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The Carriere SLX 3D Clear orthodontic ceramic bracket system is in the movement of teeth during orthodontic treatment.

The Carriere SLX 3D Clear is a ceramic passive self-ligating orthodontic bracket system that directly bonds to the teeth to provide a treatment solution for patients with malocclusions of primary, permanent, or mixed dentition. Each bracket is comprised of four individual components; a polycrystalline alumina door, a polycrystalline alumina base, and two 304 stainless steel springs. The two springs are laser welded together and borne by the springs are the force giving mechanism in the bracket system, providing tactile and audible feedback for the clinician when opening and closing the door. The springs also provide a mechanism to keep all four components assembled throughout treatment. Because the Carriere SLX 3D Clear is a passive self-ligating bracket system, wherein the door portion of the bracket opens and closes to alternatively expose and conceal the archwire slot, the door replaces the need for a conventional ligature and retains the archwire while providing minimal friction throughout the treatment process. The bracket system is intended to be used throughout orthodontic treatment with an accompanying archwire to move the teeth to the desired occlusion by the clinician. The Carriere SLX 3D Clear bracket has an integral hook design, which allows for the attachment of elastics and other alternate force giving mechanisms to assist the clinician in producing the desired tooth movement. The bonding surface of the bracket has a mechanical undercut design, allowing the bracket to retain the adhesive and bond to the facial surface of the tooth. The application and removal of the Carriere SLX 3D Clear orthodontic ceramic bracket is similar to that of other orthodontic ceramic brackets. It requires orthodontic adhesive for bonding and standard orthodontic tools and techniques for de-bonding.

This document describes a 510(k) premarket notification for the "Carriere SLX 3D Clear" orthodontic ceramic bracket. This is a medical device, not an AI/ML powered device, so many of the questions related to AI/ML device evaluations (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, ground truth for training set) are not applicable.

Here's an analysis of the provided information, focusing on the acceptance criteria and supporting studies relevant to this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

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The Carriere Motion Clear Class II orthodontic appliance is intended to provide orthodontic movement and alignment of teeth during orthodontic treatment for Class II cases with symmetrical malocclusions and Class I cases with mesially positioned maxillary molars.

The Carriere Motion Clear Class II is a direct bond, esthetic, orthodontic appliance that attaches the maxillary canine or premolar to molar to provide a treatment solution for patients with malocclusions of primary, permanent or mixed dentition. The orthodontic appliance is a two-piece design comprised of an integrated polyethersulfone, a clear thermoplastic, anterior pad and rigid arm that connects to a 17-4 stainless steel posterior pad in a "ball and socket" relationship. The orthodontic appliance is intended to be used at the beginning of orthodontic treatment when there are no competing forces in the mouth. The device allows the distalization of the posterior segments.

The Carriere Motion Clear Class II corrects the posterior occlusion to a Class I platform first by rotating and uprighting the maxillary molars while distalizing the posterior segment, from canine or premolar to molars. The orthodontic appliance independently moves each posterior segment, from canine or premolar to molar, as a unit. The anterior pad includes an integrated hook which allows for the attachment of elastics to the lower molars. The posterior pad bonds to the facial surface of the teeth and is made of 17-4 stainless steel. The pad serves as the socket in the ball and socket relationship with the plastic arm. The ball and socket has built-in stops that allow the molars to move directly to their desired position and are intended to prevent any unwanted over rotation or tipping.

The Carriere Motion Clear Class II's application and removal is similar to that of a plastic orthodontic bracket. It requires orthodontic adhesive for bonding and standard orthodontic tools and techniques for debonding.

This document is a 510(k) premarket notification for a medical device, specifically an orthodontic appliance. It primarily focuses on demonstrating substantial equivalence to existing devices rather than detailing a study proving the device meets specific acceptance criteria through performance.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of an AI/human-in-the-loop diagnostic device, cannot be fully extracted from this document. This document describes a physical orthodontic appliance, not a diagnostic algorithm.

However, I can extract information related to performance testing that was conducted:

Here's an attempt to answer your questions based only on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" due to the nature of the document.

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

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

• Sample Size for Test Set: Not explicitly provided for biocompatibility or bond strength testing.
• Data Provenance: Not provided. The tests are described as conducted in accordance with FDA and ISO standards, but the location or whether the data was retrospective/prospective is not mentioned.

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)

• Not Applicable. This document does not describe a study involving expert assessment or ground truth establishment for a diagnostic algorithm. The "ground truth" for the bond strength appears to be the measured force required for bonding/debonding, and for biocompatibility, it's compliance with standard biological evaluation tests.

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

• Not Applicable. No adjudication method is mentioned as this is not a diagnostic study requiring human expert review for establishing ground truth.

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

• No. A MRMC comparative effectiveness study was not done. This document is for a physical orthodontic appliance, not an AI-assisted diagnostic device.

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

• No. A standalone performance study of an algorithm was not done. This document is for a physical orthodontic appliance.

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

• For Biocompatibility: Compliance with established biological evaluation standards (ISO 10993). The "ground truth" is that the material does not elicit adverse biological responses.
• For Bond Strength: Measured force in lbf/MPa. The "ground truth" refers to the quantified mechanical adhesion strength.

8. The sample size for the training set

• Not Applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.

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

• Not Applicable. No training set or associated ground truth establishment is relevant to this device submission.

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These devices are intended for the correction of orthodontic malocclusions as diagnosed by a dentist or orthodontist. They are used to transmit and provide axial directional control to the kinetic energy from an orthodontic archwire, for movement of individual teeth for treatment.

These ceramic brackets will be used for correction of malocclusions as diagnosed and overseen by trained practitioners of orthodontics. These brackets will be directly bonded to teeth; will have interface with the archwire to direct applied forces. These devices are intended for single use only and are not delivered in a sterile state.

The Ceramic Bracket line of products are single-use devices intended for use in conjunction with comprehensive orthodontics to control the movement of individual teeth.

These one-piece ceramic brackets are comprised of polycrystalline aluminum oxide. The general geometric composition of these devices is made of archwire slot, tie wings, and a pad (which provides a bonding surface). The archwire slot is a channel through the bracket used to engage the archwire. The tie wings are small hook shaped protrusion use as an anchor point for the ligatures work by tying the archwire into the archwire slot. The geometry of the pad is such that the bracket has a stable footprint. The pad is coated with aluminum oxide particles to facilitate bracket bonding with orthodontic adhesives.

These brackets are comprised of several geometries that vary from bracket to bracket, corresponding to the teeth they are intended for. These geometries contribute to the fit of the bracket to the tooth and also impart the axial control of the energy from the archwire.

The provided document pertains to a 510(k) premarket notification for "Ceramic Brackets" (K110335). This document is a regulatory submission for a medical device and thus does not include the type of detailed study information (sample size, ground truth, expert qualifications, etc.) that would be found in a clinical trial or performance study report for an AI/CAD system.

The document asserts substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with detailed metrics. Therefore, many of the requested categories of information are not applicable or cannot be extracted from this type of regulatory submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't present "acceptance criteria" in the sense of predefined thresholds for sensitivity, specificity, F1-score, or similar performance metrics typically associated with AI/CAD systems. Instead, the "acceptance criteria" for this type of submission are based on demonstrating "substantial equivalence" to existing legally marketed predicate devices.

2. Sample size used for the test set and the data provenance:

• Not Applicable. This document does not describe a performance study with a "test set" in the context of AI/CAD system evaluation. The assessment is based on material properties, intended use, and design features compared to predicate devices.
• The "performance testing" mentioned is likely mechanical and material testing to ensure the bracket meets engineering specifications, not a clinical trial or diagnostic accuracy study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. No "ground truth" establishment by experts is described for this type of medical device. The "truth" is established by the known performance and safety profiles of the predicate devices and the physical/chemical identicality or similarity of the new device.

4. Adjudication method for the test set:

• Not Applicable. No test set or adjudication method as described for AI/CAD systems.

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:

• Not Applicable. This is a physical medical device (orthodontic bracket), not an AI/CAD system or a diagnostic imaging tool that would involve human readers.

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

• Not Applicable. This is a physical medical device.

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

• Not Applicable. The "ground truth" for this submission method is effectively the established safety and efficacy of the predicate devices, against which the new device is compared in terms of its material, design, and intended use.

8. The sample size for the training set:

• Not Applicable. This document does not describe the development or training of an AI algorithm.

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

• Not Applicable. This document does not describe the development or training of an AI algorithm.

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The Ortho Organizers Temporary Orthodontic Anchor is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodonic movement of teeth.

The Ortho Organizers Temporary Orthodontic Anchor is a device that is temporarily implanted in the alveolar ridge to provide a fixed anchorage point for various orthodontic tooth movements. It is a single-piece design that features a threaded shaft and a low profile proximal head. The head incorporates a button and undercut that serves as an attachment point. The tapered conical section below the button incorporates a transverse circular opening which also serves as an attachment point. Vertical flats below the conical section enable use of tools to turn the device into its fully implanted position. The head terminates in a collar that separates the attachment points from the threaded portion of the device. The device is available with a short collar or a long collar to accommodate variations in soft tissue thickness. The device is made of titanium alloy conforming to the requirements of ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The device will be sold non-sterile and is intended to be sterilized prior to use.

The provided text is a 510(k) summary for a medical device called the "Ortho Organizers Temporary Orthodontic Anchor." This document describes the device, its intended use, and its equivalence to already marketed predicate devices.

However, it does not contain any information regarding specific acceptance criteria, performance data from a study, or details about a study design (such as sample size, data provenance, ground truth establishment, or expert involvement).

The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, primarily through comparing design, materials, and intended use, rather than presenting new clinical study data with acceptance criteria for device performance.

Therefore, I cannot populate the requested table or answer most of the questions because the necessary information is not present in the provided text.

Here's a breakdown of what can be inferred from the text and why most questions cannot be answered:

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

• Cannot be provided. The document does not define any specific acceptance criteria (e.g., success rates, failure rates, accuracy metrics) or present data from a study demonstrating specific device performance against such criteria. The submission focuses on substantial equivalence based on design and material similarities to predicate devices.

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

• Cannot be provided. No clinical or performance study details are mentioned.

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)

• Cannot be provided. No ground truth establishment is described, as there is no performance study data.

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

• Cannot be provided. No adjudication method is described.

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

• Cannot be provided. This device is a physical orthodontic anchor, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

• Cannot be provided. This device is a physical medical implant, not an algorithm.

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

• Cannot be provided. No ground truth is established as no performance study is detailed. The "ground truth" for this type of submission is typically the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• Cannot be provided. No training set is relevant or mentioned for this physical device.

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

• Cannot be provided. No training set or associated ground truth is relevant or mentioned.

Information that IS present in the document:

• Device Name: Ortho Organizers Temporary Orthodontic Anchor
• Intended Use: To provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.
• Material: Titanium alloy conforming to ASTM F 136 Standard Specification (Ti-6A1-4V titanium alloy).
• Sterilization: Sold non-sterile, intended to be sterilized prior to use.
• Classification: Class II (21 CFR 872.3640), Product Code DZE.
• Predicate Devices: The submission states that equivalence was demonstrated to "legally marketed predicate devices." While specific predicate device names are not given in the provided text, the basis of the 510(k) is the substantial equivalence to these devices in terms of "intended use, design, materials and functional characteristics."

In summary, the provided text is a regulatory submission for a physical medical device (an orthodontic anchor) based on substantial equivalence, not a clinical study report with performance data and acceptance criteria.

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