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This device is intended to be used for the prescribed treatment of malocclusions by dentists. The device is used to hold the archwire in orthodontic brackets during orthodontic treatment. They are normally used for a period of 2 to 4 weeks when they are replaced.

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This document is a 510(k) premarket notification letter from the FDA regarding the "Power Coins Glow in the Dark Ligatures." It grants clearance for the device to be marketed. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The letter focuses on the regulatory clearance process, stating that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions. It does not delve into specific performance metrics, clinical studies, or technical evaluations.

Therefore, I cannot provide the requested table and study details based on the input text.

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Use to connect brackets and help to close gaps between teeth. They are normally used for a period of 4 to 6 weeks, then replaced with new chain.

Glenroe Glow-In-Dark Elastomeric Ligature Chain

This is a 510(k) clearance letter from 1998 for a Glenroe Glow-In-Dark Elastomeric Ligature Chain. This document does not contain the type of detailed information about acceptance criteria, study design, and performance metrics that you are requesting. These types of regulatory submissions for medical devices have evolved significantly over time.

In 1998, for a Class I device seeking 510(k) clearance, the regulatory pathway focused primarily on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring formal clinical trials or complex performance studies with detailed statistical analysis as is common for higher-risk devices or software as a medical device (SaMD) today.

Therefore, an exhaustive answer to your questions, based solely on the provided text, is not possible. The document states:

• Device Name: Glenroe Glow-In-Dark Elastomeric Ligature Chain
• Indications For Use: Use to connect brackets and help to close gaps between teeth. They are normally used for a period of 4 to 6 weeks, then replaced with new chain.
• Regulatory Class: I
• Product Code: ECI

The letter confirms the FDA "determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." This "substantial equivalence" is the primary "acceptance criterion" for this type of clearance in that era.

I cannot create the table or provide the detailed study information you requested because this document does not contain that level of detail. It simply states the device was found substantially equivalent to a predicate.

Modern SaMD submissions would typically include a much more extensive clinical or performance study report with specific acceptance criteria (e.g., sensitivity, specificity, accuracy, F1-score, AUC), sample sizes, ground truth establishment, expert qualifications, and potentially comparative effectiveness studies. This 1998 document for a Class I physical device does not.

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Glenroe glow in dark elastomeric ties are used to hold the archwire in orthodontic brackets during orthodontic treatment. They are normally used for a period of 4 to 6 weeks when they are replaced with new ties.

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The provided text is a 510(k) premarket notification letter from the FDA to Mr. John Bozman regarding "Glenroe Glow In Dark Elastomeric Ligatures". This document is a regulatory clearance letter and does not contain any information about acceptance criteria or a study proving device performance.

Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This information is typically found in the scientific documentation or clinical evaluations submitted as part of the 510(k) application, not in the clearance letter itself.

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