(280 days)
LingLock is an interlock retainer composed of polycrystalline alumina that is bonded to the lingual surface of the lower anterior teeth and is intended to stabilize the lower dental arch following orthodontic treatment. The LingLock retainer enables patients to floss their teeth interdentally in a regular manner.
The device is an interlock retainer composed of polycrystalline alumina (aluminum oxide) that is bonded to the lingual surface of the lower anterior teeth and is intended to stabilize the lower dental arch following orthodontic treatment. LingLock is comprised of a set of ceramic attachments (male/female) bonded to the teeth across the contact points of the lower six anterior front teeth; the male component on one side and the female component on the other. When engaged, the ceramic attachments prevent the teeth from shifting out of position, yet have a slight gap which enables patients to floss their teeth interdentally in a regular manner.
The LingLock retainer has an application tool consisting of a ceramic attachment holder (polypropylene) and a guide strip (stainless steel) which ensures an exact positioning of the ceramic attachments both in relation to each other and the teeth to be retained. An orthodontic adhesive is placed on the bonding surface of the ceramic attachments and the guide strip is guided in between two neighbouring teeth. The ceramic attachment holder is brought in contact with the enamel at the lingual surface of the teeth and the orthodontic adhesive is light cured. After curing, the guide strip is removed by pulling it forward in a slight upward rotational movement. The ceramic attachment holder is then removed.
This document describes a medical device submission (K061042) for the LingLock lingual orthodontic retainer. It is a 510(k) summary, which means the manufacturer is claiming substantial equivalence to existing devices, and therefore, an extensive clinical study to prove effectiveness or safety like those required for a PMA (Pre-Market Approval) is typically not required.
Given this context, the document does not describe a detailed study with acceptance criteria and device performance as one might find for a novel or high-risk device requiring extensive clinical trials. Instead, the basis for clearance is substantial equivalence to predicate devices.
Therefore, many of the requested items (e.g., sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.
However, I can extract the relevant information regarding the device's intent and the basis for its clearance:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)
The "acceptance criteria" in a 510(k) context for a device like this are met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance is "accepted" if it functions similarly to and is intended for the same use as the predicate, and is composed of similar materials and design.
| Acceptance Criteria (Implied by 510(k) Substantial Equivalence) | Reported Device Performance (Summary from Submission) |
|---|---|
| Intended Use Equivalence: Device intended for the same use as legally marketed predicate devices. | Intended Use: "The intended use of LingLock is to stabilize the lower dental arch following orthodontic treatment. The LingLock retainer enables patients to floss their teeth interdentally in a regular manner." |
| Predicate Comparison: "LingLock functions in a manner similar to and is intended for the same use as the Bondable Lingual Retainer currently manufactured by Ormco Corporation." | |
| Technological Characteristics Equivalence: Device has similar technological characteristics (e.g., materials, design, mechanism of action) to legally marketed predicate devices. | Device Description: "The device is an interlock retainer composed of polycrystalline alumina (aluminum oxide)..." |
| Predicate Comparison: "...is composed of the same material and has the same bonding surface as the ceramic bracket manufactured by 3M Unitek." | |
| Mechanism: "When engaged, the ceramic attachments prevent the teeth from shifting out of position, yet have a slight gap which enables patients to floss their teeth interdentally in a regular manner." | |
| Performance Data: Any performance data (e.g., bench testing, biocompatibility) demonstrates equivalence or safety/effectiveness. | While not explicitly detailed as "acceptance criteria" and "reported performance" tables, the submission implies that all necessary testing for a Class II device (e.g., biocompatibility for the material, mechanical strength to function as a retainer) would have been performed and found acceptable to support the substantial equivalence claim, aligning with existing standards for similar devices. This document doesn't detail specific test results. |
Study Information Overview:
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Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided. This 510(k) submission does not describe a clinical study with a "test set" in the traditional sense of evaluating efficacy against a specific outcome. The submission relies on demonstrating substantial equivalence to predicate devices, implying that their performance is already accepted.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided. No "ground truth" establishment using experts for a test set is described, as a clinical efficacy study was not presented.
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Adjudication method for the test set:
- Not Applicable / Not Provided. No test set or adjudication method is described.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. The LingLock is a physical dental retainer, not an AI-assisted diagnostic or therapeutic device. This type of study is irrelevant to this device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The LingLock is a physical dental retainer, not an algorithm, so standalone performance in this context is irrelevant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. No ground truth for an efficacy study is described. The "ground truth" for the device's market clearance is that it is substantially equivalent to predicate devices that are already deemed safe and effective for their intended use.
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The sample size for the training set:
- Not Applicable / Not Provided. No "training set" is relevant or described for this type of physical medical device submission.
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How the ground truth for the training set was established:
- Not Applicable / Not Provided. No training set is relevant or described.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.