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This procedural device is intended to make a myringotomy incision, aspirate middle ear fluid, and transport and insert aural ventilation tube(s)
Requirement for myringotomy, with or without the insertion of aural ventilation tube(s).

This single-use device is composed of any combinations of the components included within attachment numbers: 2b, 2c, 2d, 2f, 2h 2, 2a, 2e, 2g. Note: all kits shall contain a myringotome and an instrument for inserting the ventilation tube/ grommet. It has been sterilised by gamma irradiation and is ready for use. The ventilation tubes have been sterilised by steam.

The provided document is a 510(k) premarket notification for the Exmoor Myringotomy Kit. It does not contain information on acceptance criteria for a specific device performance study, nor does it detail a study proving the device meets particular acceptance criteria. Instead, it describes:

• Device Description: The components of the Exmoor Myringotomy Kit, which is a single-use device for myringotomy incision, middle ear fluid aspiration, and insertion of aural ventilation tubes.
• Intended Use: Making a myringotomy incision, aspirating middle ear fluid, and transporting and inserting aural ventilation tube(s).
• Predicate Devices: The Exmoor Myringotomy Kit is compared to two predicate devices:
  1. Richards Set-Op Myringotomy Kit Cat. No. 89-0205 and 89-0206
  2. Exmoor Tympanocentesis Kit
• Substantial Equivalence: The FDA's letter indicates that the device has been determined to be "substantially equivalent to legally marketed predicate devices." This determination is based on comparisons of intended use, technological characteristics (materials, sterilization methods), and safety/effectiveness with the predicate devices.

Therefore, I cannot fulfill the request as the document does not contain the information necessary to construct a table of acceptance criteria, describe a study proving the device meets such criteria, or provide details on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set ground truth.

The document's purpose is to demonstrate substantial equivalence to existing devices, not to present a de novo clinical or performance study with predefined acceptance criteria.

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