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For use as a one-way speaking valve hetween a tracheostomy tube and ventilation equipment.

Montgomery Tracheostomy Speaking Valves are designed to offer ventilator dependent patients the opportunity to speak without having to wait for the ventilator to cycle, allowing patients to speak during inspiration and expiration without interruption. The valve is placed in-line between the tracheostomy tube and the ventilator and features a thin silicone diaphragm which opens on inspiration and closes on expiration.

This 510(k) summary for the Montgomery Tracheostomy Speaking Valve (15mm / 22mm) does not contain the detailed clinical study information typically required to describe acceptance criteria and device performance in the way you've outlined for AI/diagnostic devices. The provided document focuses on manufacturing and pre-market clearance for a mechanical medical device, rather than a diagnostic algorithm or imaging interpretation system.

Therefore, many of the requested elements (like sample size for test sets, expert ground truth, MRMC studies, standalone algorithm performance, training set details, etc.) are not applicable to this submission.

However, I can still extract what information is available and indicate where information is missing or not relevant based on the provided text.

Device: Montgomery Tracheostomy Speaking Valve (15mm / 22mm)

Description: Montgomery Tracheostomy Speaking Valves are designed to offer ventilator-dependent patients the opportunity to speak without having to wait for the ventilator to cycle, allowing patients to speak during inspiration and expiration without interruption. The valve is placed in-line between the tracheostomy tube and the ventilator and features a thin silicone diaphragm which opens on inspiration and closes on expiration.

Indications For Use: For use as a one-way speaking valve between a tracheostomy tube and ventilation equipment.

1. A table of acceptance criteria and the reported device performance

Given the nature of this device (a mechanical valve), the "acceptance criteria" discussed are related to manufacturing quality and dimensional standards, not diagnostic performance metrics like sensitivity or specificity.

Note: The document only states that these tests are performed. It implies the product meets these criteria for market release but does not provide quantitative "performance" data in the context of, for example, a diagnostic accuracy study.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The document states "Each valve is visually inspected..." and "Each valve is tested...", which suggests 100% inspection/testing as part of manufacturing quality control, rather than a statistical sample for a clinical study.
• Data Provenance: Not applicable in the context of this device's testing. The testing described is manufacturing quality control.
• Retrospective/Prospective: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable. Ground truth in this context would be objective physical measurements and visual inspection against specifications.
• Qualifications of Experts: Not applicable. Manufacturing inspection personnel would perform these checks.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. The testing described involves direct measurement and visual inspection against defined standards.

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

• MRMC Study: No, this is not applicable for a mechanical tracheostomy valve. This type of study is relevant for diagnostic systems where human interpretation is involved.

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

• Standalone Performance: No, this is not applicable. The device is a mechanical valve, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: The ground truth for this device's testing involves established engineering standards and visual inspection criteria, specifically:
  • Absence of visible defects.
  • Conformance to ISO 5356-1 for 15mm and 22mm connections (dimensional accuracy).
  • Implied functional performance (opening on inspiration, closing on expiration) is part of its design, but no specific functional performance testing beyond dimensional checks is detailed in this summary.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not use machine learning or AI that would require a training set.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable. This device does not use machine learning or AI.

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