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The AP-4000, Air Pulse Sensory Stimulator, is intended to elicit Laryngeal Closure Reflex (Swallow) and to measure the sensory discrimination threshold at which the reflex occurs in the area of the Upper Airway innervated by the Superior Laryngeal Nerve. The structures being stimulated in the area of the Upper Airway innervated by the Superior Laryngeal Nerve are: the Left and Right Anterior Wall of the Pyriform Sinus and the Left and Right Aryepiglottic Folds. The device is intended to be used with the Pentax FNL-10AP or FNL-10RAP, Fiber Naso -Pharyngo- Laryngo Scope, introduced per nasally in Adult and Pediatric patient populations with suspected Dysphagia.

The AP-4000, Air Pulse Sensory Stimulator, is an endoscopic accessory that must be used with the Pentax FNL-10AP or FNL-10RAP, Fiber Naso-Pharyngo-(Laryngo) Scopes. The AP-4000 is a software controlled device. The device contains an Air Pump and the mechanics to control the pressure of a 5 0 millisecond (ms) air pulse, delivered through the FNL-10AP working channel. The device is connected to the endoscope working channel with an Air Supply Tube (two pieces are included with the device as standard set components). The device front panel has controls and displays to allow a desired pressure for the 50 ms air pulse to be selected (in the range 2 mm Hg to 10 mm Hg), the air pulse to be initiated, and the actual pressure of the delivered air pulse to be displayed. There are connections for the Air Supply Tube (to the endoscope working channel), a pneumatic footswitch (alternate control to initiate air pulse, one piece is included as a standard set component), and an RS-232 connection so that unit displays may be available to other system peripheral devices (Addon Camera).

The provided document is a 510(k) summary for the AP-4000, Air Pulse Sensory Stimulator. It describes the device, its intended use, and comparison to predicate devices, but does not include any information regarding acceptance criteria or a study proving the device meets said criteria.

The document explicitly states: "The submission for substantial equivalence was not based on an assessment of clinical performance data." This indicates that no clinical study was performed or submitted for this specific 510(k) clearance process to demonstrate performance against acceptance criteria.

Therefore, I cannot provide the requested information for the following sections based on the input document:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to predicate devices based on design, specifications, and intended use, rather than presenting a performance study with defined acceptance criteria.

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