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The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for patients 6 months and older.

The Solo+ Tympanostomy Tube Device (Solo+ TTD) is a single use, sterile, "all-in-one" surgical instrument that rapidly places a tympanostomy tube across the tympanic membrane of a patient. It combines the traditionally separate functions of creating a myringotomy, and positioning and placing a tympanostomy tube across the tympanic membrane. Placement of the tube provides ventilation to the middle ear space through the tympanic membrane.

To use the device, the user creates a myringotomy with the device's myringotomy knife, which is located at its distal tip of the Cartridge. The user advances the device until the tympanostomy tube outer flange reaches the tympanic membrane. The user then actuates the device by pressing the activation (blue) button on the Handpiece. This retracts the myringotomy knife construct and deploys the tube across the tympanic membrane.

The provided text describes the 510(k) clearance for the Solo+ Tympanostomy Tube Device (TTD). While it details the device's characteristics, comparison to predicate devices, and general non-clinical testing, the clinical study information focuses on comparative effectiveness and patient safety/success, rather than specific acceptance criteria for performance metrics that would typically be seen in a study evaluating an AI device or a device with quantifiable performance outputs like accuracy, sensitivity, or specificity.

The Solo+ TTD is a surgical instrument, and its "performance" in this context is primarily related to its ability to successfully place a tympanostomy tube and maintain patient safety. Therefore, the "acceptance criteria" discussed here are related to the success rate of tube placement and the absence of serious adverse events.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance Study

The provided document describes a clinical study to support the substantial equivalence of the Solo+ TTD for an expanded patient population (pediatric patients 6 months and older) compared to its primary predicate (K232702, which was indicated for patients 6-24 months) and a secondary predicate (K221254, which already covered patients 6 months and older). The "acceptance criteria" are implicitly derived from the successful outcomes observed in the study and their comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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