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The Bivona® Tracheostomy Tube is intended to provide direct airway access for a tracheostomized patient up to 29 days. It may be reprocessed for single-patient use up to 10 times for adults sizes and up to 5 times for pediatric sizes.

The Bivona® Tracheostomy Tubes are sterile, single patient use, silicone tracheostomy tubes. They come in a variety of configurations for adults, pediatric and neonatal patients. They come cuffed (TTS®, Aire-Cuf® or Fome-Cuf®) or cuffless. The tubes may be wire reinforced or plain silicone. Each tube is individually packaged in a peel-open tray with an obturator, decannulation cap, twill tape, and a disconnection wedge if appropriate. Additionally, a range of customizable options are offered allowing the clinician to create a tracheostomy tube to meet a specific patient's needs.

The purpose of this submission is to include the use of properly placed Bivona® Tracheostomy Tubes in the MRI environment. No changes have been made to the devices themselves.

The Bivona® Tracheostomy Tube’s acceptance criteria for MR-Conditional status were based on the ASTM F2503-05 standard. The study involved bench testing that confirmed the device's performance against these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified as a distinct "sample size" in the document. The document states "Bench testing confirms that the Bivona® cuffless and Fome-Cuf Tracheostomy Tubes with wire reinforcement and Bivona® cuffed Tracheostomy Tubes (Aire-Cuf® or TTS®) with or without wire reinforcement have been determined to be MR-Conditional..." This implies testing was conducted on representative samples of each specified configuration of the Bivona® Tracheostomy Tube.
• Data Provenance: The study was a non-clinical bench test. There is no information regarding country of origin or whether it was retrospective or prospective in the context of patient data, as no patient data was used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth was established by adherence to the ASTM F2503-05 standard for MR-Conditional status through bench testing, not through expert consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical bench test against a standardized technical specification (ASTM F2503-05), not a study involving human interpretation or 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 was not an AI device or a study involving human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This was not an algorithm or AI device.

7. The Type of Ground Truth Used

The ground truth used was the ASTM F2503-05 standard for determining MR-Conditional and MR-Safe status. The device's physical properties and behavior under specified MRI conditions were directly measured and compared against the limits defined by this standard.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" as this was a non-clinical bench test, not a machine learning or AI study.

9. How the Ground Truth for the Training Set was Established

Not applicable. There was no training set.

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