(175 days)
To measure, and regulate intra-cuff pressures of endotracheal supraglottic airways or tracheostomy tubes. The PYTON is intended for use on patients who are intubated. The PYTON is to be used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities and outpatient clinics where a patient may be intubated.
The PYTON measures the ETT cuff pressure, and automatically adjusts the air pressure inside the ETT Cuff to a level selected by the user who is intended to be a professional respiratory practitioner. Room air is the "fluid" that is utilized to inflate the ETT Cuff, so there is not any use of (or contact to) any of the patient's biological fluids by the PYTON. The monitoring function is achieved by use of a pressure sensor. The automatic ETT cuff pressure regulation is achieved by activation of either a small air pump (of the same type used in many automatic blood pressure cuff measurement systems) in order to raise the ETT cuff pressure, or by activation of a "dump" valve to lower the ETT cuff pressure. The PYTON provides an LED back-lit LCD digital display to report the ETT cuff pressures to the user, and four pushbuttons that provide the user with the ability to select the target ETT cuff pressure, and check battery charge level. The PYTON includes a mechanical pressure relief valve as a safety precaution that ensures a maximum ETT cuff pressure (in the case of a PYTON failure) to a level of 1.5 p.s.i. (105 cmH2O) +/-20%. The PYTON includes a battery back-up power supply allowing the PYTON to be used for up to 10 hours without mains power.
The provided text describes the PYTON ETT Cuff Pressure Regulator and its performance testing. However, it does not explicitly detail a study involving a "test set" with expert ground truth, adjudication methods, or a multi-reader multi-case (MRMC) comparative effectiveness study, as would typically be associated with AI/ML device evaluations.
The document focuses on substantiating substantial equivalence to predicate devices through technical comparisons and standard engineering performance tests.
Here's an attempt to extract and synthesize the information based on your request, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute/Description | Acceptance Criteria (PYTON Design Requirement/Goal) | Reported Device Performance (PYTON) |
|---|---|---|
| Cuff Pressure Regulation Accuracy | +/- 2 cmH2O (target "SET" point pressure) | Achieved +/- 2 cmH2O |
| Accuracy of Cuff Pressure Measurement | +/- 1 cmH2O | +/- 1 cmH2O (validated via Bench Tests) |
| Range of Measured Cuff Pressure | 0 to 85 cmH2O | 0 to 85 cmH2O |
| Electrical Safety | Meets EN 60601-1 | Meets EN 60601-1 |
| EMC Testing | Meets EN60601-1-2 | Meets EN60601-1-2 |
| Software Validation | Meets FDA Guidance | Meets FDA's Guidance for Premarket Submissions for Software |
| Electrical, Mechanical, Environmental Testing | Meets FDA Draft Reviewer Guidance (1993) | Meets FDA Draft Reviewer Guidance (1993) |
| Safety Valve (Max ETT Cuff Pressure) | 1.5 p.s.i. (105 cmH2O) +/- 20% | Includes mechanical safety relief valve to this level |
| Battery Back-Up Operating Time | Up to 10 hours | Up to 10 hours |
2. Sample size used for the test set and the data provenance
The document refers to "Bench Tests" for validation of the accuracy of cuff pressure measurement but does not specify the sample size (number of measurements, number of devices tested, number of ETT cuffs used) or the data provenance (e.g., country of origin, retrospective/prospective). The overall testing seems to be an engineering validation rather than a clinical study with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an ETT cuff pressure regulator, and its performance is assessed against physical measurements and engineering standards, not against expert interpretation of medical images or clinical outcomes.
4. Adjudication method for the test set
Not applicable, as there is no expert-driven ground truth requiring adjudication.
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
Not applicable. This device is not an AI-powered diagnostic tool, but rather a medical device for regulating ETT cuff pressure. The document does not describe any MRMC studies or AI involvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as the PYTON is a physical device that monitors and regulates pressure, not an algorithm, and is intended for use by a "professional respiratory practitioner."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the PYTON's performance is based on physical measurements using calibrated instruments and adherence to established engineering and safety standards (e.g., EN 60601-1, EN60601-1-2, FDA Guidances). For accuracy of cuff pressure measurement, the ground truth would be the actual pressure as measured by a highly accurate reference pressure sensor.
8. The sample size for the training set
Not applicable. The PYTON is not an AI/ML device that requires a training set. Its functionality is based on mechanical, electrical, and software engineering principles.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this 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).