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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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The device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used only.

The Orthodontic Ceramic Brackets are bonded to teeth to apply forces to the tooth, transmitted through a flexible orthodontic wire , to alter the tooth position. The ceramic bracket has both, aesthetic and self ligating qualities. This aimed at facilitating easier orthodontic wire placement and removal through self- ligatation. The function and performance of the orthodontic ceramic brackets are equal to the predicate device. The Material was selected according the requirements of ISO 6474;1994. Ceramic materials based on High purity aluminia.

This medical device submission for the Bernhard Forster GmbH Orthodontic Ceramic Brackets is a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a standalone study with performance metrics.

Therefore, the requested information cannot be fully provided in the format of a typical performance study. Instead, the "study" demonstrating acceptance is the comparison to the predicate device and the material testing conducted.

Here's how the provided information aligns with your request:

Acceptance Criteria and Device Performance (in the context of a 510(k) submission)

For a 510(k) submission, "acceptance criteria" are implicitly met by demonstrating substantial equivalence to an existing legally marketed device. Performance is primarily assessed through comparison.

Table of Acceptance Criteria and Reported Device Performance (based on substantial equivalence):

Detailed Breakdown of Study Information (as requested):

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

   • See table above. The "acceptance criteria" for a 510(k) are essentially demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "reported device performance" is the direct comparison point-by-point to the predicate device.

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

   • This is not a traditional "test set" study. The submission relies on material testing data for the device itself and comparison to the predicate device's established performance.
   • Sample Size: Not explicitly stated as a clinical "test set" sample size. The material testing would involve specific numbers of brackets or material samples as per ISO 6474;1994, but these details are not provided in this summary.
   • Data Provenance: The manufacturing company is Bernhard Forster GmbH, based in Pforzheim, Germany. Material testing would typically be conducted by the manufacturer or a certified lab. This would be considered "prospective" data for the new device's material properties, but it's not clinical human data.

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 is not a study requiring expert readers or "ground truth" establishment in the sense of diagnostic accuracy. The "ground truth" for material properties is established by adherence to recognized international standards (ISO 6474;1994). The "ground truth" for substantial equivalence is the predicate device's established regulatory status and performance.

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

   • Not applicable. No "adjudication method" as this is not a diagnostic performance study involving multiple readers.

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 device is an orthodontic bracket, not an AI-powered diagnostic tool. No MRMC study was performed.

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

   • Not applicable. This device is a physical medical device, not an algorithm.

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

   • The "ground truth" (or basis of evidence) used for this 510(k) submission is:
     • Predicate Device Equivalence: The legally marketed predicate device (Innovation C, K060837) serves as the primary "ground truth" for safety and effectiveness.
     • Material Standards: Adherence to international material standards (ISO 6474;1994 for Ceramic materials based on High purity alumina) serves as "ground truth" for the material properties and biocompatibility.

8. The sample size for the training set

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable. This is not a machine learning or AI device.

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The LAR Manufacturing, LLC Orthodontic Ceramic Brackets are indicated for orthodontic movement of teeth.

LAR Manufacturing, LLC Ceramic Brackets are available if the following prescriptions: Exceed Series Brackets Roth .018" & .022" Slot Sizes Accent Series Roth .018" & .022" Slot Sizes; Edgewise .018" & .022" Slot Sizes; Ricketts .018" Slot Size; Bio-Progressive/Hilgers .018" & .022" Slot Sizes The Exceed Series and Accent Series Ceramic Brackets are produced using Al2O3, translucent polycrystalline aluminum oxide (99.9%). These Ceramic Brackets are bonded to the teeth with commercially available materials and linked together by "archwire" that applies steady, gentle pressure to produce desired tooth movement.

This 510(k) premarket notification is for orthodontic ceramic brackets and does not describe software or AI. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies related to AI performance.

The submission focuses on demonstrating "substantial equivalence" to a predicate device (Mystic Orthodontic Ceramic Brackets, K042178), primarily through material composition and intended use.

Here's why the requested information cannot be extracted from this document:

• No AI/Software Component: The device is a physical, non-digital orthodontic bracket. The concepts of acceptance criteria for AI performance (like sensitivity, specificity, AUC), training/test sets, ground truth, or multi-reader studies are not applicable.
• Substantial Equivalence Pathway: 510(k) submissions, especially for devices like this, typically rely on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves comparing technological characteristics (materials, dimensions, manufacturing processes) and intended use, rather than conducting new clinical performance studies that would generate the kind of data you're asking for.

If this were a 510(k) for a medical device software with an AI component, the document would contain sections detailing performance metrics, validation studies, and possibly human-in-the-loop evaluations. This particular document however, does not.

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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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