(49 days)
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.
§ 872.5410 Orthodontic appliance and accessories.
(a)
Identification. An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.