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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:

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.

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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.

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.

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The Sterile Disposable Endotracheal Tube device is intended for oral or nasal intubation and for airway management.

The Accu-Cuff device is intended to inflate cuffs and to monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes.

The tracheal tube is disposable and supplied as sterile. It is available in a number of sizes/variants. The tracheal tube is primarily made of polyvinyl chloride. The device is used for airway management by connecting to oxygen delivery equipment via a connector. Reinforced ETTs may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. All variants have a radio-opaque line embedded into the tube which enables identification the device when the patient is X-rayed. All variants have a hole at the tip called a Murphy's eye and a standard connector.

Cuffed variants are composed of an inflatable cuff, a lumen and pilot balloon with a one-way valve or pressure indicator. The cuff is specified with high volume and standard volume which is intended to be inflated in the trachea in order to seal the device to prevent loss of gas bypassing the tube and the inhalation of vomit.

The patient end, the cuff and the tubular body of these tracheal tubes have short-term contact (

The provided text is a 510(k) summary for a Disposable Endotracheal Tube, Sterile, and Accu Cuff™. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and detailed device performance through a standalone study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, and training set details for an AI/algorithm-based device is not available in this document.

However, based on the information provided, I can extract details about the performance data and testing standards used to demonstrate equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative table with corresponding "reported device performance" in the context of an AI/algorithm. Instead, it compares the specifications of the proposed device to predicate devices to establish substantial equivalence.

For the Accu Cuff™, the key performance criterion mentioned is the working pressure range.

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