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The Sterile Self Ligating Spider Screw is a threaded titanium dental implant screw, intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. The device is used temporarily and shall be removed after orthodontic treatment has been completed. It is provided sterile and is intended for single use only.

The Sterile Self Ligating Spider Screw is a titanium fixation device to be inserted into the upper or lower jaws, designed to be immediately used (after the bone insertion) as fixation for orthodontic appliances. It is used temporarily and must be removed after the orthodontic treatment has been completed. It is provided sterile and is intended for single use only. The Sterile Self Ligating Spider Screw is provided in "Self Drilling and Self Tapping" configuration and is manufactured from Grade 5 Titanium alloy according to ASTM F136-98 standard. Sterile Self Ligating Spider Screw is provided with different diameters. lengths and head shapes.

The provided text is a 510(k) Summary for a medical device called the "Sterile Self Ligating Spider Screw." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with detailed acceptance criteria and performance data.

Therefore, the input document does not contain the information requested in your prompt regarding specific acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document primarily describes:

• General Information: Submitter, contact person, device name, classification, product code, regulation number, and device class.
• Device Description: A titanium fixation device for orthodontic appliances, for temporary use, sterile, single-use, available in "Self Drilling and Self Tapping" configuration, made from Grade 5 Titanium alloy, and comes in different diameters, lengths, and head shapes.
• Predicate Devices: States that the device is substantially equivalent to "HDC Sterile Spider Screw" (510(k) Number K07185).
• Intended Use/Indications for Use: To serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate orthodontic movement of teeth, used temporarily, and removed after treatment. Sterile and single-use.
• Fundamental Scientific Technology: States no changes compared to the predicate device.
• FDA Correspondence: Official FDA letter of substantial equivalence determination.

In summary, this 510(k) submission does not include the type of detailed study design and performance data you've requested. It's a regulatory document focused on demonstrating equivalence, not on presenting novel clinical trial results against pre-defined acceptance criteria.

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