Search Results

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES are indicated for orthodontic movement of natural teeth.

The ORTHODONTIC PLASTIC BRACKETS are designed to move teeth to improve their alignment. The ORTHODONTIC PLASTIC BRACKETS are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred positions can be used with bracket caps. The ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES consist of plastic orthodontic brackets, bracket caps, and buttons. The bracket caps are designed as an accessory of the orthodontic brackets for holding the archwire in the bracket's slot. Bracket caps are placed on the labial/buccal side of the brackets. The plastic buttons are designed to move teeth to improve their alignment. The plastic buttons are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position. The button design includes a round slot for attaching wires or other appliances.

This device, "ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES", is not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable here.

The document describes an orthodontic product (brackets, bracket caps, and buttons) and its substantial equivalence to previously marketed predicate devices, focusing on material composition, mechanical properties, and intended use. The performance data section refers to standard material testing and conformity to ISO standards, not AI/ML algorithm performance.

Ask a specific question about this device

ORTHODONTIC CERAMIC BRACKETS 1.1 are indicated for orthodontic movement of natural teeth.

ORTHODONTIC CERAMIC BRACKETS 1.1 are designed to move teeth to improve their alignment. ORTHODONTIC CERAMIC BRACKETS 1.1 are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.

The provided document is a 510(k) Premarket Notification for Orthodontic Ceramic Brackets 1.1 by Tomy Inc. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study for an AI/CADe device. As such, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI system is not applicable or present in this document.

However, I can extract the information relevant to the performance data and equivalence claims for the physical device as described:

Acceptance Criteria and Device Performance (for physical device)

The device, Orthodontic Ceramic Brackets 1.1, claims conformance to a recognized consensus standard and reports performance based on specific mechanical tests.

Note: The document states that the device was tested for Shear Bond Strength and Torque Strength, and it conforms to the ISO standard. It does not provide specific numerical acceptance thresholds or the measured performance results in this summary. The primary goal of this submission is to demonstrate substantial equivalence, implying these tests would have shown comparable performance to the predicate devices.

Study Information (for this physical device, not AI/CADe)

Since this document pertains to a physical orthodontic bracket and not an AI/CADe device, most of the detailed study and AI-specific questions are not applicable.

1. Sample size used for the test set and the data provenance: Not applicable. This document refers to bench testing of physical brackets, not a test set of data for an AI system.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI system is not relevant here.
3. Adjudication method for the test set: Not applicable.
4. 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 not an AI device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
6. The type of ground truth used: Not applicable for an AI device. For this physical device, the "ground truth" or standard of comparison is the performance of the predicate devices and conformance to the ISO standard for mechanical properties.
7. The sample size for the training set: Not applicable. This is not an AI device, so there is no training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document:

• Device Type: Physical orthodontic ceramic brackets.
• Purpose of Submission: To demonstrate substantial equivalence to previously cleared predicate devices, specifically the addition of brackets for mandibular bicuspids.
• Performance Data Provided: Conformance to ISO 27020 and bench testing for Shear Bond Strength and Torque Strength. Specific numerical results are not detailed in this summary.
• Biocompatibility: Not re-evaluated because the materials are the same as legally marketed predicate devices, and no material or manufacturing changes were made.
• Clinical Testing: No animal studies or clinical testing were required for these devices.
• Conclusion: The manufacturer believes the device is substantially equivalent to predicate devices based on design, principles of performance, and intended use, and the added mandibular bicuspid brackets do not raise new questions of safety or effectiveness.

Ask a specific question about this device

The CERAMIC BRACKETS Z are indicated for orthodontic movement on natural teeth surfaces.

The CERAMIC BRACKETS Z are designed to move teeth to improve their alignment.

The CERAMIC BRACKETS Z are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.

No accessories are marketed with the CERAMIC BRACKETS Z . The dental clinician is free to choose the bonding cement, supplemental ligatures and orthodontic wires for use with the brackets.

The CERAMIC BRACKETS Z are composed of a polycrystalline zirconia ceramic bracket, which includes an archwire slot and tiewings. The self-ligating CERAMIC BRACKETS Z have a metal clip so that no other ligation of the archwire is needed.

Here's a summary of the acceptance criteria and study information for the CERAMIC BRACKETS Z, based on the provided 510(k) summary:

This device is an orthodontic bracket. The acceptance criteria and testing focus on the physical performance of the brackets, as is typical for this type of medical device. There is no information provided about studies involving human subjects, reader performance, or clinical outcomes that would typically be seen in studies for diagnostic devices or AI-powered devices.

Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary states that "Bench testing was performed to ensure that the CERAMIC BRACKETS Z performance was achieved and validated, including shear bond tests and torque (fracture) tests." However, specific numerical acceptance criteria (e.g., minimum bond strength in MPa, minimum torque resistance in Ncm) and the corresponding measured device performance values are not provided in this summary. It only indicates that the tests were performed and the performance was achieved and validated.

Study Details (Based on available information)

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

   • Test Set Sample Size: Not specified.
   • Data Provenance: The tests are described as "Bench testing," implying laboratory-based testing on the physical devices rather than patient data. The manufacturer is based in Japan (TOMY, Inc., Tokyo, Japan).

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

   • Not applicable. This device does not involve expert interpretation or ground truth derived from human assessments in the context of diagnostic or AI performance. The "ground truth" for mechanical testing would be the physical properties measured by testing equipment.

3. Adjudication method for the test set:

   • Not applicable. As noted above, this does not involve human interpretation or adjudication.

4. 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. This is a physical medical device (orthodontic bracket), not a diagnostic device or an AI-powered system designed to assist human readers. Therefore, an MRMC study is not relevant or performed for this product.

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

   • No. This is a physical medical device, not an algorithm or AI system.

6. The type of ground truth used:

   • The "ground truth" in this context refers to the measured mechanical properties (shear bond strength, fracture torque) obtained through standard laboratory testing methods for orthodontic brackets. These are objective physical measurements.

7. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or an AI algorithm, so there is no "training set."

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

   • Not applicable as there is no training set.

Ask a specific question about this device

Orthodontic Ceramic Brackets are indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

The ORTHODONTIC CERAMIC BRACKETS are designed to move teeth to improve their alignment.

The ORTHODONTIC CERAMIC BRACKETS are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.

No accessories are marketed with the ORTHODONTIC CERAMIC BRACKETS. The dental clinician is free to choose the bonding cement, supplemental ligatures and orthodontic wires for use with the brackets.

The provided text describes an orthodontic ceramic bracket device seeking 510(k) clearance, not a medical device involving AI or complex software. As such, many of the requested categories (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable to the information provided in this 510(k) summary.

The regulatory submission for the "Orthodontic Ceramic Brackets" focuses on demonstrating substantial equivalence to predicate devices through bench testing of physical properties, rather than clinical efficacy studies often associated with advanced diagnostic or AI-powered devices.

Here's an analysis based only on the provided text, indicating where information is not applicable (N/A):

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state quantitative "acceptance criteria" for the bench tests in the format of a target value or range. Instead, it states that "performance was achieved and validated." It implies that the newly proposed device's performance in these tests was comparable to that expected of orthodontic ceramic brackets and sufficient to demonstrate substantial equivalence to the predicate devices.

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

This information is not provided in the 510(k) summary. The submission mentions "bench testing," implying lab-based evaluation, but does not detail the number of samples used for each test or the origin of any materials beyond the statement that the device is "composed of a polycrystalline alumina ceramic bracket." The testing is prospective for the new device as it's part of its pre-market submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

N/A. This device is an orthodontic bracket, and its performance evaluation through bench testing does not involve "ground truth" established by human experts in the manner of diagnostic AI. Its performance is assessed through physical property measurements.

4. Adjudication Method for the Test Set

N/A. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters, especially for subjective assessments. Bench testing of physical device properties does not involve such methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Assistance

N/A. This is not an AI-powered device, nor does it involve human readers interpreting data. Therefore, an MRMC study and AI assistance effect size are not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This is a physical medical device (orthodontic bracket), not an algorithm or software. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective physical measurements (friction, flexural strength, translucency, shear bond) according to established engineering and material science principles, and comparison to the characteristics of legally marketed predicate devices. It's not based on expert consensus, pathology, or outcomes data in a clinical sense for its performance metrics.

8. The Sample Size for the Training Set

N/A. As this is a physical device and not an AI/ML model, there is no "training set."

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

N/A. See point 8.

Ask a specific question about this device