(130 days)
The Accucuff Cuff Pressure Indicator is intended to monitor intra-cuff pressures of endotracheal, supraglottic airways or tracheostomy tubes. The device is indicated for the patients from pediatric to adult who have an artificial airway and for which the user would like to monitor cuff pressure.
The Accucuff™ Cuff Pressure Indicator is intended to monitor the cuff pressure of endotracheal, supraglottic airways or tracheostomy tubes. It is designed with different color coded zones to indicate the normal, negative and positive pressure. The black marker on the device will be moved when the cuff pressure is changed. The device is available in 10-20 cmH2O, 20-29 cmH2O and 40-60 cmH2O three different models to accommodate the intended populations from pediatric to adult.
The provided text describes the Accucuff Cuff Pressure Indicator, a device intended to monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Here's an analysis of the acceptance criteria and study information, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a formal "acceptance criteria" table from a study, but rather a comparison table (Table 1) outlining the proposed device's specifications against predicate devices, and then details of non-clinical tests performed. We can extract the relevant performance metrics and the proposed device's performance from these sections.
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate & Standards) | Reported Device Performance (Accucuff Cuff Pressure Indicator) |
|---|---|---|
| Pressure Range | Not explicitly stated as acceptance criteria, but compared to predicate ranges: Predicate 1: 0 | AC0100P: 10~20cm H2O |
| AC0100B: 20~29cm H2O | ||
| AC0100R: 40~60cm H2O (Available in three different models to cover different ranges) | ||
| Pressure Accuracy | Predicate 1: +/-5cm H2O up to 80cm H2O | |
| Predicate 2: +/-5% H2O up to 30cm H2O, +/-0.5cm H2O up @ 10cm H2O, +/-1cm H2O up @ 20cm H2O, +/-1.5cm H2O up @ 30cm H2O | 10~20cm H2O: +/-2cm H2O | |
| 20~29cm H2O: +/-2cm H2O | ||
| 40~60cm H2O: +/-4cm H2O (Stated as less than Predicate 2 in some ranges, but more than Predicate 1) | ||
| Biocompatibility | Conform with ISO 10993 requirements (implied by predicate, explicitly tested) | No cytotoxicity, No skin sensitization, No irritation. Conforms with ISO 10993-1, ISO 10993-5, ISO 10993-10. |
| Sterilization | Effective sterilization (implied by sterile predicate) | EO sterilization, 10^-6 SAL, established and validated per ISO 11135. |
| Conical Fitting | Compliance with ISO 594-1:1986 | Complies with ISO 594-1:1986. |
| Package Integrity | Maintain integrity (implied by ASTM standards) | Complies with ASTM F88/F88M-15 and ASTM F1929-15. Tested after accelerated aging. |
| Environmental Stability | Maintain performance after exposure to temp/transport (implied by tests) | Pressure Accuracy tested after exposure to cold and hot temperature. Performance maintained after Simulated Transportation Test. |
| Repeatability | Maintain consistent pressure accuracy (implied by "Repeatability Pressure Accuracy Test") | Test performed, results indicate compliance (details not provided, but implies acceptance). |
2. Sample Size for the Test Set and Data Provenance:
The document describes non-clinical tests, not human subject clinical trials. Therefore, there is no "test set" in the context of patient data (e.g., medical images, patient records). The samples used would be individual units of the Accucuff Cuff Pressure Indicator device. The specific number of devices tested for each non-clinical test (e.g., how many units for pressure accuracy, how many for biocompatibility) is not provided.
There is no data provenance related to country of origin of data or retrospective/prospective nature, as this was not a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. As this was a non-clinical device performance study, there was no "ground truth" to be established by human experts in a diagnostic or clinical context. The "ground truth" for the device's performance relies on objective measurements against established engineering and biocompatibility standards.
4. Adjudication Method for the Test Set:
Not applicable, as there was no test set requiring human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size:
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical study is included in this submission."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The Accucuff Cuff Pressure Indicator is a mechanical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI does not apply. The non-clinical tests evaluated the device's inherent mechanical performance.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical tests was established through:
- Established engineering and performance standards: Such as ISO 594-1 for conical fittings.
- Biocompatibility standards: ISO 10993 series for cytotoxicity, irritation, and skin sensitization.
- Packaging standards: ASTM F88/F88M-15 and ASTM F1929-15 for seal strength and leak detection.
- Internal design specifications: For characteristics like pressure range and accuracy, evaluated against the specified values.
- Reference measurements: The "Pressure Accuracy Test" and "Repeatability Pressure Accuracy Test" would have involved comparing the device's readings against a calibrated reference pressure measurement device.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
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).