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Ceramic Brackets Orthometric are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.

The Orthometric's Ceramic Brackets are composed of different designs of brackets that are made of Aluminum Oxide. The ceramic brackets are ICERAM, ICERAM-P, and ICE CLEAR.

The provided document is a 510(k) premarket notification for "Ceramic Brackets Orthometric". It focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria for a new AI/ML device. Therefore, the requested information elements related to AI/ML device performance, such as sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, are not applicable or available in this document.

However, I can extract information related to the performance tests conducted to demonstrate equivalence for this non-AI medical device.

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

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it describes performance tests carried out to prove the technical equivalence to the predicate device. The comparison table (Table 5.1) focuses on equivalence of characteristics rather than specific performance metrics and acceptance thresholds.

Based on the text: "Performance tests were carried out to prove the technical equivalence between the Orthometric's Ceramic Brackets and the predicate Clarity Advanced Ceramic Brackets (K102803)."

And the findings:

• "The data demonstrates the similarity of the dimensional characteristics when compared."
• "The results of adhesion strength tests demonstrate that both products had similar behavior, showing equivalence, both in the measurement of the external force necessary for detachment and in the shear stress."
• "The Orthometric's Ceramic Brackets demonstrated similarity in the friction resistance test."

A summary table for performance could be constructed as follows, with the understanding that "acceptance criteria" here is implicitly "demonstrate similarity/equivalence to the predicate":

2. Sample sized used for the test set and the data provenance

The document does not specify the exact sample sizes used for the performance tests (dimensional characteristics, adhesion strength, friction resistance). It also does not mention data provenance (country of origin, retrospective/prospective) for these non-clinical engineering tests.

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

Not applicable. This is not an AI/ML device requiring expert-established ground truth for a test set. This document describes material and mechanical property equivalence.

4. Adjudication method for the test set

Not applicable. This is not an AI/ML device requiring adjudication.

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 not an AI/ML medical device.

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

Not applicable. This is not an AI/ML medical device.

7. The type of ground truth used

Not applicable in the context of expert-derived ground truth for an AI/ML device. For this device, "ground truth" would refer to established physical and material properties (e.g., actual dimensions measured by instruments, measured forces, biological reactions to materials as per ISO standards).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

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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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Edgewise and Roth Ceramic Brackets are intended for use in orthodontic treatments. The brackets are affixed to teeth so that pressure can be exerted on the teeth.

Edgewise and Roth Ceramic Brackets are intended to be bonded to teeth, upon which an orthodontic wire is used to move the teeth to new positions. The Morelli bracket consists of a translucent alumina body. The bracket is uncoated. The Morelli bracket is not self-bonding and requires a primer and adhesive to bond the bracket to the teeth.

The provided text is a 510(k) summary for Edgewise Ceramic Brackets and Roth Ceramic Brackets by Dental Morelli Ltda. It describes the device, its intended use, and compares it to a predicate device (Clarity Advanced Ceramic Brackets by 3M Unitek Corporation, K102803).

This document does not describe a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device. Instead, it demonstrates substantial equivalence to an already legally marketed device to obtain FDA clearance for a physical medical device (orthodontic brackets).

Therefore, I cannot provide an answer that includes:

1. A table of acceptance criteria and reported device performance (as these are not defined for an AI/ML device in this document).
2. Sample size for a test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, or training set details (as these are relevant for AI/ML studies, not this type of medical device clearance).
3. Type of ground truth (as it would be relevant for an AI/ML study, not for demonstrating substantial equivalence of a physical bracket).

The document focuses on comparing the new device's characteristics (materials, indications for use, anatomical site, location of use, etc.) to a predicate device. The "acceptance criteria" here is effectively the demonstration of sufficient similarity and safety/effectiveness compared to the legally marketed predicate device.

However, I can extract the information related to the device comparison, which serves as the basis for establishing "acceptance" for clearance in this context:

Acceptance Criteria and Device Performance (based on Substantial Equivalence to Predicate Device)

The "acceptance criteria" for the Edgewise and Roth Ceramic Brackets are met by demonstrating their substantial equivalence to the predicate device, Clarity Advanced Ceramic Brackets (K102803). This means the new devices exhibit similar performance and safety characteristics.

Table 1: Device Comparison ("Acceptance Criteria" through Substantial Equivalence)

Study/Evaluation Proving Acceptance:

The non-clinical data and biocompatibility evaluation presented in the 510(k) submission served as the "study" to prove the device meets acceptance criteria by demonstrating substantial equivalence.

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study involving a test dataset for algorithm performance. The "test set" is the physical device being compared. Data provenance is not described in this context beyond the device's characteristics and materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) 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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For a physical device like an orthodontic bracket, "ground truth" relates to material properties, dimensions, and performance characteristics consistent with established standards or the predicate device. The core "ground truth" for clearance is the performance and safety profile of the legally marketed predicate device. The new device's characteristics are compared against this established profile.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary: The "acceptance criteria" for these orthodontic ceramic brackets were met by demonstrating that they are substantially equivalent to a predicate device (Clarity Advanced Ceramic Brackets) in terms of intended use, indications for use, materials, design, and performance characteristics. The evaluation was a non-clinical comparison and biocompatibility assessment, not a clinical trial or AI/ML performance study.

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FastBraces® Ceramic Brackets are intended for orthodontic movement of natural teeth.

Ceramic orthodontic brackets are small devices that are intended to teeth, upon which an orthodontic wire is placed to move the teeth to desired positions. They are indicated for orthodontic treatment in patients of all ages when prescribed by an orthodontist. Ceramic orthodontic brackets are primarily offered as an aesthetic alternative to metal orthodontic brackets. They are close to natural tooth coloring, and blend in well enough that they are not as visible as metal brackets. This aesthetic look is popular with many patients, and especially older patients. Ceramic orthodontic brackets have been in use throughout the orthodontic industry for approximately thirty years.

Like its predicate, FastBraces® ceramic brackets are manufactured from polycrystalline alumina (ceramic) material, and have bases that are designed to provide maximum adhesion to the tooth while still allowing for easy and complete removal when necessary. The brackets incorporate a water soluble color placement dot as an indicator for correct selection of brackets for each tooth.

Like its predicate. FastBraces® ceramic brackets do not incorporate medicinal substances, tissues, or blood products. They do not include software or accessories, and are delivered non-sterile to the end user. Ceramic brackets are intended to be used only once by a single patient. Product labels contain appropriate "do not reuse" symbols. Orthodontic ceramic brackets are used for the duration of orthodontic treatment, which can last more than 30 months. During this time, the devices remain in direct contact with the patient's oral cavity. Because the intended purpose of the device is clearly understood by licensed orthodontists, instructions for use are not provided.

With the exception of the materials from which they are constructed, the form, fit, and function of orthodontic ceramic brackets are identical to those of traditional metal orthodontic brackets. Orthodontic ceramic brackets, like metal brackets achieve their intended purpose (to move teeth into a desired position) through industry standard "prescriptions" that are programmed into the design of the brackets. Specific torques, angulations, and distal offset dimensions are designed into each bracket, along with archwire slots that are designed to accommodate the correct size archwire (typically .018" or .022" thick).

Ceramic brackets are designed with tie wing undercut spaces for orthodontic ligatures. They have a molded ceramic bracket body with rounded corners and edges, and rounded hooks on the distal-gingival tie wings to accommodate ligation during orthodontic treatment. These design characteristics allow a tensioned ligating wire to move the brackets, which are securely bonded to the teeth, along a pre-determined path until the desired tooth position is reached. Elastic ligatures may be used on the tie wings and hooks to further facilitate tooth movement, and to secure the orthodontic wire into the bracket's archwire slot.

The document describes the performance testing for FastBraces® Ceramic Brackets, an orthodontic device. The evaluation aims to demonstrate substantial equivalence to a predicate device (K922499, Reflections Ceramic Dental Bracket).

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document directly compares the new device to the predicate. The "acceptance criteria" are implied to be "comparable to or better than the predicate device" for each performance metric.

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

The document does not explicitly state the sample sizes used for each nonclinical performance test (Shear Test, Wire Torque Test, Wire Drag Test, Bracket Removal Test). The data provenance is not specified beyond "nonclinical performance testing," but it can be inferred that these tests were conducted on new FastBraces® Ceramic Brackets and the predicate device, likely in a laboratory setting. No geographical origin is mentioned, and the data is retrospective as it was conducted prior to this 510(k) submission.

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

This section is not applicable. The study involves nonclinical performance testing (physical and mechanical tests) on orthodontic brackets, not analysis of medical images or patient data that would require expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

This section is not applicable, as there is no human interpretation or subjective assessment involved in the nonclinical performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Improvement with vs. without AI Assistance

No. The document explicitly states: "No clinical performance testing was conducted on FastBraces® Ceramic Brackets." Therefore, no MRMC study or AI assistance evaluation was performed.

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

No. This device is a physical medical device (orthodontic brackets), not an AI-powered algorithm. Therefore, no standalone algorithm performance study was done.

7. The Type of Ground Truth Used

For the nonclinical performance tests, the "ground truth" is defined by the objective measurements obtained from standardized laboratory tests (e.g., measured force for shear strength, measured torque for bracket strength, measured force for wire drag, visual assessment for fracturing after removal). There is no "ground truth" in the sense of expert consensus, pathology, or outcomes data, as these are material and mechanical property tests.

8. The Sample Size for the Training Set

This section is not applicable. This device is a physical medical device, not a machine learning model, so there is no "training set."

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

This section is not applicable, as there is no training set for this device.

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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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AVEX® CX2 and AVEX® CXi2 ceramic brackets are intended for use in orthodontic treatment.

AVEX® CX2 and AVEX® CXi2 ceramic brackets are intended to be bonded to teeth, upon which an orthodontic wire is placed to move the teeth to desired positions. AVEX® CX2 and AVEX® CXi2 Ceramic brackets are manufactured from polycrystalline alumina (ceramic) material and have a base which has been designed to provide maximum adhesion to the tooth, yet allow for easy and complete removal when necessary. The brackets incorporate a water soluble color placement dot as an indicator for correct selection of brackets for each tooth. AVEX® CX2 and AVEX® CXi2 are the exact same brackets except AVEX® CXi2 has a stainless steel 17-4 insert inside the archwire slot will facilitate archwire movement without force and preventing "notching" of the slot.

This document describes the premarket notification for the AVEX® CX2 and AVEX® CXi2 ceramic orthodontic brackets. The submission demonstrates substantial equivalence to a predicate device, K973776 Reflections Ceramic Brackets by CDB Corporation, primarily through materials characterization and bench testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for each bench test conducted. It refers to "tests" and "test results" in plural, implying multiple samples were used for each test. The data provenance is from in-house testing conducted by the applicant, Opal Orthodontics by Ultradent Products, Inc., in the United States. The testing was retrospective in the sense that it was conducted as part of the R&D and 510(k) submission process for these devices, comparing them to an already marketed predicate.

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

This information is not provided in the document. The bench tests are objective physical measurements rather than subjective expert evaluations.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. The testing described is bench testing, which involves objective measurements against established physical criteria or comparison to a predicate, rather than subjective interpretation requiring adjudication.

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, an MRMC comparative effectiveness study was not done. This device is a passive orthodontic bracket and does not involve AI or human readers for diagnostic interpretation.

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

No, a standalone algorithm performance study was not done. This device is a physical orthodontic bracket and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth for the bench tests was based on:

• Performance criteria derived from the function of orthodontic brackets (e.g., sufficient bond strength, non-damaging debonding).
• Direct comparisons to the performance of the legally marketed predicate device (K973776 Reflections Ceramic Brackets by CDB Corporation) in terms of various physical properties and characteristics.
• Material specifications (polycrystalline alumina, 17-4 Stainless steel) with established biocompatibility and performance histories.

8. The Sample Size for the Training Set

This refers to the sample size for the bench tests to evaluate performance, not a "training set" in the context of an algorithm. As mentioned in point 2, the exact numerical sample sizes for the bench tests are not explicitly stated in the provided text.

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

Similarly to point 7, the "ground truth" for these bench tests was established by:

• Pre-defined engineering and material specifications.
• The performance characteristics and material composition of the legally marketed predicate device, used as a direct benchmark for "substantial equivalence."
• Accepted industry standards for materials (e.g., biocompatibility of polycrystalline alumina and 17-4 stainless steel, as proven by decades of use and literature).

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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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Clarity™ Advanced Ceramic Brackets are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.

Clarity Advanced Ceramic Brackets are intended to teeth, upon which an orthodontic wire is used to move the teeth to new positions. Clarity Advanced Ceramic Brackets consist of a translucent alumina body and a glass-grit bonding base. The bracket is either uncoated or coated with a thin film of stabilized zirconia. The brackets incorporate a watersoluble color placement indicator system that marks archwire and vertical slots to aid in bracket positioning and color codes tie wing(s) to facilitate bracket identification.

The provided text describes the 510(k) summary for the Clarity™ Advanced Ceramic Brackets, focusing on substantial equivalence to predicate devices through non-clinical performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes "nonclinical performance testing."

• Sample Size for Test Set: Not explicitly stated in the provided text. The text only mentions "The test results showed that..." for each test, implying a sample was used but not quantifying it.
• Data Provenance: The data is based on bench testing conducted by the manufacturer, 3M Unitek Corp, a US-based company. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate performance. There is no indication of external data sources or retrospective analysis of patient data.

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

This question is not applicable to this type of submission. The "ground truth" for the non-clinical performance tests (bond strength, bracket strength, friction, debonding) is established by the physical and mechanical properties of the materials and device and measured through standardized engineering tests, not through expert human interpretation or consensus.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, the "truth" for these physical performance tests is directly measured by instruments, not human review or adjudication.

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 a physical orthodontic bracket, not an AI-powered diagnostic or treatment planning tool that involves human readers or interpretation of medical images. No MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used:

The "ground truth" for these non-clinical tests is based on objective, quantitative measurements of physical properties, such as force (bond strength, debond strength, bracket strength) and coefficients of friction, using standardized testing methodologies.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance data is generated through physical bench testing.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant to the device described.

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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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Allure® MB Ceramic Brackets and Mystique MB Ceramic Brackets are indicated for orthodontic movement of natural teeth excluding mandibular bicuspid teeth.

The marketed product Allure® has a chemically treated base. A modification has been made to replace that base with a new mechanical lock base, Allure® MB. The mechanical lock base includes rhomboid and "torque-in-the-base" features.

The provided 510(k) summary for the Allure® MB Ceramic Brackets (K090454) is for a dental device, specifically orthodontic brackets. This type of submission focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and material composition, rather than a clinical study evaluating AI performance. Therefore, many of the requested categories related to AI performance, ground truth, expert adjudication, and sample sizes for training/test sets are not applicable to this submission.

Here's the information that can be extracted and a clear indication of what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This 510(k) relies on demonstrating substantial equivalence through technical characteristics and material composition, not a clinical study with a test set of data.

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

• Not Applicable. As no clinical study or test set with ground truth was presented in this 510(k) for AI performance.

4. Adjudication method for the test set

• Not Applicable. No test set requiring adjudication for AI performance was presented.

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 device modification for an orthodontic bracket, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not Applicable. This is not an AI algorithm.

7. The type of ground truth used

• Not Applicable. While the device seeks "substantial equivalence," the "ground truth" in this context is the safety and effectiveness of the predicate devices and their components. This is not derived from expert consensus, pathology, or outcomes data in the way an AI system's performance would be.

8. The sample size for the training set

• Not Applicable. This device did not involve an AI training set.

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

• Not Applicable. No training set was used for this type of device submission.

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