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DynaFlex® Clear Aligner is a series of clear, lightweight, plastic retainers indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state.

DynaFlex ® Clear Aligner Appliance is a series of clear, lightweight, plastic retainers indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state.

The device will be patient-specific and will be sold by prescription. The device is manufactured with medical grade thermo plastic that is standard throughout the industry.

Aligners are fabricated from .030 thermoformed plastic. The mechanism of force application to the teeth is via intentional distortion of the plastic as the aligners are seated in the mouth. Each subsequent aligner in the overall progressive series is made from a mold of the patient's teeth which reflect subtle changes in the teeth from the previous aligner. The positional changes are introduced into each aligner in the laboratory by moving the teeth on the construction model and then forming the aligner on the same model. The overall treatment is prescribed by the dentist to the laboratory where they are fabricated.

Aligners may be adjusted by the dentist. Aligners are completely removable by the patient and treatment may be discontinued at any time. The appliance if provided as a non-sterile device and single use.

The provided text is a 510(k) Summary for the DynaFlex Clear Aligner. It primarily demonstrates substantial equivalence to predicate devices and does not describe AI/ML device performance or a clinical study that proves the device meets specific acceptance criteria in the context of an AI-powered medical device.

The document states:

• "Bench testing of the Aligners has not been performed; however, there is sufficient information available from the scientific literature & other legally FDA cleared device of similar characteristics and material to demonstrate that the preformed aligner provides reasonable assurance of effectiveness." (Page 5)
• "The DynaFlex Clear Aligner passed all the testing in accordance with internal requirements, national standards, and international standards to support substantial equivalence of the subject device." (Page 5)
• "Manufacturing Process Flow validation was performed to ensure that the finished device matches the specification of the doctors' requirements. The output and work model and aligner were tested and compared. DynaFlex Clear Aligners met the specifications of this testing." (Page 5)
• "DynaFlex has completed biocompatibility testing per ISO 10993-1 and its applicable parts, as appropriate for the aligner contact and duration. The mechanical properties of the thermoformed plastic has been previously demonstrated by the manufacturer as appropriate for use with aligners, therefore no additional testing was required to demonstrate substantial equivalence." (Page 5)

This 510(k) summary focuses on demonstrating substantial equivalence based on material, design, manufacturing process, and intended use to existing predicate devices (Clear Image™ Aligner and Clear Correct). It does not involve AI/ML performance, diagnostic accuracy, or a clinical study in the typical sense of evaluating an AI model. Therefore, I cannot provide an answer that includes:

1. A table of acceptance criteria and reported device performance (in the context of AI metrics).
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or related effect sizes.
6. Standalone performance (algorithm only).
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is for a physical medical device (orthodontic aligner), not an AI/ML-powered diagnostic or assistive device. The "performance characteristics" detailed relate to material safety, manufacturing quality, and physical properties, not diagnostic or clinical accuracy determined by an AI algorithm.

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DynaFlex® Anti-Snoring & Sleep Apnea Devices are intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The devices are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist, and is removable by the patient.

The proposed DynaFlex® Anti-Snoring & Sleep Apnea Devices are intraoral devices used for treating snoring and sleep apnea, and will consist of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable lugs, or by the industry standard Herbst mechanism which is a rod and tube type assembly that orientates the jaws in a predetermined relationship. These devices function as a mandibular re-positioner which acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep. The devices will be custom made for each patient and have the ability of the adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The devices will be sold by prescription only.

The LISA Appliance is a one piece, non-adjustable design. The LISA II Appliance is a dynamic, adjustable design. The Dorsal Appliance is a two-piece design with separate upper and lower acrylic portions that when engaged posture the mandible into protrusive position via acrylic fins built in the lower acrylic portion. The adjustable Herbst Appliance is a one piece construction held together by two adjustment mechanisms on the buccal or outer are of the upper and lower appliance.

The provided text describes a 510(k) summary for DynaFlex® Anti-Snoring & Sleep Apnea Devices. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria is largely not present in the provided text.

The document states: "It has been shown in this 510(k) submission that the differences between the DynaFlex® Anti-Snoring & Sleep Apnea Devices and the predicate devices do not raise any questions regarding their safety and effectiveness. DynaFlex® Anti-Snoring & Sleep Apnea Devices, as designed and manufactured, are therefore determined to be substantially equivalent to the referenced predicate devices."

This implies that the predicate devices have established safety and effectiveness, and the DynaFlex device is considered equivalent based on its similar intended use and technological characteristics (or differences that don't raise new questions). There is no standalone performance study described for the DynaFlex device with specific acceptance criteria.

However, based on the information provided, here's an attempt to answer the questions, noting where information is absent:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided text. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not on proving performance against specific quantitative acceptance criteria in a dedicated study.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the provided text. No specific test set or study data for the DynaFlex device is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not present in the provided text. As no specific test set or study is detailed, there's no mention of experts establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not present in the provided text.

5. 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

This information is not present in the provided text. The device is a physical intraoral device, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not present in the provided text. The device is a physical intraoral device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not present in the provided text.

8. The sample size for the training set

This information is not present in the provided text. As this is not an AI device, the concept of a "training set" in this context is not applicable.

9. How the ground truth for the training set was established

This information is not present in the provided text.

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