(172 days)
The device is intended for airway management by oral intubation and aid in the removal of subglottic secretions.
The proposed device, Endotracheal Tube is indicated for airway management and aid in the removal of subglottic secretions. The proposed device is available in ETT-X32 and ETT-X22 two types, the difference between these two types is that the ETT-X32 is provided with pressure indicator which is used to monitor intra-cuff pressure. Both two types are available in a series sizes from 6.0mm in an increment of 0.5mm. The proposed device is intended for adult, provided in sterile and single use.
The provided text describes the regulatory clearance of an Endotracheal Tube (K190274) and details some of the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices. However, it does not contain information about a study that uses 'acceptance criteria' in the context of device performance against specific metrics like accuracy, sensitivity, or specificity, which are typically found in clinical effectiveness studies or standalone algorithm performance evaluations for AI/ML devices.
The document focuses on demonstrating substantial equivalence through non-clinical testing (physical, mechanical, chemical, biocompatibility, sterilization, and packaging) and comparison to predicate devices, rather than a clinical effectiveness study with defined performance acceptance criteria.
Therefore, the following points will be addressed based on the available information, noting where the requested information is not present in the provided document:
1. A table of acceptance criteria and the reported device performance
The document provides a list of non-clinical tests conducted and states that the test results "met all design specifications" or "comply with related standards requirements" or "can meet the requirements of ISO 10993 series standards." However, it does not explicitly list quantitative acceptance criteria for each test and then report a specific numerical performance result against that criterion. Instead, it broadly states compliance.
Here's an example of the closest information available, framed as acceptance criteria and performance based on the general statements:
| Test Category | Specific Test / Parameter | Acceptance Criteria (Inferred from text) | Reported Device Performance (As stated in text) |
|---|---|---|---|
| Physical, Mechanical, Chemical | Dimension | Clause 5.2 of ISO 5361:2016 | "met all design specifications." |
| Material | Clause 5.3 of ISO 5361:2016 | "met all design specifications." | |
| Tracheal tube bevel | Clause 5.4 of ISO 5361:2016 | "met all design specifications." | |
| Tracheal tube cuffs | Clause 5.5 of ISO 5361:2016 | "met all design specifications." | |
| Inflating system for cuffs | Clause 5.6 of ISO 5361:2016 | "met all design specifications." | |
| Curvature of the tube | Clause 5.7 of ISO 5361:2016 | "met all design specifications." | |
| Radiopaque marker | Clause 5.8 of ISO 5361:2016 | "met all design specifications." | |
| Kink resistance | Clause 5.9 of ISO 5361:2016 | "met all design specifications." | |
| Conical connectors | Clause 5.1 of ISO 5356-1:2004 | "met all design specifications." | |
| Gauging | Clause 4.1 of ISO 594-1:1986 | "met all design specifications." | |
| Liquid leakage | Clause 4.2 of ISO 594-1:1986 | "met all design specifications." | |
| Air leakage | Clause 4.3 of ISO 594-1:1986 | "met all design specifications." | |
| Separation force | Clause 4.4 of ISO 594-1:1986 | "met all design specifications." | |
| Stress cracking | Clause 4.5 of ISO 594-1:1986 | "met all design specifications." | |
| Sterile Barrier Packaging | Seal strength | ASTM F88/F88-15 | "can maintain its integrity during transportation." and "can maintain the sterility of the product during its claimed shelf life" |
| Dye penetration | ASTM F1929-15 | "can maintain its integrity during transportation." and "can maintain the sterility of the product during its claimed shelf life" | |
| Sterilization & Shelf Life | EO residue | ISO 10993-7:2008 | Device complies with related standards. |
| ECH residue | ISO 10993-7:2008 | Device complies with related standards. | |
| Bacteria Endotoxin Limit | USP | Device complies with related standards. | |
| Shelf Life Evaluation | Verification of claimed shelf life through Physical, Mechanical, Chemical, and Package Tests on accelerated aging samples. | "can demonstrate that the package of the proposed device can maintain the sterility of the product during its claimed shelf life and the performance test result can meet the requirements of related standards." | |
| Biocompatibility | Cytotoxicity, Sensitization, etc. | ISO 10993 standards requirements (e.g., No Cytotoxicity, No Sensitization, No Irritation, No Systemic Toxicity, Non-mutagenic, Non-irritant to subcutaneous tissue, No pyrogen) | "can meet the requirements of ISO 10993 series standards." and specifically states "No Cytotoxicity", "No Irritation", "No Sensitization", "No Systemic Toxicity", "Non-mutagenic", "Non-irritant", "No pyrogen". |
| Simulated Transportation | Package integrity during transportation | ASTM D 4169 | "can demonstrate the device package can maintain its integrity during transportation." |
| Bond Strength | All joints bond strength | Unspecified acceptance criteria, but must "meet acceptance criteria." | "can meet acceptance criteria." |
| Air Flow Resistance | Comparison to equivalent device | No significant difference from equivalent device. | "have no significant difference between proposed device and equivalent device." |
| Sterilization Assurance Level | SAL | 10-6 | 10-6 |
| Pressure Range (ETT-X32 only) | Pressure range | $20cm H_2O \le P \le 29cm H_2O$ (matching predicate) | "identical to predicate device K160694" |
| Pressure Accuracy (ETT-X32 only) | Pressure measurement accuracy | $\pm 4cm H_2O$ at $20cm H_2O$ and $-4cm H_2O$ at $29cm H_2O$ (matching predicate) | "identical to predicate device K160694" for range and accuracy, implying these specific values are met. |
regarding clinical efficacy or AI/ML performance, is not discussed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical bench testing. For these tests, specific sample sizes are not explicitly provided (e.g., how many tubes were tested for kink resistance or biocompatibility). Data provenance in a geographic sense is not applicable as these are laboratory tests rather than human subject data. The tests are prospective in the sense that they were conducted for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable as the document describes non-clinical engineering and biological safety testing, not clinical studies requiring expert ground truth for interpretation (e.g., image annotation for an AI device).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the same reasons as point 3.
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
This question is not applicable. The device is an Endotracheal Tube, not an AI/ML-powered diagnostic or assistive tool. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests performed, the "ground truth" refers to the established international and national standards (e.g., ISO 5361, ISO 10993, ASTM standards, USP). Compliance with these standards serves as the "ground truth" for confirming the physical, mechanical, chemical, and biological safety and performance of the device.
8. The sample size for the training set
This question is not applicable as the device is not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).