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The Tracoe Phon Assist I (Ref Models 650-S/SO and 650-T/TO) are one way valves with a supplemental oxygen port designed to allow tracheostomy patients with an intact larynx to vocalize without the need for finger occlusion. The single patient use valves are attached to the tracheostomy tube with a 15mm standard connector (Phon Assist I Ref Models 650-T/TO) or a Tracoe Stoma Button (Phon Assist I Ref Model 650-S/SO). Both valves consist of an identical cylindrical housing with a silicone membrane whereby the airflow is redirected up to the larynx and through the mouth. Air is allowed to enter in a unidirectional fashion upon inspiration and close upon expiration whereby the airflow is redirected up to the larynx and through the mouth. Tracoe Phon Assist I (Ref Models 650-T/TO) Speaking Valves are indicated for uncuffed tracheostomy tubes or cuffed tubes that have been fenestrated or deflated and Tracoe Stoma Buttons(Ref Model 650-S/SO) in the cases of:

• Mild Tracheal Stenosis
• Laryngeal Tumors
• Bilateral Vocal Cord Paralysis
• Trachealmalacia
• Head Trauma
• Broncheopulmonary Dysplasia
• Amyotrophic Lateral Scierosis
• Chronic Obstructive Pulmonary Disease

The Tracoe Phon Assist I (Ref Models 650-S/SO and 650-T/TO) are one way valves with a supplemental oxygen port designed to allow tracheostomy patients with an intact larynx to vocalize without the need for finger occlusion. The single patient use valves are attached to the tracheostomy tube with a 15mm standard connector (Phon Assist I Ref Models 650-T/TO) or a Tracoe Stoma Button (Phon Assist I Ref Model 650-S/SO). Both valves consist of an identical cylindrical housing with a silicone membrane whereby the airflow is redirected up to the larynx and through the mouth. Air is allowed to enter in a unidirectional fashion upon inspiration and close upon expiration whereby the airflow is redirected up to the larynx and through the mouth.

The provided document is a 510(k) premarket notification letter from the FDA regarding the Tracoe Phon Assist I. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive new performance studies with specific acceptance criteria like those often seen for novel or high-risk devices. For devices deemed substantially equivalent, the performance is generally considered acceptable if it is comparable to the predicate device.

Therefore, I cannot provide the requested information based solely on the provided text. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample size or data provenance for a test set.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Whether an MRMC comparative effectiveness study was done or its effect size.
• Whether standalone algorithm performance was done.
• The type of ground truth used.
• Sample size for the training set or how its ground truth was established.

This information would typically be found in detailed performance studies submitted as part of the 510(k) application, but it is not summarized in the FDA's decision letter.

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