
| Resistance to separation from axial load | Test conducted, expected to comply with requirements |
| Resistance to separation from unscrewing | Test conducted, expected to comply with requirements |
| Resistance to overriding | Test conducted, expected to comply with requirements |
| Response time | Test conducted, expected to comply with requirements |
| Repeatability pressure accuracy | Test conducted, expected to comply with requirements |
| Pressure accuracy exposure to cold and hot temperature | Test conducted, expected to comply with requirements |
| Inflation and deflation functions | Test conducted, expected to comply with requirements |
| Battery Shelf Life | Test conducted, expected to comply with requirements |
Regarding the other points of the prompt, based on the provided text:
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Sample sizes used for the test set and the data provenance:
- The document mentions "Performance Testing" and "Non-Clinical Study" but does not specify the sample sizes (e.g., number of devices, number of measurements) for these tests.
- Data provenance: Not explicitly stated, but implies laboratory testing of the device. Given the manufacturer's address in Shanghai, China, the testing could have occurred there or elsewhere. It is non-clinical performance data, not patient data (retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was a non-clinical device performance study, not a study involving expert human interpretation or ground truth establishment from patient data.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this was a non-clinical device performance study, not a study involving expert human interpretation.
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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, a MRMC study was not done. The document explicitly states "Clinical Study: Not applicable." This device is a measurement and regulation device, not an AI diagnostic tool requiring human reader studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, performance testing of the device itself (analogous to "standalone" for a physical device) was done. This includes tests like accuracy, response time, fluid leakage, etc. The results are summarized in the table above where specific values are mentioned (e.g., accuracy ±2 cmH2O). The document states that "Non-clinical tests were conducted to verify that the proposed devices met all design specifications."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance tests, the "ground truth" would be established by calibrated laboratory standards and measurement equipment, comparing the device's output to known inputs or reference measurements. For example, for pressure accuracy, the device's reading would be compared against a high-accuracy reference pressure meter.
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The sample size for the training set:
- Not applicable. This is not a machine learning/AI model that requires a "training set." It is a physical medical device.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this physical device.
§ 868.5750 Inflatable tracheal tube cuff.
(a)
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.(b)
Classification. Class II (performance standards).