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The HDC 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.

The HDC Spider Screws are titanium fixation devices to be inserted into the upper or lower jaws, designed to be immediately used (after the bone insertion) as fixation for orthodontic appliances. Spider Screws are provided in two configuration "Self Tapping" and "Self Drilling and Self Tapping." Self Tapping Spider Screws are manufactured from ASTM F67. Self Drilling and Self Tapping Spider Screws are manufactured from ASTM F136. The HDC Spider Screws are provided in two tip size diameters, 1.5 mm and 2.0 mm. These devices are provided non-sterile and must be sterilized prior to use.

The provided text is a 510(k) summary for the HDC Spider Screw, a dental implant device. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with acceptance criteria and detailed statistical analysis.

Therefore, I cannot provide the requested information about acceptance criteria and a study that proves the device meets them because the document does not contain this type of data.

Specifically, the document discusses:

• Device Description: Materials, configurations ("Self Tapping" and "Self Drilling and Self Tapping"), and tip sizes.
• Intended Use: As a temporary fixed anchorage point for orthodontic appliances.
• Basis of Substantial Equivalence: Similarities to predicate devices in intended use, material, design, and function.
• Regulatory Information: Device classification, product code, and predicate devices.
• FDA Clearance Letter: Confirming substantial equivalence based on the submitted information.

There is no mention of:

1. Acceptance criteria defined for performance metrics.
2. A study designed to test the device against specific performance criteria.
3. Sample sizes for test sets or training sets.
4. Data provenance or details about a study cohort.
5. Number or qualifications of experts for ground truth.
6. Adjudication methods.
7. MRMC comparative effectiveness studies.
8. Standalone algorithm performance.
9. Type of ground truth used in a study.
10. How ground truth for a training set was established.

The 510(k) pathway for medical device clearance in the US often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical trials or performance studies with predefined acceptance criteria for novel safety and effectiveness endpoints that are typically found in PMA applications or for devices with entirely new technologies.

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