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The PMV 2020 (Clear) JIT is designed to be used in conjunction with the Passy-Muir Adapter PMA-S JIT 4-6 for use on the Pilling Weck metal Jackson Improved tracheostomy tubes sizes #4, #5 and #6 or equivalent in providing vocalization without finger occlusion for both short-term and long-term tracheostomized patients. It is appropriate for neonatal, pediatric and adult patients and is ideal for use in decannulation as an assessment device for physicians, as well as providing the patient comfort and confidence in upper airway usage. The PMV 2020 (Clear) JIT Valve is also designed to be used without an adapter on the Bivona (Non-Foam Filled Cuffed) tracheostomy tubes currently on the market.

Indications for Use - Including but not limited to the following:

• For Sleep Apnea patients who are tracheostomized as an alternative to plugging when awake
• Bilateral Vocal Cord Paralysis without significant airway obstruction
• Tracheomalacia
• Mild Tracheal and Laryngeal Stenosis
• Non-Obstructive Laryngeal Tumors (can include patients who have intact vocal cords following surgical resection of the tumor)
• Neuromuscular Disease
• Chronic Obstructive Pulmonary Disease
• Brain Injury
• Non-Ventilator Dependent Quadriplegics
• Patients who emotionally or physically are unable to tolerate plugging

Passy-Muir Low-Profile Tracheostomy Speaking Valve PMV 2020 (Clear) JIT to be used in conjunction with the Passy-Muir Adapter PMA 2020-S JIT 4-6 for use on Pilling Weck metal Jackson Improved tracheostomy tubes sizes #4. #5 and #6 or equivalent, and also for use without an adapter on the Bivona (Non-Foam Filled Cuffed) tracheostomy tubes currently on the market.

I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a medical device and does not contain information about acceptance criteria or a specific study designed to prove the device meets such criteria.

The document primarily focuses on:

• The FDA's determination of substantial equivalence to a predicate device.
• The device's classification and regulatory controls.
• The intended use and indications for use of the device.

There is no mention of specific performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment that would allow me to answer your request.

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