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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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The HDC Sterile 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. 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 HDC Sterile 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 Spider Screw is provided in two configuration "Self Tapping" and "Self Drilling and Self Tapping." Self Tapping Spider Screw is manufactured from ASTM F67 and ASTM F136. Self Drilling and Self Tapping Spider Screw is manufactured from ASTM F136. HDC Sterile Spider Screw is provided in three tip size diameters: 1.3 mm, 1.5 mm and 2.0 mm.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (HDC Sterile Spider Screw) to establish substantial equivalence to predicate devices, rather than a performance study report.

Therefore, I cannot provide the requested table or details about a study.

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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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