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The Clear Image Aligners are indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion.

The Clear Image Aligners are a sequential set of removable aligners prescribed by an orthodontist or dentist, used to gradually move a patient's teeth in order to treat misalignment and malocclusion. Each aligner in the sequential set is created by a trained technician utilizing 3Shape orthodontic software (K171634/K152086) and tooth movement recommendations from the prescribing orthodontist/dentist. Aligners are then fabricated from plastic. Corrective force to progressively reposition the teeth is delivered via minor changes from one aligner to the next within the series.

Each aligner set is patient specific and can only be used for an individual patient for whom it is prescribed. Clear Image Aligners are provided non-sterile and are completely removable by the patient and treatment/use may be discontinued at any time.

The provided text describes a 510(k) premarket notification for "Clear Image Aligners" by Specialty Appliance Works, Inc. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.

Therefore, many of the requested details about acceptance criteria and study design are not applicable or not provided in this regulatory submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This submission does not define specific acceptance criteria (e.g., accuracy, sensitivity, specificity) for device performance. Instead, it aims to demonstrate substantial equivalence to a legally marketed predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No "test set" in the context of performance evaluation (e.g., for AI algorithm metrics) is described. The submission states that clinical testing was not necessary due to the established performance of sequential aligners.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable. No ground truth establishment by experts for a performance study is described.

4. Adjudication Method

Not applicable. No adjudication method for a test set is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No MRMC study is mentioned. This device is an aligner, not an AI or imaging diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical orthodontic aligner, not an algorithm. The manufacturing process uses 3Shape orthodontic software, but the submission doesn't describe a standalone performance study of this software or the aligner.

7. Type of Ground Truth Used

Not applicable. No performance study with ground truth is described.

8. Sample Size for the Training Set

Not applicable. No training set for an AI algorithm is described.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set or ground truth establishment process is described.

Summary of the Study and Substantial Equivalence Claim:

The submission asserts that clinical testing was not necessary because:

• Established Performance: "The performance of sequential aligners in the clinical environment has been well established since the first aligners were cleared by the FDA under product code NXC in 1998."
• Substantial Equivalence: The Clear Image Aligners are deemed substantially equivalent to the predicate device (Derby Dental Laboratory Custom Clear Aligner System, K173785) in terms of:
  • Indications for Use
  • Design and Technology
  • Device Classification Name (Orthodontic Plastic Bracket)
  • Product Code (NXC)
  • Classification (Class II)
  • Mode of Action (alignment of teeth by application of continuous gentle force, by sequential use of preformed plastic trays)
  • Method of Use
  • Prescription Status (Prescription)
  • Software Used during manufacturing (3Shape Ortho System)
  • Sterility (Provided Non-Sterile)
  • Material (Essix Ace plastic - K062828, described as a thin thermoformed polyurethane). The mechanical properties of this plastic were previously demonstrated by the manufacturer.

In essence, the "study" demonstrating the device meets the acceptance criteria (of being safe and effective) is the history of successful use of similar predicate devices and the demonstration that the proposed device shares the same fundamental technological characteristics and intended use as the predicate. This is a common approach for 510(k) clearances when a novel technology is not being introduced.

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The Acrylic Splint Herbst Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep apnea. The Acrylic Splint Herbst Appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.

The Acrylic Splint Herbst Appliance consists of an upper and lower acrylic splint custom fabricated to the teeth. These full arch splints are connected to each other by the Herbst mechanism which is a rod and tube type assembly that orientates the jaws in a predetermined relationship. The Herbst mechanism allows the patient vertical and lateral range of motion while the jaws are orientated in the biting relationship dictated by the positioning of the Herbst mechanism as it connects to the respective arch splints.

The functional relationship built into the appliance positions the lower jaw forward and open vertically from its normal location which causes a protrusion of the mandible in relation to the maxilla. This forward repositioning, which is temporary while the appliance is being used, increases the pharyngeal space which assists the patient with improved air exchange.

The prescribing dentist determines the exact repositioning of the lower bite via a wax construction bite obtained from the patient in the clinic. The dentist is also able to fine tune the jaw positioning clinically as needed by altering the Herbst mechanism and/or adjusting the acrylic portions of the appliance.

The provided text is a 510(k) summary for the Acrylic Splint Herbst Appliance. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as one might find for a novel or entirely different technology.

Therefore, the document does not contain the information requested in the prompt regarding specific acceptance criteria, a study proving device performance against those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document primarily states:

• Intended Use: "The Acrylic Splint Herbst Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep apnea."
• Substantial Equivalence: Claims substantial equivalence to the Removable Acrylic Herbst by Allesee Orthodontic Appliances (K070327) based on "the same intended use and technological characteristics."
• Risk Mitigation: Describes the design features to address potential risks like oral soreness, TMD concerns, obstruction of oral breathing, and tooth movement, as identified in the Class II Special Controls Guidance Document.

In summary, the provided text does not contain a study demonstrating device performance against specific acceptance criteria. Its purpose is to argue for substantial equivalence based on intended use, technological characteristics, and risk mitigation strategies aligned with existing guidance, rather than presenting a de novo performance study.

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The Clear Image™ Aligners system is intended to correct minor discrepancies in the alignment of maloccluded anterior teeth on patients with permanent dentition (second molars) by moving the teeth with a progressive series of clear thin, thermoformed plastic aligners, fabricated in stages to gradually align the teeth over a period of several months. The aligners are completely removable by the patient and may be discontinued at any time.

Specialty Appliances' Clear Image™ Aligners primarily are directed toward treating a patient's anterior teeth. Such treatment involves the relatively minor orthodonic tooth movements intended to impact a patient's appearance and self image. The aligners are fabricated in clear, thin, thermoformed plastic in a sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner. Aligners are fabricated from .035 or .040 thermoformed polycarbonate 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 position of 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. Specialty Appliances fabricates its aligners from the prescription of an orthodontist or dentist. The dentist selects the teeth to be repositioned and indicates the type of movements desired. The patient's plaster models are then supplied to the laboratory by the attending orthodontist. The model is prepared to allow repositioning the target teeth. Next, an aligner is formed over the master model with the slightly altered to positions. As an aligner with a positionally-biased tooth receiving compartment is seated in the mouth, the positional distance between each compartment and its corresponding living tooth causes a subtle change in the semi-elastic structure of the aligner. In order for a slightly out of register aligner compartment to engage its target tooth, the material surrounding the aligner compartment becomes elastically loaded as if the plastic structure of the aligner were a spring. The subtle pressure of the aligners stored energy acts similar to a spring does when it is loaded. It is the slow dissipation of the stored energy in the structure of the aligner that urges the root structures of the teeth to move through the supportive bone.

The provided text is a 510(k) summary for the Clear Image™ Aligners and does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Device Identification: Trade name, classification, regulation, product code, and device class.
• Predicate Devices: Listing Align Technologies Align System and Allesee Orthodontic Appliances Red, White & Blue for substantial equivalence.
• Device Description: Explaining how the aligners are fabricated from thermoformed plastic, how they apply force to move teeth, and their adjustability and removability.
• Intended Use: Correcting minor discrepancies in maloccluded anterior teeth on patients with permanent dentition through a series of aligners.
• Substantial Equivalence Claim: Stating the device is substantially equivalent to other FDA-approved, legally marketed orthodontic devices (Invisalign and Red, White & Blue).
• FDA Communication: The FDA's letter confirming review of the 510(k) and determination of substantial equivalence, allowing the device to be marketed.
• Indications for Use Statement: Reiterating the intended use for prescription use.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as this information is not present in the provided text.

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