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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.

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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.

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MISO Translucent Orthodontic Bracket is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

MISO Translucent Orthodontic Bracket is comprised of single crystal(mono clear sapphire) alumina. The translucent properties of the bracket make the bracket less visible than polycrystalline ceramic and metal brackets. MISO Translucent Orthodontic Bracket consists of 3parts. The bracket consists of three distinct parts: (1) arch wire slot, (2) four tie wings, and (3) base. The arch wire slot allows the placenient of an arch wire which applies the necessary force to effect tooth movement. The tie wings allow the placement of an elastic o-ring, which holds the arch wire in place. The base is adhered to a patient's tooth using adhesive, thereby anchoring the bracket to the tooth.

The provided text describes a 510(k) submission for the MISO Translucent Orthodontic Bracket. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria and study details for a medical device AI/software will not be present in this document.

Here's the breakdown of what can be extracted and what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify general "acceptance criteria" in the typical sense of a target performance metric for AI/software (e.g., sensitivity, specificity). Instead, it compares the technical characteristics of the proposed device with predicate devices. The key performance characteristic mentioned for the device itself is Bond Strength.

Note on "Acceptance Criteria": The document implies that demonstrating comparable or superior performance (within acceptable variations) to the predicate devices, especially regarding bond strength, and adherence to relevant ISO standards, serves as the basis for establishing "substantial equivalence." The predicate device's bond strengths ($5.51 \pm 1.65$ MPa and $19.41 \pm 5.08$ MPa) could be interpreted as the "acceptance range" or reference points for demonstrating equivalence. The MISO device's bond strength ($11.73 \pm 3.04$ MPa) falls within the range of the predicate devices.

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

The study described is not a clinical AI/software validation; it's a materials testing study.

• Sample Size: Not explicitly stated for bond strength testing, other than "results are detailed in Section 12" which is not provided.
• Data Provenance: Not applicable as it's a material property test, not patient data.

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

Not applicable. Ground truth for material bond strength is established through laboratory measurement, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable.

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 material properties submission, not an AI/software device.

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

Not applicable. This is a material properties submission, not an AI/software device.

7. The Type of Ground Truth Used

• Ground Truth Type: Laboratory measurements of material properties, specifically "Bond strength testing was carried out according to ISO 11405-2003(E)."

8. The Sample Size for the Training Set

Not applicable. This is a material properties submission for a physical device, not an AI model.

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

Not applicable.

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Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth

Orthodontic Ceramic bracket, "ABSOLUTE" is made of alumina single crystal (mono clean sapphire) intended to be placed on teeth to straighten teeth. ABSOLUTE ceramic bracket consists of 3 parts. The first part is slot part is a ABOOLOTE ocramic bracket sencond part is round groove part that is to hold a wire with elastic "O" ring. And, the third part is base part is to adhere to tooth surface. Also, it has a marking on fore surface to indicate a location.

The provided text is a 510(k) summary for a medical device called "Orthodontic Ceramic Bracket (ABSOLUTE)". However, it does not contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Here's an analysis based on the information available:

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

The document states: "Testing was performed according to 'Harmonized Standard'. Test results support the conclusion that actual device performance satisfies the design intent."

This is a very general statement and does not provide specific acceptance criteria or detailed device performance metrics. It indicates that some testing was done to a standard, but the specifics are not included in this summary. Therefore, a table cannot be populated.

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

This information is not provided in the given text.

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 provided in the given text. The device is a physical bracket, not an AI diagnostic tool that would typically involve expert ground truth for a test set in the same way.

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

This information is not provided in the given 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 applicable or provided. This device is a physical orthodontic bracket, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant to this product.

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

This information is not applicable or provided. As above, this is a physical medical device, not an algorithm.

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

This information is not provided and is likely not relevant in the same way it would be for diagnostic AI. For a physical device, "ground truth" would typically relate to material properties, mechanical integrity, biocompatibility, and intended function verified against engineering standards or clinical benchmarks. The document only mentions "Harmonized Standard".

8. The sample size for the training set

This information is not provided. This device is a manufactured product, not an AI model that undergoes "training" in the same sense.

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

This information is not provided and is not applicable for a physical device in the same way it is for an AI model.

Summary of available information regarding acceptance criteria and study:

• Device Name: Orthodontic Ceramic Bracket (ABSOLUTE)
• Intended Use: Orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
• Comparison: Substantially equivalent to SAPPHIRE CERAMIC BRACKET (K073045) ORTHO TECHNOLOGY, INC.
• Testing Information: "Testing was performed according to 'Harmonized Standard'. Test results support the conclusion that actual device performance satisfies the design intent."

Conclusion:

The provided 510(k) summary only offers a very high-level statement about testing being performed according to a "Harmonized Standard" and that the device meets its "design intent." It lacks specific quantitative acceptance criteria, detailed study designs, sample sizes, expert qualifications, or adjudication methods that would be present in a comprehensive study report. This is typical for a 510(k) summary, which is meant to summarize equivalence, not to be a full clinical or engineering study report. For a physical device like an orthodontic bracket, "acceptance criteria" would primarily revolve around mechanical strength, biocompatibility, bond strength, and dimensional accuracy, likely assessed through bench testing and adherence to recognized standards (e.g., ISO standards for orthodontics).

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Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

The ORTHODONTIC CERAMIC BRACKETS are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The dimpled, beveled bracket base includes rhomboid and "torque-in-the-base" features. The modified ceramic, orthodontic brackets have indented walls and are available with or without glass coating in the wire slot. The modified brackets are more transparent than the predicate device.

The provided text is a 510(k) summary for Orthodontic Ceramic Brackets. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/medical device study with performance metrics like sensitivity, specificity, or AUC.

This document describes a traditional medical device (orthodontic brackets) and its substantial equivalence to a predicate device based on material, design, and intended use, rather than a data-driven performance study. Therefore, the requested information elements related to AI model evaluation are not applicable or present in this document.

To be specific:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document discusses "technological characteristics" and states "The function and performance of the modified brackets is very similar to the predicate." No quantifiable performance metrics are provided.
2. Sample size used for the test set and the data provenance: Not applicable. There is no test set in the context of an AI performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, as this is not an AI diagnostic/prognostic device being evaluated.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The 510(k) summary focuses on demonstrating that the new orthodontic ceramic brackets are substantially equivalent to previously marketed devices (predicate device K852179) by highlighting minor design changes (dimpled, beveled base, rhomboid and "torque-in-the-base" features, indented walls, optional glass coating, and increased transparency) without changes to the intended use or fundamental scientific technology. All materials used are stated to have been in legally marketed DENTSPLY devices.

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