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The ORLUS mini screw is intended for use as temporary anchor for orthodontic treatment.

ORLUS mini screw is intended to provide a fixed anchorage for orthodontic movement of teeth. It is 1.41.8mm in diameter and ranges from 513mm in total length. It is made of Titanium 6Al-4V alloy. There is a hole in the screw head with which a wire can be hung to fix the maxilla and mandible. It is used temporarily and removed after orthodontic treatment has been completed. It is supplied sterile and intended for single use only.

This 510(k) summary for K082838 does not contain the results of a study with specific acceptance criteria and device performance metrics. Instead, it demonstrates substantial equivalence to predicate devices (K050568, K052968, and K033767) based on similarities in device characteristics, material, design, and intended use.

Therefore, I cannot provide the requested information in the format of acceptance criteria and reported device performance, sample size, data provenance, expert information, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information.

The document explicitly states: "ORLUS Mini Screw has the same device characteristics, material, design and intended use as the predicate device." and concludes that it is "safe and effective and substantially equivalent to the predicate device as described herein." This indicates a comparison to existing devices rather than a new performance study with quantified acceptance criteria.

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The ORLUS Mini Screw is intended for use as a temporary anchor for orthodontic treatment.

ORLUS mini screw is intended to provide a fixed anchorage for orthodontic movement of teeth. It is 1.4 - 1.8 mm in diameter and range from 5-13 mm in total length and is made of Titanium 6Al-4V alloy. There are dual heads in the screw with which a wire can be hung to fix the maxilla and mandible. It is used temporarily and is removed after orthodontic treatment has been completed. It is supplied sterile and intended for single use only.

The provided document is a 510(k) summary for the ORLUS mini screw, a dental device. It declares substantial equivalence to a predicate device and outlines the device's characteristics and intended use.

However, the document does not contain any information regarding acceptance criteria or a study proving the device meets specific acceptance criteria. It is a regulatory submission for premarket notification, not a clinical or performance study report.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set, data provenance, or details on training sets.
• Information on experts, ground truth establishment, or adjudication methods for any test data.
• Details about a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.

The document states, "ORLUS mini screw has been subjected to product validations prior to release," but it does not provide any specifics of these validations, their methodologies, or their results in relation to performance criteria.

Therefore,Based on the provided text, I cannot describe the acceptance criteria or a study that proves the device meets specific acceptance criteria. This document is a 510(k) summary and does not contain the detailed performance study information requested.

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The ORLUS mini screw is intended for use as temporary anchor for orthodontic treatment.

ORLUS mini screw is intended to provide a fixed anchorage for orthodontic movement of teeth. It is 1.6 and 1.8 mm in diameter and range from 5-14mm in total length and is made of Titanium 6Al-4V alloy. There are dual heads in the screw with which a wire can be hung to fix the maxilla and mandible. It is used temporarily and is removed after orthodontic treatment has been completed. It is supplied sterile and intended for single use only.

The provided document is a 510(k) summary for the ORLUS mini screw, a temporary anchor for orthodontic treatment. It states that the device has undergone "extensive safety, performance, and product validations prior to release" and that "Safety tests have been performed to ensure the devices comply to applicable industry and US regulations." It also mentions an "extensive review of literature pertaining to the safety and biocompatibility of ORLUS mini screw has been conducted" and that "Appropriate safeguards have been incorporated in the design of ORLUS mini screw."

However, the document does not contain specific acceptance criteria or detailed results of a study that proves the device meets such criteria. It relies on substantial equivalence to predicate devices (Osterned Orthodontic Screw System, OsteoMed L.P., K031936 and Dual Top Anchor System Screws, Jeil Medical Corporation, K033767) based on material, design, and use concept being similar.

Therefore, I cannot populate the table or answer the specific questions below as the information is not present in the provided document. The document describes a regulatory submission pathway focused on equivalence rather than detailed performance study results against predefined acceptance criteria.

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